SSII 10-K
SS Innovations International, Inc. (SSII)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
SECURITIES AND EXCHANGE ACT OF 1934
For the fiscal year ended
SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____________ to _____________
Commission file number:
(Exact name of registrant as specified in its charter)
| (State or Other Jurisdiction of | (I.R.S. Employer | |
| Incorporation or Organization) | Identification No.) |
(Address of Principal Executive Offices)
Registrant’s telephone number, including
area code:
Securities registered under Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| The |
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined by Rule 405 of the Securities Act. Yes ☐
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐
Indicate by check mark whether
the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such a shorter period that the registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days.
Indicate by check mark whether
the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
(ss.232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such
files).
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☐
Indicate by check mark whether the registrant is a large, accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large, accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
| Large Accelerated Filer ☐ | Accelerated Filer ☐ |
| Smaller reporting company | |
| Emerging Growth Company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether
the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control
over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm
that prepared or issued its audit report.
If securities are registered
pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing
reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether
the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
No
State the aggregate market value of the voting and non-voting common equity
held by non-affiliates computed by reference to the price at which the common equity was sold, or the average bid and asked prices of
such common equity as of the last business day of the registrant’s most recently completed second fiscal quarter: $
The number of shares outstanding of the issuer’s common stock,
$0.0001 par value, as of March 9, 2026, was
DOCUMENTS INCORPORATED BY
REFERENCE:
TABLE OF CONTENTS
i
Unless the context otherwise requires, the terms “SSi,” “the Company,” “we,” “us,” and “our” refer to SS Innovations International, Inc., and where appropriate, our subsidiaries.
FORWARD LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Annual Report”) contains certain statements that constitute forward-looking statements. Any and all statements contained in this Annual Report that are not statements of historical fact may be deemed forward-looking statements. Terms such as “may,” “might,” “would,” “should,” “could,” “project,” “estimate,” “pro-forma,” “predict,” “potential,” “strategy,” “anticipate,” “attempt,” “develop,” “plan,” “help,” “believe,” “continue,” “intend,” “expect,” “future” and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Those statements appear in this Annual Report, and include statements regarding the intent, belief or current expectations of our Company and management that are subject to known and unknown risks, uncertainties and assumptions and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in “Item 1. Business” and “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
Forward-looking statements in this Annual Report may include, without limitation, statements regarding:
| (i) | the plans and objectives of management for future operations, including plans or objectives relating to the marketing of our surgical robotic systems; |
| (ii) | the timing or likelihood of regulatory filings, approvals and required licenses for marketing our surgical robotic systems; |
| (iii) | our ability to adequately protect our intellectual property rights and enforce such rights to avoid violation of the intellectual property rights of others; |
| (iv) | the timing, costs and other aspects of the commercial marketing of our surgical robotic systems; |
| (v) | our estimates regarding the market opportunity, clinical utility, potential advantages and market acceptance of our surgical robotic systems; |
|
(vi) |
the impact of government laws and regulations; | |
| (vii) | the potential effect U.S. tariff policies may have on our ability to import our surgical robotic systems and related devices into the U.S., once approval to market has been obtained; |
| (viii) | our ability to recruit and retain qualified research and development personnel; |
| (ix) | difficulties in maintaining commercial scale manufacturing capacity and capability and our ability to generate growth; |
| (x) | uncertainty in industry demand; |
| (xi) | general economic conditions and market conditions in our industry; |
| (xii) | a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items; and |
| (xiii) | our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). |
These statements are not guarantees of future performance and are subject to numerous risks, uncertainties, and assumptions that are difficult to predict.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely upon forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we do not assume any obligation to update any forward-looking statement.
ii
TRADEMARKS, TRADE NAMES, SERVICE MARKS AND LOGOS
“SSi,” “SSi Mantra,” SSi logos and other trade names, trademarks or service marks of the Company appearing in this Annual Report are the property of SSi. Other trade names, trademarks or service marks appearing in this Annual Report are the property of their respective holders. Solely for convenience, trade names, trademarks and service marks referred to in this Annual Report appear without the ®, ™ and SM symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trade names, trademarks and service marks.
MARKET, INDUSTRY AND OTHER DATA
Unless otherwise indicated, information contained in this Annual Report concerning our industry and the market in which we operate, including our general expectations and market position, market opportunity and market size, is based on information from various third-party industry and research sources, on assumptions that we have made based on that data and other similar sources and on our knowledge of the markets for our services. This information involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.
In addition, industry publications, studies and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in this Annual Report. These and other factors could cause our actual results to differ materially from those expressed in the estimates made by the independent parties and by us.
iii
PART I
Item 1. Business.
Overview
We are a commercial-stage surgical robotics company focused on transforming patient lives by democratizing access to advanced surgical robotics technologies. We design, manufacture and market an advanced, next-generation and affordable surgical robotic system called the SSi Mantra Surgical Robotic System (the “SSi Mantra”) intended for use in urology, general, gynecology, colorectal, gastroenterology, head and neck, thoracic and cardiac surgeries. While surgical robotic systems have gained acceptance globally in the past two decades for providing greater efficiency, better clinical outcomes and reducing healthcare costs, access to such systems remains largely limited to developed countries such as the United States (the “U.S.”), the European Union (the “EU”) and Japan. With the SSi Mantra, we are breaking down barriers and accelerating access to surgical robotics technologies in underserved regions of the world.
Led and developed by Dr. Sudhir P Srivastava, our founder, Chairman and Chief Executive Officer with a visionary team of engineers, surgeons and industry veterans, the SSi Mantra includes several innovative features to address shortcomings of the current generation of robotic surgery systems. The SSi Mantra marks the realization of Dr. Srivastava’s vision to develop and commercialize a surgical robotic system which would facilitate making robotic surgery affordable and accessible to a global population. We commenced development of the SSi Mantra in 2014, received regulatory approval by the Central Drugs Standard Control Organization (“CDSCO”) India’s equivalent of the U.S. Food and Drug Administration (“FDA”), for its sale and use in India and commercially launched sales in late 2022. We also received ISO 13485 (quality management system) approval for the SSi Mantra in November 2021. The latest generation SSi Mantra 3 was introduced in India with telesurgery and tele-proctoring capabilities along with advanced energy instrumentation. The SSi Mantra 3 received CDSCO approval in November 2024 and has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries.
As of December 31, 2025, we have installed 168 systems, of which 154 are located in India, and 14 at overseas locations, including 21 systems installed on pay per use basis, 8 systems installed for demonstration purposes, and 10 upgraded systems. Including our strong foundational market of India, the SSi Mantra installed base currently spans 10 countries. We are currently focusing our efforts on marketing our latest generation SSi Mantra 3 in international markets and anticipate receiving EU and U.S. regulatory approvals to market in those regions in 2026, however, there can be no assurance as to when or if we will secure such regulatory approvals.
Our commercially installed SSi Mantra systems have been used to perform more than 7,800 surgical procedures including approximately 400 cardiac robotic surgeries across 153 hospitals as of December 31, 2025. The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than 100 different types of surgical procedures without any device-related adverse events. These procedures have spanned across the following nine surgical specialties:
| Type of Surgical Procedure | No. of Procedures performed as of December 31, 2025 | % of total procedures | ||||||
| General Surgery | 3,409 | 43.2 | % | |||||
| Urology | 2,004 | 25.4 | % | |||||
| Gynecology | 1,247 | 15.8 | % | |||||
| Colorectal | 444 | 5.6 | % | |||||
| Cardiac | 390 | 4.9 | % | |||||
| Gastroenterology | 217 | 2.8 | % | |||||
| Head and Neck | 93 | 1.2 | % | |||||
| Thoracic | 73 | 0.9 | % | |||||
| Plastic/Reconstructive | 8 | 0.1 | % | |||||
| Total | *7,885 | 100 | % | |||||
| * | Includes: 121 pediatric surgeries, 120 telesurgeries and 232 surgeries outside of India |
1
In December 2024, we became the first and only company in India to receive CDSCO regulatory approval for use of a robotic surgical system in the performance of Telesurgery and Tele-proctoring procedures. Since receiving such approvals, we have performed more than 120 telesurgeries using our SSi Mantra as of December 31, 2025, including a robotic cardiac surgery over a distance of more than 5,000 miles.
In addition to India, the SSi Mantra has also been granted regulatory approval in Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and the United Arab Emirates.
Our ISO 13485 (quality management system) approval, CDSCO approval for the manufacture, sale and distribution of our systems and related devices and our Indian export license allow us to market our systems and related devices in 50 non-FDA and non-EU countries without further regulatory approvals, including Chile, Nepal and Nigeria. An additional 79 countries require only minimal registration. Our marketing efforts outside India have been limited to date.
On December 5, 2025, we submitted a 510(k) premarket notification to the FDA for the SSi Mantra for multiple specialty procedure types, including: general, urological, colorectal, gynecological, and cardiac surgery. We believe that the 510(k) regulatory pathway offers potential speed and cost advantages. The FDA has stated that its goal is to complete reviews of 510(k) submissions within 90 days of receipt. However, time to approval could be longer due to factors such as the 15-day acceptance review, the submission of additional information, and a submitter’s response time. We have engaged RQM+, a leading MedTech-focused CRO, to assist with the 510(k) submission. If approved by the FDA, the SSi Mantra would be cleared to market in the U.S. Submission of a 510(k) premarket notification request does not guarantee FDA approval. We have also submitted our technical files to Szutest, an EU Notified Body for the CE certification, which if obtained will allow us to market the SSi Mantra in the EU. We believe that we will be able to secure FDA approval and EU certification in 2026. However, there can be no assurance as to when or if we will secure such regulatory approvals.
We generate revenues from the sale of the SSi Mantra. We offer our SSi Mantra through three selling models: (i) outright purchase, where revenue is realized upfront; (ii) purchase on a deferred or installment payment basis; and (iii) purchase on a pay-per-procedure basis, where revenue is recognized over time. We also earn recurring revenue from the sales of instruments, accessories and services. We sell our systems and related devices directly to customers as well as through distributors.
We believe the SSi Mantra improves patient experience, reduces variabilities and disruption and lowers per-procedure costs. We believe that the SSi Mantra benefits patients, physicians and hospitals by providing access to an advanced and optimized robotic system.
Recent Development
On March 6, 2026 (the “Closing Date”), the Company completed a private placement of its common stock which generated gross proceeds of $18,621,498, before deducting offering expenses.
In the offering, we offered and sold (shares are under issuance as on the date of Annual Report) a total of 5,774,839 shares of common stock consisting of:
| ● | an aggregate of 1,300,006 shares of common stock at an average price of $4.00 per share for a total of $5,197,000 to directors, details of the same are as below: |
| Ø | 498,753 shares to Dr. Sudhir Srivastava, our Chairman and Chief Executive Officer at $4.01 per share amounting to $2,000,000; |
| Ø | 501,253 shares to Dr. Frederic Moll, our Vice Chairman at $3.99 per share amounting to $2,000,000; |
| Ø | 300,000 shares to Tim Adams, a director at $3.99 per share amounting to $1,197,000; and |
| ● | an aggregate of 4,474,833 shares of common stock at $3.00 per share and total consideration of $13,424,498, to existing and new investors, led by Manipal Global Health Services, an existing shareholder. |
SSi intends to use the net proceeds from this private placement for working capital and other general corporate purposes, which include, but are not limited to advancing the Company’s our growth initiatives in India and other existing global markets and supporting preparation for entry into the United States and European Union markets.
In connection with a $2,499,999 investment by one of the non-affiliated investors in the private placement, the Company will pay a FINRA member firm a cash commission of $175,000 (7% of the investment) and issue to such firm five-year warrants to purchase 41,667 shares of our common stock at an exercise price of $3.45 per share.
The purchase price paid by participating directors and executive officers, reflects the “Minimum Price” as determined under the applicable rules of the Nasdaq Stock Market LLC.
The Company has advised the non-affiliate investors in the private placement that within ninety (90) days of the Closing Date, it will file a Registration Statement on Form S-3 (or other applicable form) under the Securities Act covering the resale of their shares and thereafter will use its commercially reasonable efforts to have the Registration Statement declared effective by the SEC as soon as practicable.
The securities in the private placement were offered and sold in in accordance with the exemption from registration afforded by Section 4(a)(2) of and Rule 506(b) of Regulation D under the Securities Act.
2
Corporate Information
The Company was incorporated in the state of Florida on February 4, 2015, under the name “Avra Surgical Microsystems, Inc.,” and changed its name to “Avra Medical Robotics, Inc.” on November 5, 2015.
Our principal executive offices are located at 404-405, 3rd Floor, iLabs Info Technology Centre, Udyog Vihar, Phase III, Gurugram, Haryana 122016, India. Our telephone number is +91 73375 53469. Our corporate website is https://ssinnovations.com. Information appearing on our corporate website is not part of this Annual Report and is not incorporated by reference herein. We have included our website address as an inactive textual reference only.
Products
The SSi Mantra
The SSi Mantra is designed to enable surgeons to perform a wide range of surgical procedures including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries. The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than 100 different types of surgical procedures in India without any device related adverse events. As of the date of this Annual Report, surgeons have performed over 7,800 surgical procedures in a wide array of fields using the SSi Mantra, including many complex surgeries. The SSi Mantra offers the entire operating room staff three-dimensional, high definition (“3D 4K”) vision, and gives the surgeon a magnified view up to ten times magnification. Our system uses specialized instrumentation, including a miniaturized surgical camera (endoscope) and wristed instruments (for example, scissors, scalpels and forceps) that are designed to help with the precise dissection and reconstruction of anatomical structures within the body. We are currently focusing our efforts on marketing our SSi Mantra 3 in international markets.
The SSi Mantra 3 is comprised of the following components:
Surgeon Console. The SSi Mantra 3 allows surgeons to operate while comfortably seated at an ergonomic open-faced console. Surgeons use a special pair of passive 3D glasses to view a 3D 4K image of the surgical field on a 32-inch 3D 4K resolution monitor with up to ten (10) times magnification, resulting in significantly enhanced vision for the surgeon. The surgeon also has a second large 23-inch 2D touch monitor for system controls and digital imaging and communications in medicine (“DICOM”) applications. The surgeon’s fingers grasp extremely precise ergonomic lightweight magnetic hand controls, with the surgeon’s hands naturally positioned relative to his or her eyes, thereby minimizing strain during the surgeon’s movements. Using electronic hardware, software, algorithms and mechanics, our technology translates the surgeon’s hand movements into precise and corresponding real-time movements of the SSi Mantra instruments positioned through surgical ports going inside of the patient. When using the SSi Mantra 3, the surgeon is able to sit in an ergonomic position and can see both the specific positioning of his or her hands and feet, thereby reducing the learning curve and maintaining comfortable ergonomics during the surgical procedure. The SSi Mantra is also equipped with a head-tracking camera safety feature that detects when the surgeon looks away from the 3D 4K monitor to help prevent inadvertent instrument movement. In addition, the SSi Mantra’s robotic arms hold the camera and instruments steady, offering greater stability for surgeons and operating room staff.
Patient-Side Robotic Arm Carts. The robotic arm carts are modular in design with robotic arms mounted on individual carts, each with a maximum height of 7.2 feet. The modular design offers the flexibility of cart and robotic arm positioning to provide better placement in relation to the procedure and avoid collisions. Further, there is the option of using three, four or five robotic arm configurations based on the users’ preference and specific surgical procedures. Each robotic arm cart includes stability via parking locks, freedom of patient docking and advanced touch-screen controls. Each robotic arm cart has a built-in auto-leveling feature which allows each individual arm cart to be perfectly horizontally level with respect to uneven floor surfaces that may be present in an operating room.
Vision Cart. The vision cart provides an additional 32-inch 3D 4K resolution monitor, identical to the surgeon’s console, for the operating room staff. While wearing the 3D glasses, the entire operating team can view what the surgeon sees with the same depth perception. This ability also helps in reducing the entire team’s learning curve and translates into a safer and more efficient exchange of instruments and introduction of supplies required in surgery. The vision cart also houses the control system for the articulating endoscope and camera and pre-operative guidance software. It has uninterruptible power supply battery backup; universal safety features and incorporates the SSi Mantra multimedia recording and streaming platform.
Tele-Proctoring/Tele-Mentoring Capabilities. The SSi Mantra has a built-in live streaming platform, which provides for remote mentoring and proctoring, thereby resulting in efficient and cost-effective teaching and training capabilities.
Instruments and Accessories
We offer a comprehensive suite of stapling, energy and core instrumentation for our surgical systems, under the brand name of SSi Mudra.
Mudra Technology. The technology employed in our instruments is designed to transform the surgeon’s natural hand movements outside of the body into corresponding controlled movements inside the patient’s body, just as would be available to the surgeon in open surgery. With our technology, a surgeon can also use “motion scaling,” a feature that translates, for example, a three-centimeter hand movement outside the patient’s body into a one-centimeter instrument movement in the surgical field inside the patient’s body. Motion scaling is designed to allow precision and control for delicate tasks. In addition, the advanced software technology of the robotic system filters and eliminates any tremors that may be present in a surgeon’s hands.
3
Mudra Endo-surgical Instruments. Over 40 instruments that we manufacture have endo wrist technology with 7 degrees of freedom for natural dexterity and tips customized for various surgical procedures. Mudra instruments are offered in an 8.6 mm diameter. We recently completed the development of five new 5-millimeter surgical instruments for clinical use across multiple specialties, including pediatric, cardiac, and head and neck surgery, among other procedures involving smaller anatomical structures. Various Mudra instrument tips include forceps, scissors, electrocautery tools, scalpels and other surgical tools that are familiar to the surgeon from open surgery and conventional minimally invasive surgery (“MIS”). We have also developed and made available over 20 cardiac surgery specific instruments. A variety of instruments may be selected and used interchangeably during surgery. All instruments are sterilizable at the hospital, and most have a minimum reusable lifecycle of 10 uses. A programmed memory chip inside each instrument performs several functions that help determine how the SSi Mantra and our instruments work together. In addition, the chip generally will not allow the instrument to be used for more than the prescribed number of procedures to help ensure that its performance meets specifications during each procedure.
Accessory Products. We sell various accessory products, which are used in conjunction with the SSi Mantra as surgical procedures are performed. Accessory products include sterile drapes used to help ensure a sterile field during surgery, vision products—such as replacement 3D stereo endoscopes, cannulas for the instruments and camera and special seals to prevent leakage of carbon dioxide gas used during a procedure.
Tele proctoring and Telesurgery. We are the first surgical robotic company to have received a regulatory approval from CDSCO for both tele proctoring and telesurgery. Following the demonstration of our telesurgery capabilities at the SMRSC 2024, a global conference organized by the Company, we began our clinical trials that were conducted to validate this novel approach towards remote surgery. We first conducted two animal trials at a leading laparoscopy hospital in Delhi NCR region located five kilometers away from our telesurgery lab facility. Thereafter, we performed a simple robotic gall bladder removal (Cholecystectomy) to demonstrate safety and efficacy of our SSi Mantra system, when utilized in a remote setting. After this trial, SSi commenced clinical trials wherein six complex urology, oncology and gynecology procedures were performed at Rajiv Gandhi Cancer Institute at a distance of approximately 35 kilometers (approximately 22 miles). We have successfully performed five robotic cardiac telesurgeries between our telesurgery lab in Gurugram and at a hospital in Jaipur located at a distance of approximately 286 kilometers (approximately 179 miles), marking the world’s first accomplishment in the field of robotic cardiac surgery. In March 2025, we used the SSi Mantra to perform robotic cardiac telesurgery over a 2,000-kilometer (1,250 mile) distance between SSi’s headquarters in Gurugram, and the Aster CMI Hospital in Bengaluru. In July 2025, we successfully completed the world’s first inter-continental robotic cardiac telesurgery on July 19, 2025, from Strasbourg, France to Indore, India, a distance of over 4,000 miles (2,500 miles), using the SSi Mantra and the world’s first robotic bariatric telesurgery over a distance of 896 kilometers (560 miles) from Gurugram, India to Indore, India using the SSi Mantra. In September 2025, we announced the successful completion of the first robotic telesurgery performed from our MantraM bus mobile robotic telesurgery unit and the successful completion of the world’s first pediatric pyeloplasty telesurgery utilizing our SSi Mantra from our headquarters in Gurugram, India to a 16-month-old patient in Hyderabad, India nearly 1,600 kilometers (1,000 miles) away. As of the date of this Annual Report, more than 120 telesurgeries have been performed, at distances of up to 9,600 kilometers (6,000 miles), utilizing the SSi Mantra.
Instruments under Development
We also have a number of additional sophisticated instruments currently under development. These include:
NADI – Automated Coronary Anastomotic Connector. This instrument is a micro stapling device intended to join two arteries together in cardiac bypass procedures. We intend to offer the instrument in both robotic surgery and manual versions. The manual version is for use by cardiac surgeons who do not have a robotic system and can be utilized in an open or minimally invasive procedure.
SSi Multi-Fire Clip Applier. The SSi Multi-Fire Clip Applier is a cartridge-based clip applicator being developed to be utilized for the hemostasis of blood vessels. Use of such a device is a requirement during many surgical procedures. Currently, the clip applicators traditionally used in surgical procedures require withdrawal of the instrument after each clip is placed resulting in a time-consuming process. By providing a cartridge with multiple clips we believe the SSi Multi-Fire Clip Applier will allow for greater efficiency and time savings during surgical procedures.
SSi Robotic Stapler. We are in the process of finalizing the design and manufacturing of our SSI Robotic Stapler that would have broad applications in General Surgery, Thoracic Surgery and Oncology Surgery. Once development of the SSi Robotic Stapler has been completed, SSI will be the second company globally with a robotic stapler compatible with its robotic surgical platform.
4
SSi Maya. SSi Maya is an enabling digital platform that compliments the SSI Mantra system and enhances surgical capabilities with Mixed Reality (XR) and AI enabled technologies including the following:
| ● | SSi Guru. SSi Guru is a virtual tele illustration feature used for tele mentoring with the help of a portable 3D surgery viewer, XR headset and interactive virtual screens. |
| ● | SSi XR Cognitive Skill Simulator. SSi XR Cognitive Skill Simulator is an extended reality (XR) software platform developed to train and educate surgeons and surgical assistants in the application of the SSi Mantra. The system combines a console-based interface with VR-driven instructional modules that provide instrument tracking overlays and guided procedural workflows. This integrated learning environment is designed to strengthen cognitive understanding, reinforce muscle memory, and improve motor skills through repetitive, structured practice, supporting immersive and innovative pre-operative training. The simulator incorporates SSi’s AR Smart Glasses 3D Visualization System, delivering 3D HD 1080p imaging with adjustable interpupillary distance, direct endoscope video input, advanced signal processing, and IMU-based head tracking. |
SSi Holographic Anatomy. SSi Holographic Anatomy is an advanced augmented reality tool being developed for the purpose of visualizing anatomies, providing comprehensive patient education, and offering guidance for surgical procedures. SSi Holographic Anatomy is being designed to present patients with three-dimensional DICOM data, enabling them to better understand and engage with their own health information.
SSi Chitrasa - Advanced DICOM Viewer. SSi Chitrasa is being designed to empower robotic surgeons with DICOM visualization capabilities. It includes a state-of-the-art AI enabled application viewer which is seamlessly integrated with the SSi Mantra to provide surgeons with comprehensive tools to enhance their surgical confidence and precision in the operating room.
SSi Mixed Reality Headset. The SSi Mixed Reality Headset is a light-weight set of glasses with a magnified 3D view aimed at improving surgeons’ intraoperative experience by seamlessly interfacing with the SSi Mantra. This device is being designed to offer surgeons an immersive 3D endoscopic feed visualization, while interactable augmented objects provide real-time patient vitals and data for enhanced surgical precision. The collaboration between the SSi Mixed Reality Headset and SSi Mantra technologies will create a comprehensive surgical platform, setting a new standard for intraoperative medical advancements and pushing the boundaries of surgical excellence. Features include:
| ● | Peripheral view; |
| ● | 1080p resolution 3DHD vision; |
| ● | 32-inch image projection which allows for one meter depth perception; |
| ● | Two separate left and right eye video signals projected through an optical engine onto an opaque micro-LED screen; and |
| ● | Natural reconstruction of the 3D image by the human brain. |
SSi MantraM. In March 2025, we unveiled our Mobile Tele-Surgical Unit, the “SSi MantraM” which is designed to offer access to remote robotically assisted surgical procedures, to geographic areas, which have only limited access to that level of healthcare.
SSi Mantra Tele Surgeon Console (TSC). The SSi Mantra Tele Surgeon Console (TSC) is a compact, self-contained telesurgery workstation designed to enable safe and effective remote surgical operation in environments with limited space. The TSC integrates a compact ergonomic chair with inbuilt electronics, magnetic sensor-based control systems, lightweight 3D viewing glasses, and a magnified three-dimensional view of the surgical field, while its portable, space-efficient design allows deployment in physician offices and other locations with small physical footprints.is a compact, self-contained telesurgery workstation designed to enable safe and effective remote surgical operation in environments with limited space. The TSC integrates a compact ergonomic chair with inbuilt electronics, magnetic sensor-based control systems, lightweight 3D viewing glasses, and a magnified three-dimensional view of the surgical field, while its portable, space-efficient design allows deployment in physician offices and other locations with small physical footprints.
5
Unlike conventional consoles where the surgeon sits opposing a stationary unit, the TSC features a “surgeon-within-the-console” design, integrating the surgeon directly into the station and offering extensive ergonomic adjustments, including foot pedal retraction and extension, console height adjustment, and fully configurable armrests, along with comprehensive back and neck support to maintain optimal posture and minimize fatigue during prolonged procedures. In October 2025, the first telesurgery using the TSC was successfully performed by Dr. Sudhir Srivastava from his residence in New Delhi, India, demonstrating the system’s portability, ergonomic effectiveness, and feasibility for remote surgical applications.
5mm Surgical Instruments. We recently completed the development of five new 5-millimeter surgical instruments for clinical use across multiple specialties, including pediatric, cardiac, and head and neck surgery, among other procedures involving smaller anatomical structures.
Services
General. We have a network of field service engineers in India and maintain relationships with various distributors around the globe. This infrastructure of service and support specialists offers a full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system health monitoring.
Our comprehensive support and program assistance helps ensure customers and care teams maximize program performance and protect their investment.
Readiness and Maintenance Support. Readiness support is operational support to ensure smooth onboarding and the adoption of new systems and technology. Maintenance support helps to maximize operational efficiency and reduce unplanned equipment downtime. It includes services care plans, support teams, monitoring, software upgrades and updates, as well as a customer portal. The service care plan portfolio offers flexible service plans to ensure reliability of the systems and instruments and help optimize the robotics program. Our support team consisting of expert field service, remote technical support and customer care agents assist customers to resolve and prevent any technology issues that could inhibit optimal utilization of our SSi Mantra system. Software upgrades and updates enable the latest product innovations, enhancements and reliability improvements.
Peer Review Papers
The following peer review papers have been published with respect to the SSi Mantra and our technology:
In a peer review paper entitled, “Initial experience of SSI Mantra robot-assisted transabdominal pre-peritoneal repair of primary ventral hernias” by Magan Mehrotra and Chukka Gautam Kumar published on July 30, 2024 in the Journal of Minimal Access Surgery, the authors describe their initial experience with robot-assisted transabdominal pre-peritoneal (rTAPP) repair of small- and medium-sized primary midline ventral hernias using the SSi Mantra.
In a peer review paper entitled, “Robotic uro-oncology applications of SSI Mantra robot” by Sudhir K. Rawal, Ashish Khanna, Amitabh Singh, Sarbartha K. Pratihar, Ishan Malla, Mujahid Ali, Vivek Vasudeo, Kaushik Jaganthan, Bhuvan Kumar, and Nikhil Saurabh published on April 19, 2024 in the Asian Journal of Urology, the authors report on their preliminary clinical experience with the SSi Mantra.
In a peer review paper entitled, “Safety and Efficacy of Robotic Hysterectomy Using the SSI Mantra Robotic System” by Gajbhiye et al. published in 2025 in the Cureus Journal of Medical Science, the authors evaluate the safety, feasibility, and peri-operative outcomes of robotic hysterectomy performed using the SSi Mantra.
In a peer review paper entitled, “Feasibility of One Anastomosis Gastric Bypass Using the SSI Mantra Robotic Platform” by Magan Mehrotra, Chukka Gautam Kumar and Nikhil Mehrotra published on September 16, 2024 in the Journal of Bariatric Surgery, the authors describe the first robotic one anastomosis gastric bypass (OAGB) performed using the SSI Mantra in a patient with severe obesity.
In a peer review paper entitled, “Real-world performance of the SSI Mantra™ robotic system: a multicentric multi-specialty study evaluating its safety and surgical applications” by Somashekhar S.P. (a director of the Company), Medha Sugara, Kushal Agrawal, Sudhir Kumar Rawal, Amitabh Singh, Magan Mehrotra, Raj Gajbhiye, Chandramohan Vaddi, Srikarthik Voleti, Leena Mehrotra, Ganesh Gorthi, Manjiri Somashekhar, and Nitin Kumar Rajput on December 23, 2025 in the Journal of Robotic Surgery, the authors evaluate the real-world safety, feasibility, and learning curves of the SSI Mantra across India.
6
Macro Healthcare Trends
Advances in surgical technology are making next-generation robotic systems increasingly versatile across a broad spectrum of procedures, at a time when demographic shifts, including an aging global population, are driving higher demand for surgical interventions and the disease burden from chronic and lifestyle-related conditions continues to rise. These trends are further compounded by workforce challenges, as healthcare systems face shortages of trained professionals, which robotic and digital technologies help address by reducing labor intensity per care episode. From an economic perspective, such systems improve value for both providers and payers through greater efficiency and optimized resource utilization. They also deliver meaningful patient benefits, including reduced surgical trauma, shorter recovery times, and improved clinical outcomes, while offering surgeons significant benefits through enhanced ergonomics, precision, and reduced fatigue. In addition, hospitals benefit from increased revenue potential, lower complication rates, shorter lengths of stay, and overall improved operational efficiency.
Increasing demand for healthcare: The increasing demand for healthcare in emerging markets such as India is driven by population growth and a growing middle class, rising per capita incomes, growing health insurance penetration and changing lifestyles.
These trends are increasingly resulting in patients demanding specialized, higher quality products and services that deliver better clinical outcomes, improved efficiency and an overall superior healthcare experience. According to the New Indian Express, India’s healthcare industry is expected to grow from $638 billion in 2025 to $1.5 trillion by 2030. This growth is supported by favorable demographics, with India continuing to benefit from a large working-age population. The proportion of the Indian population in the working age-group (15–64 years of age) is expected to reach 68.9% by 2030, with a median age of 28.4 years, according to www.dristiias.com. This demographic represents a sizeable consumer base with rising purchasing power and we believe is willing to spend on high-quality healthcare services. Together, these factors create strong long-term demand fundamentals for advanced healthcare solutions and specialized medical technologies in India.
Growing adoption of technology: India has a large and growing unmet need for advanced surgical care. The country has an extensive healthcare delivery network with tens of thousands of hospitals (including public, private and multi-specialty institutions) performing a very high volume of procedures each year. According to recent industry data, over 30 million surgeries are performed annually in India across various specialties, reflecting the sheer scale of surgical demand in the country, while robotic surgery adoption remains a small but rapidly growing segment of this total surgical volume.
Although precise consolidated national figures on total robotic surgeries in India varies, recent reports indicate that India recorded more than 10,000 robotic assisted procedures in 2024 and industry associations estimate that up to 60,000 robotic-assisted surgeries are now performed annually by over 1,500 trained surgeons spanning general surgery, urology, oncology, gynecology, cardiology, and other specialties. Recent market intelligence also shows that India has over 950 trained robotic surgeons and more than 180 installed robotic surgical systems across government and private hospitals, with growth expected to accelerate as more systems and training capacity come online.
Significant unmet need: Despite this growth, surgical robotic procedures represent only a small fraction of total surgical volumes in India nationwide, highlighting a significant unmet need for surgical robotic platforms that are affordable, accessible, and supported with strong aftermarket service networks across urban and non-urban centers. The established prevalence of laparoscopic surgery in India has created a large base of laparoscopic surgeons, many of whom are well-positioned to adopt surgical robotic systems as they seek technologies that can facilitate the transition from traditional laparoscopy to robot-assisted surgery, improve precision, reduce recovery times, and expand the scope of minimally invasive procedures.
Increasing health insurance penetration: Health insurance coverage is a critical determinant of access to and demand for healthcare services in India. Insurance penetration has expanded steadily over the last decade, primarily driven by public schemes and growing private insurance adoption. As of 2025, government-backed schemes led by Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (PM-JAY) have issued over 420 million health cards, making it the world’s largest public health insurance program. When combined with state government schemes and private insurance, a significant share of the population has some form of financial health protection, although household-level surveys indicate that coverage is not yet universal and remains uneven across income groups and states.
India has also made progress in reducing the financial burden on patients. Out-of-pocket expenditure (“OOPE”), which exceeded 60% of total health spending in 2014-2015, declined to approximately 39.4% in 2021-2022. This improvement reflects increased public health spending, wider insurance penetration, and expanded access to empaneled hospitals. Key enablers of this transformation include the National Health Mission, Ayushman Bharat, and the continued growth of medical value travel.
7
Medical value travel: India has emerged as one of the world’s leading destinations for medical value travel, attracting patients from Asia, Africa, the Middle East, and other markets. According to Mordor Intelligence, the Indian medical tourism market estimated at approximately $12.32 billion in 2026, is projected to grow to $22.1 billion by 2031, at a CAGR of 12.42% during the forecast period (2026-2031), supported by a strong pipeline of complex surgical procedures. Medical tourism has become an important growth driver for surgical volumes, including advanced minimally invasive and robotic procedures. Key factors underpinning this growth include significantly lower treatment costs compared to developed markets, availability of highly skilled doctors, advanced infrastructure in private hospitals, English language proficiency, and improving ease of travel. The Government of India has actively supported this segment through policy initiatives such as e-Medical visas, multiple-entry visas, and extended stay provisions for patients and caregivers.
Favorable regulatory environment: India’s healthcare sector continues to benefit from a supportive and evolving regulatory environment. Public health expenditure has increased steadily, with government policy reiterating a long-term target of raising public health spending toward 2.5% of GDP. The government has also committed substantial investments in healthcare and medical infrastructure over the past decade, alongside structural reforms under the Aatma Nirbhar Bharat Abhiyaan. To strengthen domestic manufacturing, the government introduced the Production-Linked Incentive (PLI) Scheme for Medical Devices, the Scheme for Promotion of Medical Device Parks, and is progressing toward PLI 2.0, including support for in-vitro diagnostics. These initiatives offer capital incentives, infrastructure support, and scale advantages, positioning India as an increasingly attractive hub for medical technology manufacturing and innovation.
Our Strategy
Our initial strategy is to focus on underserved markets, such as India, where market penetration for surgical robotic systems has in large part been limited because of the high costs and steep learning curve for existing systems. After validating the SSi Mantra in these markets, we intend to leverage our advanced technology, significantly lower cost and ease of training to move into other markets, such as the U.S. and Europe. Key elements of this strategy include:
Focus on underserved markets. India, where our operations are based and where we have commercially launched the SSi Mantra, has a population of approximately 1.4 billion people, supported by an extensive network of roughly 70,000 hospitals providing diverse care across urban and rural regions. Compared to the United States, which has approximately 6,000 hospitals, India’s healthcare infrastructure is far larger in scale but still developing in advanced surgical capabilities. Despite this scale, the adoption of robotic surgery in India remains relatively low. As of 2024, India accounted for approximately 6% of the Asia-Pacific robotic surgical systems market and reported over 10,000 robotic-assisted surgeries in 2024 alone, with over 180 installed systems and more than 950 trained robotic surgeons supporting growth in major specialty centers.
Given this under-penetration—surgical robotic procedures comprise only a small fraction of overall surgical volumes in India despite millions of annual operations. We believe there is significant opportunity for affordable, high-performance systems like the SSi Mantra to expand access in underserved domestic markets and globally across Asia, Africa, Europe, Central and South America, and other regions. The surgical robotics market in India is projected to grow robustly over the coming decade, driven by increasing demand for minimally invasive procedures, rising chronic disease prevalence, and broader capability adoption in tertiary care centers, yet accessibility outside of premier institutions remains limited.
Focus on key institutions. Our marketing efforts are focused on large multi-specialty care hospitals where most complex surgical procedures are performed. Following the initial placement at a given hospital, we intend to expand the number of physicians who use the SSi Mantra and work with the hospitals and their surgeons to promote patient education as to the benefits and cost effectiveness of our system. We believe that these efforts will not only result in both increased usage and additional sales of instruments and systems at hospitals that purchase the system, but also increased demand from competing hospitals, surgeons and other physicians.
Focus on Leading Surgeons to Drive Rapid and Broad Adoption. We place significant emphasis on marketing the SSi Mantra to leading surgeons who are “thought leaders” in their institutions and fields. In this regard, we have established both an Indian Medical Advisory Board and an International Advisory Board consisting of leading surgeons in their respective fields. We believe that the participation of these surgeons in our product development and their use of the SSi Mantra will generate confidence in many other surgeons to utilize the system for all types of surgical procedures.
8
Continued Development and Marketing. We intend to continue developing and enhancing our technology and products and to communicate the benefits and advantages of the SSi Mantra (lower cost, ease of training and improved patient outcomes) in India and the other markets we plan to enter.
Evaluation, Familiarization and Training Agreements with Major Medical Facilities. We have and intend to continue entering into agreements with major medical facilities to install the SSi Mantra for evaluation, familiarization and training purposes. As of the date of this Annual Report, we had entered into such agreements with approximately ten hospital networks in India and with Johns Hopkins University in Baltimore, Maryland.
National and International Medical Conferences. We have and intend to continue to participate in International and National Conferences hosted by nationally accredited and internationally acclaimed bodies to help raise awareness about the SSi Mantra platform and provide surgeons with the opportunity to view our SSi Mantra system. Our first Global SMRSC (SSi Mantra Robotic Surgery Conference) that was hosted in January 2024, was attended by over 700 national and international faculty and our second Global SMRSC that was hosted in March 2025, was attended by over 1,400 participants and displayed the increased capabilities of the SSi Mantra 3, including the performance of telesurgery and the introduction of our mobile robotic surgical system. At both conferences, key opinion leaders from India and abroad were given a platform to discuss their experience with the SSi Mantra and foster discussions regarding the global potential of our cost-effective surgical robotic system, we have plans to host the next Global SMRSC in April 2026 as part of our market outreach plans.
Clinical Applications
The SSi Mantra has been clinically validated for safety, efficacy and effectiveness for its intended use to perform robotically assisted surgeries in more than one hundred different types of surgical procedures in India without any device related adverse events. As of December 31, 2025, we have installed 168 systems, of which 154 are located in India, and 14 at overseas locations, including 21 systems installed on pay per use basis, 8 systems installed for demonstration purposes, and 10 upgraded systems which have been used to perform more than 7,800 surgical procedures (compared to 2,759 cumulative surgical procedures as of December 31, 2024), including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries. We maintain productive collaborations with leading surgeons to explore and develop new techniques and applications for robotic-assisted surgery with the SSi Mantra. We primarily focus our development efforts on those procedures in which we believe our products bring the highest patient value, surgeon value and hospital value. Representative surgical applications are described below.
Cardiovascular Surgery
Internal Mammary Artery Dissection. In a coronary artery bypass graft procedure used in cardiac surgery, a blocked coronary artery is bypassed with a graft. When available, an artery from the chest called the internal mammary artery is dissected from its natural position and grafted into place to perform the bypass. Because the internal mammary artery is located inferior to the anterior surface of the chest, dissection of the vessel is challenging using existing surgical instruments through the three- to five-inch incision commonly used in a non-robotic coronary artery bypass graft procedure. Our products have multiple joints that emulate the surgeon’s shoulders and elbows, allowing exact positioning of the instruments inside the patient’s chest. In addition, our Mudra instrument joints are designed to permit the surgeon to reach behind the tissues for easier dissection of the internal mammary artery. Thus, we believe that the internal mammary artery can be dissected with greater ease and precision using the SSi Mantra.
Totally Endoscopic Coronary Artery Bypass Surgery (TECAB). Coronary artery bypass graft surgery demands that the surgeon delicately dissect and precisely suture very small structures, which are less than two millimeters in diameter, under significant magnification. These procedures are difficult when performed in open surgery. They are even more difficult when performed using a limited incision approach and can be challenging to perform when the heart is beating. As a result, this procedure is typically done as open surgery by stopping the heart and using a heart/lung bypass machine. The technology employed by the SSi Mantra is designed to allow surgeons to perform scaled instrument movements that can be even more precise than the movements used in open surgery, thus enabling precise suturing of single and multiple coronary vessels on a stopped or beating heart.
9
Mitral and Aortic Valve Repair/Replacement. Valve repair and replacement surgeries are challenging even when using open surgical techniques. Significant exposure of the surgical field is essential to the identification and precise manipulation of valves and other structures inside the heart and is key to successful surgical outcomes with minimal complications. Motion scaling allows a surgeon using the SSi Mantra to maneuver instruments inside the patient even more precisely than is possible in open surgery. The SSi Mantra has enabled heart valve repairs to be performed through small ports in a manner that could not have been accomplished with open surgery.
Thoracic Surgery
Conventional approaches to surgical procedures in the thorax include both open and video-assisted thoracoscopic approaches. Procedures performed via these methods include pulmonary wedge resection, pulmonary lobectomy, thymectomy, mediastinal mass excision and esophagectomy.
Head and Neck Surgery
Transoral Surgery. Head and neck cancers are typically treated by either surgical resection or chemo-radiation, or a combination of both. Surgical resection performed by an open approach may require a “jaw-splitting” mandibulotomy. This procedure, while effective in treating cancer, is potentially traumatic and disfiguring to the patient. Less invasive approaches via the mouth (transoral surgery) are challenged by line-of-sight limitations dictated by conventional endoscopic tools. Chemo-radiation as a primary therapy allows patients to avoid traumatic surgical incisions however, medical literature suggests that this modality diminishes patients’ ability to speak and swallow normally. Robotically assisted transoral surgery allows surgeons to operate on tumors occurring in the oropharynx (i.e., tonsil and base of tongue) and larynx via the mouth and to overcome some of the line-of-sight limitations of conventional transoral surgery.
Gynecologic Surgery
Hysterectomy. Removal of the uterus is one of the most commonly performed surgeries in gynecology and is performed for a variety of underlying benign and cancerous conditions. Hysterectomies can be performed using open surgery or minimally invasive techniques, which include vaginal, laparoscopic, and robotic-assisted approaches. We believe that robotic-assisted surgery with the SSi Mantra provides patients with the opportunity to receive a minimally invasive treatment as an alternative to an open hysterectomy.
Sacro colpopexy. The abdominal (open) Sacro colpopexy is a type of operation performed to treat vaginal vault prolapse. Sacro colpopexy involves suturing a synthetic mesh that connects and supports the vagina to the sacrum (tailbone). A Sacro colpopexy can be performed using a conventional laparoscopic technique; however, it is often difficult and cumbersome to perform. Robotic assisted surgical capabilities enable a larger number of these procedures to be performed through a minimally invasive technique, conferring the benefits of MIS to a broader range of Sacro colpopexy patients.
Urologic Surgery
Prostatectomy. Radical prostatectomy is the removal of the prostate gland and accompanying lymph nodes in patients diagnosed with clinically localized prostate cancer. The standard approach to the removal of the prostate is via an open surgical procedure. The conventional laparoscopic approach is difficult and poses challenges to even the most skilled urologist. The SSi Mantra will enable a larger number of surgeons to transition from open surgical techniques to a minimally invasive robotic surgical technique.
Partial Nephrectomy. Partial nephrectomy is the removal of a small portion of a kidney (typically, an area of the kidney containing a tumor). Partial nephrectomies are most commonly performed in patients diagnosed with clinically localized renal cancer. Excluding robotic-assisted surgery, there are three common surgical approaches to performing partial nephrectomies: open surgical technique, laparoscopy, and hand-assisted laparoscopy, which is a hybrid of open surgery and laparoscopic techniques. Robotic assisted surgical capabilities may enable a large number of these procedures to be performed through a minimally invasive technique, conferring the benefits of MIS to a broader range of partial nephrectomy patients.
10
Radical Nephrectomy. Radical nephrectomy is a surgery to remove the entire kidney, typically done to treat kidney cancers and occasionally or other reasons. In some instances, the adrenal gland and lymph nodes may be removed as well.
Cystectomy. Robotic-assisted cystectomy is a minimally invasive bladder surgery with the same cancer removal success as open surgery. During robotic cystectomy, robotically trained urology surgeons remove the bladder and redirect the urinary tract using a surgical robot. A robotic cystectomy is performed through a series of small keyhole-sized incisions across the abdomen, which is less painful, heals faster, and produces significantly less surface scarring than the larger incision associated with open surgery.
General Surgery
Hernia Repair. A hernia occurs when an organ or other tissue squeezes through a weak spot in a surrounding muscle or connective tissue. During hernia repair surgery, the weakened tissue is secured, and defects are repaired. Common types of hernias are ventral and inguinal. Ventral, or abdominal hernia, may occur through a scar after surgery in the abdomen. Inguinal hernia is a bulge in the groin and is more common in men.
Colorectal Surgery. These procedures typically involve benign or cancerous conditions of the lower digestive system, in particular the rectum or colon. Common procedures in this area include hemicolectomy, sigmoidoscopy, low anterior resection and abdominoperineal resection.
Cholecystectomy. Cholecystectomy, or the surgical removal of the gall bladder, is a commonly performed general surgery procedure. Cholecystectomy is the primary method for the treatment of gallstones and other gall bladder diseases. Most cholecystectomies are performed using multi-port MIS techniques, although some surgeons choose to perform cholecystectomies using manual single-port instrumentation.
The Global Robotic Surgery Market
General
According to Markets and Markets research, the global surgical robotics market is projected to reach $27.14 billion by 2030 from $11.98 billion in 2024, at a CAGR of 14.7% during the forecast period. Surgical robots offer significant advantages in MIS by enabling exceptionally precise manipulation of surgical instruments within constrained operation spaces, surpassing human capabilities. Robotic surgery is a procedure which involves a minimally invasive spectrum and represents an evolution in practice across numerous medical disciplines. Surgical robotics technology is used across various medical specialties, enabling surgeons to perform complex procedures through small incisions, resulting in reduced patient trauma, shorter recovery times, and enhanced patient outcomes.
Market Dynamics
Increase in demand and acceptance of laparoscopic or MIS due to the benefits to patients and surgeons, such as better screening, greater precision, shorter hospitalization, reduced pain and discomfort has fueled the growth in the global surgical robotics market. In addition, the surge in the number of gynecological, neurological and urological diseases is a primary factor driving the surgical robotics market growth.
In addition, surgical robotics enable minimally invasive procedures, which involve smaller incisions, reduced trauma to surrounding tissues, and quicker recovery times. Patients are increasingly seeking procedures that result in less pain and shorter hospital stays, and surgical robots fulfill these demands and the rise in adoption of minimally invasive procedures has fueled market growth.
Many surgical robotic systems incorporate advanced visualization technologies, such as high-definition 3D imaging and augmented reality. These technologies grant surgeons a clearer view of the surgical site, enhancing their ability to visualize complex anatomical structures and perform intricate tasks. The growth of the surgical robotics market is expected to be driven by the availability of improved healthcare infrastructure, increase in unmet healthcare needs, rise in prevalence of chronic diseases, and surge in demand for advanced surgical robotics products.
11
Furthermore, the increase in need for automation in the healthcare industry and the shifting trend towards advanced robotic surgeries fuels market growth. Moreover, untapped economies such as Brazil, India, China and other developing economies create a lucrative surgical robotics market opportunity.
The demand for surgical robotics is not only limited to developed countries such as the U.S. but is also being witnessed in the developing countries, such as China, and India, which fuel the growth of the market. Factors such as the rise in the number of surgeries drive the adoption of robotic technologies across different specialties, contributing to the robust growth of the surgical robotics market.
Furthermore, as the global population ages, we expect that there will be a greater need for surgical interventions to address age-related health conditions which boosts market growth. Surgical robots assist surgeons in handling the complexities of these procedures, allowing for safer and more effective outcomes in elderly patients. Moreover, initially limited to specific procedures, robotic technologies are now being adapted for a broader spectrum of surgeries across various medical fields, including cardiac, neurology, urology, gynecology, and more. This versatility attracts hospitals and clinics to aim to offer comprehensive robotic surgical services which is expected to drive the market growth.
High initial costs associated with acquiring and implementing robotic systems, including infrastructure and training, pose a financial challenge for many healthcare facilities which may impede market growth. Regulatory complexities and concerns regarding patient safety, as well as the need for rigorous clinical validation of robotic procedures, slow down the adoption process. In addition, the intricate nature of surgical robotics necessitates specialized training for surgeons, potentially leading to a shortage of skilled professionals. These factors collectively have hindered expansion of the surgical robotics market.
Segmental Overview
The surgical robotics industry is segmented into components, surgery type, and region. By component, the market is categorized into systems, accessories, and services. Based on surgery type, the market is segregated into gynecology surgery, urology surgery, neurosurgery, orthopedic surgery, general surgery, and other surgeries. Region wise, the market is analyzed across North America, Europe, Asia-Pacific, Latin America, the Middle East and Africa (“LAMEA”).
By Component
With a consistently expanding installed base of surgical robotic systems globally (i.e., Colombia, Ecuador, India, Indonesia, Iraq, Nepal, Oman, Philippines and the United Arab Emirates) and increasing utilization thereof, the accessories and services segment dominated the global surgical robotics market in 2022 and is expected to remain dominant throughout the forecast period, due to a rise in the number of surgical robotics procedures performed with precision, accuracy, and improved patient outcomes, coupled with the increased adoption of surgical robotics technology. However, the systems segment is expected to register the highest CAGR during the forecast period, owing to a rise in technological advancements and an increase in demand for advanced robotic surgical systems.
By Surgery Type
The general surgery segment dominated the global surgical robotics market share in 2023 and is anticipated to continue this trend during the forecast period. This is attributed to versatility and effectiveness of surgical robotics in a wide range of general surgery procedures, increase in patient demand for minimally invasive surgeries, and ongoing advancements in technology.
By Region
The surgical robotics market size is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America accounted for a major share of the surgical robotics industry in 2024 in terms of the number of surgical robotic systems installed and is expected to maintain its dominance during the forecast period. In addition, the presence of well-established healthcare infrastructure, high purchasing power, and rise in adoption rate of advanced surgical robotics products are expected to drive the market growth. Furthermore, product launches, collaborations, and acquisitions adopted by the key players in this region help to boost the growth of the market.
Asia-Pacific is expected to grow at the highest rate during the surgical robotics market forecast period. The market growth in this region is attributable to the growing industrial infrastructure, the rise in prevalence of chronic diseases, such as cancer and cardiovascular conditions which has driven the need for sophisticated surgical interventions, which surgical robotic systems can provide. Moreover, the increase in awareness and acceptance of minimally invasive procedures among patients in the Asia-Pacific region along with the benefits offered by surgical robotics further propels the market growth in this region.
12
India
Within the Asia-Pacific region, India stands out as the fastest-growing large economy and a critical growth engine for advanced healthcare technologies, including surgical robotics. Rising incomes, rapid urbanization, demographic shifts, and a significant unmet need for high-quality tertiary care position India as a pivotal driver of regional healthcare expansion.
India’s healthcare sector has expanded rapidly over the past decade, growing from approximately $110 billion in 2016 to about $372 billion in 2023. Over the longer term, industry and policy projections indicate India’s healthcare market could approach $1.5 trillion by 2030, supported by sustained demand and structural reforms.
Healthcare spending in India, while increasing, remains below global averages. Over the next five years, healthcare spending as a percentage of GDP is expected to trend upward toward 5%, though it may still remain below many OECD and emerging-market peers.
According to Niti Aayog, it is estimated that 70% of the Indian population is covered under public or voluntary private health insurance. while the remaining 30% (approximately 400 million people) remain uninsured. The India health insurance market in terms of gross written premiums was estimated at $15.06 billion in 2024 and is projected to grow at a CAGR of 20.9% from 2025 to 2030.
Despite strong growth, India continues to face structural gaps in healthcare infrastructure. The doctor-to-population ratio has improved to roughly 1:811, yet regional disparities persist, particularly in non-urban areas. These gaps are driving both public and private investment in hospital capacity, medical colleges, and advanced care facilities.
In 2026, hospital revenue growth of 16–18% is projected, supported by higher insurance-funded procedures, medical value travel, and increasing adoption of advanced technologies.
India’s healthcare ecosystem in 2025 was characterized by rapid market expansion, rising insurance penetration, declining out-of-pocket spending, and accelerating investment in infrastructure and technology. While capacity constraints remain, these structural trends strongly support the long-term growth of advanced healthcare solutions, including surgical robotics, positioning India as a central pillar of healthcare growth in the Asia-Pacific region.
Sales, Marketing and Customer Support
Sales Model
We provide our systems and related devices through a direct sales organization in India and, outside of India, through an expanding distributor network that, as of December 31, 2025, included distributors in Colombia, Ecuador, Guatemala, Indonesia, the Philippines, the United Arab Emirates, CIS Countries, the Baltic Region, Greece, Cyprus, Sri Lanka, Bangladesh, Nepal, Oman, Iraq, the West Indies, Mauritius, Madagascar, Seychelles, and Australia.
Our direct sales organization is composed of a capital sales team of ten individuals, who are responsible for selling systems, and a clinical support team of thirty individuals, which is responsible for supporting the systems used in procedures performed at our hospital accounts. Our hospital accounts include both individual hospitals and healthcare facilities as well as hospitals and healthcare facilities that are part of an integrated chain. The initial system sale into an account is a major capital equipment purchase by our customers and typically has a lengthy sales cycle that can be affected by evaluation periods, macroeconomic factors, capital spending prioritization, the timing of budgeting cycles and competitive bidding processes. Capital sales activities include educating surgeons, physicians and other hospital staff across multiple specialties on the benefits of robotic-assisted surgery with the SSi Mantra, total treatment costs and the clinical applications that our technology enables. We also train our sales organization to educate hospital management on the potential benefits of adopting our system, including the clinical benefits of robotic-assisted surgery with the SSi Mantra, such as improved patient outcomes.
Our clinical sales team works onsite at hospitals, interacting with surgeons and physicians, operating room staff and hospital administrators to develop and sustain successful robotic-assisted surgery. They assist the hospital in identifying surgeons or physicians who have an interest in robotic-assisted surgery and the potential benefits provided by the SSi Mantra. Our clinical sales team provides current clinical information on robotic-assisted surgery and new product applications to the hospital teams.
13
We offer our SSi Mantra through three selling models— outright purchase, purchase on a deferred or installment payment basis, and purchase on a pay-per-procedure basis.
In cases where the systems are installed on a pay-per-procedure basis, the Company earns revenue share which is a mix of fixed and variable components. Variable components consist of revenue share which is agreed based on the number and type of procedures performed by the customer, while the fixed component involves an agreed amount which the customer is obliged to pay over the lease term. Accordingly, the fixed component is recognized on a straight-line basis as lease income. Since title for the system is not getting transferred to the customer, the cost relating to those systems is capitalized under property, plant and equipment and accordingly depreciation is charged over its period of useful life.
Our customers place orders to replenish their supplies of instruments and accessories on a regular basis. New direct customers who purchase a system typically place an initial stocking order of instruments and accessories soon after they receive their system.
To date, substantially all of our sales have been in India, with one sale each in the United Arab Emirates, Ecuador, Iraq and Nepal, and two sales in Colombia, Indonesia and the Philippines.
Training and Customer Support
We also provide training for surgeons, physicians and staff on the operation and use of the SSi Mantra using a variety of training approaches. These include didactic modules training, hands on training, dry runs with the surgeons and their entire team, in-person proctored initial cases, on-site support for additional cases and remote proctoring support for complex cases. With respect to the sale of surgical robotic systems, training is provided at the time of delivery to the end customer, however the effort involved is considered negligible.
We have a network of field service and technical support engineers in India and are establishing relationships with various distributors around the globe where we intend to market and sell the SSi Mantra. This infrastructure of service and support specialists, along with advanced service tools and solutions, offers a full complement of services for our customers, including installation, repair, maintenance, 24/7 technical support and proactive system health monitoring.
Research and Development
We focus our research and development efforts on enhancing and improving our products and services with a view to fulfilling our vision that the benefits of advanced robotic surgery should be cost-effective and available to everyone. Through ingenuity and intelligent technology, we believe that we can expand the potential of physicians to heal without constraints due to both cost and accessibility of these technologies. We employ engineering and research and development staff and currently have a research and development team of 81 employees to focus on delivering future innovations and sustaining improvements that advance our mission.
Manufacturing
Our systems and instruments are manufactured by our employees at our approximately 75,000 square-foot facility in Gurugram, Delhi NCR, India. Our facility currently operates with a production capacity of 20 systems per month across multiple shifts. The manufacturing of our products is a complex operation involving a number of separate processes and components.
We purchase both custom and off-the-shelf components from a large number of suppliers from both within India and overseas and subject them to stringent quality specifications, inspections, and processes. Some of the components necessary for the assembly of our products are currently provided to us by sole-sourced suppliers (the only recognized supply source available to us) or single-sourced suppliers (the only approved supply source for us among other sources). We believe, however, that alternative suppliers are available if it should become necessary, although no assurance can be given that we could secure such alternative sources of supply, if required, on commercially reasonable terms or without undue operational disruption.
14
We purchase the majority of our components and major assemblies through purchase orders rather than long-term supply agreements and generally do not maintain large volumes of finished goods relative to our anticipated demand.
Subject to receipt of necessary financing, we plan to expand our in-house manufacturing capacity in order to meet anticipated increases in demand and to reduce our reliance on third-party suppliers.
Competition
We face competition in the forms of existing open surgery, conventional MIS, drug therapies, radiation treatment and other emerging diagnostic and interventional surgical approaches. Our success depends on continued clinical and technical innovation, quality and reliability, as well as educating hospitals, surgeons and patients on the demonstrated results associated with robotic-assisted medical procedures using the SSi Mantra and its efficacy and cost-effectiveness relative to other techniques.
We compete with a number of U.S. and foreign companies that have developed and currently manufacture and market products in the field of robotic-assisted medical procedures, including but not limited to: Intuitive Surgical, Inc.; Asensus Surgical, Inc.; avateramedical GmbH; CMR Surgical Ltd.; Johnson & Johnson; Medicaroid Corporation; Medrobotics Corporation; Medtronic plc; meerecompany Inc.; Olympus Corporation; Samsung Electronics Co., Ltd.; Shandong Weigao Group Medical Polymer Company Ltd.; Shanghai Microport Medbot (Group) Co., Ltd.; and Titan Medical Inc. Most, if not all of these companies have longer operating histories and greater financial resources than SSi. In addition, other companies with substantial experience in industrial robotics could potentially expand into the field of medical robotics and become competitors.
Our failure to compete effectively with these existing and potential competitors could adversely affect our results of operations, business and prospects.
Intellectual Property
We place considerable importance on obtaining and maintaining patent, copyright, and trademark protection for our technologies, products and processes.
We generally rely upon a combination of intellectual property laws, confidentiality procedures and contractual provisions to protect our proprietary technology. For example, we have patents and trademarks, both registered and unregistered, that provide distinctive identification of our products in the marketplace.
15
As of the date of this Annual Report, our intellectual property portfolio consists of 15 granted utility patents and 70 pending utility patent applications, and 8 PCT international WIPO applications as follows:
| Granted | Pending | |||||||||||||
| Country | No. of Patents | Earliest Expiration | Latest Expiration | No. of Patents | Earliest Expiration | Latest Expiration | Product | |||||||
| Europe | 5 | February 8, 2043 | December 1, 2043 | MANTRA | ||||||||||
| Europe | 1 | June 9, 2043 | June 9, 2043 | MAYA | ||||||||||
| India | 12 | January 28, 2042 | May 09, 2044 | 12 | March 3, 2042 | February 17, 2042 | MANTRA | |||||||
| India | 1 | November 10, 2043 | November 10, 2043 | 1 | March 31, 2043 | March 31, 2043 | MANTRA & MAYA | |||||||
| India | 1 | June 10, 2042 | June 10, 2042 | 1 | July 27, 2043 | July 27, 2043 | MAYA | |||||||
| India | 7 | October 05, 2041 | August 23, 2045 | MUDRA | ||||||||||
| USA | 1 | June 10, 2043 | June 10, 2043 | 9 | January 28, 2043 | December 27, 2044 | MANTRA | |||||||
| USA | 1 | July 15, 2044 | July 15, 2044 | MANTRA & MAYA | ||||||||||
| USA | 2 | June 9, 2043 | June 27, 2044 | MAYA | ||||||||||
| USA | 1 | November 4, 2042 | November 4, 2042 | MUDRA | ||||||||||
| Japan | 4 | November 09, 2043 | December 27, 2044 | MANTRA | ||||||||||
| Japan | 1 | July 15, 2044 | July 15, 2044 | MANTRA & MAYA | ||||||||||
| Korea | 3 | November 09, 2043 | December 27, 2044 | MANTRA | ||||||||||
| Korea | 1 | July 15, 2044 | July 15, 2044 | MANTRA & MAYA | ||||||||||
| Singapore | 2 | September 19, 2044 | December 27, 2044 | MANTRA | ||||||||||
| Singapore | 1 | July 15, 2044 | July 15, 2044 | MANTRA & MAYA | ||||||||||
| Australia | 4 | October 20, 2043 | December 27, 2044 | MANTRA | ||||||||||
| Australia | 1 | July 15, 2044 | July 15, 2044 | MANTRA & MAYA | ||||||||||
| Israel | 2 | September 19, 2044 | December 27, 2044 | MANTRA | ||||||||||
| Israel | 1 | July 15, 2024 | July 15, 2024 | MANTRA & MAYA | ||||||||||
| BRAZIL | 6 | February 08, 2043 | December 27, 2044 | MANTRA | ||||||||||
| BRAZIL | 1 | July 15, 2044 | July 15, 2044 | MANTRA & MAYA | ||||||||||
| INDONESIA | 2 | October 20, 2043 | November 09, 2043 | MANTRA | ||||||||||
| INDONESIA | 1 | June 09, 2043 | June 09, 2043 | MAYA | ||||||||||
| Total | 15 | 70 | 85 | |||||||||||
16
Further, our intellectual property portfolio also consists of 8 PCT international WIPO applications as follows:
| Granted | Pending | |||||||||||||
| Country | No. of Patents |
Earliest Expiration |
Latest Expiration |
No. of Patents |
Earliest Expiration |
Latest Expiration |
Product | |||||||
| WIPO | 7 | August 18, 2026 | June 27, 2027 | MANTRA | ||||||||||
| WIPO | 1 | June 10, 2026 | June 10, 2026 | MANTRA & MAYA | ||||||||||
| Total | 8 | 8 | ||||||||||||
Further, our intellectual property portfolio also consists of 32 granted design patents and 4 pending design patent application as follows:
| Granted | Pending | |||||||||||||
| Country | No. of Patents | Earliest Expiration | Latest Expiration | No. of Patents | Earliest Expiration | Latest Expiration | Product | |||||||
| India | 24 | January 31, 2038 | September 27, 2039 | 2 | October 28, 2040 | October 31, 2040 | MANTRA | |||||||
| India | 8 | August 29, 2038 | January 20, 2040 | 2 | October 25, 2039 | March 17, 2040 | MUDRA | |||||||
| Total | 32 | 4 | 36 | |||||||||||
In addition, we have filed 98 applications for trademark registrations in India of which 56 have been registered. Further, we have filed 21 applications for trademark registrations through both Madrid and direct foreign filings of which 10 have been registered.
We intend to apply for additional utility patents, designs and trademarks in various jurisdictions.
Notwithstanding the foregoing, we cannot be certain as to the scope of protection that the patents granted will afford our technology and products, nor can we be certain that any pending or future patent applications will be granted. Furthermore, if any protection we obtain is reduced or eliminated, others could use our intellectual property without compensating us, resulting in harm to our business. In addition, others may assert that our products infringe on their intellectual property rights, which may cause us to engage in costly disputes and, if we are not successful in defending ourselves, could also cause us to pay substantial damages and prohibit us from selling our products.
None of our patents and patent applications are licensed to or from third parties.
Government Regulation
General
Our systems and related devices and operations are subject to regulation in India by the CDSCO, by the FDA in the U.S. and by similar agencies in other countries and regions in which we market or plan to market our products. In addition, our products must meet the requirements of a large and growing body of international standards, which govern the design, manufacture, materials content and sourcing, testing, certification, packaging, installation, use and disposal of our systems and related devices. We must continually keep abreast of these regulations, standards and requirements and integrate our compliance into the development and regulatory documentation for our systems and related devices. Failure to meet these standards could limit our ability to market our systems and related devices in those regions that require compliance with such standards. Examples of standards to which we are subject include ISO 13485, an internationally recognized quality management system for the design, development and manufacture of medical devices.
17
ISO 13485 Quality Management System
ISO 13485 is an internationally recognized quality management system for the design, development and manufacture of medical devices. It sets out the requirements for a quality management system specific to the medical device industry. This standard is designed to be used by manufacturers throughout the life cycle of a medical device. We are required to meet this standard to register our systems and related devices for sale globally and are subject to rigorous annual reassessment and audit procedures.
Our Company has developed a Harmonized ISO 13485 QMS system in line with EN ISO 13485 and 21 CFR 820, for compliance with U.S. and EU quality management systems requirements.
We received ISO 13485 certifications in 2021. During the course of 2024, we conducted a recertification audit from EU Notified Body for EN ISO 13485 and ISO 13485 and we received the certification in Q4 of 2024.
India Regulation
In the past medical devices in India had been mostly unregulated, but that has changed in recent years, with the adoption of rules and regulations designed to improve and enhance patient safety. Our systems and related devices are primarily regulated under the IMDR promulgated and administered by the CDSCO. These rules cover various aspects of medical device related regulations, including classification, registration, manufacturing and import, labeling, sales, and post-market requirements. Similar to rules in the EU, these regulations mandate that devices be safe and perform their intended function.
Based on intended use of the device, the risks associated with the device and other parameters referred to in the IMDR, the Central Licensing Authority of India classifies Medical Devices into four risk classes: A (low risk); B (low moderate risk); C (moderate high risk); and D (high risk).
The CDSCO has further divided the device classifications into 24 panels, where our surgical robotic system is classified as a Class B device pertaining to operating room procedures. This license has been updated to Class C to be in line with the international classification System.
We currently have CDSCO approval for the manufacture, sale and distribution of our systems and related devices under Class C including the Telesurgery approvals and a license to export our systems and related devices from India.
In December 2024 we became the first company in India to receive CDSCO regulatory approval for telesurgery and tele proctoring capabilities of a surgical robotic system.
U.S. Regulation
Our systems and related devices will be subject to regulation as medical devices in the U.S. under the FFDCA, as implemented and enforced by the FDA. The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, recordkeeping, complaint and adverse event reporting, clearance, approval, certification, promotion, marketing, export, import, distribution and service of medical devices in the U.S. to ensure that medical devices distributed domestically are safe and effective for their intended uses.
We filed a pre-submission application with the U.S. FDA, requesting feedback on the SSi Mantra. We had a feedback meeting with the FDA on April 2, 2024. The pre-submission meeting (Reference number Q240119) was organized with the FDA to seek interactive feedback from the FDA regarding the regulatory strategy, biocompatibility assessment, reprocessing validation, and clinical data. While FDA acknowledged that certain similarities exist between the SSi Mantra and the proposed predicate device(s), the recommendation was to proceed with a de novo review instead of the 510(k) route.
18
Under the FDA’s regulatory scheme, medical devices are classified into one of three classes—Class I, Class II or Class III, depending on the degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness. We believe that our current SSi Mantra system and related devices will be classified as Class II medical devices.
The de novo classification process under the FFDCA provides a pathway for certain new types of devices to obtain marketing authorization as Class I or Class II devices, rather than remaining automatically designated as a Class III device, which would require premarket approval.
Class II medical devices are those that are subject to general controls, and most require premarket demonstration of adherence to certain performance standards, as specified by the FDA, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents.
Based on further discussions with the FDA, in August 2025, the Company pivoted from filing a de novo request for the SSi Mantra to pursuing the 510(k) regulatory pathway which offers potential speed and cost advantages We successfully completed a human factors validation study for our SSi Mantra system at Johns Hopkins Hospital in September 2025. On December 5, 2025, we submitted a 510(k) premarket notification to the FDA for the SSi Mantra surgical robotic system for multiple specialty procedure types, including: general, urological, colorectal, gynecological, and cardiac surgery. We have engaged RQM+, a leading MedTech-focused CRO, to assist with the 510(k) submission. If approved by the FDA, the SSi Mantra would be cleared to market in the U.S. Submission of a 510(k) premarket notification request does not guarantee FDA approval. We believe that we will be able to secure FDA certification in 2026. However, there can be no assurance as to when or if we will secure such regulatory approval.
The FDA generally reviews a 510(k) premarket notification submission within 90 calendar days of receipt; however, in practice, review timelines may extend if additional information is requested. During the review, the FDA may issue requests for additional data or clarification to determine whether the subject device is substantially equivalent to a legally marketed predicate device. If the FDA determines that the device is not substantially equivalent (NSE) to a predicate device, the product may be considered a novel device that does not qualify for the 510(k) pathway. In such cases, the sponsor may pursue the de novo classification process for low-to-moderate-risk devices or, if the device presents a higher risk, proceed with a PMA application.
The PMA process is more demanding and requires a full evaluation of clinical trial data and extensive documentation. In a PMA application, the manufacturer must demonstrate that the device is safe and effective, and the PMA application must be supported by extensive data, including data from preclinical studies and human clinical trials. The FDA, by statute and regulation, has 180 days to review a PMA application, although the review more often occurs over a significantly longer period of time and can take up to several years. In approving a PMA application or clearing a de novo classification request under Class II, the FDA may also require additional manufacturing controls, design control activities and approvals, as well as specific post-market surveillance requirements when necessary to protect the public health or to provide additional safety and effectiveness data for the device. In such cases, the manufacturer might be required to follow certain patient groups for a number of years and make periodic reports to the FDA on the clinical status of those patients.
Clinical trials are almost always required to support a PMA and are sometimes required to support a de novo classification request. All clinical investigations designed to determine the safety and effectiveness of a medical device must be conducted in accordance with the FDA’s investigational device exemption (“IDE”) regulations, which govern investigational device labeling, prohibit the promotion of the investigational device and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. Regardless of the degree of risk presented by the medical device, clinical studies must be approved by, and conducted under the oversight of, an Institutional Review Board (“IRB”) for each clinical site. During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring, selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record keeping and prohibitions on the promotion of investigation devices or on making safety or effectiveness claims for them. The clinical investigators in the clinical study are also subject to the FDA’s regulations and must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition of the investigational device and comply with all reporting and recordkeeping requirements. Additionally, after a trial begins, we, the FDA, or the IRB could suspend or terminate a clinical trial at any time for various reasons, including a belief that the risks to studying subjects outweigh the anticipated benefits.
After a device receives premarket authorization from the FDA, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance or depending on the modification, PMA approval or de novo classification. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo classification or a PMA in the first instance, but the FDA can review any such decision and disagree with the manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance, approval of a PMA or issuance of a de novo classification. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.
19
In addition, the FDA may place significant limitations upon the intended use of our systems and related devices as a condition of granting marketing authorization. Moreover, after a device is placed on the market, numerous FDA and other regulatory requirements continue to apply. These requirements include establishment registration and device listing with the FDA; compliance with medical device reporting regulations, which require that manufacturers report to the FDA if their device has caused or contributed, or may have caused or contributed, to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur; compliance with corrections and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FFDCA that may present a risk to health; the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device. In addition, the FDA and the Federal Trade Commission also regulate the advertising and promotion of our systems and related devices to ensure that any claims we make are consistent with our regulatory clearances, that there is scientific data to substantiate the claims and that our advertising is neither false nor misleading. In general, we may not promote or advertise our systems and related devices for uses not within the scope of our intended use statement in our clearances or make unsupported safety and effectiveness claims.
In addition, the FDA collects user fees for certain medical device submissions and annual fees for medical device establishments.
In the U.S., our manufacturing processes will be required to comply with the Quality System Regulation (“QSR”). The QSR covers, among other things, the methods used in, and the facilities and controls used for, the design, testing, controlling, documenting, manufacture, packaging, labeling, storage, installation and servicing of all medical devices intended for human use. The QSR also requires maintenance of extensive records, which demonstrate compliance with the FDA regulations, the manufacturer’s own procedures, specifications and testing, as well as distribution and post-market experience. Compliance with the QSR is necessary for a manufacturer to be able to continue to market cleared or approved product offerings in the U.S. A company’s facilities, records and manufacturing processes are subject to periodically scheduled or unscheduled inspections by the FDA. Failure to maintain compliance with applicable QSR requirements could result in the shutdown of, or restrictions on, manufacturing operations and the recall or seizure of marketed products. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:
| ● | warning letters, untitled letters, fines, injunctions, consent decrees, administrative penalties, and civil or criminal penalties; |
| ● | recalls, withdrawals, or administrative detention or seizure of our systems and related devices; |
| ● | operating restrictions or partial suspension or total shutdown of production; |
| ● | refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new or modified systems or devices; |
| ● | withdrawing 510(k) clearances or PMA approvals that have already been granted; |
| ● | refusal to grant export approvals for our systems and related devices; or |
| ● | criminal prosecution. |
In addition, the discovery of previously unknown problems with any marketed systems and related devices, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.
Products manufactured outside of the U.S. by or for us are subject to U.S. Customs and FDA inspection upon entry into the U.S. We must demonstrate compliance of such products with U.S. regulations and carefully document the eventual distribution or re-exportation of such products. Failure to comply with all applicable regulations could prevent us from having access to products or components critical to the manufacture of finished products and lead to shortages and delays.
European Union Regulation
In the EU, all medical devices placed on the EU market must meet the essential requirements (“Essential Requirements”), including the requirement that a medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients or the safety and health of users and others. In addition, the device must achieve the performance intended by the manufacturer and be designed, manufactured and packaged in a suitable manner.
All medical devices are currently regulated by Regulation (EU) No 2017/745 (the “EU Medical Devices Regulation” or the “MDR”), which became effective on May 26, 2021, and replaced the former regulatory framework set forth in Council Directive 93/42/EEC (the “MDD”).
20
We have submitted our technical file to Szutest, an EU Notified body for CE certification, which if approved will allow us to market the SSi Mantra in the EU. We expect to receive a scheduled audit in the second quarter of 2025 and CE marking by the end of 2025. Szutest may require us to perform additional clinical trials, which if required will be conducted under the guidance of EU MDR regulation. There can be no assurance that we will receive CE certification.
The MDR was adopted with the aim of ensuring better protection of public health and patient safety. The MDR establishes a uniform, transparent, predictable and sustainable regulatory framework across the EU for medical devices and ensures a high level of safety and health while supporting innovation. Unlike directives, regulations are directly applicable in EU member states without the need for member states to implement them into national law. This aims to increase harmonization across the EU member states.
The MDR requires that, before placing a device on the market, other than a custom-made device, manufacturers (as well as other economic operators, such as authorized representatives and importers) must register by submitting identification information to the EUDAMED electronic system, which is in the process of being implemented. The information to be submitted by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons responsible for regulatory compliance. The MDR also requires that, before placing a device on the market, other than a custom-made device, manufacturers must assign a unique identifier to the device and provide it along with other core data to the unique device identifier (“UDI”) database.
All manufacturers placing medical devices on the market in the EU must comply with the EU medical device vigilance system. Under this system, serious incidents and Field Safety Corrective Actions (“FSCAs”) must be reported to the relevant authorities of EU member states. These reports are to be submitted through EUDAMED (once fully functional) and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states, other actors, such as the economic operators in the supply chain, will also be informed. Until EUDAMED is fully functional, the corresponding provisions of the MDD continue to apply. Manufacturers are required to take FSCAs, which are defined as any corrective action for technical or medical reasons to prevent or reduce the risk of a serious incident associated with the use of a medical device that is made available on the market.
The advertising and promotion of medical devices is subject to some general principles set forth in EU legislation. According to the MDR, only devices that are Conformité Européene (“CE”) marked may be marketed and advertised in the EU in accordance with their intended purpose. Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on unfair commercial practices, while not specific to the advertising of medical devices, also apply to the advertising thereof and contain general rules, such as, for example, requiring that advertisements be evidenced, balanced and not misleading. Specific requirements are defined at a national level. EU member states’ laws related to the advertising and promotion of medical devices, which vary between jurisdictions, may limit or restrict the advertising and promotion of products to the general public and may impose limitations on promotional activities with healthcare professionals.
Many EU member states have adopted specific anti-gift statutes that further limit commercial practices for medical devices, in particular vis-à-vis healthcare professionals and organizations. Additionally, there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities and many EU member states have adopted national “Sunshine Acts,” which impose reporting and transparency requirements (often on an annual basis), similar to the requirements in the U.S., on medical device manufacturers. Certain EU member states also mandate implementation of commercial compliance programs.
In the EU, regulatory authorities have the power to carry out announced and, if necessary, unannounced inspections of companies, as well as of suppliers and/or sub-contractors and, where necessary, the facilities of professional users. Failure to comply with the applicable regulatory requirements could require time and resources to respond to the regulatory authorities’ observations and to implement corrective and preventive actions, as appropriate. Regulatory authorities have broad compliance and enforcement powers and, if such issues cannot be resolved to their satisfaction, can take a variety of actions, including untitled or warning letters, fines, consent decrees, injunctions, or civil or criminal penalties.
The aforementioned EU rules are generally applicable in the EEA, which consists of the twenty-seven EU member states, as well as Iceland, Liechtenstein and Norway.
21
Other countries
Regulations in other countries, including the requirements for approvals, certification or clearance and the time required for regulatory review, vary from country to country. Certain countries, such as South Korea, Brazil, Australia and Canada, have their own regulatory agencies. These countries typically require regulatory approvals and compliance with extensive safety and quality system regulations included in the Medical Device Single Audit Program that we will be required to comply with on an ongoing basis. We have partnered with a MDSAP-Recognized Auditing Organization, TUV-SUD to obtain MDSAP certification.
Failure to obtain regulatory approval in any foreign country in which we plan to market our systems and related devices or failure to comply with any regulation in any foreign country in which we market our systems and related devices may negatively impact on our ability to generate revenue and harm our business.
In addition, local regulations may apply, which govern the use of our systems and related devices, and which could have an adverse effect on our product utilization if they are unfavorable. All such regulations are revised from time to time and, in general, are increasing in complexity and in the scope and degree of documentation and testing required. There can be no assurance that the outcomes from such documentation and testing will be acceptable to any particular regulatory agency or will continue to be acceptable over time. There are further regulations governing the importation, marketing, sale, distribution, use, and service as well as the removal and disposal of medical devices in the regions in which we operate and market our systems and related devices. Failure to comply with any of these regulations could result in sanctions or fines and could prevent us from marketing our systems and related devices in these regions.
Our ISO 13485 (quality management system) approval, CDSCO approval for the manufacture, sale and distribution of our systems and related devices and our Indian export license allows us to market our systems and related devices in fifty (50) non-FDA and non-CE (EU) countries without further regulatory approvals and in an additional seventy-nine (79) countries which require only minimal registration. We have received regulatory approval to market and sell our systems and related devices in Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and the United Arab Emirates and have initiated the regulatory approval process, in many other countries, which if successful, will allow us to market our systems and related devices in more than fifty (50) countries within approximately one year. However, there can be no assurance as to when or if we will secure any such regulatory approvals.
Data Privacy and Security Laws
Numerous state, federal, and foreign laws, regulations, and standards govern the collection, use, access to, confidentiality, and security of health-related and other personal information and could apply now or in the future to our operations or the operations of our partners. In the U.S., numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure, and protection of health-related and other personal information. In addition, certain foreign laws govern the privacy and security of personal data, including health-related data. Privacy and security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.
We collect, process, share, disclose, transfer, and otherwise use data, some of which contains personal information about identifiable individuals including, but not limited to, our employees, clinical trial participants, partners, and vendors. Therefore, if we commence marketing our systems and related devices in the U.S., the EU and other countries, we will be subject to U.S. (federal, state and local) and international laws and regulations, including those in the EEA regarding data privacy and security and our use of such data.
22
If we market our products in the EU, we will be subject to the GDPR. The GDPR imposes comprehensive data privacy compliance obligations in relation to our collection, processing, sharing, disclosure, transfer and other use of data relating to an identifiable living individual or “personal data,” including a principle of accountability and the obligation to demonstrate compliance through policies, procedures, training, and audits.
The GDPR also regulates cross-border transfers of personal data out of the EEA. Recent legal developments in Europe have created complexity and uncertainty regarding such transfers, in particular in relation to transfers to the U.S.
Cybersecurity
In the normal course of business, we may collect and store personal information and other sensitive information, including proprietary and confidential business information, trade secrets, intellectual property, patient information, sensitive third-party information and employee information. To protect this information, our existing cybersecurity policies require continuous monitoring and detection programs, network security precautions, encryption of critical data and in-depth security assessments of vendors. We maintain various protections designed to safeguard against cyberattacks, including firewalls and virus detection software. We have established and regularly test our disaster recovery plan, and we protect against business interruption by backing up our major systems. In addition, we periodically scan our environment for any vulnerabilities, perform penetration testing and engage third parties to assess the effectiveness of our data security practices.
Cybersecurity Governance
We are in the process of implementing a cybersecurity governance and risk management framework. We consider cybersecurity risk as part of our overall enterprise risk management and are developing policies, procedures, and controls to identify, assess, and manage cybersecurity and information technology risks.
Our management team, including IT leadership, is responsible for overseeing cybersecurity risk management and for implementing our cybersecurity program. Management provides updates to senior leadership on cybersecurity matters, including the status of implementation efforts and any identified cybersecurity risks or incidents.
We monitor cybersecurity risks on an ongoing basis and intend to establish regular internal reporting processes as our cybersecurity program matures. Management may also engage external cybersecurity consultants and service providers to support the implementation, monitoring, and improvement of cybersecurity controls.
As part of our ongoing implementation efforts, we plan to obtain relevant cybersecurity and information security certifications and to enhance our capabilities to prevent, detect, mitigate, and respond to cybersecurity incidents. However, our cybersecurity program is still under development, and there can be no assurance that these measures will be fully implemented in a timely manner or will be effective in preventing all cybersecurity incidents.
Employees
As of the date of this Annual Report, we had 483 employees, 204 of whom were engaged in manufacturing, 122 in marketing, sales, clinical support and field service, 81 in research and development, 22 in sourcing, 4 in quality control and 50 in administration. Most of our employees are based at our facility in Gurgaon, Delhi NCR, India.
23
Item 1A. Risk Factors.
As a “smaller reporting company,” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we are not required to provide the information required by this Item.
Item 1B. Unresolved Staff Comments.
Not applicable.
Item 1C. Cybersecurity.
In the normal course of business, we may collect
and store personal information and other sensitive information, including proprietary and confidential business information, trade secrets,
intellectual property, patient information, sensitive
Our cybersecurity program is primarily overseen by our Head-Server and Network Administrator, who works closely with our information technology team and our senior management to develop and advance our cybersecurity strategy, as well as to respond to cybersecurity incidents. Our Head-Server and Network Administrator report to our Chief Operating Officer on cybersecurity matters and collaborates with stakeholders to assess risks and implement strategies.
We have engaged a specialized consulting firm from India to enhance and develop the cybersecurity framework for our products with the aim of protecting sensitive patient data and proprietary device information from cyber threats and ensuring compliance with the latest cybersecurity standards including, HIPPA, FDA regulations, IEC 62443, and NIST guidelines for medical devices.
We have
Item 2. Properties.
We lease approximately 75,000 square feet in Gurugram, Delhi NCR, India, which serves as our headquarters as well as our manufacturing facility. The facility, spread over three floors, is leased pursuant to a nine-year lease expiring in March 2030 for the third floor, another nine-year lease expiring in May 2032 for the ground floor, another six-year lease expiring in July 2030 for the first floor and a five-year lease expiring in March 2030 for Basement 3. All the leases are further renewable under similar mutually agreed terms.
24
Item 3. Legal Proceedings.
| 1. | In 2014, Avra Surgical Robotics, Inc., a Delaware corporation (“Avra Surgical”), of which Barry F. Cohen, our Chief Operating Officer – Americas and a director, was Chief Executive Officer, a director and a principal shareholder, had a dispute with Quinn Emmanuel Urquhart & Sullivan LLP (“Quinn Emmanuel”) over legal fees allegedly due to Quinn Emmanuel. Avra Surgical, which was seeking to develop a robotic surgery system using certain technology developed in Germany by then had ceased operations. These events occurred prior to our formation as Avra Medical Robotics, Inc. Other than the facts that both Avra Surgical and we shared the Avra name and that Mr. Cohen was an officer, director and principal shareholder of both companies, there was no relationship between the two companies. |
On May 26, 2020, Quinn Emmanuel filed a petition in the Supreme Court of the State of New York, New York County against Avra Surgical, the Company (then known as Avra Medical Robotics, Inc.), Barry F. Cohen, Jared B. Stamell, an attorney affiliated with Avra Surgical, and various individuals who at that time were or had been affiliated with Avra Surgical and or us (collectively, “Respondents”). The petition sought to recover the legal fees from the Respondents on the basis that they were “alter egos” of Avra Surgical.
As we and Mr. Cohen never received notice of the filing of the petition or of subsequent proceedings (although Quinn Emmanuel filed affidavits with the court stating that they had been duly served), neither we nor Mr. Cohen entered an appearance in the matter.
In early 2024, we learned from a third party that in November 2020, the court had rendered a decision holding that we and Messrs. Cohen and Stamell were “alter egos” of Avra Surgical and therefore were liable for payment of the Quinn Emmanuel legal fees. In addition, we also learned that in December 2023, the court ordered the entry of a judgment against Avra Surgical, us and Messrs. Cohen and Stamell in the amount of $296,000 plus interest from November 2020.
In 2023, Mr. Stamell appealed the judgement against him on the basis that Quinn Emmanuel had not presented any evidence to support the finding that Mr. Stamell was an alter ego of Avra Surgical or that Avra Surgical had transferred any assets to us. The Appellate Division, First Department ruled in favor of Mr. Stamell and in December 2024 entered an order vacating the judgment against him.
As a result of the foregoing, in April 2025, Quinn Emmanuel moved to sever Mr. Stamell from the case and for judgement to be reentered against Avra Surgical, Mr. Cohen and us. That motion was granted on July 22, 2025. In addition, in June 2025, Quinn Emmanuel moved on an ex parte basis to authorize service on Mr. Cohen and us by email to Mr. Cohen’s email or text to his cell phone. In connection therewith, Quinn Emmanuel alleged that Mr. Cohen and we had made efforts to evade service. That motion was granted on July 1, 2025. Quinn Emmanuel entered a revised judgment against Avra Surgical, Mr. Cohen and us on November 13, 2025. We are not aware of any efforts Quinn Emmanuel has undertaken to enforce the judgment since that time.
Notwithstanding the foregoing, Mr. Cohen and the Company have entered into an indemnification agreement, pursuant to which Mr. Cohen has agreed to fully indemnify us for any damages and costs (including legal fees) we incur in connection with the action.
| 2. | In April 2024, an ex-shareholder of Otto Pvt Ltd., an indirect wholly owned Bahamian subsidiary of the Company (“Otto”) commenced litigation in the Bahamas, seeking legal confirmation that it holds 9,000 shares (approximately a 9% interest) in Otto. The litigation, in which Otto is one of the defendants, relates to a purported transaction in 2021, at which time Dr. Sudhir Srivastava, our Chairman, Chief Executive Officer and principal shareholder, was the sole shareholder of Otto. The plaintiff in the litigation alleges that at that time, it acquired the 9,000 Otto shares from Dr. Srivastava. However, as the plaintiff failed to pay the agreed upon consideration for the shares, in July 2022, the shareholding was cancelled. Dr. Srivastava along with Otto, has recently filed an action in the Bahamas to confirm the cancellation of the shares and reconfirm their ownership and both actions are pending in the Bahamian courts. The Bahamian court has issued an interim order to maintain the status quo as it stands today with respect to the 9,000 Otto shares at the center of the dispute, as well as Otto’s shareholdings in Sudhir Srivastava Innovations Pvt. Ltd., our Indian operating subsidiary (“SSI-India”) and SSI-India’s assets during the pendency of the litigation. Based on legal opinions obtained from counsel, we believe that there will be a favorable outcome in this case. |
Notwithstanding the foregoing, we have entered into an Indemnification Agreement with Dr. Srivastava on October 12, 2024, pursuant to which Dr. Srivastava has agreed to fully indemnify us for any claims, damages and costs (including legal fees) which we incur in connection with this litigation or in relation to any of his ventures prior to consummation of our acquisition by merger of CardioVentures, Inc. in April 2023.
Other than the foregoing, there are no legal proceedings currently pending or threatened against us. However, from time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in any such matter may harm our business.
Item 4. Mine Safety Disclosures.
Not applicable.
25
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Market Information
Our common stock is listed on The Nasdaq Stock Market LLC and commenced trading on April 24, 2025, under the symbol “SSII.” Prior to this listing, our common stock was quoted on the OTC Pink tier of the over-the-counter market maintained by OTC Markets Group, Inc., where trading was sporadic and extremely limited.
The listing of our common stock on Nasdaq represents a transition to a national securities exchange, which we believe enhances the visibility of our securities and provides greater access to institutional and retail investors. Notwithstanding our Nasdaq listing, there can be no assurance that an active, orderly, or liquid trading market for our common stock will be sustained, or that the market price of our common stock will not experience significant volatility.
Holders of our Common Stock
As of the date of this Annual Report, we had 194,356,696 shares of common stock issued and outstanding (not including 5,774,839 shares issuable in connection with the private placement completed on March 6, 2026 – See “Item1. Business – Recent Development”) and 303 holders of record of our common stock. One of these holders is CEDE and Company, which is the mechanism used for brokerage firms to hold securities in book entry form on behalf of their clients and as of the date of this Annual Report, they held approximately 42,977,899 shares of common stock for these shareholders.
Dividends
The payment by us of dividends, if any, in the future rests within the discretion of our board of directors and will depend, among other things, upon our earnings, capital requirements and financial condition, as well as other relevant factors. We have not paid any dividends since our inception and we do not intend to pay any cash dividends in the foreseeable future, but intend to retain all earnings, if any, for use in our business. Any future dividends will be subject to the discretion of our board of directors and will depend upon, among other things, our earnings (if any), operating results, financial condition and capital requirements, general business conditions and other pertinent facts. Under its bank overdraft facility with HDFC Bank, SSI–India is prohibited from declaring and paying dividends, which effectively makes us, as a parent holding company, unable to declare and pay dividends as well.
Securities Authorized for Issuance under Equity Compensation Plans
| Plan category | Number of securities to be issued upon exercise of outstanding options, grants warrants and rights | Weighted- average exercise price of outstanding options, grants warrants and rights | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) | |||||||||
| Equity compensation plans approved by security holders | 11,647,844 Shares | $ | 4.343 | 7,787,826 Shares | ||||||||
| Equity compensation plans not approved by security holders | 0 Shares | - | 0 Shares | |||||||||
| Total | 11,647,844 | $ | 4.343 | 7,787,826 | ||||||||
| (1) | Represents shares of common stock under our 2016 Incentive Stock Plan (the “2016 Incentive Plan”). As of the date of this Annual Report, 11,647,844 shares of common stock (comprised of 7,739,432 stock options and 3,908,412 stock grants) were issued under the Incentive Stock Plan. The 2016 Incentive Plan (but not awards under the 2016 Incentive Plan) expired on February 1, 2026, in accordance with its terms. |
26
Recent Sales of Unregistered Securities
On October 22, 2025, the Company issued 16,000 shares of common stock to an advisor in exchange for advisory services to be rendered over a 5-year period. The total value of such services is $174,240. The value of services is calculated at the fair market value of shares as of the date of the advisory services contract.
On December 12, 2025, the Company issued 667 shares of common stock to one individual upon the exercise of warrants previously issued by the Company. The warrants were exercised at $2.50 per share in accordance with their terms resulting in net proceeds of $2,500 in the Company.
All of the foregoing securities were issued in accordance with the exemption from registration afforded by Section 4(a)(2) of and/or Regulation D under the Securities Act, as amended, as the persons receiving such shares having provided the Company with appropriate representations as to their investment intent and their status as “accredited investors” as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.
Item 6. [Reserved]
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Introduction
The Company is engaged in the business of developing, manufacturing, and selling a surgical robotic system under our proprietary brand “SSi Mantra,” together with related accessories and a wide range of surgical instruments capable of supporting cardiac and a variety of other surgical procedures under our proprietary brand “SSi Mudra.” Having commenced commercial sales of our surgical robotic system in the second half of 2022, the year 2023 was our first full year of commercial sales and during the year 2024, we further consolidated our installed base of SSi Mantra in various parts of India and also expanded our presence in the global markets.
Our financial performance is largely driven by increasing awareness of the benefits of robotically assisted surgery, reduced learning curves for robotic surgeons and the affordability and accessibility of surgical robotic technology. Our financial performance is also dependent on our obtaining regulatory approvals in various regulated markets where we have plans to sell our products. Robotically assisted surgeries are increasingly being recognized as an approved treatment modality from an insurance coverage perspective.
Our manufacturing operations being based in India derive significant operating cost advantages in terms of availability of quality and cost-effective fabrication/3D printing solutions, electronic/electrical/mechanical components, outsourced services and skilled manpower. All these factors help us in having lower costs of production which eventually helps us make our surgical robotic system cost effective and relatively affordable.
Results of Operations
Introduction
The consolidated financial statements appearing elsewhere in this Annual Report have been prepared assuming that we will continue as a going concern. We are still in our initial years of revenue generation by way of the sale of our product and have not yet established consistent operational revenue cash flows to meet all our fixed operating costs and hence may continue to incur losses for some time. These conditions raise substantial doubt about our ability to continue as a going concern.
27
The following table provides selected financial data about our Company at December 31, 2025, and December 31, 2024:
Balance Sheet Data
| As of | As of | |||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Cash | 3,206,406 | 466,500 | ||||||
| Restricted cash** | 6,396,614 | 6,157,035 | ||||||
| Total Assets | 74,226,217 | 42,385,213 | ||||||
| Total Liabilities | 36,007,966 | 28,928,110 | ||||||
| Total stockholders’ equity | 38,218,251 | 13,457,103 | ||||||
| ** | Represents Fixed Deposits held by the bank as security for bank facilities and certain performance guarantees. |
To date, the Company has mainly relied on debt and equity raised in private offerings to finance its operations. During 2026, the Company plans to raise additional capital through further private or public offerings. However, if we are unable to do so and if we experience a shortfall in operating capital, we could be faced with having to limit our expansion plans, research and development and marketing activities.
| For the year ended | ||||||||||
| December 31, 2025 | December 31, 2024 | |||||||||
| 1 | Total Revenue | 42,484,747 | 20,649,528 | |||||||
| 2 | Cost of revenue | (22,940,492 | ) | (12,197,162 | ) | |||||
| 3 | Gross profit | 19,544,255 | 8,452,366 | |||||||
| 4 | Research & development expense | 3,685,840 | 2,491,771 | |||||||
| 5 | Stock compensation expense | 8,128,103 | 14,342,784 | |||||||
| 6 | Depreciation and amortization expense | 1,075,907 | 436,005 | |||||||
| 7 | Selling, general and administrative expense | 14,848,439 | 10,157,768 | |||||||
| 8 | Loss from operations | (8,194,034 | ) | (18,975,962 | ) | |||||
| 9 | Other income (expenses) | 33,087 | (175,235 | ) | ||||||
| 10 | Income tax expense | 3,966,440 | - | |||||||
| 11 | Net loss | (12,127,387) | (19,151,197 | ) | ||||||
Year ended December 31, 2025, as compared to year ended December 31, 2024
Revenues. During the year ended December 31, 2025, the Company had revenues of $42,484,747 (comprising $38,353,048 of system sales, $3,183,757 of instrument sales, $877,033 of warranty sales and $70,909 of lease income), compared to revenues of $20,649,528 (comprising $19,457,767 of system sales, $942,548 of instrument sales, $177,518 of warranty sales and $71,695 of lease income) during the year ended December 31, 2024. The increase in revenue is primarily due to sale of increased number of surgical robotic systems and instruments in the year ended December 31, 2025 as compared to the year ended December 31, 2024.
Research and Development Expenses. Research and Development expenses during the year ended December 31, 2025, were $3,685,840, as compared to $2,491,771 for the year ended December 31, 2024. The increase in the research and development expenses as compared to the previous year is in line with the Company’s continued focus on improving the design and technological capabilities of its existing SSi Mantra system and further expanding its product offerings.
Stock Compensation Expenses. We had stock compensation expenses of $8,128,103 for the year ended December 31, 2025, compared to $14,342,784 for the year ended December 31, 2024. The substantial decrease in stock-based compensation expense for the year ended December 31, 2025 was primarily due to award of stock options in February 2024 under the Company’s 2016 Incentive Plan to certain executive officers. These were vested immediately upon grant and were fully expensed in the year ended December 31, 2024, resulting in the recognition of approximately $4,656,807 of stock-based compensation expense in the previous year. These options were awarded in recognition of the executives’ efforts in advancing the development and commercialization of the Company’s SSi Mantra system and the residual impact is primarily due to resignation of employees in the current year.
Depreciation and amortization expenses. We had depreciation and amortization expense of $1,075,907 for the year ended December 31,2025, as compared to $436,005 in the year ended December 31, 2024. The depreciation and amortization expenses primarily consist of depreciation on fixed assets only.
Selling, General and Administrative expenses. We incurred $14,848,439 in selling, general and administrative expenses during the year ended December 31, 2025, as compared to $10,157,768 for the year ended December 31, 2024.
28
Our Selling, General and Administrative expenses (“SG&A”) comprise of expenses relating to salaries and benefits, retirement benefits as well as costs related to recruitment, other compensation expenses of sales and marketing and client management personnel, sales commission, travel and brand building, client events and conferences, training and retention of senior management and other support personnel in enabling functions, telecommunications, utilities, travel and other miscellaneous administrative costs. SG&A expenses also include legal and professional fees (which represent the costs of third party legal, tax, accounting, immigration and other advisors), investment in product development, digital technology, advanced automation and robotics, related to grant of our equity awards to members of our board of directors. We expect our SG&A costs to increase as we continue to strengthen our support and enabling functions and invest in leadership development, performance management and training programs. The increase in selling, general and administrative expenses resulted from the increased manpower strength and an increased scale of commercial operations during 2025 as compared to the year ended December 31, 2024.
Other Income (Expenses). We have recognized $33,087 in interest income (net) during the year ended December 31, 2025, as compared to an interest expense (net) of $175,235 during the year ended December 31, 2024. The increase in interest income by $343,724 relating to fixed deposits which is offset by increase in interest expense by $135,402 related to interest on our bank overdraft facility and convertible notes.
Net Loss. We incurred a net loss of $12,127,387 for the year ended December 31, 2025, compared to a net loss of $19,151,197 for the year ended December 31, 2024. The decrease in net loss of $7,023,810 was primarily attributable to an increase in gross profit of $11,091,889 and a decrease in stock-based compensation expense of $6,214,681. These favorable variances were partially offset by increases in research and development expenses of $1,194,069, depreciation expense of $639,902, selling, general and administrative expenses of $4,690,671, and income tax expense of $3,966,440.
Liquidity and Capital Resources
The Company expects to require substantial funds for scaling up its operations, incurring capital expenditures to have its own manufacturing facility for in-house machining and tooling capacity and to continue to finance its research and development work in the field of surgical robotics.
As of December 31, 2025, the Company had shareholders’ equity of $38,218,251 and a working capital surplus of $22,558,961 as compared to shareholders’ equity of $13,457,103 and a working capital surplus of $6,086,069 as of December 31, 2024.
| For the year ended | ||||||||||
| S. No. | Particulars |
December 31, 2025 |
December 31, 2024 |
|||||||
| Net cash provided by operating activities: | ||||||||||
| 1 | Net loss | (12,127,387 | ) | (19,151,197 | ) | |||||
| 2 | Non-cash adjustments | 9,378,429 | 16,435,264 | |||||||
| 3 | Change in operating assets and liabilities | (15,794,029 | ) | (6,787,097 | ) | |||||
| 4 | Net cash used in operating activities | (18,542,987 | ) | (9,503,030 | ) | |||||
| 5 | Net cash used in investing activities | (3,659,058 | ) | (661,479 | ) | |||||
| 6 | Net cash provided by financing activities | 26,166,556 | 9,425,980 | |||||||
| 7 | Net change in cash | 3,964,511 | (738,529 | ) | ||||||
| 8 | Effect of exchange rate on cash | (985,026 | ) | 274,219 | ||||||
| 9 | Cash at beginning of year | 6,623,535 | 7,087,845 | |||||||
| 10 | Cash at end of year | 9,603,020 | 6,623,535 | |||||||
29
Cash Flows Used in Operating Activities
Net cash used in operating activities was $18,542,987 for the year ended December 31, 2025, compared to $ 9,503,030 for the year ended December 31, 2024, representing an increase of $9,039,957 year over year, reflecting the increase in net cash used in operating activities was primarily driven by higher working capital requirements associated with the Company’s expanded scale of operations, which more than offset improvements in operating results. The major drivers contributing to the increase of $9,039,957 in net cash used in operating activities year-over-year included the following:
| ● | Accounts receivable amounted to $13,037,284 in fiscal year 2025, compared to $4,890,032 in fiscal year 2024, reflecting higher billings and the timing of customer collections. |
| ● | Inventory amounted to $8,070,786 in fiscal year 2025, compared to $7,691,518 in fiscal year 2024, reflecting production levels and inventory management in support of anticipated demand. |
| ● | Prepaid expenses and other assets amounted to $5,101,794 in fiscal year 2025, compared to $1,411,621 primarily related to advance payments made in connection with operating activities. |
These uses of cash were partially offset by deferred revenue of $3,953,938 in fiscal year 2025 and accounts payable of $2,877,810 in fiscal year 2025, reflecting customer advance payments and vendor activity.
In addition, net loss was $12,127,387 in fiscal year 2025, compared to $19,151,197 in fiscal year 2024, and stock-based compensation expense was $8,128,103 in fiscal year 2025, compared to $14,342,784 in fiscal year 2024. These items impacted operating cash flows during the respective periods and were considered together with the working capital changes discussed above.
Cash Flows from Investing Activities
During the year ended December 31, 2025, we had net cash used in investing activities of $3,659,058 resulting from purchases of property, plant and equipment.
During the year ended December 31, 2024, we had net cash used in investing activities of $661,479 resulting from purchase of property, plant and equipment.
Cash Flows from Financing Activities
During the year ended December 31, 2025, we had net cash provided by financing activities of $26,166,556, which comprised of $3,448,042 in proceeds from our bank overdraft facility, $28,000,000 in proceeds from the issuance of convertible notes to our principal shareholder, partially offset by repayments of $4,212,637 related to convertible notes to our principal shareholder, including interest, and repayments of $1,068,849 related to convertible notes to other investors, including interest.
During the year ended December 31, 2024, we had net cash, provided by financing activities of $9,425,980, which comprised of $1,975,980 in proceeds from our bank overdraft facility, $3,000,000 each in proceeds from issuance of convertible notes and promissory notes to our principal shareholder and $1,450,000 in proceeds from issuance of convertible notes to other investors.
30
Critical Accounting Estimates
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
We consider the policies discussed below to be critical to an understanding of our consolidated financial statements, as their application places the most significant demands on management’s judgment regarding matters that are inherently uncertain at the time an estimate is made.
These policies include fair value of stock options and standalone selling price in case of bundled revenue contracts.
These accounting policies, estimates and the associated risks are set out below. Future events may not develop exactly as forecasted and estimates routinely require adjustment.
Stock Compensation Expense
Under the fair value recognition provisions of ASC Topic 718, Compensation-Stock Compensation, cost is measured at the grant date based on the fair value of the award and is amortized on a straight-line basis over the requisite service periods of the awards, which is generally the vesting period.
Determining the fair value of stock-based awards at the grant date requires significant judgment, including estimating the expected term over which the stock awards will be outstanding before they are exercised and the expected volatility of our stock.
As of December 31, 2025, the Company has issued two types of equity incentives:
Stock Options: These provide employees with the right, but not the obligation, to purchase shares of our stock at a specified price, within a defined period, as per the terms of the stock option agreement. Stock-based compensation expense associated with our 2016 Incentive Plan is measured at fair value using a Black-Scholes option-pricing model at commencement of each offering period and recognized over that offering period.
Stock Units (Restricted Stock Units, or RSUs): These do not require the employee to exercise any options. Each stock unit automatically converts into a specified number of shares upon vesting. We use last three months’ average share price of common stock on OTC (prior to April 24, 2025) or on Nasdaq (subsequent to April 24, 2025) as grant date fair value for RSUs.
Standalone Selling Price
Our system sale arrangements contain multiple products and services, including system, accessories, instruments and services. Other than services, we generally deliver all of the products upfront. Each of these products and services is a distinct performance obligation. System, instruments, accessories and services are also sold on a standalone basis. For multiple-element arrangements, revenue is allocated to each performance obligation based on its relative standalone selling price. Standalone selling prices are based on observable prices at which we separately sell the products or services. If a standalone selling price is not directly observable, then we estimate the standalone selling prices considering market conditions and entity-specific factors including, but not limited to, historical pricing data, features and functionality of the products and services and industry benchmark. We regularly review standalone selling prices and maintain internal controls over establishing and updating these estimates. Revenue that is allocated to the service obligation is deferred and recognized ratably over the service period upon expiration of first year of service which is free and included in the system sale arrangements.
Off-Balance Sheet Arrangements
There are no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
31
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Not applicable.
Item 8. Financial Statements and Supplementary Data.
See the Index to the Consolidated Financial Statements beginning on page F-1 below.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
Item 9A. Controls and Procedures.
Disclosure Controls and Procedures
Our Chief Executive Officer and Chief Financial Officer evaluated the effectiveness of the design and operation of our disclosure controls and procedures and internal control over financial reporting, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of December 31, 2025.
To ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the SEC, including to ensure that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Based on the evaluation performed as of December 31, 2025, as a result of the material weaknesses in internal control over financial reporting that are described below in Management’s Report on Internal Control Over Financial Reporting, our Chief Executive Officer and Chief Financial Officer determined that our disclosure controls and procedures were not effective as of such date.
Internal Controls over Financial Reporting
(a) Management’s Report on Internal Controls Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). A company’s internal control over financial reporting is a process designed by, or under the supervision of, its Chief Executive Officer and Chief Financial Officer, and effected by such company’s board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
| ● | pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; |
| ● | provide reasonable assurance that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and |
| ● | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the consolidated financial statements. |
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements will not be prevented or detected on a timely basis.
32
Management, with the participation of our Chief Executive Officer and Chief Financial Officer, has conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2025, based on the framework set forth in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment, management has concluded that the Company did not maintain effective internal control over financial reporting as of December 31, 2025 due to the material weaknesses described below.
| ● | We do not have written documentation of our internal control policies and procedures. Written documentation of key internal controls over financial reporting is a requirement of Section 404 of the Sarbanes-Oxley Act. |
| ● | We do not have sufficient segregation of duties within accounting functions, which is a basic internal control. Due to our size and nature, segregation of all conflicting duties may not always be possible and may not be economically feasible. However, to the extent possible, the initiation of transactions, the custody of assets and the recording of transactions should be performed by separate individuals. |
(b) Remediation Plan
The Company has been addressing and remediating these material weaknesses with the support and assistance of the accounting and financial staff employed by SSI-India, our Indian operating subsidiary. We have enhanced the review process for significant transactions to ensure proper accounting treatment under applicable guidelines and have engaged the external experts to provide guidance to the Company staff in the areas of financial reporting, internal controls, and enterprise risk management and assist it in the application of accounting principles to complex transactions. This external expert group is also helping the Company in strengthening its existing internal controls, policies and Standard Operating Procedures (“SOPs”) in all the major functional areas.
In addition, we have also engaged services of external experts in the field of designing, development and implementation of a comprehensive cloud-based ERP system. The ERP implementation process involves a detailed process study of each of the business functions and engagement with their respective process owners, identifying their linkages with other business functions and designing report formats, data sourcing and customizing the ERP system and training of the respective teams to meet the business data flow and reporting requirements of each business function. Post completion of roll out of all the functional modules under this new cloud-based ERP system which is designed to integrate all business functions within the accounting and financial department would help us in further addressing the abovementioned weaknesses.
Our Chief Executive Officer and Chief Financial Officer do not expect that our disclosure controls or internal controls will prevent all errors and all fraud. Although our disclosure controls and procedures were designed to provide reasonable assurance of achieving their objectives, a control system, no matter how well conceived and operated, can provide only reasonable, not absolute assurance that the objectives of the system are met. Further, the design of any control system is subject to resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the fact that judgments in decision-making can be faulty, and that breakdowns can occur because of simple errors or mistakes. There can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
(c) Changes in Internal Controls Over Financial Reporting
Except for the remediation efforts described above, there were no changes in our internal controls over financial reporting that occurred during the last fiscal quarter covered by this Annual Report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
None.
33
PART III
Item 10. Directors, Executive Officers and Corporate Governance.
Our directors and executive officers and their respective ages and titles are as follows:
| Name | Age | Position(s) and Office(s) Held | ||
| Sudhir Srivastava, M.D. | 78 | Chairman, Chief Executive Officer and Director | ||
| Milan Rao | 55 | Global Chief Operating Officer and Chief Financial Officer | ||
| Vishwajyoti P. Srivastava, M.D. | 49 | Chief Executive Officer – Asia Pacific and Director | ||
| Barry F. Cohen | 85 | Chief Operating Officer – Americas and Director | ||
| Dr. Mylswamy Annadurai | 67 | Director | ||
| Dr. S.P. Somashekhar | 53 | Director | ||
| Dr. Frederic H Moll | 73 | Director | ||
| Tim Adams | 56 | Director |
Set forth below is a brief description of the background and business experience of our directors and executive officers.
Sudhir Srivastava, M.D., joined the Company on April 14, 2023, as its Chairman, Chief Executive Officer and a director upon completion of the CardioVentures Merger. Dr. Srivastava founded SSI-India, our Indian operating subsidiary in 2019 and has served as its Chairman, Managing Director and Chief Executive Officer since that time. SSI-India was founded with the objective of launching the development of an advanced, affordable, and accessible surgical robotic system that would benefit greater numbers of patients around the world. Dr. Srivastava completed his medical degree in India in 1971 and moved to the U.S. in 1972, where he underwent a residency in general surgery in St. Louis and further completed his training, including in cardiothoracic surgery, at the University of British Columbia Hospitals in Vancouver, Canada. He is double board certified by the American Board of Surgery and Thoracic Surgery. Dr. Srivastava, after moving to Texas to begin his practice in 1981, became heavily involved in advancing minimally invasive cardiac surgical approaches and robotic cardiac surgery procedures during his time in Texas. While in Texas, in 2002 Dr. Srivastava was the founding chairman of Alliance Hospital, which became one of the busiest robotic cardiac centers globally. In 2007, Dr. Srivastava joined the University of Chicago faculty and served as the Director of Robotic Cardiac Surgery to launch their program. In 2009, Dr. Srivastava moved to Atlanta, Georgia, and founded the International College of Robotic Surgery and launched the Robotic Revascularization Program at St. Joseph’s Hospital. While in the U.S., he performed over 1,400 robotic cardiothoracic procedures and trained over 350 surgical teams from around the world. His passion and experience took him to various countries around the world, where he helped launch robotic cardiac surgery programs. Dr. Srivastava returned to India in 2011 to establish robotic surgery programs throughout the country during a time when robotic surgery was still nascent in India. He founded the International Centre for Robotic Surgery in Delhi, India, and trained surgeons in different specialties, introducing them to high-level robotic cardiac surgery procedures. Recognizing the high cost and limited access to robotic surgery in India, in 2012, Dr. Srivastava undertook the mission of developing an affordable system that would be technologically advanced, so that greater numbers of patients could benefit from robotic cardiac surgery in India and worldwide. His efforts led to the development of the SSi Mantra by the SSi Companies Group, which was commercially introduced in August 2022. Dr. Srivastava is globally recognized as a pioneer and leader in robotic cardiac surgery and has received numerous awards worldwide for advancing the field.
Milan Rao, joined the Company as Global Chief Operating Officer and Chief Financial Officer on January 16, 2026. Mr. Rao, has more than three decades of executive leadership experience driving technology-enabled transformation, operational efficiency and growth at leading global companies across industries, including the healthcare sector. From June 2024 until joining the Company, Mr. Rao served as Chief Operating Officer and Chief Revenue Officer of Markets & Markets, a global consulting firm based in New York City, where he led global operations, sales, marketing and consulting, and was responsible for global partnerships and the firm’s inorganic growth initiatives. From September 2021 to December 2023, Mr. Rao served as President and Global Business Head of Smart Energy Water (“SEW”), a cloud-based SaaS company based in California and New York, connecting consumers with energy and water providers worldwide. Following SEW’s acquisition of Choice Technologies, in 2022 he served as Interim Chief Executive Officer of Choice Technologies and led its global integration with SEW, expanding platform capabilities in artificial intelligence, machine learning and data analytics and growing its customer base. From August 2017 to August 2021, Mr. Rao was President at Wipro Limited (“Wipro”) a Technology Services company. He also led Wipro’s Technology & Transformation Office, including innovation, IP and platforms, marketing, and revenue operations, and launched a digital-first, AI-led transformation program. From June 2013 to August 2017, Mr. Rao served as President and Chief Executive Officer of GE Healthcare for India, South Asia, and emerging markets. Mr. Rao holds a BS in Computer Science and Engineering from IIT (BHU) Varanasi, where he was recognized as a Distinguished Alumnus, and an MBA in Finance from IIM Calcutta.
34
Vishwajyoti P. Srivastava, M.D., joined the Company on April 14, 2023, as its President, Chief Operating Officer – South Asia and a director upon completion of the CardioVentures Merger. In May 2025 Dr. Srivastava was appointed to the position of Chief Executive Officer – Asia Pacific and served as the Company’s interim Chief Financial Officer from July 23, 2025 through September 24, 2025. Dr. Srivastava joined SSI-India as President and Chief Operating Officer for South Asia in November 2020. Prior to that, he served as President of OMNI 3DHD from January 2018 to November 2020, where he led the development of a secondary 3D Visualization System that was designed with the objective of giving 3D vision to the entire robotic surgical team. In 2015, Dr. Srivastava served as the COO of a Miami, Florida based health and wellness startup, Reshape Inc., which developed an online platform for healthy living initiatives. Dr. Srivastava was also instrumental in the creation of the International College of Robotic Surgery in Atlanta, Georgia, in 2009 as well as the International Centre for Robotic Surgery in New Delhi, India, in 2011. Dr. Srivastava has been deeply involved in the field of surgical robotics since 2008, covering the wide spectrum of clinical applications, teaching and training, tele-mentoring platforms, web-based surgeon didactic training modules, digital media and marketing. Dr. Srivastava graduated from Saint James School of Medicine in Anguilla, receiving his M.D. degree in August 2020. Dr. Srivastava also holds a B.A. in International Studies with a focus on South Asia from the University of Washington in Seattle that he received in 2000. Dr. Srivastava completed all his premedical requirements at Columbia University’s Post Baccalaureate Program in New York City, graduating in 2003. He is fluent in English, Hindi and French.
Barry F. Cohen co-founded the Company (then known as Avra Medical Robotics, Inc.) and served as its Chief Executive Officer and a director from February 4, 2015, until completion of CardioVentures Merger on April 14, 2023, when he assumed the position of Chief Operating Officer-Americas and continued as a director. Between 2006 and 2008, Mr. Cohen was a private investor and founded AVRA Surgical, Inc., a medical technology company. Prior to founding the Company, Mr. Cohen was a director of Dualis Med-Tech from 2012 to 2014 and was a director of AvraMiro GmbH from 2009 to 2014 and Avra Surgical Robotics, Inc. since 2011, which is currently inactive. From approximately 1979 to 1983 he served as director of Synalloy Corp., a manufacturer of pipe, piping systems and specialty chemicals after which he was appointed to serve as President from 1984 to 1985. Mr. Cohen also served as Chairman of the Executive Board of Wolverine Technologies, Inc., a NYSE listed company from 1979 to 1983 and President of Barry F. Cohen & Co., an NASD member from 1983 to 1999. Mr. Cohen has over fifty years’ experience in managing private and public industrial companies, and forty-seven years’ experience as a securities executive.
Dr. Mylswamy Annadurai joined the Company as a director on July 30, 2023. Dr. Annadurai is a distinguished space scientist of international repute, who has been involved in the Indian space program for over forty years, approximately thirty-six of which (1982-2018) were spent in various positions with the Indian Space Research Organization (“ISRO”), most recently as Director of the ISRO Satellite Center from April 2015 to July 2018. During that period, he was responsible for overseeing the development, manufacture and launch of twenty-nine satellites. Prior thereto, he also served as Program Director of Indian Remote Sensing and Small Satellite Program at ISRO from 2011-2015, where among other matters, he was responsible for overseeing ISRO’s Mars Orbiter Mission and as Project Director of India’s firs lunar mission, Chandarayaan-1, from 2004-2010. From August 2018 until March 2022, Dr. Annadurai served as Chairman of the National Design and Research Forum and from October 2018 to March 2023, he served as Vice President of the Tamil Nadu State Council for Science and Technology. Since May 2019. Dr. Annadurai has been serving as Chairman of the Aerospace Committee of the Southern India Chamber of Commerce and Industries in Chennai and since March 2021, as a director of Moon Land Technologies Pvt. Ltd. Since February 2023, he is also serving as a Trustee Member of the India Trustee Board of the America-India Foundation. Dr. Annadurai has received numerous awards from the Indian government, ISRO, international space organizations, academic institutions and professional bodies and societies. Dr. Annadurai holds B.E. (ECE), M.E. (Applied Electronics) and Ph.D. degrees from Anna University.
Dr. S.P. Somashekhar joined the Company as a director on July 30, 2023. Dr. Somashekhar is a highly respected surgical oncologist and one of the first physicians to employ robotic surgery in India. Since January 2022, he has been affiliated with the Aster Group of Hospitals in India, where he serves as Global Director of the Aster International Institute of Oncology and Head of Department and Lead Consultant in Surgical and Gynecological Oncology and Robotic Surgery. He also serves as Chairman of the Medical Advisory Board for Aster DM Healthcare. For over twenty years prior to joining Aster, he was affiliated with Manipal Hospitals in Bengaluru, most recently as Head of Department of Surgical Oncology and Chairman of the Surgical Oncology Advisory Board. Dr. Somashekhar has served in a number of teaching positions, significant experience in conducting clinical studies, authored numerous medical papers and articles and received multiple awards in the medical field. He holds an M.B.B.S. degree from Mysuru University, an M.S. in General Surgery from the Sheth K.M. School of Postgraduate & Research in Ahmedabad, and an MCh in Oncosurgery from the Gujarat Cancer & Research Institute in Ahmedabad. He is also a Fellow of the Royal College of Surgeons (Edinburgh).
Dr. Frederic H Moll joined the Company as a Director on August 20, 2024. Dr. Moll is a renowned physician and visionary entrepreneur whose pioneering work in medical robotics has shaped the field of MIS. He did his B.A. from the University of California at Berkeley, an M.D. from the University of Washington, and an M.S. in Business Management from Stanford University. He is a pioneer in Medical Robotics, particularly in MIS. Dr. Moll co-founded Intuitive Surgical in 1995, where he co-developed the da Vinci robotic-assisted surgery system, a global standard for MIS. He also founded Hansen Medical and Auris Health, creating advanced robotic technologies for vascular procedures and lung cancer diagnosis, respectively. His innovations have shaped the field of surgery, and he has served on the boards of directors of influential Healthcare Tech companies like Mako Surgical and RefleXion.
35
Tim Adams joined the Company as a Director on August 20, 2024. Mr. Adams served as President and CEO of Ascension Saint Thomas Health and Ministry Market Executive for Ascension Tennessee from January 2018 until January 2023, leading a network of nine inpatient facilities across Middle Tennessee. Prior to this, he was the Texas Region Chief Executive Officer at Tenet Healthcare, overseeing 26 hospitals and leading operational efforts for one of the Company’s largest regions. Earlier in his career, Mr., Adams served as CEO of Cedar Park Regional Medical Center, a partner with Ascension’s Seton Healthcare Family, and held executive roles at Community Health Systems and IASIS Healthcare, overseeing multi-hospital operations in Texas and Florida. Beyond his professional commitments, he is also an active member of the healthcare community, serving on numerous boards, including the Tennessee Hospital Association, Nashville Health Care Council, and the United Way of Greater Nashville. He holds a Bachelor of Business Administration from Baylor University and an MBA from The University of Texas at El Paso. In January 2023, Tim transitioned to the role of Regional Operating Officer and Senior Vice President for Ascension, overseeing Ascension ministries in 10 states, including Tennessee.
Terms of Office
Our directors are appointed for a one-year term to hold office until the next annual meeting of our shareholders and until a successor is appointed and qualified, or until their removal, resignation, or death. Executive officers serve at the pleasure of the board of directors.
Family Relationships
Dr. Sudhir Srivastava and Dr. Vishwajyoti P. Srivastava are father and son.
There are no other familial relationships among our officers and directors.
Board Committees and Independence
The Company has constituted three standing committees: an audit committee, a compensation committee and a nominating and corporate governance committee.
Our board of directors has determined that Dr. Annadurai, Dr. Somashekhar and Mr. Adams are currently “independent” within the meaning of the applicable rules and regulations of the SEC and the listing standards of the Nasdaq Stock Market. In addition, the board of directors has determined that Mr. Adams is an “audit committee financial expert” as the term is defined by the applicable rules and regulations of the SEC and the Nasdaq Stock Market listing standards, based on his business and management experience. Our board of directors has also determined that at present, Dr. Moll is not “independent” at the present time because his beneficial ownership of our common stock exceeds 10%. Dr. Sudhir Srivastava, Dr. Vishwajyoti P. Srivastava and Mr. Barry F. Cohen are not independent as they are officers and employees of the Company.
Members of the aforesaid Committee (s) are as follows:
| Name of the Committee | Members of the Committee | |
| Audit Committee | Mr. Tim Adams | |
| Dr. SP Somasekhar | ||
| Dr. Mylswamy Annadurai | ||
| Compensation Committee | Mr. Tim Adams | |
| Dr. SP Somasekhar | ||
| Mr. Barry F. Cohen | ||
| Nominating and Corporate Governance Committee | Mr. Tim Adams | |
| Dr. SP Somasekhar |
36
Audit Committee
The audit committee assists our board of directors in its oversight of the Company’s accounting and financial reporting processes and the audits of the Company’s consolidated financial statements, including (a) the quality and integrity of the Company’s consolidated financial statements; (b) the Company’s compliance with legal and regulatory requirements; (c) the independent auditors’ qualifications and independence; and (d) the performance of our Company’s internal audit functions and independent auditors, as well as other matters which may come before it as directed by the board of directors. Further, the audit committee, to the extent it deems necessary or appropriate, among its several other responsibilities, shall:
| ● | be responsible for the appointment, compensation, retention, termination and oversight of the work of any independent auditor engaged for the purpose of preparing or issuing an audit report or performing other audit, review or attest services for the Company; |
| ● | discuss the annual audited consolidated financial statements and the quarterly unaudited condensed consolidated financial statements with management and the independent auditors prior to their filing with the SEC in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q; |
| ● | review with the Company’s financial management on a periodic basis (a) issue regarding accounting principles and consolidated financial statement presentations, including any significant changes in the Company’s selection or application of accounting principles; and (b) the effect of any regulatory and accounting initiatives, as well as off-balance sheet structures, on the consolidated financial statements of the Company; |
| ● | monitor the Company’s policies for compliance with federal, state, local and foreign laws and regulations and the Company’s policies on corporate conduct; |
| ● | maintain open, continuing, and direct communication between the board of directors, the audit committee and our independent auditors; and |
| ● | monitor our compliance with legal and regulatory requirements and shall have the authority to initiate any special investigations of conflicts of interest, and compliance with federal, state and local laws and regulations, including the Foreign Corrupt Practices Act, as may be warranted. |
Compensation Committee
The compensation committee aids our board of directors in meeting its responsibilities relating to the compensation of the Company’s executive officers and to administer all incentive compensation plans and equity-based plans of the Company, including the plans under which Company securities may be acquired by directors, executive officers, employees and consultants. Further, the compensation committee, to the extent it deems necessary or appropriate, among its several other responsibilities, shall:
| ● | review periodically the Company’s philosophy regarding executive compensation to (a) ensure the attraction and retention of corporate officers, (b) ensure the motivation of corporate officers to achieve the Company’s business objectives, and (c) align the interests of key management with the long-term interests of our shareholders; |
37
| ● | review and approve corporate goals and objectives relating to Chief Executive Officer compensation and other executive officers of SSi and its subsidiary companies; |
| ● | make recommendations to the board of directors regarding compensation for non-employee directors, and review periodically non-employee director compensation in relation to other comparable companies and in light of such factors as the compensation committee may deem appropriate; and |
| ● | review periodically reports from management regarding funding the Company’s pension, retirement, long-term disability and other management welfare and benefit plans. |
Nominating and Corporate Governance Committee
The nominating and corporate governance committee shall recommend to the board of directors individuals qualified to serve as directors and on committees of the board of directors to advise the board of directors with respect to the board of directors composition, procedures and committees to develop and recommend to the board of directors a set of corporate governance principles applicable to the Company; and to oversee the evaluation of our board of directors and management.
Further, the nominating and corporate governance committee, to the extent it deems necessary or appropriate, among its several other responsibilities shall:
| ● | recommend to the board of directors and for approval by a majority of independent directors for election by shareholders or appointment by the board of directors as the case may be pursuant to our bylaws and consistent with the board of directors’ criteria for selecting new directors; |
| ● | review the suitability for continued service as a director of each member of the board of directors when his or her term expires or when he or she has a significant change in status; |
| ● | review annually the composition of the board of directors and to review periodically the size of the board of directors; |
| ● | make recommendations on the frequency and structure of board of directors’ meetings or any other aspect of procedures of the board of directors; |
| ● | make recommendations regarding the chairmanship and composition of standing committees and monitor their functions; |
| ● | review annual committee assignments and chairmanships; |
| ● | recommend the establishment of special committees as may be necessary or desirable from time to time; and |
| ● | develop and review periodically corporate governance procedures and consider any other corporate governance issue. |
38
Compliance with Section 16(a) of the Securities Exchange Act of 1934
Section 16(a) of the Exchange Act requires our executive officers and directors and persons who own more than 10% of a registered class of our equity securities to file with the SEC initial statements of beneficial ownership, reports of changes in ownership and annual reports concerning their ownership of our common stock and other equity securities, on Forms 3, 4 and 5 respectively. Executive officers, directors and greater than 10% stockholders are required by the SEC regulations to furnish us with copies of all Section 16(a) reports that they file.
Based solely on our review of the copies of such forms received by us, or written representations from certain reporting persons, we believe that all filing requirements applicable to our officers, directors and greater than 10% beneficial owners were complied with under Section 16 of the Exchange Act during the year ended December 31, 2025, and up through the date of this Annual Report, except for the following late filings resulting from administrative oversights:
| ● | A Form 4 reporting the acquisition by Dr. Sudhir Srivastava of a $2,000,000 principal amount 7% One-Year Convertible Promissory Note from the Company on December 4, 2024, was filed on January 23, 2025. |
| ● | A Form 4 reporting the acquisition by Dr. Sudhir Srivastava of a $5,000,000 principal amount 7% One-Year Convertible Promissory Note from the Company on January 3, 2025, was filed on January 23, 2025. |
| ● |
A Form 4 reporting the disposition by gift of 221,788 shares of common stock by Dr. Sudhir Srivastava on February 5, 2025, was filed on February 11, 2025. | |
| ● | A Form 4 reporting the acquisition by Dr. Sudhir Srivastava of a $5,000,000 principal amount 7% One-Year Convertible Promissory Note from the Company on January 30, 2025, was filed on February 21, 2025. |
| ● |
A Form 4 reporting the acquisition of 50,000 shares of common stock by Prof. Dr. Somashekar S.P. on August 31, 2024, was filed on February 28, 2025. | |
| ● |
A Form 4 reporting the acquisition of 100 shares of common stock by Barry Cohen on April 17, 2025, was filed on April 22, 2025. | |
| ● |
A Form 3 initial statement of beneficial ownership of securities reporting for Arvind Palaniappan on May 1, 2025, was filed on May 19, 2025. | |
| ● | A Form 4 reporting the disposition by gift of 1,000,000 shares of common stock by Barry Cohen on May 22, 2025, was filed on June 30, 2025. | |
| ● |
A Form 4 reporting the various dispositions and acquisitions of shares of common stock by gift by Dr. Sudhir Srivastava between May 12, 2025 and July 14, 2025, was filed on August 13, 2025. | |
| ● |
A Form 4 reporting the acquisition by gift of 2,500 shares of common stock by Dr. Sudhir Srivastava on September 3, 2025, was filed on September 8, 2025. | |
| ● |
A Form 4 reporting the disposition by gift of 3,300 shares of common stock by Barry Cohen on October 8, 2025, was filed on November 17, 2025. | |
| ● |
A Form 3 initial statement of beneficial ownership of securities reporting for Milan Rao on January 16, 2026, was filed on January 30, 2026. |
Rule 10b5-1 Trading Arrangements
During the year ended December 31, 2025,
no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company
Code of Ethics
We have adopted a Code of Ethics that applies to employees, including our principal executive officer, principal financial officer and/or people performing similar functions.
Board of Directors Role in Risk Oversight
Members of the board of directors have periodic meetings with management and the Company’s independent auditors to perform risk oversight with respect to the Company’s internal control processes. The Company believes that the board’s role in risk oversight does not materially affect the leadership structure of the Company.
Insider Trading Policies and Procedures
We have adopted insider trading policies and procedures governing the purchase, sale, and/or other dispositions of our securities by our directors, officers and employees, and the Company itself, that are reasonably designed to promote compliance with insider trading laws, rules and regulations, and any listing standards applicable to the Company.
39
Involvement in Certain Legal Proceedings
To the best of our knowledge, during the past ten years, none of our directors or executive officers were involved in any of the following: (1) any bankruptcy petition filed by or against any business of which such person was a general partner or executive officer either at the time of the bankruptcy or within two years prior to that time; (2) any conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offenses); (3) being subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction, permanently or temporarily enjoining, barring, suspending or otherwise limiting his involvement in any type of business, securities or banking activities; and (4) being found by a court of competent jurisdiction (in a civil action), the Securities and Exchange Commission or the Commodities Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended or vacated.
Compensation Committee Interlocks and Insider Participation
None of our officers currently serves, or in the past year has served, as a member of the compensation committee of any entity that has one or more officers serving on our board of directors.
Item 11. Executive Compensation.
Summary Compensation Table
The table below summarizes all compensation awarded to earned by or paid to our Chief Executive Officer (our principal executive officer) and our two most highly compensated executive officers other than our Chief Executive Officer (collectively, the “named executive officers”) for the year ended December 31, 2025.
| Name and Principal Position | Year | Salary ($) | Bonus ($) | Stock Awards (#) | Options Awards (#)(1) | Option Awards ($)(1) | Non-Equity Incentive Plan Compensation ($) | Nonqualified Deferred Compensation Earnings ($) | All Other Compensation ($) | Total ($) | ||||||||||||||||||||||||||||||
| Sudhir Srivastava, M.D. | 2025 | 600,000 | - | - | 5,886,997 | 13,307,213 | - | - | 299,538 | 14,206,751 | ||||||||||||||||||||||||||||||
| Chairman and Chief Executive Officer (1) | ||||||||||||||||||||||||||||||||||||||||
| Vishwajyoti P. Srivastava, M.D. | 2025 | 266,668 | - | - | 845,592 | 2,883,468 | - | - | 54,333 | 3,204,469 | ||||||||||||||||||||||||||||||
| Chief Executive Officer – Asia Pacific (2) | ||||||||||||||||||||||||||||||||||||||||
| Barry F. Cohen | 2025 | 180,000 | - | - | 845,592 | 2,883,468 | - | - | - | 3,063,468 | ||||||||||||||||||||||||||||||
| Chief Operating Officer – Americas | ||||||||||||||||||||||||||||||||||||||||
| (1) | Represents an option to purchase common stock granted under our 2016 Incentive Plan. The option vests in five equal annual installments commencing upon the date of grant and expires five years from the date of grant. |
| (2) | Dr. Vishwajyoti Srivastava served as our President and Chief Operating Officer – South Asia from April 2023 until May 2025, when he was appointed Chief Executive Officer – Asia Pacific. |
40
Employment Agreements
The Company is party to an employment agreement with Dr. Sudhir Srivastava for a three year period expiring on July 31, 2027, which provides for an annual base salary of $600,000.
Dr. Vishwajyoti P. Srivastava is party to an employment agreement with the Company expiring on April 30, 2030, which provides for a base annual salary of $300,000 effective May 1, 2025.
The Company is party to an employment agreement with Barry F. Cohen expiring in April 2026, which provides for an annual base salary of $180,000.
The Company and Milan Rao entered into a one-year services agreement, effective January 16, 2026 (the “Services Agreement”), providing for monthly base compensation of $41,667. In addition, the Services Agreement provides for Mr. Rao to receive a stock grant under the Company’s 2016 Incentive Plan) in the amount of 120,000 shares of the Company’s common stock vesting in equal monthly installments of 10,000 shares, subject to continued engagement of Mr. Rao by the Company and the other terms and conditions of the 2016 Incentive Plan. In the event, the Services Agreement is terminated by the Company “Without Cause” (as defined in the Services Agreement) prior to the six month anniversary of the effective date of the Services Agreement, then Mr. Rao shall be entitled to receive, (i) payment of his base compensation through the six month anniversary of the effective date of the Services Agreement; and (ii) any unvested installment of the stock grant which would vest on or before the six month anniversary of the effective date shall vest in full as of the termination date. Any other unvested portion of his stock grant will terminate as of the termination date of the Services Agreement.
Each of the above agreements provides for reimbursement of reasonable business expenses incurred in the performance of the executive’s duties and contains customary confidentiality, assignment of proprietary rights, non-competition and non-solicitation provisions.
Outstanding Equity Awards at Fiscal Year-End Table
The table below summarizes all unexercised options, stock that has not vested, and equity incentive plan awards for each of our executive officers outstanding as of December 31, 2025
| Number of Securities Underlying Unexercised Options Exercisable |
Number of Securities Underlying Unexercised Options Unexercisable |
Option Exercise Price* |
Option Expiration Date |
Number of shares that have not vested |
Market value of shares of stock that have not vested |
|||||||||||||||||
| Sudhir Srivastava, M.D. | 4,872,286 | 1,014,710 | $ | 5.00 | Nov 27, 2028 | |||||||||||||||||
| Vishwajyoti P. Srivastava | 507,355 | 338,237 | $ | 5.00 | Nov 27, 2028 | |||||||||||||||||
| Barry F. Cohen | 507,355 | 338,237 | $ | 5.00 | Nov 27, 2028 | |||||||||||||||||
| * | The volume weighted average exercise price per share for all options awarded is $5.00. |
The above are options to purchase common stock granted under our 2016 Incentive Plan. The options vest in five equal annual instalments commencing upon the date of grant and expire five years from the date of grant.
41
Compensation of Directors Table
The table below summarizes all compensation paid to our directors for the year ended December 31, 2025, our last completed fiscal year.
| DIRECTOR COMPENSATION | ||||||||||||||||||||||||||||||||
| Name | Fees Earned or paid in Cash ($) |
Stock Awards ($) |
Option Awards (#) |
Option Awards(1) ($) |
Non-Equity Incentive Plan Compensation ($) |
Non-Qualified Deferred Compensation Earnings ($) |
All Other Compensation ($) |
Total ($) |
||||||||||||||||||||||||
| Sudhir Srivastava, M.D. | 600,000 | 0 | 5,886,997 | 13,307,213 | 0 | 0 | 299,538 | 14,206,751 | ||||||||||||||||||||||||
| Vishwajyoti P. Srivastava, M.D. | 266,668 | 0 | 845,592 | 2,883,468 | 0 | 0 | 54,333 | 3,204,469 | ||||||||||||||||||||||||
| Barry F. Cohen | 180,000 | 0 | 845,592 | 2,883,468 | 0 | 0 | 0 | 3,063,468 | ||||||||||||||||||||||||
| Dr. Mylswamy Annadurai | 0 | 0 | 0 | 0 | 0 | 0 | 6,000 | 6,000 | ||||||||||||||||||||||||
| Dr. S.P. Somashekhar | 0 | 0 | 0 | 0 | 0 | 0 | 6,000 | 6,000 | ||||||||||||||||||||||||
| Tim Adams | 0 | 0 | 0 | 0 | 0 | 0 | 6,000 | 6,000 | ||||||||||||||||||||||||
| Frederic H Moll | 0 | 0 | 0 | 0 | 0 | 0 | 4,500 | 4,500 | ||||||||||||||||||||||||
| (1) | Represents the value of options to purchase common stock granted under our 2016 Incentive Plan. The option vests in five equal annual instalments commencing upon the date of grant and expires five years from the date of grant. |
Narrative Disclosure to the Director Compensation Table
We compensate our non-employee directors with cash fees of $1,500 per meeting. Non-employee directors are also reimbursed for travel and lodging expenses in connection with their attendance at in-person meetings of the board. In 2026, we intend to implement an equity-based compensation plan for our non-employee directors in conjunction with our advisors.
2016 Incentive Stock Plan
Our 2016 Incentive Plan provides for equity incentives to be granted to our employees, executive officers or directors or to key advisers or consultants. Equity incentives may be in the form of stock options with an exercise price not less than the fair market value of the underlying shares as determined pursuant to the 2016 Incentive Plan, restricted stock awards, other stock-based awards, or any combination of the foregoing. In the absence of a compensation committee, the 2016 Incentive Plan was administered by the board of directors. However, with the recent constitution of compensation committee, the Plan will henceforth be administered by the compensation committee, 3,000,000 shares of our common stock were originally reserved for issuance pursuant to the exercise of awards under the 2016 Incentive Plan. In August 2019, our board of directors and our majority shareholders approved an increase in the number of shares reserved under the 2016 Plan to 10,000,000 shares of our common stock. Our board of directors and majority shareholders in July 2022, approved a subsequent increase in the number of shares of our common stock reserved under the 2016 Incentive Plan to 20,000,000 shares of common stock. Our board of directors and majority shareholders in October 2023 mandated to keep 10% of our issued and outstanding common shares reserved under the 2016 Incentive Stock Plan. As of December 31, 2025, we have granted options to purchase 7,578,181 shares under the 2016 Plan, exercisable at a weighted average price of $5.00 per share and 3,592,779 shares in stock grants.
The 2016 Incentive Plan (but not awards under the 2016 Incentive Plan) expired in accordance with its terms on February 1, 2026. We intend to implement a new equity incentive plan in 2026.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The following table sets forth, as of the data of this Annual Report, the beneficial ownership of our common stock by (i) each director and executive officer; (ii) directors and executive officers as a group; (iii) each five percent (5%) beneficial owner of our common stock.
The percentage ownership information shown in the table reflects beneficial ownership based upon 194,356,696 shares of common stock outstanding as of the date of this Annual Report (not including 5,774,839 shares issuable in connection with the private placement completed on March 6, 2026 – See “Item1. Business – Recent Development”). Unless otherwise stated, the address of the persons set forth on the table is c/o the Company.
42
Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities. Except as otherwise indicated, each person or entity named in the table has sole voting and investment power with respect to all shares of our capital shown as beneficially owned, subject to applicable community property laws. In accordance with SEC rules, shares of our common stock which may be acquired upon exercise of stock options which are currently exercisable or which become exercisable within sixty (60) days of the date of this Annual Report are deemed beneficially owned by the holders of such options and are deemed outstanding for the purpose of computing the percentage of ownership of such person, but are not treated as outstanding for the purpose of computing the percentage of ownership of any other person.
| Names and addresses of beneficial owners | Number of shares of common stock | Percentage of class (%) | ||||||
| Directors and executive officers | ||||||||
| Sudhir Srivastava, M.D.(1) | 114,257,301 | 57.35 | % | |||||
| Milan Rao(2) | 30,000 | * | ||||||
| Vishwajyoti P. Srivastava, M.D.(3) | 2,507,355 | 1.29 | % | |||||
| Barry F. Cohen(4) | 8,313,443 | 4.27 | % | |||||
| Dr. Mylswamy Annadurai | - | * | ||||||
| Dr. S.P. Somashekhar(5) | 341,165 | * | ||||||
| Tim Adams | 5,031,902 | 2.59 | % | |||||
| Dr. Frederic H Moll | 20,335,045 | 10.46 | % | |||||
| All directors and executive officers as a group (eight persons)(6) | 150,816,211 | 76.15 | % | |||||
| 5% or greater shareholders | ||||||||
| Manipal Global Health Services(7) | 14,949,070 | 7.69 | % | |||||
| 22, St. Georges Street, Port Louis 11302, Mauritius | ||||||||
Unless otherwise indicated, the address for all our directors and executive officers is, care of the Company, 404-405, 3rd Floor, iLabs Info Technology Centre, Udyog Vihar, Phase III, Gurugram, Haryana 122016, India.
| * | Less than 1%. |
| (1) | Includes (a) 109,353,014 shares held of record by Sushruta Pvt. Ltd. (“Sushruta”), a Bahamian holding company beneficially owned by Dr. Sudhir Srivastava; (b) 32,000 shares held by Dr Sudhir Srivastava; and (c) 4,872,287 shares issuable upon the exercise of vested stock options granted under our 2016 Incentive Plan. Sushruta also holds all 1,000 issued and outstanding Series A Preferred Shares, which entitles the holder to 51% of the total voting power of the Company. |
| (2) | Represents a grant of shares of our common stock awarded under our 2016 Incentive Plan which vests within 60 days of the date of this Annual Report. |
| (3) | Includes (a) 2,000,000 shares held of record by Matilda Pvt. Ltd. (“Matilda”), a Bahamian holding company beneficially owned by Dr. Vishwajyoti P Srivastava; and (b) 507,355 shares issuable upon the exercise of vested stock options granted under the 2016 Incentive Plan. |
| (4) | Includes 507,355 shares issuable upon the exercise of vested stock options granted under the 2016 Incentive Plan. |
| (5) | Includes a grant of 166,348 fully vested restricted shares of our common stock awarded under our 2016 Incentive Plan and 58,469 shares of common stock held by his spouse Dr. Manjiri Somashekhar. |
| (6) | Includes the items in footnotes (1) – (5) above. |
| (7) | Dr. Ranjan R. Pai is the beneficial owner of the shares of common stock held of record by Manipal Global Health Services. |
The people named above have full voting and investment power with respect to the shares indicated. Under the rules of the SEC, a person (or group of persons) is deemed to be a “beneficial owner” of a security if he or she, directly or indirectly, has or shares the power to vote or to direct the voting of such security, or the power to dispose of or to direct the disposition of such security. Accordingly, more than one person may be deemed to be a beneficial owner of the same security.
43
Securities Authorized for Issuance under Equity Compensation Plans
| Plan category | Number of securities to be issued upon exercise of outstanding options, grants warrants and rights | Weighted- average exercise price of outstanding options, grants warrants and rights | Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) | |||||||||
| Equity compensation plans approved by security holders | 11,647,844 Shares | $ | 4.343 | 7,787,826 Shares | ||||||||
| Equity compensation plans not approved by security holders | ||||||||||||
| Total | 11,647,844 | $ | 4.343 | 7,787,826 | ||||||||
| (1) | Represents shares of common stock under our 2016 Incentive Plan. As of the date of this Annual Report, 11,647,844 shares of common stock (comprised of 7,739,432 stock options and 3,908,412 stock grants) were issued under the Incentive Stock Plan. The 2016 Incentive Plan (but not awards under the 2016 Incentive Plan) expired on February 1, 2026, in accordance with its terms. |
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Related Party Transactions
Information to be filed pursuant to this Item 13 are appended to this Annual Report on Form 10-K filed herewith can be found at Part IV “Item 15, Exhibits and Consolidated Financial Statement Schedules” under Note 20.
44
Item 14. Principal Accountant Fees and Services
Fees billed by our independent registered public accountant firm, BDO India Services Private Limited (“BDO”) for services provided for the years ended December 31, 2025 and December 31, 2024 were as follows:
| Year Ended December 31, 2025 | Year Ended December 31, 2024 | |||||||
| Audit Fees(1) | 347,580 | 686,326 | ||||||
| Audit-Related Fees | - | - | ||||||
| Tax Fees | - | - | ||||||
| All Other Fees | - | - | ||||||
| Total | 347,580 | 686,326 | ||||||
| (1) | Audit fees represent fees for professional services rendered in connection with the audit of the Company’s annual consolidated financial statements, the review of condensed consolidated financial statements included in the Company’s Quarterly Reports on Form 10-Q, and audit services provided in connection with other statutory and regulatory filings or engagements. Audit fees decreased to $347,580 for fiscal year 2025, compared to $686,326 for fiscal year 2024. |
Audit Fees
This category includes the audit of our annual consolidated financial statements, review of condensed consolidated financial statements included in our Quarterly Reports on Form 10-Q and services that are normally provided by the independent registered public accounting firm in connection with engagements for those fiscal years. This category also includes advice on audit and accounting matters that arose during, or as a result of, the audit or the review of interim consolidated financial statements.
Audit-Related Fees
This category consists of assurance and related services by the independent registered public accountant firm that are reasonably related to the performance of the audit or review of our consolidated financial statements and are not reported above under “Audit Fees.” The services for the fees disclosed under this category include consultation regarding our correspondence with the SEC and other accounting consulting.
Tax Fees
This category consists of professional services rendered by our independent registered public accounting firm for tax compliance and tax advice. The services for the fees disclosed under this category include tax return preparation and technical tax advice.
All Other Fees
This category consists of fees for other miscellaneous items.
Pre-Approval Policy
Our board of directors has adopted a procedure for pre-approval of all fees charged by our independent registered public accounting firm. Under the procedure, the audit committee of the board of directors and/or the board of directors as a whole, approves the engagement letter with respect to audit, tax and review services. Other fees are subject to pre-approval by the audit committee and/or the board of directors. Any services and fees of BDO are also approved pursuant to the pre-approval policy of the Company.
Provision of the above-mentioned services was approved by our audit committee.
45
PART IV
Item 15. Exhibits and Financial Statement Schedules.
| (a) | The following documents are filed as part of this Report: |
| (1) | Financial Statements. The following financial statements and the report of our independent registered public accounting firm are filed as “Item 8. Financial Statements and Supplementary Data” of this Annual Report: |
| (2) | Financial Statement Schedules. |
Financial Statement Schedules are omitted because the information required is not applicable or the required information is shown in the financial statements or notes thereto.
46
| (3) | Exhibits. |
| (1) | Filed as an exhibit to the Company’s Registration Statement on Form S-1 (File No. 333-216054) and incorporated herein by reference. |
| (2) | Filed as an exhibit to the Company’s Current Report on Form 8-K filed on April 19, 2023, and incorporated herein by reference. |
| (3) | Filed as an exhibit to the Company’s Registration Statement on Form S-1 (File No. 333-293114) and incorporated herein by reference. |
| (4) | Filed as an exhibit to the Company’s Current Report on Form 8-K, filed on January 8, 2026, and incorporated herein by reference. |
| (5) | Filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed on April 15, 2025, and incorporated herein by reference. |
| (6) | Filed herewith. |
| + | Indicates management contract or compensatory plan or arrangement. |
Item 16. Form 10-K Summary.
None.
47
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| SS INNOVATIONS INTERNATIONAL, INC. | ||
| Dated: March 10, 2026 | By: | /s/ Sudhir Prem Srivastava |
| Sudhir Prem Srivastava, M.D. | ||
| Chairman and Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| Dated: March 10. 2026 | By: | /s/ Milan Rao |
| Milan Rao | ||
| Global Chief Operating Officer | ||
| And Chief Financial Officer |
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated:
| Dated: March 10, 2026 | By: | /s/ Sudhir Prem Srivastava |
| Sudhir Prem Srivastava, M.D. Chairman, Chief Executive Officer and Director | ||
| (Principal Executive Officer) |
| Dated: March 10, 2026 | By: | /s/ Milan Rao |
| Milan Rao Chief Financial Officer | ||
| (Principal Financial Officer and Principal Accounting Officer) |
| Dated: March 10, 2026 | By: | /s/ Vishwajyoti P. Srivastava |
| Vishwajyoti P. Srivastava, M.D., Chief Executive Officer – Asia Pacific and Director |
| Dated: March 10, 2026 | By: | /s/ Barry F. Cohen |
| Barry F. Cohen, Chief Operating Officer – Americas and Director |
| Dated: March 10, 2026 | By: | /s/ Mylswamy Annadurai |
| Dr. Mylswamy Annadurai, Director | ||
| Dated: March 10, 2026 | By: | /s/ S.P. Somashekhar |
Dr. S.P. Somashekhar | ||
Director | ||
48
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Shareholders and Board of Directors
SS Innovations International Inc.
Gurugram, India
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of SS Innovations International Inc. (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, consolidated statements of changes in equity, and consolidated statements of cash flows for each of the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered recurring losses from operations and has negative cash flows from operating activities during the year ended December 31, 2025. The Company is dependent on further funding to meet its obligations to sustain its operations. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to this matter is also described in Note 1 to the consolidated financial statements. These consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
F-2
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Determination of Standalone Selling Price
As described in Note 2 to the consolidated financial statements, during the year ended December 31, 2025, the Company recognized revenue for system sale arrangements of $38,353,048. The Company’s system sale arrangements could include a combination of the following performance obligations: system(s); system accessories or instruments and extended warranty. For multiple-element arrangements, revenue is allocated to each distinct performance obligation based on its relative standalone selling price (“SSP”). SSP are based on observable prices at which the Company separately sells the products or services. If a SSP is not directly observable, then management estimates the SSP considering market conditions and entity-specific factors including historical pricing data, features and functionality of the products and services and industry data.
We identified the determination of the SSP of distinct performance obligations as a critical audit matter. The determination of SSP requires management’s significant judgments and assumptions. Auditing management’s significant judgments and assumptions involved especially challenging and subjective auditor judgment due to the nature and extent of audit effort required to address these matters.
The primary procedures we performed to address this critical audit matter included:
| ● | Assessing the appropriateness of management’s process and methodology for determining the SSP against relevant accounting literature. |
| ● | Testing the reasonableness of management’s significant assumptions and judgments used in determining the SSP through: (i) assessing a sample of revenue contracts and identifying distinct performance obligations, (ii) evaluating the consistency of assumptions used against internal and external market data and competitor margin data, and (iii) testing the completeness and accuracy of the data used in developing the SSP assumptions. |
/s/
We have served as the Company’s auditor since 2024.
Date: March 10, 2026
F-3
SS INNOVATIONS INTERNATIONAL, INC.
CONSOLIDATED BALANCE SHEETS
| As of | ||||||||||
| Notes | December 31, 2025 | December 31, 2024 | ||||||||
| ASSETS | ||||||||||
| Current Assets: | ||||||||||
| Cash and cash equivalents | 7 | $ | $ | |||||||
| Restricted cash | 7 | |||||||||
| Accounts receivable, net | 6 | |||||||||
| Inventory, net | 14 | |||||||||
| Prepaids and other current assets | 8 | |||||||||
| Total Current Assets | ||||||||||
| Property, plant, and equipment, net | 4 | |||||||||
| Right of use asset | 15 | |||||||||
| Deferred tax assets, net | 16 | |||||||||
| Accounts receivable, net | 6 | |||||||||
| Restricted cash | 7 | |||||||||
| Prepaids and other non current assets | 8 | |||||||||
| Total Assets | $ | $ | ||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||
| Current Liabilities | ||||||||||
| Bank overdraft facility | 11 | $ | $ | |||||||
| Notes payable | 10 | |||||||||
| Current portion of operating lease liabilities | 15 | |||||||||
| Accounts payable | 9 | |||||||||
| Deferred revenue | 12 | |||||||||
| Accrued expenses & other current liabilities | 9 | |||||||||
| Total Current Liabilities | ||||||||||
| Operating lease liabilities, less current portion | 15 | |||||||||
| Deferred Revenue | 12 | |||||||||
| Other non current liabilities | 9 | |||||||||
| Total Liabilities | $ | $ | ||||||||
| Commitments and contingencies | 21 | |||||||||
| Stockholders’ equity: | ||||||||||
| Preferred stock, authorized | 13 | |||||||||
| Common stock, | 13 | |||||||||
| Accumulated other comprehensive income (loss) | ( | ) | ( | ) | ||||||
| Additional paid in capital | ||||||||||
| Capital reserve | ||||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||||
| Total stockholders’ equity | ||||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-4
SS INNOVATIONS INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| For The Year Ended | ||||||||||
| Notes | December 31, 2025 | December 31, 2024 | ||||||||
| REVENUES | ||||||||||
| System sales | 12 | |||||||||
| Instruments sale | 12 | |||||||||
| Warranty sale | 12 | |||||||||
| Lease income | 12 | |||||||||
| Total revenue | $ | $ | ||||||||
| Cost of revenue | ( | ) | ( | ) | ||||||
| GROSS PROFIT | ||||||||||
| OPERATING EXPENSES: | ||||||||||
| Research & development expense | ||||||||||
| Stock compensation expense | 19 | |||||||||
| Depreciation and amortization expense | 4 | |||||||||
| Selling, general and administrative expense | ||||||||||
| TOTAL OPERATING EXPENSES | ||||||||||
| Loss from operations | ( | ) | ( | ) | ||||||
| OTHER INCOME (EXPENSE): | ||||||||||
| Interest Expense | ( | ) | ( | ) | ||||||
| Interest and other income, net | ||||||||||
| TOTAL INCOME / (EXPENSE), NET | ( | ) | ||||||||
| LOSS BEFORE INCOME TAXES | ( | ) | ( | ) | ||||||
| Income tax expense | 16 | |||||||||
| NET LOSS | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share - basic and diluted | 2(r) | $ | ( | ) | $ | ( | ) | |||
| Weighted average - basic shares | 2(r) | |||||||||
| Weighted average - diluted shares | 2(r) | |||||||||
| CONSOLIDATED STATEMENTS OF OTHER COMPREHENSIVE LOSS | ||||||||||
| NET LOSS | $ | ( | ) | $ | ( | ) | ||||
| OTHER COMPREHENSIVE INCOME (LOSS): | ||||||||||
| Foreign currency translation loss | ( | ) | ( | ) | ||||||
| Retirement Benefit | 17 | ( | ) | ( | ) | |||||
| RECLASSIFICATION ADJUSTMENTS: | ||||||||||
| Retirement Benefit (1) | 17 | |||||||||
| Income tax effects relating to retirement benefit | 16 | |||||||||
| TOTAL OTHER COMPREHENSIVE LOSS | ( | ) | ( | ) | ||||||
| TOTAL COMPREHENSIVE LOSS | $ | ( | ) | $ | ( | ) | ||||
| (1) |
The accompanying notes are an integral part of these consolidated financial statements.
F-5
SS INNOVATIONS INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
| Preferred Stock | Common Stock | Common Stock to be Issued | Accumulated other comprehensive | Additional Paid-In | Capital | Accumulated | Total Stockholders’ | |||||||||||||||||||||||||||||||||||||
| Number | Amount | Number | Amount | Number | Amount | income (loss) | Capital | Reserve | Deficit | equity | ||||||||||||||||||||||||||||||||||
| Balance as at December 31, 2023 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Stock compensation | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||
| Common stock issued against exercise of warrants | - | ( | ) | ( | ) | - | ||||||||||||||||||||||||||||||||||||||
| Stock issued for services | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Stock grants | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||
| Balance as at December 31, 2024 | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||
| Stock compensation | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||
| Common stock issued against exercise of warrants | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Conversion of notes payable to equity | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Stock issued for services | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Stock grants | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||
| Balance as at December 31, 2025 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-6
SS INNOVATIONS INTERNATIONAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| For the Year Ended | ||||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Operating lease expense | ||||||||
| Interest Expense | ||||||||
| Interest and other income, net | ( | ) | ( | ) | ||||
| Property, plant and equipment written off | ||||||||
| Provision for credit loss reserve, net | ||||||||
| Deferred income tax benefit | ( | ) | ||||||
| Stock compensation expense | ||||||||
| Provision for slow moving inventory | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable, net | ( | ) | ( | ) | ||||
| Inventory, net | ( | ) | ( | ) | ||||
| Deferred revenue | ||||||||
| Prepaids and other assets | ( | ) | ( | ) | ||||
| Accounts payable | ||||||||
| Income taxes payable, net | ||||||||
| Accrued expenses & other liabilities | ||||||||
| Operating lease payment | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchase of property, plant and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from bank overdraft facility (net) | ||||||||
| Proceeds from issuance of promissory notes to principal shareholder | ||||||||
| Proceeds from issuance of convertible notes to principal shareholder | ||||||||
| Proceeds from issuance of convertible notes to other investors | ||||||||
| Repayment of convertible notes to principal shareholder, including interest | ( | ) | ||||||
| Repayment of convertible notes to other investors, including interest | ( | ) | ||||||
| Net cash provided by financing activities | ||||||||
| Net change in cash | ( | ) | ||||||
| Effect of exchange rate on cash | ( | ) | ||||||
| Cash and cash equivalents at the beginning of the year | ||||||||
| Cash and cash equivalents at end of the year | $ | $ | ||||||
| ^ For cash and cash equivalents and restricted cash, refer Note 7 | ||||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Conversion of convertible notes into common stock, including interest | $ | |||||||
| Transfer of systems from inventory to property, plant and equipment | $ | $ | ||||||
| Transfer of systems from property, plant and equipment to inventory | $ | |||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-7
SS INNOVATIONS INTERNATIONAL, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – FINANCIAL STATEMENTS
Organization
SS Innovations International, Inc. (the “Company”
or “SSII”) was incorporated as AVRA Surgical Microsystems, Inc. in the State of Florida on
On April 14, 2023, a wholly owned subsidiary
of the Company, AVRA-SSI Merger Corporation (“Merger Sub”) merged with CardioVentures, Inc., a Delaware corporation
(“CardioVentures”), the indirect parent of Sudhir Srivastava Innovations Pvt. Ltd., an Indian private limited company
engaged in the business of developing innovative surgical robotic technologies. As a result of the transaction, a “change in
control” of the Company took place. In addition, among other matters, the Company changed its name to “SS Innovations
International, Inc.” and implemented a
The Transaction was accounted for as a recapitalization in accordance with GAAP (the “Recapitalization”). Under this method, AVRA was treated as the “acquired” company (the “Accounting Acquiree”) and Cardio Ventures Inc., the accounting acquirer, was assumed to have issued stock for the net assets of AVRA, accompanied by a recapitalization. Accordingly, for the year ended December 31, 2022, CardioVentures has been considered the ultimate holding company. Prior to October 18, 2022, Cardio Ventures Pvt Ltd., Bahamas (Cardio Bahamas), was in existence and served as the ultimate holding company. On October 18, 2022, Cardio Ventures Inc. acquired controlling interest in Otto Pvt Ltd. from Cardio Bahamas, making Cardio Ventures Inc. the ultimate holding company.
In April 2025, the Company successfully completed its uplisting to the Nasdaq Stock Market LLC (“NASDAQ”), with its common stock listed for trading on NASDAQ under the ticker symbol “SSII” effective April 25, 2025.
Basis of Presentation
The consolidated financial statements have been prepared in conformity with United States generally accepted accounting principles (“U.S. GAAP”). The accompanying financial statements have been prepared on a consolidated basis and reflect the financial statements of SS Innovations International, Inc. and all of its subsidiaries (“Company”).
The standalone financial statements of subsidiaries are fully consolidated on a line-by-line basis. Intra-group balances and transactions, and gains and losses arising from intra-group transactions, are eliminated while preparing consolidated financial statements.
Accounting policies of the respective individual subsidiaries are aligned wherever necessary, so as to ensure consistency with the accounting policies that are adopted by the Company under U.S. GAAP.
Principles of Consolidation
The consolidated financial statements include our accounts and all majority-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation. The Company follows a monthly reporting calendar, with its fiscal year ending on December 31.
Reclassifications
Certain prior period amounts in the consolidated statements of operations and consolidated balance sheets have been reclassified to conform with the current period presentation.
F-8
Concentrations of Business and Credit Risk
We maintain certain cash balances in excess of limits insured by Federal Deposit Insurance Corporation for US and Deposit Insurance and Credit Guarantee Corporation for India. We periodically evaluate the credit worthiness of the financial institutions with which we maintain cash deposits. We have not experienced any losses in such accounts and do not believe that there is any material credit risk to our cash. Concentration of credit risk with respect to accounts receivable is limited due to the wide variety of customers to whom our products are sold. Receivables from individual customers exceeding 10% of our total receivables as of December 31, 2025, and 2024 are disclosed separately in Note-6.
Going Concern
The accompanying consolidated financial statements
have been prepared on a going concern basis which implies the Company will continue to meet its obligations for the next 12 months as
of the date these consolidated financial statements are issued. As of December 31, 2025, the Company had a working capital surplus of
$
On March 6, 2026 (the “Closing Date”),
the Company completed a private placement of its common stock which generated gross proceeds of $
In the offering, we offered and sold (shares are
under issuance as on the date of Annual Report) a total of
| ● | an aggregate of |
| Ø |
| Ø |
| Ø |
| ● | an aggregate
of |
SSi intends to use the net proceeds from this private placement for working capital and other general corporate purposes, which include, but are not limited to advancing the Company’s our growth initiatives in India and other existing global markets and supporting preparation for entry into the United States and European Union markets.
However, the Company’s existing cash resources and income from operations, are not expected to provide sufficient funds to carry out the Company’s operations and business development through the next twelve (12) months. The management of the Company is making efforts to raise further funding to scale up operations and meet its longer-term capital needs. While management of the Company believes that it will be successful in its capital formation and planned expansion of its operating activities, there can be no assurance that the Company will be able to raise additional equity capital or be successful in generating additional revenues and ultimately achieving profitability. The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern.
F-9
NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
| (a) | Use of Estimates |
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and expenses. The Company regularly evaluates estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates made by management. Significant estimates include fair value of stock options and standalone selling price in case of bundled revenue contracts.
| (b) | Cash and Cash Equivalents |
The Company considers all highly liquid investments purchased with original maturity of ninety days or less to be cash equivalents.
| (c) | Restricted Cash |
Restricted cash includes any cash and cash equivalents that are legally restricted as to withdrawal or usage for the Company’s operations. For the purposes of the consolidated statement of cash flows, the Company includes in its cash and cash-equivalent balances those amounts that have been classified as restricted cash and restricted cash equivalents.
| (d) | Accounts Receivable and Allowance for Expected Credit Loss |
The Company’s account receivables are
due from customers relating to contracts to supply surgical robotic systems, instruments, and accessories and to provide post sales
warranty/maintenance services. The Company also sells surgical robotic systems under deferred payment arrangements and in such
cases, the amounts due and recoverable beyond the one year period at the balance sheet date are classified as long-term receivables.
Collateral is currently not required. The Company also maintains allowances for credit losses for estimated losses resulting from
the inability of the Company’s customers to make payments. The Company periodically reviews these estimated allowances,
including an analysis of the customers’ payment history and creditworthiness, the age of the trade receivable balances and
current economic conditions that may affect a customer’s ability to make payments as well as historical collection trends for
its customers as a whole. Based on this review, the Company specifically reserves for those accounts deemed uncollectible or likely
to become uncollectible. When receivables are determined to be uncollectible, principal amounts of such receivables outstanding are
deducted from the allowance. The allowance for credit losses as of December 31, 2025, and December 31, 2024, amounted to $
| (e) | Employee Benefits |
Contributions to defined contribution plans are charged to the Consolidated Statements of operations and comprehensive loss in the period in which services are rendered by the covered employees. Current service costs for defined benefit plans are recognized in the period to which they relate. The liability in respect of defined benefit plans is calculated annually by the Company using the projected unit credit method. The Company records annual amounts relating to its defined benefit plans based on calculations that incorporate various actuarial and other assumptions, including discount rates, mortality, future compensation increases and attrition rates. The Company reviews its assumptions on an annual basis and makes modifications to the assumptions based on current rates and trends when it is appropriate to do so. The effect of modifications to those assumptions is recorded in other comprehensive income (loss) (“OCI”) and amortized to net periodic benefit cost over the expected remaining period of service of the covered employees using the corridor method. The Company believes that the assumptions utilized in recording its obligations under its plans are reasonable based on its experience and market conditions. These assumptions may not be within the control of the Company and accordingly it is reasonably possible that these assumptions could change in future periods. The Company includes the service cost component of the net periodic benefit cost in the same line item or items as other compensation costs arising from services rendered by the respective employees during the period. The interest cost, expected return on plan assets and amortization of actuarial gains/loss, are included in “Other income/(expense), net.” Refer to Note 17 - Employee Benefit Plans to the consolidated financial statements for details.
F-10
| (f) | Foreign Currency Translation |
The Company’s reporting currency is U.S. dollars. The functional
currency of the Company is the U.S. dollar. The functional currency of the Company’s subsidiary in India is Indian National Rupee
(“INR”). Transactions denominated in INR are translated to U.S. dollars at rates which approximate those in effect on the
transaction dates. Monetary assets and all liabilities denominated in foreign currencies on December 31, 2025 and December 31, 2024 are
translated at the exchange rate in effect as of those dates. Non-monetary assets and stockholders’ equity are translated at the
appropriate historical rates. Included in selling, general and administrative expense were foreign exchange loss resulting from such translations
of approximately $
The functional currency of each entity in the group is the currency of the primary economic environment in which it operates. Transactions in foreign currencies are initially recorded into functional currency at the rates of exchange prevailing on the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are remeasured into functional currency at the rates of exchange prevailing at the balance sheet date. Non-monetary assets and liabilities are remeasured to the functional currency at exchange rates that prevailed on the date of inception of the transaction. All foreign exchange gains and losses arising on re-measurement are recorded in the Company’s Consolidated Statements of operations and comprehensive loss.
The assets and liabilities of the subsidiaries for which the functional currency is other than the U.S. dollar are translated into U.S. dollars, the reporting currency, at the rate of exchange prevailing on the balance sheet date. Revenues and expenses are translated into U.S. dollars at the exchange rates prevailing on the last business day of each month, which approximates the average monthly exchange rate. Share capital and other equity items are translated at exchange rates that prevailed on the date of inception of the transaction. Resulting translation adjustments are included in “Accumulated other comprehensive loss” in the consolidated balance sheets.
The relevant translation rates are as follows:
for the year ended December 31, 2025, closing rate at
The relevant translation rates are as follows: for the year ended December 31, 2024,
closing rate at
| (g) | Inventory |
The Company’s inventory consists of finished goods in the form of fully assembled and tested surgical robotic systems, semi-finished goods in the form of various sub-systems of the surgical robotic systems in various stages of assembly and manufacturing and raw material in the form of various mechanical, electrical, and other material components, parts, motors, encoders etc. which are not yet assembled/manufactured. The inventory is valued at the lower of cost (first-in, first-out) or estimated net realizable value.
| (h) | Cost of Sales |
Cost of sales primarily consists of manufacturing cost incurred for production of the Mantra System and the related instruments and accessories which are used to facilitate the use of the Mantra System. Further, Cost of sales also includes other costs such as salaries and rent which are directly attributable to the manufacturing process.
| (i) | Selling and Administrative Expenses |
Selling and administrative expenses primarily consist of indirect expenses which are not directly attributable to any other identified expense category of the Company.
F-11
| (j) | Fair value measurements |
ASC Topic 820, Fair Value Measurements and Disclosures define fair value as the price that would be received upon sale of an asset or paid upon transfer of a liability in an orderly transaction between market participants at the measurement date and in the principal or most advantageous market for that asset or liability. The fair value should be calculated based on assumptions that market participants would use in pricing the asset or liability as against assumptions specific to the entity. In addition, the fair value of liabilities should include consideration of non-performance risk, including the Company’s own credit risk. The fair value hierarchy consists of the following three levels:
| ● | Level I — Quoted prices for identical instruments in active markets. |
| ● | Level II — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. |
| ● | Level III — Instruments whose significant value drivers are unobservable. |
| (k) | Concentration of Credit Risk |
Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, time deposits and accounts receivable. By their nature, all such financial instruments involve risks including the credit risks of non-performance by counterparties. The surplus funds are maintained as cash and cash equivalents and time deposits, placed with highly rated financial institutions to reduce its exposure to market risk with regard to these funds. The Company’s exposure to credit risk on account receivable is influenced mainly by the individual characteristic of each customer and the concentration of risk from the top few customers. To mitigate this risk the Company evaluates the creditworthiness of its customers in conjunction with its revenue recognition processes as well as through its ongoing collectability assessment processes for accounts receivable. The Company does not enter into or trade financial instruments, including derivative financial instruments, for speculative purposes.
| (l) | Commitments and Contingencies |
Liabilities for loss contingencies arising from claims, assessments, litigation, fines and penalties, and other sources are recognized when it is probable that a liability has been incurred, and the amount of the assessment and/or remediation can be reasonably estimated. A disclosure for a contingent liability is made when there is a possible obligation that may require an outflow of resources. When there is a possible obligation or a present obligation in respect of which the likelihood of an outflow of resources is remote, no provision or disclosure is made. Legal costs incurred in connection with such liabilities are expensed as they are incurred. Capital commitments are disclosed in the consolidated financial statements.
| (m) | Revenue Recognition |
The Company recognizes revenue in accordance with Accounting Standards Codification, or ASC606, the core principle of which is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled to receive in exchange for those goods or services. To achieve this core principle, five basic criteria must be met before revenue can be recognized:
| ● | Identification of a contract with a customer or placement of a purchase order by the customer. |
| ● | Identification of the performance obligations in the contract or the purchase order as the case may be. |
| ● | Determination of the transaction price which is reflected in the purchase order placed by the customer. |
| ● | Allocation of the transaction price to the performance obligations in the contract; and |
| ● | Recognition of revenue when or as the performance obligations are satisfied as per the terms of the purchase order received from the customer. |
The Company accounts for revenues when both parties to the contract have approved the contract, the rights and obligations of the parties are identified, payment terms are identified, and collectability of consideration is probable. Product type and payment terms vary by client.
F-12
System Sales:
The Company recognizes revenue when the “transfer of control” occurs, which typically takes place upon the delivery of the system to the customer. In cases where a deferred payment arrangement exists, revenue is recognized at the present value of the consideration receivable, adjusted by the present value of any extended warranty obligations.
Standalone Selling Price:
Our system sale arrangements contain multiple products and services, including system, accessories, instruments and services. Other than services, we generally deliver all of the products upfront. Each of these products and services is a distinct performance obligation. System, instruments, accessories and services are also sold on a standalone basis. For multiple-element arrangements, revenue is allocated to each performance obligation based on its relative standalone selling price. Standalone selling prices are based on observable prices at which we separately sell the products or services. If a standalone selling price is not directly observable, then we estimate the standalone selling prices considering market conditions and entity-specific factors including, but not limited to, historical pricing data, features and functionality of the products and services and industry benchmark. We regularly review standalone selling prices and maintain internal controls over establishing and updating these estimates. Revenue that is allocated to the service obligation is deferred and recognized ratably over the service period upon expiration of first year of service which is free and included in the system sale arrangements.
Key Terms of Customer Contracts
The Company enters into binding contracts with customers through either an agreement or a sales order, with all terms and conditions mutually agreed upon by both parties. The key terms and conditions include:
| 1. | Finalization of Product and Price: Agreement on the specific model of the “SSI Mantra” system and its selling price. |
| 2. | Payment Terms: Determination of payment terms, which may involve either a deferred payment arrangement or a one-time payment upon delivery and installation of the system at the customer’s premises. |
| 3. | Deferred Payment Model: For deferred payments, customers typically pay an advance amount before the dispatch of the system. The remaining balance is payable in yearly installments over a period of |
| 4. | Warranty Services: Instead of negotiating the sales price, the Company provides a warranty service that includes a |
| 5. | Delivery, Installation, and Training: The Company is responsible for delivering and installing the system at the customer’s premises. Post-installation, the Company provides free training to surgeons and surgical staff to enable them to operate the system effectively. With respect to the sale of surgical robotic systems, training is provided at the time of delivery to the end customer, however the effort involved is considered negligible. |
| 6. | Transfer of Risk and Rewards: The risks and rewards associated with the system are transferred to the customer upon delivery to their premises. |
Instrument and accessories sales:
We also sell instruments for use by surgeons in conjunction with the use of our surgical robotic systems. These instruments are consumable items for our hospital customers, and we recognize the revenues from the sale of instruments as and when the instruments are dispatched to the customer.
Warranty and Annual Maintenance Contract Sales:
By application of ASC 606, a portion of the equipment sales value which is attributable towards the component of annual maintenance contracts is shown separately as Warranty sales. Once the assurance warranty or standard warranty periods are over, the actual maintenance contracts become effective and actual income from maintenance contracts is recognized as a distinct revenue stream.
Lease Income:
Under ASC 842, in cases where the systems are installed on a pay per procedure basis, the Company earns revenue which is a mix of fixed and variable components. Variable component consists of revenue share which is agreed based on the number and type of procedures performed by the customer, while the fixed component involves an agreed amount which the customer is obliged to pay over the lease term. Accordingly, the fixed component is recognized on a straight-line basis as lease income. Since the title to the system is not getting transferred to the counterparty, hence the cost relating to those systems is capitalized under property, plant and equipment and accordingly depreciation is charged over its period of useful life.
F-13
| (n) | Property Plant & Equipment |
Property and equipment are stated at cost, which is generally comprised of the purchase price for such property or equipment, non-refundable duties and taxes, Installation cost, freight, other associated costs, but excludes any discounts and/or rebates, less accumulated depreciation and impairment.
The Company reviews property and equipment for impairment whenever events or changes in circumstances indicate that the related carrying amounts may not be recoverable.
Property Plant & Equipment depreciated using the straight-line method at rates determined as per estimated useful lives of the assets. The estimated useful lives used in in calculating depreciation are as follows:
| Years | ||||
| Computer & peripherals | ||||
| Furniture | ||||
| Leasehold improvement | ||||
| Office equipment | ||||
| Plant and machinery | ||||
| Server & networking | ||||
| Vehicles | ||||
| Pay per use systems | ||||
| Demo system | ||||
| (o) | Long-lived Assets |
In accordance with ASC 360, “Property Plant and Equipment”, the Company tests long-lived assets or asset groups for recoverability when events or changes in circumstances indicate that their carrying amount may not be recoverable. Circumstances which could trigger a review include, but are not limited to: significant decreases in the market price of the asset; significant adverse changes in the business climate or legal factors; accumulation of costs significantly in excess of the amount originally expected for the acquisition or construction of the asset; current cash flow or operating losses combined with a history of losses or a forecast of continuing losses associated with the use of the asset and current expectation that the asset will more than likely not be sold or disposed significantly before the end of its estimated useful life. Recoverability is assessed based on the carrying amount of the asset and its fair value which is generally determined based on the sum of the discounted cash flows expected to result from the use and the eventual disposal of the asset, as well as specific appraisal in certain circumstances. An impairment loss is recognized when the carrying amount is not recoverable and exceeds fair value.
| (p) | Stock Compensation Expense |
Under the fair value recognition provisions of ASC Topic 718, Compensation-Stock Compensation, cost is measured at the grant date based on the fair value of the award and is amortized on a straight-line basis over the requisite service periods of the awards, which is generally the vesting period.
Determining the fair value of stock-based awards at the grant date requires significant judgment, including estimating the expected term over which the stock awards will be outstanding before they are exercised and the expected volatility of our stock.
Stock Options: These provide employees with the right, but not the obligation, to purchase shares of the Company’s stock at a specified price within a defined period, as per the terms of the stock option agreement. Stock-based compensation expense associated with AVRA 2016 Stock Incentive Plan is measured at fair-value using a Black-Scholes option-pricing model at commencement of each offering period and recognized over that offering period.
F-14
Stock Units (Restricted Stock Units, or RSUs): These do not require the employee to exercise any options. Each stock unit automatically converts into a specified number of shares upon vesting. The Company uses last three month’s average share price of common stock on OTC (prior to April 24, 2025) or on NASDAQ (subsequent to April 24, 2025) as grant date fair value for RSUs.
The Company recognizes stock-based compensation expense in the condensed consolidated statement of operations and comprehensive loss for both employees and non-employee directors based on the grant-date fair value of the awards. These costs are recognized on a straight-line basis over the requisite service period, or until the date at which the recipient becomes eligible for retirement, if shorter. Forfeitures of equity awards are accounted for as they occur.
The Company accounts for equity instruments issued in exchange for goods or services from non-employees in accordance with ASC Topic 718 Stock Compensation. The costs associated with these equity instruments are measured at the estimated fair market value of the consideration received or the estimated fair value of the equity instruments issued, whichever is more reliably measurable.
| (q) | Income Taxes |
We record income taxes under the asset and liability method, whereby deferred tax assets and liabilities are recognized based on the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and attributable to operating loss and tax credit carry forwards. The carrying amounts of deferred tax assets are reduced by a valuation allowance if, based on available evidence, it is more likely than not that such assets will not be realized. Accordingly, the need to establish valuation allowances for deferred tax assets is assessed periodically based on the more-likely-than-not realization threshold. This assessment considers, among other matters, the nature, frequency, and severity of current and cumulative losses, the duration of statutory carry forward periods, and tax planning alternatives. We use a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals and litigation processes, if any. The second step is to measure the largest amount of tax benefit as the largest amount that is more likely than not to be realized upon settlement. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs.
Management judgment is required in determining provision for income taxes, deferred tax assets and liabilities, tax contingencies, unrecognized tax benefits, and any required valuation allowance, including taking into consideration the probability of the tax contingencies being incurred. Management assesses this probability based upon information provided by its tax advisers, its legal advisers and similar tax cases. If at a later time the assessment of the probability of these tax contingencies changes, accrual for such tax uncertainties may increase or decrease.
The Company has a valuation allowance due to management’s overall assessment of risks and uncertainties related to its future ability in the U.S. to realize and, hence, utilize certain deferred tax assets, primarily consisting of net operating losses (“NOLs”), carry forward temporary differences and future tax deductions.
The effective tax rate for annual and interim reporting periods could be impacted if uncertain tax positions that are not recognized are settled at an amount which differs from the Company’s estimate. Finally, if the Company is impacted by a change in the valuation allowance resulting from a change in judgment regarding the realizability of deferred tax assets, such effect will be recognized in the interim period in which the change occurs.
F-15
| (r) | Basic and Diluted Loss per Share |
The following table sets forth the computation of basic and diluted earnings per share:
| December 31, 2025 | December 31, 2024 | |||||||
| Net loss (a) | ( | ) | ( | ) | ||||
| Basic weighted average common shares outstanding (b) | ||||||||
| Dilutive effect of convertible note(1) | ||||||||
| Dilutive effect of stock-based awards | ||||||||
| Diluted weighted average common shares outstanding | ||||||||
| Earnings per share attributable to SS Innovations International, Inc. stockholders: | ||||||||
| Basic and Diluted (a)/(b) | ( | ) | ( | ) | ||||
| (1) |
Basic net loss per share is calculated by dividing the net loss attributable to SSII stockholders by the weighted-average number of shares of common stock outstanding for the period. The diluted net loss per share is computed by giving effect to all potentially dilutive securities outstanding for the period. For periods in which we report net losses, diluted net loss per share is the same as basic net loss per share because potentially dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.
| (s) | Research and Development Costs |
In accordance with ASC Topic 730 Research and development costs are expensed as incurred and include costs of material, salaries, benefits and other headcount-related costs, contract and other outside service fees, and facilities and overhead costs.
| (t) | Fair Value of Financial Instruments |
Our financial instruments consist principally of accounts receivable, amounts due to related parties and promissory notes payable. The carrying amounts of cash and cash equivalents and promissory notes approximate fair value because of the short-term nature of these items.
| (u) | Recent Accounting Pronouncements |
In November 2024, FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40), which requires entities to disaggregate any relevant expense caption presented on the face of the income statement within continuing operations into the following required natural expense categories, as applicable: (1) purchases of inventory, (2) employee compensation, (3) depreciation, (4) intangible asset amortization, and (5) depreciation, depletion, and amortization recognized as part of oil- and gas-producing activities or other depletion expenses. An entity’s share of earnings or losses from investments accounted for under the equity method is not a relevant expense caption that requires disaggregation. Such ASU’s amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. We are currently evaluating the impact of this pronouncement on our disclosures and our consolidated financial statements.
In July 2025, the FASB issued ASU No. 2025-05, Financial Instruments-Credit Losses (“ASC Topic 326”): Measurement of Credit Losses for Accounts Receivable and Contract Assets. This ASU provides a practical expedient when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under ASC Topic 606. The ASU will be effective for annual reporting periods beginning after December 15, 2025, including interim periods within those years, with early adoption permitted. We are currently evaluating the impact of this ASU and does not expect it to have a material effect on the consolidated financial statements.
In December 2025, the FASB issued ASU No. 2025-11, Interim Reporting (“ASC Topic 270”): Narrow-Scope Improvements. This ASU provides a comprehensive list of interim disclosures that are required by U.S. GAAP and incorporates disclosure principle of material events or changes occurred since the prior year-end. The ASU will be effective for interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. We are currently evaluating the impact of this ASU on its consolidated financial statements.
F-16
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. Under this ASU, public entities must annually (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than five percent of the amount computed by multiplying pretax income or loss by the applicable statutory income tax rate). This ASU’s amendments are effective for all entities that are subject to Topic 740, Income Taxes, for annual periods beginning after December 15, 2024, with early adoption permitted.
We adopted this ASU effective for this Annual Report on Form 10-K for the year ended December 31, 2025. (refer to Note 16, Income Tax, for further details)
| (v) | Leases |
The Company determines if an arrangement is a lease at inception of the contract. The Company’s assessment is based on whether: (1) the contract involves the use of a distinct identified asset, (2) the Company obtains the right to substantially all the economic benefit from the use of the asset throughout the term of the contract, and (3) the Company has the right to direct the use of the asset. A lease is classified as a finance lease if any one of the following criteria are met: (1) the lease transfers ownership of the asset by the end of the lease term, (2) the lease contains an option to purchase the asset that is reasonably certain to be exercised, (3) the lease term is for a major part of the remaining useful life of the asset or (4) the present value of the lease payments equals or exceeds substantially all of the fair value of the asset.
Operating leases are presented within “Right-of-use assets, operating lease” “Current portion of operating lease liabilities” and “Operating lease liabilities, less current portion” in the Company’s consolidated balance sheets.
Right-of-use assets (ROU) assets represent the Company’s right to use an underlying asset during the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease arrangement. Lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Operating lease ROU assets are recognized at commencement date in an amount equal to lease liability, adjusted for any lease prepayments, initial direct costs, and lease incentives. For leases in which the rate implicit in the lease is not readily determinable, the Company uses its incremental borrowing rate based on the information available at commencement date. The Company determines the incremental borrowing rate by adjusting the benchmark reference rates with appropriate financing spreads applicable to the respective geographies where the leases are entered and lease specific adjustments for the effects of collateral, if applicable. Lease terms include the effects of options to extend or terminate the lease when it is reasonably certain at commencement of the lease that the Company will exercise that option. Lease expense for operating lease arrangements is recognized on a straight-line basis over the lease term reflecting single operating lease cost. The Company evaluates lease agreements to determine lease and non-lease components, which are accounted for separately.
Lease payments that depend on factors other than an index or rate are considered variable lease payments and are excluded from the operating lease assets and liabilities and are recognized as expense in the period in which the obligation is incurred. Lease payments include payments for common area maintenance, utilities such as electricity, heating and water, among others, and property taxes, and other similar payments paid to the landlord, which are treated as non-lease component.
The Company accounts for lease-related concessions in accordance with guidance in Topic 842, Leases, to determine, on a lease-by-lease basis, whether the concession provided by lessor should be accounted for as a lease modification.
The Company accounts for a modification as a separate contract when it grants an additional right of use not included in the original lease and the increase is commensurate with the standalone price for the additional right of use, adjusted for the circumstances of the particular contract. Modifications which are not accounted for as a separate contract are reassessed as of the effective date of the modification based on its modified terms and conditions and the facts and circumstances as of that date. Upon modification, the Company remeasures the lease liability to reflect changes to the remaining lease payments and discount rates and recognizes the amount of the remeasurement of the lease liability as an adjustment to the ROU assets. However, if the carrying amount of the ROU assets is reduced to zero as a result of modification, any remaining amount of the remeasurement is recognized as an expense in Consolidated Statements of Operations and Comprehensive Loss.
The Company reviews ROU assets for impairment whenever events or changes in circumstances indicate that the related carrying amount may not be recoverable.
F-17
Sales-type Leases
Lease Classification
In determining whether a transaction should be classified as a sales-type or operating lease (whether fixed-payment or usage-based), the Company considers the following terms at lease commencement: (1) whether title of the system transfers automatically or for a nominal fee by the end of the lease term; (2) whether the present value of the minimum lease payments equals or exceeds substantially all of the fair value of the leased system; (3) whether the lease term is for the major part of the remaining economic life of the leased system; (4) whether the lease grants the lessee an option to purchase the leased system that the lessee is reasonably certain to exercise; and (5) whether the underlying system is of such a specialized nature that it is expected to have no alternative use to the Company at the end of the lease term. However, if classifying a lease as a sales-type lease would result in a selling loss at commencement (day-one selling loss), the Company classifies such lease as an operating lease.
Derecognition and Selling Profit
At the commencement date of a qualifying sales-type lease, the Company derecognizes the underlying asset and recognizes a net investment in the lease, which includes (i) the present value of future lease payments, (ii) any guaranteed or unguaranteed residual value, and (iii) unearned interest income. The resulting selling profit or loss is measured as the difference between the net investment in the lease and the carrying amount of the derecognized asset.
Variable lease payments
Variable lease payments under the arrangement do not depend on an index or a rate but are instead based on the customer’s actual usage of the leased equipment or related surgical activity. Because such payments are usage-based, they are excluded from the initial measurement of the lease. SSII recognizes these variable amounts as revenue in the period in which the underlying surgical procedures occur, consistent with the terms of the pay-per-use arrangement.
Interest Income Recognition
Interest income on sales-type leases is recognized using the rate implicit in the lease so as to produce a constant periodic rate of return on the net investment.
Credit Losses
The Company applies the current expected credit loss (“CECL”) model to its net investment in sales-type leases. Expected credit losses are estimated based on historical loss experience, current conditions, and reasonable and supportable forecasts. The allowance for credit losses is reassessed each reporting period and included as a contra-asset to the net investment in sales-type leases.
Comprehensive Loss
Comprehensive loss consists of net loss and other gains and losses affecting stockholders’ equity that, under GAAP, are excluded from net loss. Our other comprehensive loss represents foreign currency translation adjustment attributable to Indian operations. Refer to Consolidated Statements of Comprehensive Loss. Total foreign currency transaction gains and losses were immaterial for the years ended December 31, 2025, and 2024.
F-18
NOTE 3 – SEGMENT INFORMATION
The Company is focused on designing, manufacturing and marketing an advanced, next-generation and affordable surgical robotic system called the SSi Mantra, and the instruments and accessories used with SSi Mantra to perform a wide range of soft-tissue, robotically assisted surgeries. The Company is committed to accelerating access to surgical robotics technologies in all parts of the world and particularly in underserved regions through a comprehensive ecosystem of providing an affordable surgical robotic system, its related instruments and accessories backed up by clinical, field service and maintenance support also provided by the Company. The systems as well as instruments and accessories are primarily designed, developed and manufactured by the Company in its manufacturing facility located in India.
During the year ended December 31, 2025, and
2024, the Company’s revenues from within India accounted for
The Company’s is
the Chief Operating Decision Maker (“CODM”). The CODM utilizes the Company’s long-range plan, which includes product
development, technology refinement plans and long-range selling and financial models, as a key input to resource allocation.
Significant expenses within income from operations, as well as within net income / loss, include cost of revenue, research and development, and selling, general and administrative expenses, which are each separately presented on the Company’s Consolidated Statements of Operations. Other segment items within net income include interest and other income, net, and income tax expense.
The Company’s long-lived assets consist
primarily of property, plant and equipment. As of December 31, 2025, and 2024,
NOTE 4 – PROPERTY, PLANT AND EQUIPMENT, NET
The Company’s property, plant and equipment consisted of the following:
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| Gross Amount | ||||||||
| Computer & peripheral | ||||||||
| Furniture | ||||||||
| Leasehold improvement | ||||||||
| Office equipment | ||||||||
| Pay Per Use Systems | ||||||||
| Plant and machinery | ||||||||
| Server & networking | ||||||||
| Vehicles | ||||||||
| Demo system | ||||||||
| Capital work in progress | ||||||||
| Accumulated depreciation | ( | ) | ( | ) | ||||
| Total | ||||||||
Depreciation expenses for the year ended December
31, 2025, and December 31, 2024, amounted to $
The Company deployed eight systems for demonstration purposes. As of December 31, 2025, four systems were located at the Company’s premises, and four systems were installed at a partner’s facility. These systems remain under the Company’s ownership and control and are therefore capitalized as property, plant, and equipment in accordance with ASC 360.
F-19
NOTE 5 – NET INVESTMENT IN SALE-TYPE LEASE
Measurement of net investment
The components of the Company’s investments in sales-type leases, net as of December 31, 2025 was as follows:
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| Gross lease receivables | ||||||||
| Unearned income | ( | ) | ||||||
| Subtotal | ||||||||
| Allowance for credit loss | ||||||||
| Net investment in sales-type leases | ||||||||
The net investment in sales-type leases was classified in the consolidated balance sheets as follows:
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| Other Current Assets | ||||||||
| Long-term investment in sales-type leases, net | ||||||||
| Net investment in sales-type leases | ||||||||
Interest income recognition
Interest income under sales-type leases during period ended December 31, 2025 were as follows:
| For the year ended December 31, 2025 | For the year ended December 31, 2024 | |||||||
| Interest income | ||||||||
Maturity analysis of lease receivables
The following table presents the undiscounted cash flows related to gross lease receivables as of December 31, 2025
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| 2026 | ||||||||
| 2027 | ||||||||
| 2028 | ||||||||
| 2029 | ||||||||
| 2030 | ||||||||
| 2031 and thereafter | ||||||||
| Total | ||||||||
F-20
NOTE 6 – ACCOUNTS RECEIVABLE
Accounts receivable consisted of:
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| Accounts receivable, net | ||||||||
| Accounts receivable, net (non-current) | ||||||||
The Company performed an analysis of the trade
receivables related to SSI India and determined, based on the deferred payment terms of the contracts, that $
Activity in the allowance for the credit losses for the year ended December 31, 2025 and 2024 was as follows:
For the Year Ended December 31, | For the Year Ended December 31, | |||||||
| Balance at the beginning | ||||||||
| Additions charged to expense | ||||||||
| Foreign currency translation adjustment | ( | ) | ( | ) | ||||
| Balance at the end | ||||||||
Details of customers which accounted for 10% or more of total revenues or 10% or more of total accounts receivables during the years ended December 31, 2025 and 2024:
| Percentage of revenue for year ended December 31, |
Percentage of accounts receivables as of December 31, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Customer A | % | % | ||||||||||||||
| ^ |
F-21
NOTE 7 – CASH, CASH EQUIVALENTS AND RESTRICTED CASH
For the purpose of consolidated statement of cash flows, cash, cash equivalents and restricted cash (Current) & (Non-Current) consisted of the following:
| As of December 31, 2025 | As of December 31, 2024 | |||||||||
| Cash and cash equivalents | ||||||||||
| Fixed Deposit | Lien Against Overdraft Facility | |||||||||
| Lien Against Letter of Credit | ||||||||||
| Lien Against Bank Guarantee | ||||||||||
| Lien Against Credit Card Facility | ||||||||||
| Restricted cash (Current) | ||||||||||
| Fixed Deposit | Lien Against Bank Guarantee | |||||||||
| Lien Against Credit Card Facility | ||||||||||
| Restricted cash (Non-current) | ||||||||||
| Total Cash, cash equivalents and restricted cash | ||||||||||
We have classified fixed deposits (FDs), which are subject to withdrawal restrictions, as Restricted cash. Additionally, time deposits with a maturity of over one year have been classified as non-current.
The Company has secured a bank overdraft facility from HDFC Bank, collateralized by fixed deposits held with HDFC Bank. This facility includes a withdrawal restriction tied to the fixed deposit. (Refer Note 11 – Bank Overdraft.)
NOTE 8 – PREPAID, CURRENT AND NON- CURRENT ASSETS
Prepaid, Current and Non-Current Assets consisted of the following:
As of December 31, | As of December 31, | |||||||
| Balances from statutory authorities | ||||||||
| Prepaid expense- stock compensation current | ||||||||
| Net investment in sale-type leases- current | ||||||||
| Security deposits | ||||||||
| Other prepaid- current assets | ||||||||
| Prepaid and other current assets | ||||||||
| Prepaid expense- stock compensation non current | ||||||||
| Net investment in sale-type leases- non current | ||||||||
| Security deposits | ||||||||
| Other prepaid- non current assets | ||||||||
| Prepaid and other non current assets | ||||||||
| Total prepaid, current and non current assets | ||||||||
Prepaid expenses – stock compensation represents unamortized portion of common stock granted to advisors for services to be rendered by them in future. (Refer Note 19 – Stock Compensation Expenses).
Refer Note-20 for Related Party Balances.
F-22
NOTE 9 – ACCOUNTS PAYABLE, ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accounts payable and accrued current and non-current expenses consisted of the following:
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| Accounts payable | ||||||||
| Payable to statutory authorities | ||||||||
| Client liabilities | ||||||||
| Salary payable | ||||||||
| Other accrued liabilities | ||||||||
| Total accrued liabilities | ||||||||
| Provision for gratuity- non current | ||||||||
| Client liabilities | ||||||||
| Total accrued liabilities- Non Current | ||||||||
| Total accounts payable, accrued current and non current liabilities | ||||||||
Accounts payable at $
Refer Note-20 for Related Party Balances.
NOTE 10 – NOTES PAYABLE
In February 2024, the Company raised $
In April 2024, the Company raised $
In July 2024, the Company raised $
In October and November 2024, the Company raised
$
In December 2024, the Company raised $
In January 2025, the Company raised $
In February 2025, the Company paid $
In February 2025, the Company paid $
F-23
In February 2025, the Company converted three
In February 2025, the Company converted Convertible
Notes totaling $
In March 2025, the Company converted Convertible Notes totaling $
Refer Note-20 for Related Party Balances.
NOTE 11 – BANK OVERDRAFT
Bank Overdraft consisted of:
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| HDFC Bank Ltd overdraft (OD1) | ||||||||
| HDFC Bank Ltd overdraft (OD2) | ||||||||
| HDFC Bank Ltd overdraft (OD3) | ||||||||
| Bank overdraft | ||||||||
The HDFC Bank overdraft facility (OD1), amounting
to $
In October 2025, the Company converted its overdraft
facility into a short-term working capital demand loan (“WCDL”) repayable on demand for a period of six months. The WCDL is
secured against the lien on fixed deposits of $
The cash credit facility is sanctioned at an interest rate of
NOTE 12 – DEFERRED REVENUE
Contract liabilities (deferred revenue) consist of advance billings and billing in excess of revenues recognized. Deferred revenue also includes the amount for which services have been rendered but other conditions of revenue recognition are not met, for example, where the Company does not have an enforceable contract.
The revenue attributable to the warranty is recognized over the period to which it relates. During the year ended December 31, 2025, Company sold 73 surgical robotic systems. The revenues attributable to warranty for the agreed warranty period in respect of each of the sales contracts are deferred for recognition over the period to which it relates.
F-24
In case of systems sold on a deferred payment
basis, the present value of the invoiced system sales, realizable over the deferred payment period, is recognized as system sales. The
difference between the invoiced amount and its present value is adjusted (reduced) in the accounts receivable balance. This difference
is recorded as interest income under other income, with a corresponding impact on accounts receivable over the collection period of contract.
The Company recorded $
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| Deferred revenue- beginning of period | ||||||||
| Additions | ||||||||
| Net changes in liability for pre-existing contracts | ||||||||
| Revenue recognized for system sales | ||||||||
| Revenue recognized for instrument sales | ||||||||
| Revenue recognized for warranty sales | ||||||||
| Deferred revenue- end of period | ||||||||
| Deferred revenue expected to be recognized in: | ||||||||
| One year or less | ||||||||
| More than one year | ||||||||
The following table disaggregates our revenue by major source:
For the Year Ended December 31, | For the Year Ended December 31, | |||||||
| System sales | ||||||||
| Instruments sale | ||||||||
| Warranty sale | ||||||||
| Lease income | ||||||||
| Total revenue | ||||||||
Revenues for each of the two years in the period ended December 31, 2025 and 2024 by geographic region (determined based upon customer domicile), were as follows:
For the Year Ended December 31, | For the Year Ended December 31, | |||||||
| India | ||||||||
| Philippines | ||||||||
| Indonesia | ||||||||
| South America | ||||||||
| Iraq | ||||||||
| Cyprus | ||||||||
| Oman | ||||||||
| UAE | ||||||||
| Nepal | ||||||||
F-25
NOTE 13 – STOCKHOLDERS’ EQUITY
Common stock
The Company is authorized to issue up to
As of December 31, 2025, there were
Preferred stock
The Company is authorized to issue up to
As of December 31, 2025, there were
Common stock issued at the time of Merger
At Closing of the Merger on April 14, 2023,
Common Stock issued post-Merger
On November 27, 2023, the Company issued
On November 27, 2023, the Company issued
During the year ended December 31, 2023, $
During the year ended December 31, 2023, the
Company converted warrants and issued
In December 2023, the Company received $
During the year ended December 31, 2023, Farhan
Taghizadeh exercised options and received
During the year ended on December 31, 2023, the
Company issued
During the year ended on December 31, 2023, the
Company issued
During the year ended on December 31, 2023, the
Company issued
F-26
During the year ended on December 31, 2023, the
Company issued
During the year ended on December 31, 2023, the
Company issued
During the year ended on December 31, 2023, the
Company issued
During the year ended on December 31, 2023, the
Company issued
During the year ended on December 31, 2023, the
Company issued
During the year ended on December 31, 2023, the
Company issued
On March 1, 2024, the Company issued
On August 31, 2024, the Company issued
On November 27, 2024, the Company issued
On November 27, 2024, the Company issued
On December 2, 2024, the Company issued
On February 12, 2025, the Company issued
On February 13, 2025, the Company issued
F-27
On February 20, 2025, the Company issued
On March 1, 2025, the Company issued
On March 31, 2025, the Company issued
On April 2, 2025, the Company issued
On April 30, 2025, the Company issued
On May 22, 2025, the Company issued
On May 28, 2025, the Company issued
On August 28, 2025, the Company issued
On October 1, 2025, the Company issued
On October 22, 2025, the Company issued
On November 27, 2025, the Company issued
On December 12, 2025, the Company issued
Holders of common stock are entitled to
F-28
NOTE 14 – INVENTORY
Inventory consisted of the following:
As of December 31, | As of December 31, | |||||||
| Raw materials (includes goods in transit $ | ||||||||
| Work-in-progress | ||||||||
| Finished goods | ||||||||
| Less: Inventory valuation allowance | ( | ) | ||||||
Changes in the inventory valuation allowance were as follows:
For the Year Ended December 31, | For the Year Ended December 31, | |||||||
| Balance at the beginning | ||||||||
| Additions charged to expense | ||||||||
| Foreign currency translation adjustment | ( | ) | ||||||
| Balance at the end | ||||||||
NOTE 15 – LEASES
The Company conducts its operations using facilities leased under operating lease agreements that expire at various dates.
The following is a summary of operating lease assets and liabilities:
| Operating leases | As of December 31, 2025 | As of December 31, 2024 | ||||||
| Assets | ||||||||
| Right of use operating lease assets | ||||||||
| Liabilities | ||||||||
| Current portion of operating lease liabilities | ||||||||
| Non Current portion of operating lease liabilities | ||||||||
| Total lease liabilities | ||||||||
| Operating leases | As of December 31, 2025 | As of December 31, 2024 | ||||||
| Weighted average remaining lease terms (years) | ||||||||
| Ilabs Info Technology 3rd Floor | | | ||||||
| Ilabs Info Technology 1st Floor | ||||||||
| Ilabs Info Technology Ground Floor | ||||||||
| Ilabs Info Technology Basement-3 | ||||||||
| Village Chhatarpur-1849-1852-Farm | ||||||||
| Weighted average discount rate | ||||||||
| Ilabs Info Technology 3rd Floor | % | % | ||||||
| Ilabs Info Technology 1st Floor | % | % | ||||||
| Ilabs Info Technology Ground Floor | % | % | ||||||
| Ilabs Info Technology Basement-3 | % | |||||||
| Village Chhatarpur-1849-1852-Farm | % | % | ||||||
F-29
Supplemental cash flow and other information related to leases are as follows:
| For the Year Ended | ||||||||
| December 31, 2025 | December 31, 2024 | |||||||
| Cash payments for amounts included in the measurement of lease liabilities: | ||||||||
| Operating cash outflows for operating leases | ||||||||
Maturities of lease liabilities as of December 31, 2025 were as follows:
| Fiscal year | Operating Leases Amount (in $) | |
| 2026 | ||
| 2027 | ||
| 2028 | ||
| 2029 | ||
| 2030 | ||
| 2031 and thereafter | ||
| Total lease payment | ||
| Less: Imputed Interest | ||
| Present value of lease liabilities |
NOTE 16 – INCOME TAX
The Company recorded an income tax expense of
$
The components of income/(loss) before income taxes consist of the following:
| For the year ended | ||||||||
| Particulars | December 31, 2025 | December 31, 2024 | ||||||
| Domestic | ||||||||
| USA | ( | ) | ( | ) | ||||
| Foreign | ||||||||
| India | ( | ) | ||||||
| Bahamas | ( | ) | ( | ) | ||||
| Total | ( | ) | ( | ) | ||||
Income tax expense/(benefit) consists of the following:
| For the year ended | ||||||||
| Particulars | December 31, 2025 | December 31, 2024 | ||||||
| Current Provision: | ||||||||
| Domestic | ||||||||
| Federal | ||||||||
| State | ||||||||
| Foreign | ||||||||
| India | ||||||||
| Deferred Provision/(Benefit): | ||||||||
| Domestic | - | - | ||||||
| Federal | ||||||||
| State | ||||||||
| Foreign | ||||||||
| India | ( | ) | ||||||
| Income tax expense/(benefit) | ||||||||
F-30
Deferred income taxes recognized in OCI are as follows:
| For the year ended | ||||||||
| Particulars | December 31, 2025 | December 31, 2024 | ||||||
| Deferred taxes benefit / (expense) recognized on: | ||||||||
| Domestic | ||||||||
| Federal | ||||||||
| State | ||||||||
| Foreign | ||||||||
| India | ||||||||
| Retirement benefits | ( | ) | ||||||
| Total | ( | ) | ||||||
The Company has federal net operating losses of $
The Company elected to prospectively adopt the guidance
in ASU No. 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”.
| For the year ended | ||||||||
| Particulars | December 31, 2025 | Percent | ||||||
| Accounting loss before income tax | ( | ) | ||||||
| US Federal Statutory Tax Rate | ( | ) | % | |||||
| US State and Local Statutory Tax Rate^ | ( | ) | % | |||||
| Statutory Tax Rate Difference between India and US | ( | )% | ||||||
| US GAAP accounting difference over Indian jurisdiction profit* | ( | )% | ||||||
| Non-deductible expenses | ( | )% | ||||||
| Excess tax expense/(benefit) on depreciation | ( | ) | % | |||||
| Excess tax expense/(benefit) on carry forward loss | ( | ) | % | |||||
| Excess tax expense/(benefit) on account of late payment | ( | )% | ||||||
| Others | ( | )% | ||||||
| Effect of Cross-Border Tax Laws | ||||||||
| Tax Credits | ||||||||
| Non-taxable or Non-Deductible Items | ||||||||
| Section 162(m) | - | |||||||
| Changes in valuation allowance | ( | )% | ||||||
| Other adjustment | ( | )% | ||||||
| Income tax expense/(benefit) | ( | )% | ||||||
| * |
|
^
F-31
The reconciliation of the U.S. statutory rate of
| For the year ended |
||||
| Particulars | December 31, 2024 |
|||
| Accounting Profit/(Loss) before income tax | ( |
) | ||
| Income tax expense (benefit) at federal statutory rate at |
( |
) | ||
| Foreign tax rate differential | ( |
) | ||
| Non-deductible expenses | ||||
| Excess tax expense/(benefit) on depreciation | ( |
) | ||
| Excess tax expense/(benefit) on security deposit | ||||
| Impact of unrecognized deferred tax asset on the loss of the year | ||||
| Income tax expense/(benefit) | ||||
The components of the deferred tax assets/liabilities balances are as follows:
| For the year ended | ||||||||
| Particulars | December 31, 2025 | December 31, 2024 | ||||||
| Deferred tax assets: | ||||||||
| Net operating loss carry forwards | ||||||||
| Stock Compensation Expenses | ||||||||
| Lease payments | ||||||||
| Credit loss reserve | ||||||||
| End of Service Benefits | ||||||||
| Payment to Vendor | ||||||||
| Provisions | ||||||||
| Others | ||||||||
| Deferred tax assets | ||||||||
| Valuation allowance | ( | ) | ( | ) | ||||
| Deferred tax assets | ||||||||
| Deferred tax liabilities: | ||||||||
| Depreciation and amortization | ( | ) | ( | ) | ||||
| Others | ( | ) | ||||||
| Deferred tax liabilities | ( | ) | ( | ) | ||||
| Net deferred tax assets/(liability) | ||||||||
As of December 31, 2025, and 2024, the Company
recorded a valuation allowance of $
F-32
Management has considered available positive and negative evidence, including forecasted taxable income, reversal of temporary differences, and tax planning strategies. Based on this assessment, deferred tax assets related to the Indian operations are considered realizable, and no valuation allowance has been recorded for those jurisdictions.
The Company’s accounting for deferred taxes involves
the evaluation of a number of factors concerning the realizability of the Company’s deferred tax assets. Assessing the realizability of
deferred tax assets is dependent upon several factors, including the likelihood and amount, if any, of future taxable income in relevant
jurisdictions during the periods in which those temporary differences become deductible. The Company’s management forecasts taxable income
by considering all available positive and negative evidence including its history of operating income or losses and its financial plans
and estimates which are used to manage the business. These assumptions require significant judgment about future taxable income.
| For the year ended | ||||||||
| Particulars | December 31, 2025 | December 31, 2024 | ||||||
| Valuation Allowance at the beginning | ||||||||
| Additions | ||||||||
| Reversals | ( | ) | ||||||
| Valuation Allowance at the end | ||||||||
During the current year ended December 31, 2025, the Company identified that certain information returns (Form 5471 – Information Return of U.S. Persons With Respect to Certain Foreign Corporations) relating to its investment in an Indian subsidiary had not been filed for prior years. The Company will complete and submit all required delinquent Forms 5471 before any notice from IRS along with detailed reasonable-cause statements requesting abatement of any related penalties.
Management has evaluated this matter under ASC 740
and concluded that it is not more-likely-than-not that penalties will ultimately be imposed. However, in light of the Company’s
overall compliance history, the proactive remedial filings, and the strength of its reasonable position, the management will seek abatement
of penalties. Accordingly, liability to the extent of $
A tabular reconciliation of the total amounts of unrecognized tax benefits for the years presented was as follows:
| Particulars | For the year ended December 31, 2025 | For the year ended December 31, 2024 | ||||||
| Unrecognized tax benefits at the beginning | ||||||||
| Increase / (decrease) in balances related to tax positions taken in prior years | ||||||||
| Increase / (decrease) in balances related to tax positions taken in current year | ||||||||
| Decrease due to settlement with tax authorities | ||||||||
| Lapses in statutes of limitations | ||||||||
| Unrecognized tax benefits at the end | ||||||||
The Company’s policy is to recognize interest
and penalties related to uncertain income tax matters within income tax expense in the consolidated statements of operations. As of December
31, 2025, the Company had accrued $
Income tax paid (net of refunds received) including tax deducted at source consisted of the following :
| Particulars | For the year ended December 31, 2025 | For the year ended December 31,2024 | ||||||
| United States | ||||||||
| India | | |||||||
| Total | ||||||||
The Company’s Indian subsidiary is subject to regular tax assessments under the Income Tax Act, 1961. The most recent assessment year under review is AY 2025–26. No material adjustments have been proposed to date. The U.S. entity has not been selected for IRS examination for any of the open tax years.
NOTE 17 – EMPLOYEE BENEFIT PLAN
The Company’s Gratuity Plan in India provides for a lump sum payment to vested employees on retirement or upon termination of employment in an amount based on the respective employee’s salary and years of employment with the Company. Liabilities under this plan are determined by actuarial valuation using the projected unit credit method. Current service costs for these plans are accrued in the year to which they relate. Actuarial gains or losses or prior service costs, if any, resulting from amendments to the plans, are recognized and amortized over the remaining period of service of the employees.
The Gratuity Plan is unfunded, and the company does not make contributions to the plan assets.
F-33
The benefit obligation has been measured as of December 31, 2025, and December 31, 2024. The following table sets forth the activity and the amounts recognized in the Company’s consolidated financial statements at the end of the relevant periods:
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| Change in projected benefit obligation | ||||||||
| Projected benefit obligation as on beginning | ||||||||
| Service cost | ||||||||
| Amortization of prior service cost^^ | ||||||||
| Interest cost | ||||||||
| Benefits paid | ||||||||
| Actuarial loss ^ | ||||||||
| Prior service cost^^ | ||||||||
| Effect of exchange rate changes | ( | ) | ( | ) | ||||
| Projected benefit obligation at end | ||||||||
| Unfunded status in the end | ||||||||
| Unfunded amount recognized in consolidated balance sheets | ||||||||
| Non-current liability (included under other non-current liabilities) | ||||||||
| Current liability (included under accrued employee costs) | ||||||||
| Total accrued liability | ||||||||
| Accumulated benefit obligation at end | ||||||||
| (^) | |
(^^) |
Components of net periodic benefit costs recognized in Consolidated Statements of operations and comprehensive loss and actuarial loss reclassified from OCI, were as follows:
| For the Year Ended December 31, 2025 | For the Year Ended December 31, 2024 | |||||||
| Service cost | ||||||||
| Amortization of prior service cost | ||||||||
| Interest cost | ||||||||
| Expected return on plan assets | ||||||||
| Amortization of actuarial loss, gross of tax | ||||||||
| Net gratuity cost | ||||||||
The components of retirement benefits included in AOCI, excluding tax effects, were as follows:
| For the Year Ended December 31, 2025 | For the Year Ended December 31, 2024 | |||||||
| Net actuarial loss | ||||||||
| Net prior service cost | ||||||||
| Amount recognized in AOCI, excluding tax effects | ||||||||
The weighted average actuarial assumptions used to determine benefit obligations and net gratuity cost were:
| As
of December 31, 2025 | As
of December 31, 2024 | |||||||
| Discount rate | | % | | % | ||||
| Rate of increase in compensation levels | % | % | ||||||
| Expected long-term rate of return on plan assets per annum | ||||||||
F-34
The Company evaluates these assumptions annually based on its long-term plans of growth and industry standards. The discount rates are either based on current market yields on government securities or yields on government securities adjusted for a suitable risk premium, if available.
| Expected benefit payments as of December 31, 2025 | |||
| 2025 | |||
| 2026 | |||
| 2027 | |||
| 2028 | |||
| 2029 | |||
| 2030-2034 |
NOTE 18 – FAIR VALUE MEASUREMENT – FINANCIAL INSTRUMENTS
Assets and liabilities recorded at fair value are measured using the fair value hierarchy, which prioritizes the inputs used in measuring fair value. The levels of the fair value hierarchy are:
| ● | Level 1: observable inputs such as quoted prices in active markets. |
| ● | Level 2: inputs other than quoted prices in active markets that are either directly or indirectly observable; and |
| ● | Level 3: unobservable inputs for which little or no market data exists, therefore requiring the Company to develop its own assumptions. |
The Company’s financial assets which are set out below in the table are measured at fair value by considering the level III inputs. The Company does not have financial assets which are measured using Level I or Level II inputs.
Carrying value and fair value of Level III Financial assets and liabilities:
| Carrying Value | Fair Value | |||||||||||||||
| December 31, 2025 | December 31, 2024 | December 31, 2025 | December 31, 2024 | |||||||||||||
| Financial Assets | ||||||||||||||||
| Account receivables, net (1) | ||||||||||||||||
| Net investment in sale-type lease-non current (2) | ||||||||||||||||
| Other non-current financial assets (3) | ||||||||||||||||
| Total | ||||||||||||||||
| Financial Liabilities | ||||||||||||||||
| Lease liabilities (4) | ||||||||||||||||
| Total | ||||||||||||||||
| (1) |
| (2) |
| (3) |
| (4) |
F-35
The Company has assessed that the financial instruments that are not carried at fair value consist primarily of cash and cash equivalents, restricted cash, prepaid and other current assets, note payable, Bank overdraft facility and account payable for which fair values approximate their carrying amounts due to the short-term maturities of these instruments.
NOTE 19 – STOCK COMPENSATION EXPENSES
Stock options to Employees: The Company
grants shares of the Company’s common stock, par value $
Restricted Stock Award to Employees: The
Company grants restricted shares of the Company’s common stock, $
Stock Options issued to Doctors/Proctors/Advisors (“Advisor’s”): The Company issues shares of the Company’s common stock (“Advisory Shares”) to retain and compensate certain Advisors for performing services for the Company and in exchange for the compensation, which is issued in a phased manner as determined by the company. The “Services” include but are not limited to (a) providing proctoring and medical advisory services, (b) advising the Company on the development of surgical robotics procedures and improvements in design and technology (c) participation in case of observation and performance of live surgeries, and (d) disseminating information about the Company’s products in various scientific meetings and surgical robotic conferences globally (e) investor’s digital marketing support. The Company issues such Advisory Shares in a phased manner commensurate with the period over which the services are to be performed, as determined by the Company.
F-36
Stock Options
Stock options activity for the year ended December 31, 2025, was as follows:
| Number of shares options | Weighted average grant date fair value per share | |||||||
| Unvested balance as of December 31, 2024 | $ | |||||||
| Granted | ||||||||
| Vested | $ | |||||||
| Forfeited | ||||||||
| Unvested balance as of December 31, 2025 | $ | |||||||
| Number of shares options | Weighted average grant date fair value per share | |||||||
| Exercisable balance as of December 31, 2025 | $ | |||||||
Stock options activity for the year ended December 31, 2024, was as follows:
| Number of shares options | Weighted average grant date fair value per share | |||||||
| Unvested balance as of December 31, 2023 | $ | |||||||
| Granted | $ | |||||||
| Vested | $ | |||||||
| Forfeited | ||||||||
| Unvested balance as of December 31, 2024 | $ | |||||||
| Number of shares options | Weighted average grant date fair value per share | |||||||
| Exercisable balance as of December 31, 2024 | $ | |||||||
The aggregate fair value of the stock options vested was $
F-37
Restricted Stock Awards (RSA)
Restricted Stock Awards activity for the year ended December 31, 2025, was as follows:
| Number of shares RSAs | Weighted average grant date fair value per share | |||||||
| Unvested balance as of December 31, 2024 | $ | |||||||
| Granted | ||||||||
| Vested | $ | |||||||
| Forfeited | $ | |||||||
| Unvested balance as of December 31, 2025 | $ | |||||||
| Number of Shares RSAs | Weighted average grant date fair value per share | |||||||
| Exercisable balance as of December 31, 2025 | ||||||||
Restricted Stock Awards activity for the year ended December 31, 2024, was as follows:
| Number of shares RSAs | Weighted average grant date fair value per share | |||||||
| Unvested balance as of December 31, 2023 | $ | |||||||
| Granted | ||||||||
| Vested | $ | |||||||
| Forfeited | $ | |||||||
| Unvested balance as of December 31, 2024 | $ | |||||||
| Number of Shares RSAs | Weighted average grant date fair value per share | |||||||
| Exercisable balance as of December 31, 2024 | ||||||||
During the year ended December 31, 2025,
F-38
Advisory shares:
Common stock issued to consultants as advisory shares during the year as follows:
| Grant dates | Fair value on grant date | Unvested shares in the beginning | Shares granted during the year | Shares vested during the period | Unvested shares at the end of the period | |||||||||||||||
| 31-Oct-23 | ||||||||||||||||||||
| 31-Oct-23 | ||||||||||||||||||||
| 31-Oct-23 | ||||||||||||||||||||
| 31-Oct-23 | ||||||||||||||||||||
| 30-Apr-25 | ||||||||||||||||||||
| 16-May-25 | ||||||||||||||||||||
| 15-May-25 | ||||||||||||||||||||
During the year ending December 31, 2025,
The aggregate vesting date fair value of
Advisory shares vested was $
Stock compensation expenses
During the year ended December 31, 2025, the Company
has recorded share compensation expense of $
| For the Year Ended December 31, 2025 | For the Year Ended December 31, 2024 | |||||||
| Stock options | ||||||||
| Restricted stock units (RSU) | ||||||||
| Advisory shares | ||||||||
| Total stock compensation expenses | ||||||||
Stock option model & assumptions
The Black-Scholes-Merton option pricing model
is used to estimate the fair value of stock options and RSU granted under the Company’s share based compensation plans and the
rights to acquire stock granted under the stock options plans.
| Year ended December 31, 2025 | ||||||||||||
| Grant date | Stock Options February 13, 2024 | Stock Options November 27, 2023 | Restricted stock awards November 27, 2023 | |||||||||
| Fair value on grant date | $ | $ | | $ | | |||||||
| Risk free interest rate | % | % | % | |||||||||
| Expected volatility | % | % | % | |||||||||
| Exercise prices | $ | $ | ||||||||||
| Share price on the grant date | $ | $ | $ | |||||||||
| Expected term of vesting | | |||||||||||
As share-based compensation expense recognized in the Consolidated Statements of operations and comprehensive loss during the years ended December 31, 2025, and 2024, is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures, if any.
As of December 31, 2025, there was $
F-39
NOTE 20 – RELATED PARTY
The details of transactions and balances outstanding with the related parties for the year ended December 31, 2025 and 2024 are as follows:
| Particulars | For the Year Ended December 31, 2025 | For the Year Ended December 31, 2024 | ||||||
| Transactions during the year: | ||||||||
| Expenses incurred on behalf of affiliates | ||||||||
| Srivastava Robotic Surgery Pvt Ltd | ||||||||
| SS International Centre for Robotics Surgery Pvt Ltd | ||||||||
| Sudhir Srivastava Medical Innovations Pvt Ltd | ||||||||
| Telegnosis Pvt Ltd | ||||||||
| Expense incurred on behalf of Company | ||||||||
| Sudhir Prem Srivastava | ( | ) | ||||||
| Barry F. Cohen | ||||||||
| Dr. Frederic H Moll | ||||||||
| Dr. S.P. Somashekhar | ||||||||
| Mr. Tim Adams | ||||||||
| 2016 Stock Incentive Plans Expenses/(Reversal) | ||||||||
| Anup Sethi# | ( | ) | ||||||
| Barry F. Cohen | ||||||||
| Dr. S.P. Somashekhar | ||||||||
| Sudhir Prem Srivastava | ||||||||
| Vishwajyoti P. Srivastava, M.D | ||||||||
| Consultancy charges, Sitting fees and other perquisites | ||||||||
| Anup Sethi# | ||||||||
| Barry F. Cohen | ||||||||
| Sudhir Prem Srivastava | ||||||||
| Vishwajyoti P. Srivastava, M.D | ||||||||
| Arvind Palaniappan# | ||||||||
| Naveen Kumar Amar# | ||||||||
| Dr. Frederic H Moll | ||||||||
| Dr. S.P. Somashekhar | ||||||||
| Mr. Tim Adams | ||||||||
| Mylswamy Annadurai | ||||||||
| Proceeds from notes issued | ||||||||
| Sushruta Private Limited | ||||||||
| Interest accrued on notes | ||||||||
| Sushruta Private Limited | ||||||||
| Conversion of notes into common stock | ||||||||
| Sushruta Private Limited | ||||||||
F-40
Balances outstanding as on year end:
| As of December 31, 2025 | As of December 31, 2024 | |||||||
| Accrued expenses & other current liabilities: | ||||||||
| Balance receivable / (payable) | ||||||||
| Barry F. Cohen | ( | ) | ( | ) | ||||
| Sushruta Private Limited | ||||||||
| Vishwajyoti P. Srivastava, M.D | ( | ) | ||||||
| Prepaids and other current assets: | ||||||||
| Srivastava Robotic Surgery Pvt Ltd | ||||||||
| SS International Centre for Robotics Surgery Pvt Ltd | ||||||||
| Cardio Bahamas^ | ( | ) | ( | ) | ||||
| SSI PTE Singapore^ | ( | ) | ( | ) | ||||
| Sudhir Prem Srivastava, M.D.^ | ||||||||
| Sudhir Srivastava Medical Innovations Pvt Ltd | ||||||||
| Telegnosis Private Limited | ||||||||
| Sushruta Private Limited | ||||||||
| Vishwajyoti P. Srivastava, M.D | ||||||||
| Notes payable: | ||||||||
| Sushruta Private Limited | ( | ) | ||||||
| ^ |
| # |
NOTE 21 – COMMITMENTS AND CONTINGENCIES
Other Commitments
The Company, through its Indian subsidiary, occupies office, manufacturing,
and assembly space in Gurugram, Haryana (India) under a lease agreement entered into in March 2021, with monthly payments of $
F-41
Contingencies
The Company’s Indian Subsidiary namely “Sudhir Srivastava
Innovations Private Limited” has received the draft assessment order dated November 29, 2023 under section 144C(1) related to proposed
transfer pricing adjustment of $
Further, the Company had filed its objections
before the Dispute Resolution Panel (DRP). The DRP, vide its directions dated August 28, 2024, granted partial relief of $
Subsequently, the Company has filed an appeal before the Income Tax Appellate Tribunal (ITAT) on the remaining disputed issues. As informed by the Management, the matter is pending adjudication before the ITAT. The Company believes that its position will more likely than not be sustained upon final examination by the tax authorities and accordingly has not accrued any liabilities with respect to these matters in its consolidated financial statements.
NOTE 22 – SUBSEQUENT EVENTS
| 1. | On January 2, 2026, Mr. Naveen Kumar Amar has resigned from his position of Company’s Chief Financial Officer. |
| 2. | On January 16, 2026, the Company appointed Milan Rao as Chief Operating Officer and as the Company’s Chief Financial Officer. |
| 3. | On March 6, 2026 (the “Closing Date”),
the Company completed a private placement of its common stock which generated gross proceeds of $ |
In the offering, we offered and sold (shares are
under issuance as on the date of Annual Report) a total of
| ● | an aggregate of |
| Ø |
| Ø |
| Ø |
| ● | an aggregate
of |
SSi intends to use the net proceeds from this private placement for working capital and other general corporate purposes, which include, but are not limited to advancing the Company’s our growth initiatives in India and other existing global markets and supporting preparation for entry into the United States and European Union markets.
F-42