Microbot Medical Inc 10-K for FY2025

Microbot Medical Inc. (MBOT)

10-K 2026-03-26 For: 2025-12-31

Added on April 08, 2026

About this 10-K

Microbot Medical Inc filed this 10-K on March 26, 2026, covering the fiscal year ended December 31, 2025 (FY2025).

Headline figures

Fiscal year ended December 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $13.14M; compared with a net loss of $11.44M a year earlier
Diluted EPS: -$0.29; compared with -$0.73 a year earlier

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Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, Par value $0.01		MBOT		NASDAQ Capital Market

Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging Growth Company ☐

		Page
	PART I
Item 1.	Business	1
Item 1A.	Risk Factors	13
Item 1B.	Unresolved Staff Comments	30
Item 1C	Cybersecurity	30
Item 2.	Description of Property	31
Item 3.	Legal Proceedings	31
Item 4.	Mine Safety Disclosures	31

	PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	32
Item 6.	[Reserved]	32
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	32
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	37
Item 8.	Financial Statements and Supplementary Data	38
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	38
Item 9A.	Controls and Procedures	38
Item 9B.	Other Information	38
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	38

	PART III
Item 10.	Directors, Executive Officers and Corporate Governance	39
Item 11.	Executive Compensation	44
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	50
Item 13.	Certain Relationships and Related Transactions, and Director Independence	51
Item 14.	Principal Accountant Fees and Services	52

	PART IV
Item 15.	Exhibits and Financial Statement Schedules	53
Item 16	Form 10-K Summary	55

●	Through December 31, 2025, Microbot has not recognized any revenues, and cannot make any assurances of generating significant revenues in the future. It has incurred significant operating losses since inception and is expected to continue to incur significant operating losses for the foreseeable future. The Company may never become profitable or, if achieved, be able to sustain profitability.
●	Microbot has a limited operating history as a commercial-stage company since it ceased primarily being a research and development-stage company, which may make it difficult to evaluate the prospects for the Company’s future viability.
●	Microbot expects to need additional funding, to continue to transition to a profitable commercial enterprise and build a sustainable business model. If Microbot is unable to raise capital, it could be forced to delay, reduce or eliminate its commercialization efforts or future product development programs.

●	Microbot’s business depends heavily on the success of its sole product, the LIBERTY^®Endovascular Robotic Surgical System. If Microbot is unable to commercialize the LIBERTY^®Endovascular Robotic Surgical System, or experiences significant delays in doing so, Microbot’s business will be materially harmed.
●	If the commercial opportunity for the LIBERTY^® Endovascular Robotic Surgical System and any other commercial products that may be developed by Microbot is smaller than Microbot anticipates, Microbot’s future revenue from the LIBERTY^® Endovascular Robotic Surgical System and such other products will be adversely affected and Microbot’s business will suffer.
●	Customers will be unlikely to buy the LIBERTY^® Endovascular Robotic Surgical System or any other product candidates unless Microbot can demonstrate that they can be produced for sale to consumers at attractive prices.
●	If Microbot is not able to both obtain and maintain adequate levels of third-party reimbursement for procedures involving LIBERTY^® or any other of its product candidates after they are approved for marketing and launched commercially, it would have a material adverse effect on Microbot’s business.
●	Unsuccessful studies, trials or procedures relating to product candidates under development or that we may develop, or applications for such candidates, could have a material adverse effect on our prospects.
●	The results of Microbot’s research and development efforts are uncertain and there can be no assurance of the commercial success of Microbot’s future product applications or candidates.
●	Microbot may not meet its development and commercialization objectives in a timely manner or at all.
●	Microbot’s ability to expand its technology platforms for other uses may be limited.
●	Microbot does not know whether any data submitted with any future 510(k) application will satisfy all FDA requirements to support clearance of any future product candidate of Microbot, which would create uncertainty for Microbot as well as the possibility of increased product development costs and time to market for any such product candidate
●	Microbot will depend upon the ability of third parties, including contract research organizations, collaborative academic groups, future clinical trial sites and investigators, to conduct or to assist the Company in conducting clinical trials for any future product applications and candidates, if such trials become necessary.

●	Our research and development program is dependent on the availability of certain components from suppliers, the delay in delivery of which could materially adversely affect our ongoing development and ability to manufacture and package devices in the timeframes currently expected.
●	Microbot has relied on, and intends to continue to rely on, third-party manufacturers to produce its products and product candidates.
●	If Microbot’s products and product candidates are not considered to be a safe and effective alternative to existing technologies, Microbot will not be commercially successful.
●	Microbot may be subject to penalties and may be precluded from marketing its products and product candidates if Microbot fails to comply with extensive governmental regulations.
●	Microbot products may in the future be subject to mandatory product recalls that could harm its reputation, business and financial results.
●	If LIBERTY^® or other of Microbot’s future commercialized products cause or contribute to a death or a serious injury, Microbot will be subject to Medical Device Reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.
●	Microbot could be exposed to significant liability claims if Microbot is unable to obtain insurance at acceptable costs and adequate levels or otherwise protect itself against potential product liability claims.
●	If Microbot fails to retain certain of its key personnel and attract and retain additional qualified personnel, Microbot might not be able to pursue its growth strategy effectively.
●	Our profitability may be negatively impacted by inflation in the cost of labor, materials, and services.

●	If Microbot fails to obtain regulatory clearances in other countries for LIBERTY^® or any other future product candidates, Microbot will not be able to commercialize these products or product candidates in those countries.
●	Microbot operations in international markets involve inherent risks that Microbot may not be able to control.

●	Intellectual property litigation and infringement claims could cause Microbot to incur significant expenses or prevent Microbot from selling certain of its product candidates.
●	If Microbot or TRDF are unable to protect the patents or other proprietary rights relating to Microbot’s product candidates, or if Microbot infringes on the patents or other proprietary rights of others, Microbot’s competitiveness and business prospects may be materially damaged.
●	Dependence on patent and other proprietary rights and failing to protect such rights or to be successful in litigation related to such rights may result in Microbot’s payment of significant monetary damages or impact offerings in its product portfolios.

●	Existing and historical risks relating to our operations in Israel are being exacerbated by the current military actions and operations, and related activities.
●	Microbot has facilities located in Israel, and therefore, political conditions in Israel may affect Microbot’s operations and results.
●	Political relations could limit Microbot’s ability to sell or buy internationally.
●	Israel’s economy may become unstable.
●	Exchange rate fluctuations between the U.S. dollar and the NIS currencies may negatively affect Microbot’s operating costs.
●	Funding and other benefits provided by Israeli government programs may be terminated or reduced in the future and the terms of such funding may have a significant impact on future corporate decisions.
●	Some of Microbot’s employees are obligated to perform military reserve duty in Israel.

●	Political, social and geopolitical conditions can adversely affect our business.
●	Political uncertainty may have an adverse impact on our operating performance and results of operations.
●	The issuance of shares upon exercise of outstanding warrants and options could cause immediate and substantial dilution to existing stockholders.
●	Information technology failures and data security breaches could harm our business.

●	Compact size - Eliminates the need for large capital equipment in dedicated cath-lab rooms with dedicated staff.
●	Fully disposable - To our knowledge, the first fully disposable robotic system for endovascular procedures.
●	One & Done^® - Has the potential to be compatible with our NovaCross^® products or possibly other instruments that combines guidewire and microcatheter into a single device. We are currently evaluating this combination in different applications.
●	State of the art maneuverability - Provides linear and rotational control of its guidewire, as well as linear and rotational control of a guide catheter, and the linear motion for an additional microcatheter (“over the wire”) device.
●	Compatibility with a wide range of commercially-available guidewires, microcatheters and guide-catheters.
●	Enhanced operator safety and comfort - Aims to reduce exposure to ionizing radiation and reduce physical strain due to the need for heavy lead vests otherwise to be worn during procedures.
●	Ease of use - A remote control designed to be intuitive aims to simplify advanced procedures while shortening the physician’s learning curve.
●	Telemedicine capability – May serve as a platform for supporting tele-catheterization, carried out remotely by highly trained specialists. The Company’s research collaboration with Corewell Health™ has demonstrated the feasibility of using the LIBERTY^® Endovascular Robotic System between separate and remote facilities in a coronary simulation model. The project assesses the feasibility of using LIBERTY^® to perform simulated cardiovascular interventional procedures across two sites within the Corewell Health™ system located 5 miles apart. The telesurgery feature of LIBERTY^® is still being evaluated and is not covered under the Company’s 510(k) clearance with the U.S. Food and Drug Administration (“FDA”).

●	Expand our global commercial footprint to establish LIBERTY^® as the standard of care for robotic endovascular procedures in targeted accounts. We seek to partner with Key Opinion Leaders (KOLs) to conduct post-market clinical research and develop centers of excellence that are capable of educating and training future users.
●	Continue to refine LIBERTY^® and develop additional surgical robotic solutions. Microbot also expects to continue to innovate in the surgical robotics field by continuing to find ways of using its core technology to solve unmet needs, with the overarching goal of providing a safer, more effective and more efficient surgical environment for patients and physicians.
●	Continuously invest in research and development. Microbot’s most significant expense has historically been research and development, and Microbot expects to continue investing in research and development activities, including expenses it expects to incur to improve LIBERTY^® and any other prototype products it may have from time to time in order to respond to clinical data, to develop additional applications using its technologies and to develop future product candidates.
●	Explore partnerships for the introduction of Microbot’s products. In parallel to its efforts to establish direct sales and marketing capabilities, Microbot intends to continue its efforts on pursuing collaborations with global medical device companies that have established sales and distribution networks. Microbot will seek to enter collaborations and partnerships with strategic players that offer synergies with Microbot’s product candidates and expertise.
●	Seek additional IP and technologies to complement and strengthen Microbot’s current IP portfolio. Microbot intends to continue exploring new technologies, IP and know-how to add to its current portfolio through licensing, mergers and/or acquisitions and to allow Microbot to enter new spaces and strengthen its overall product portfolio.

●	That some of our Israeli subcontractors, vendors, suppliers and other companies in which the Company relies, may not be fully active and operational, as instructed by the relevant authorities;
●	A slowdown in the number of international flights in and out of Israel;
●	The decreasing international regard for Israeli-based companies in certain quarters, including as a result of the Israeli government’s policies in Gaza and the West Bank in particular, and the Middle East in general; and
●	Possible and actual boycotts of Israel and Israeli-based companies, which may adversely affect our ability to do business in certain jurisdictions or with certain industry groups or potential customers, among others.

●	product design, and development;
●	product safety, testing, labeling and storage;
●	record keeping procedures; and
●	product marketing.

●	the timely submission of product listing and establishment registration information, along with associated establishment user fees;
●	continued compliance with the Quality Management System Regulation, or QMSR, which require specification developers and manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process, and incorporates as a reference the ISO 13485 standard for medical device;
●	labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label use or indication;
●	clearance or approval of product modifications that could significantly affect the safety or effectiveness of the device or that would constitute a major change in intended use;
●	Medical Device Reporting regulations (MDR), which require that manufacturers keep detailed records of investigations or complaints against their devices and to report to the FDA if their device 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;
●	adequate use of the Corrective and Preventive Actions process to identify and correct or prevent significant systemic failures of products or processes or in trends which suggest same;
●	post-approval restrictions or conditions, including post-approval study commitments;
●	post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device; and
●	notices of correction or removal and recall regulations.

●	Class I devices, which are low risk and subject to only general controls (e.g., registration and listing, medical device labeling compliance, MDRs, Quality System Regulations, and prohibitions against adulteration and misbranding) and, in some cases, to the 510(k) premarket clearance requirements;
●	Class II devices, which are moderate risk and generally require 510(k) or 510(k) de-novo premarket clearance before they may be commercially marketed in the United States as well as general controls and potentially special controls like performance standards or specific labeling requirements; and
●	Class III devices, which are devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a predicate device. Class III devices generally require the submission and approval of a PMA supported by clinical trial data.

●	Development of comprehensive product description and indications for use;
●	Comprehensive review of predicate devices and development of data supporting the new product’s substantial equivalence to one or more predicate devices; and
●	If appropriate and required, certain types of clinical trials (IDE submission and approval may be required for conducting a clinical trial in the U.S.).

●	Assuming successful completion of all required testing, a detailed 510(k) premarket notification or 510(k) de-novo is submitted to the FDA requesting clearance to market the product. The notification includes all relevant data from pertinent preclinical and clinical trials, together with detailed information relating to the product’s manufacturing controls and proposed labeling, and other relevant documentation.
●	A 510(k) clearance letter from the FDA will authorize commercial marketing of the device for one or more specific indications for use.
●	After 510(k) clearance, Microbot will be required to comply with a number of post-clearance requirements, including, but not limited to, Medical Device Reporting and complaint handling, and, if applicable, reporting of corrective actions. Also, quality control and manufacturing procedures must continue to conform to QMSRs. The FDA periodically inspects manufacturing facilities to assess compliance with QMSRs, which impose extensive procedural, substantive, and record keeping requirements on medical device manufacturers. In addition, changes to the manufacturing process are strictly regulated, and, depending on the change, validation activities may need to be performed. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with QMSRs and other types of regulatory controls.
●	After a device receives 510(k) clearance from the FDA, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use or technological characteristics, requires a new 510(k) clearance or could require a PMA. The FDA requires each manufacturer to make the determination of whether a modification requires a new 510(k) notification or PMA in the first instance, but the FDA can review any such decision. If the FDA disagrees with a manufacturer’s decision not to seek a new 510(k) clearance or PMA for a particular change, the FDA may retroactively require the manufacturer to seek 510(k) clearance or PMA. The FDA can also require the manufacturer to cease U.S. marketing and/or recall the modified device until additional 510(k) clearance or PMA approval is obtained.
●	The FDA and the Federal Trade Commission, or FTC, will also regulate the advertising claims of Microbot’s products to ensure that the claims Microbot makes are consistent with its regulatory clearances, that there is scientific data to substantiate the claims and that product advertising is neither false nor misleading.

●	Name and address of the manufacturer, and of the importer as applicable;
●	Description of the intended use of the medical device and of its medical indications;
●	Technical details of the medical device and of its components, and in the event that the device or the components are not new, information should be provided on the date or renovation;
●	Certificate attesting to the safety of the device, issued by a competent authority of one of the following countries: Australia, Canada, European Community (EC), Member States (MSs), Israel, Japan, or the United States;
●	Information on any risk which may be associated with the use of the device (including precautionary measures to be taken);
●	Instructions for use of the device in Hebrew; the MOH may allow the instructions to be in English for certain devices;
●	Details of the standards to which the device complies;
●	Description of the technical and maintenance services, including periodic checks and inspections; and
●	Declaration, as appropriate: of the local manufacturer/importer, and of the foreign manufacturer.

●	Reside and maintain a place of business in Israel and serve as the regulatory representative.
●	Respond to questions from AMAR concerning the registered products.
●	Report adverse events to AMAR.
●	Renew the registration on time to keep the market approval active.

●	the costs to secure or establish sales, marketing and commercial manufacturing capabilities or arrangements with third parties regarding same;
●	the Company’s need and ability to hire additional management, sales, marketing, scientific and medical personnel;
●	the timing and outcomes of any applicable regulatory reviews, subsequent approvals or clearances, or other regulatory actions;
●	the costs, design, duration and any potential delays of the clinical trials that could be conducted at the FDA’s request using Microbot’s product candidates;
●	the costs of acquiring, licensing or investing in new and existing businesses, product candidates and technologies;
●	the costs to maintain, expand and defend the scope of Microbot’s intellectual property portfolio; and
●	the costs to operate as a public company in the United States.

●	establishing commercial manufacturing arrangements with one or more third parties;
●	establishing sales, marketing and distribution capabilities;
●	protecting Microbot’s rights in its intellectual property portfolio;
●	generating commercial sales, if and when approved, whether alone or in collaboration with other entities;
●	our ability to obtain additional capital;
●	market acceptance that the device is safe and effective for its intended use;
●	acceptance by the medical community, patients and third-party payors;
●	effectively competing with existing and competitive products on the market and any new competing products that may enter the market; and
●	maintaining quality and an acceptable safety profile.

●	limitations on supply availability resulting from capacity, internal operational problems or scheduling constraints of third parties;
●	potential regulatory non-compliance or other violations by the third-party manufacturer that could result in quality assurance;
●	the possible breach of manufacturing agreements by third parties because of various factors beyond Microbot’s control; and
●	the possible termination or non-renewal of manufacturing agreements by third parties for various reasons beyond Microbot’s control, at a time that is costly or inconvenient to Microbot.

●	untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;
●	detention or seizure of Microbot products;
●	operating restrictions or partial suspension or total shutdown of production;
●	refusing or delaying requests for 510(k) clearance or premarket approval of new products or modified products;
●	withdrawing 510(k) clearances or other types of regulatory authorizations -that have already been granted;
●	refusing to grant export approval for Microbot products; or
●	criminal prosecution.

●	adverse macroeconomic conditions affecting geographies where Microbot intends to do business;
●	closing of international borders, including as a result of biohazards or pandemics;
●	foreign currency exchange rates;
●	political or social unrest or economic instability in a specific country or region;
●	higher costs of doing business in certain foreign countries;
●	infringement claims on foreign patents, copyrights or trademark rights;
●	difficulties in staffing and managing operations across disparate geographic areas;
●	difficulties associated with enforcing agreements and intellectual property rights through foreign legal systems;
●	trade protection measures and other regulatory requirements, which affect Microbot’s ability to import or export its product candidates from or to various countries;
●	adverse tax consequences;
●	unexpected changes in legal and regulatory requirements;
●	military conflict, terrorist activities, natural disasters and medical epidemics; and
●	Microbot’s ability to recruit and retain channel partners in foreign jurisdictions.

●	difficulties in the integration of acquired operations, services and products;
●	failure to achieve expected synergies;
●	diversion of management’s attention from other business concerns;
●	assumption of unknown material liabilities of acquired companies;
●	amortization of acquired intangible assets, which could reduce future reported earnings;
●	Lack of funding to properly and adequately develop and commercialize the technologies acquired;
●	potential loss of clients or key employees of acquired companies; and
●	dilution to existing stockholders.

●	actual or anticipated fluctuations in our quarterly or annual operating results;
●	changes in financial or operational estimates or projections;
●	conditions in markets generally;
●	changes in the economic performance or market valuations of companies similar to ours;
●	announcements by us or our competitors of new products, acquisitions, strategic partnerships, joint ventures or capital commitments;
●	our intellectual property position; and
●	general economic or political conditions in the United States, Israel or elsewhere.

●	All computers are protected using a cloud-powered endpoint security solution that helps enterprises prevent, detect, investigate, and respond to advanced threats on their networks. It offers endpoint protection, endpoint detection and response, mobile threat defense, and integrated vulnerability management. It also provides, among other things, malware and spyware detection and remediation, rootkit detection and remediation and network vulnerability detection.
●	All Company computer hard drives are automatically encrypted.
●	All Company e-mails are protected by a cloud-based email filtering service designed to protect the Company against advanced threats related to email and collaboration tools.
●	Periodically, all users on the Company’s computer network are required to perform multi-factor authentication.
●	The Company uses a cloud-based identity and access management service that enables access to external resources.
●	Backup is performed using a secure, automatic cloud-based backup and restore service.
●	From time to time, the Company considers and evaluates, and adopts if appropriate, additional cyber security procedures and tools.

	Number of securities to be issued upon exercise of outstanding options, warrants and rights		Weighted-average exercise price of outstanding options, warrants and rights		Number of securities remaining available for future issuance
Plan Category
Equity compensation plans approved by security holders:
2017 Equity Incentive Plan		467,133	$	10.72		156,585
2020 Omnibus Performance Award Plan, as amended		2,624,123	$	3.03		2,587,548
Equity compensation plans not approved by security holders:
Microbot Israel Employee Stock Option Plan(1)		14,359	$	0.01		-
Total		3,105,615				2,744,133

	For the Years Ended December 31,
	2025			2024			Change
Research and development expenses, net	$	(6,283	)	$	(6,630	)	$	347
Sales, general and administrative expenses		(8,460	)		(4,995	)		(3,465	)
Financing income, net		1,285			182			1,103
Other income		316			-			316

●	An aggregate of approximately $1.1 million in January 2025, before fees and expenses of $65,452, through our then-existing At-the-Market facility;
●	In January 2025, an aggregate of approximately $15.6 million in gross proceeds, before fees and expenses of approximately $1.4 million, from institutional investors;
●	In January 2025, approximately $916,000 in gross proceeds from the exercise of outstanding preferred investment options, before fees and expenses of $64,164;
●	In February 2025, an aggregate of approximately $13.0 million in gross proceeds, before fees and expenses of approximately $1.2 million, from the sale of our securities to institutional investors;
●	In April 2025, approximately $2.3 million in gross proceeds from the exercise of outstanding Series E and Series F preferred investment options, before fees and expenses of approximately $161,000;
●	In May 2025, approximately $1.4 million in gross proceeds from the exercise of outstanding Series F preferred investment options, before fees and expenses of approximately $98,000;

●	In June 2025, approximately $1.3 million in gross proceeds from the exercise of outstanding Series E, F and G preferred investment options, before fees and expenses of approximately $93,000;
●	In July 2025, approximately $12.2 million in gross proceeds from the exercise of outstanding Series F and G preferred investment options, before fees and expenses of approximately $706,000;
●	In August 2025, approximately $15.2 million in gross proceeds from the exercise of outstanding Series E, G, H, I preferred investment options, before fees and expenses of approximately $1.1 million;
●	In September 2025, approximately $472,500 in gross proceeds from the exercise of outstanding Series H preferred investment options, before fees and expenses of $33,075;
●	In September 2025, approximately $895,744 in gross proceeds from the exercise of placement agent options;
●	In September 2025, an aggregate of approximately $26.5 million in gross proceeds from an inducement transaction exercise of outstanding preferred investment options, before fees and expenses of approximately $2.2 million, from institutional investors; and
●	In October 2025, an aggregate of approximately $2.8 million in gross proceeds from the inducement transaction exercise of outstanding preferred investment options, before fees and expenses of approximately $223,000, from institutional investors.

	For the Years Ended December 31,
	2025			2024
Net cash flows used in operating activities	$	(13,046	)	$	(8,827	)
Net cash flows (used in) provided by investing activities		(72,384	)		1,537
Net cash flows provided by financing activities		86,240			7,936
Net increase in cash, cash equivalents and restricted cash	$	810		$	646

Name	Age	Position
Harel Gadot	54	President, Chief Executive Officer and Chairman of the Board of Directors
Scott Burell(1)(2)	61	Director
Martin Madden(1)(3)	65	Director
Prattipati Laxminarain(2)	68	Director
Aileen Stockburger(3)	63	Director
Tal Wenderow(2)	51	Director
David J. Wilson (1)(3)	58	Director

(1)	Member of Audit Committee.
(2)	Member of Corporate Governance Committee.
(3)	Member of Compensation Committee.