Microbot Medical Inc S-1/A, filed Apr 1, 2024

Microbot Medical Inc. (MBOT)

S-1/A 2024-04-01

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Delaware	2836	94-3078125
(State or other jurisdiction of	(Primary Standard Industrial	(I.R.S. Employer
incorporation or organization)	Classification Code Number)	Identification Number)

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

		Page

ABOUT THIS PROSPECTUS		1
RISK FACTOR SUMMARY		2
PROSPECTUS SUMMARY		5
THE OFFERING		10
RISK FACTORS		11
USE OF PROCEEDS		29
MARKET FOR COMMON STOCK		29
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS		29
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS		30
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK		33
BUSINESS		34
BOARD OF DIRECTORS AND MANAGEMENT		50
EXECUTIVE COMPENSATION		56
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS		62
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT		63
SELLING STOCKHOLDERS		64
PLAN OF DISTRIBUTION		65
DESCRIPTION OF CAPITAL STOCK		66
LEGAL MATTERS		70
EXPERTS		70
WHERE YOU CAN FIND MORE INFORMATION		70
FINANCIAL STATEMENTS		F-1

	●	There is substantial doubt regarding our ability to continue as a going concern.

	●	Microbot has had no revenue and 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 outside of being a research and development-stage company, which may make it difficult to evaluate the prospects for the Company’s future viability.

	●	Microbot will need additional funding. If Microbot is unable to raise capital when needed, it could be forced to delay, reduce or eliminate its product development programs or commercialization efforts.

	●	Unsuccessful animal studies, clinical trials or procedures relating to product candidates under development could have a material adverse effect on Microbot’s prospects.

	●	Microbot’s business depends heavily on the success of its sole lead product candidate, 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.

	●	The results of Microbot’s research and development efforts are uncertain and there can be no assurance of the commercial success of Microbot’s product 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.

	●	At this time, Microbot does not know the extent of the clinical trial that the FDA will require it to submit in support of its future marketing applications for the LIBERTY^®Endovascular Robotic Surgical System, which creates uncertainty for Microbot as well as the possibility of increased product development costs and time to market.

	●	Microbot’s technology acquired from CardioSert and part of its One & Done^® feature is subject to a buy-back clause which was triggered, thus causing us to lose rights to the technology.

	●	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 its product 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.

	●	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.

	●	Microbot has relied on, and intends to continue to rely on, third-party manufacturers to produce its product candidates.

	●	If Microbot’s 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 product candidates if Microbot fails to comply with extensive governmental regulations.

	●	If Microbot is not able to both obtain and maintain adequate levels of third-party reimbursement for procedures involving its product candidates after they are approved for marketing and launched commercially, it would have a material adverse effect on Microbot’s business.

	●	Clinical outcome studies for the LIBERTY^®Endovascular Robotic Surgical System may not provide sufficient data to make Microbot’s product candidates the standard of care.

	●	Microbot products may in the future be subject to mandatory product recalls that could harm its reputation, business and financial results.

	●	If 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.

	●	If Microbot fails to obtain regulatory clearances in other countries for its product candidates under development, Microbot will not be able to commercialize these 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, that commenced with the surprise attack on the State of Israel on October 7, 2023.

	●	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.

	●	That some of the Company’s Israeli subcontractors, vendors, suppliers and other companies in which the Company relies, are currently only partially active, as instructed by the relevant authorities; and

	●	A slowdown in the number of international flights in and out of Israel.

	●	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® - Can be made compatible with Microbot’s NitiLoop’s NovaCross® products or possibly other guidewire/microcatheter technologies, that combines guidewire and microcatheter into a single device.

	●	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 “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 the need for heavy lead vests otherwise to be worn during procedures, as well as reducing the exposure to Hospital Acquired Infections (HAI).

	●	Ease of use - Its intuitive remote controls aims to simplify advanced procedures while shortening the physician’s learning curve.

	●	Telemedicine compatible - Capable of supporting tele-catheterization, carried out remotely by highly trained specialists.

Common stock offered by the selling stockholders		1,005,965 shares
Common stock outstanding before the offering (1)		14,398,964 shares
Common stock to be outstanding after the offering		14,398,964 shares
Nasdaq Capital Market Symbol		MBOT

	●	the timing and outcomes of the product candidates’ 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;

	●	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 and scientific and medical personnel; and

	●	the costs to operate as a public company in the United States.

	●	our ability to obtain additional capital;

	●	successful completion of animal studies and human clinical trials and the collection of sufficient data to demonstrate that the device is safe and effective for its intended use;

	●	receipt of marketing approvals or clearances from the FDA and other applicable regulatory authorities, which we continue to seek;

	●	establishing commercial manufacturing arrangements with one or more third parties;

	●	obtaining and maintaining patent and trade secret protections;

	●	protecting Microbot’s rights in its intellectual property portfolio;

	●	establishing sales, marketing and distribution capabilities;

	●	generating commercial sales, if and when approved, whether alone or in collaboration with other entities;

	●	acceptance of our product candidates, if and when commercially launched, 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 of our products following clearance or approval.

	●	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.

	For the Years Ended December 31,
	2023			2022			Change
Research and development expenses, net	$	(5,724	)	$	(7,736	)	$	2,012
General and administrative expenses, net		(4,131	)		(5,545	)		1,414
Financing income, net		228			118			110
Loss on disposal of property and equipment		(2	)		(5	)		3
Loss on legal settlement, net		(1,111	)		-			(1,111	)

	For the Years Ended December 31,
	2023			2022
Net cash flows from operating activities	$	(8,533	)	$	(11,549	)
Net cash flows from investing activities		1,973			(3,836	)
Net cash flows from financing activities		6,558			4,324
Net decrease in cash, cash equivalents and restricted cash	$	(2	)	$	(11,061	)

	●	Continue to refine existing product candidates and develop additional surgical robotic solutions. As Microbot prepares to bring its initial product through the support of preclinical and clinical trials, it continues gathering patients, patient and clinical data, and patient and physician feedback post-market. 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.

	●	Establish and leverage relationships with key institutions and leading clinicians. Microbot’s objective will be to maintain clinical focus with leading hospitals and clinics so as to establish the LIBERTY^® Endovascular Robotic Surgical System, as well as possibly other future products, as the standard of care in such institutions for their respective procedures. Microbot also expects to identify Key Opinion Leaders (KOLs) with the relevant specialties (for instance interventional radiology) with the expectation that such clinical focus will accelerate the adoption of its candidate products.

	●	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 on its prototype products 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.

	●	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 System Regulation, or QSR, 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;

	●	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 QSRs. The FDA periodically inspects manufacturing facilities to assess compliance with QSRs, 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 QSRs 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.

	●	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.

Name	Age	Position
Harel Gadot	52	President, Chief Executive Officer and Chairman of the Board of Directors
Yoseph Bornstein(1)(3)	65	Director
Scott Burell(1)(2)	59	Director
Martin Madden(1)(3)	63	Director
Prattipati Laxminarain(2)	66	Director
Aileen Stockburger(3)	61	Director
Tal Wenderow(2)	49	Director

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