What the changes say
- Microbot transitioned from a research-stage company to commercializing its sole product, the LIBERTY Endovascular Robotic Surgical System.
What changed since the prior 10-K
New
- NewRisks Relating to the Development and Commercialization of Microbot’s Products
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
Microbot depends entirely on commercializing its sole product, the LIBERTY Endovascular Robotic Surgical System, and has no product revenues as of December 31, 2025.
- NewRisks Relating to the Development and Commercialization of Microbot’s Products
If Microbot does not achieve one or more of these factors in a timely manner or at all, it could experience significant delays or an inability to successfully commercialize the LIBERTY ® Endovascular Robotic Surgical System or any other product candidate, which would materially harm its business
If market adoption and commercial opportunities for the LIBERTY Endovascular Robotic Surgical System fall short, business growth and profitability will suffer.
- NewRisks Relating to the Development and Commercialization of Microbot’s Products
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
The Israel-Hamas war and the U.S.-Israeli conflict with Iran have caused component supply delays from Israeli vendors for the LIBERTY system.
- NewRisks Relating to the Development and Commercialization of Microbot’s Products
Our profitability may be negatively impacted by inflation in the cost of labor, materials, and services
Inflation on plastic components and new Trump administration tariffs on trading partners threaten to increase operating costs and capital expenditures for the LIBERTY device.
Dropped
- DroppedRisks Relating to Microbot’s Financial Position and Need for Additional Capital
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
Expected continued operating losses and history of no revenue.
- DroppedRisks Relating to Microbot’s Financial Position and Need for Additional Capital
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
- DroppedRisks Relating to the Development and Commercialization of Microbot’s Product Candidates
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
Need for additional funding to avoid delaying product development.
- DroppedRisks Relating to the Development and Commercialization of Microbot’s Product Candidates
If the size of the commercial opportunities in any of Microbot’s target markets is smaller than it anticipates, Microbot may not be able to achieve profitability and growth. It is difficult to predict the penetration, future growth rate or size of the market for Microbot’s product candidate
- DroppedRisks Relating to the Development and Commercialization of Microbot’s Product Candidates
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
- DroppedRisks Relating to the Development and Commercialization of Microbot’s Product Candidates
Microbot’s business plan with respect to the LIBERTY® Endovascular Robotic Surgical System relies on the broad adoption by doctors of the product for its planned applications
Reworded
- 80% rewrittenRisks Relating to the Development and Commercialization of Microbot’s Products
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
Updated to reflect that Microbot shifted its focus to commercialization in 2025 and has limited manufacturing experience.
- 75% rewrittenRisks Relating to Operations in Israel
Existing and historical risks relating to our operations in Israel are being exacerbated by the current military actions and operations, and related activities, following the U.S.-Israel joint attach on Iran
Updated to include expanded military operations into Syria, Yemen, and Iran, and the February 28, 2026 'Epic-Fury' attack.
Was: 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
- 67% rewrittenRisks Relating to Microbot’s Financial Position and Need for Additional Capital
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
Changed operating history description from a research-and-development stage to a commercial-stage company.
Was: 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
- 55% rewrittenRisks Relating to the Development and Commercialization of Microbot’s Products
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
Minor phrasing adjustments regarding the impact of unfavorable clinical data on regulatory approvals.
- 49% rewrittenRisks Relating to the Development and Commercialization of Microbot’s Products
Microbot’s ability to expand its technology platforms for other uses may be limited
Clarified that future 510(k) applications for product candidates create uncertainty and potential cost increases.
- 37% rewrittenRisks Relating to Operations in Israel
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 an impact on future corporate decisions
Updated Israeli Innovation Authority royalty-bearing grants total to approximately $2.5 million through December 31, 2025.
Was: 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
- 30% rewrittenRisks Relating to the Development and Commercialization of Microbot’s Products
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
Removed specific salary reduction references from the May 2023 cost reduction program and generalized executive retention risks.
- 25% rewrittenRisks Relating to the Development and Commercialization of Microbot’s Products
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
Updated classification language to state that LIBERTY products are categorized as Class II devices requiring 510(k) clearance.
Was: Microbot may be subject to penalties and may be precluded from marketing its product candidates if Microbot fails to comply with extensive governmental regulations
- 24% rewrittenRisks Relating to the Development and Commercialization of Microbot’s Products
Microbot may not meet its development and commercialization objectives in a timely manner or at all
- 21% rewrittenRisks Relating to International Business
In order for Microbot to market its product candidates in countries other than the United States, it must comply with the safety and quality regulations in such countries
All 41 risk factors
Headings as the filing states them, in filing order.
Risks Relating to Microbot’s Financial Position and Need for Additional Capital
- 01Microbot 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 viability67% rewritten
Risks Relating to the Development and Commercialization of Microbot’s Products
- 02Microbot’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 harmedNew
- 03If Microbot does not achieve one or more of these factors in a timely manner or at all, it could experience significant delays or an inability to successfully commercialize the LIBERTY ® Endovascular Robotic Surgical System or any other product candidate, which would materially harm its businessNew
- 04Customers 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 prices80% rewritten
- 05Unsuccessful 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 prospects55% rewritten
- 06The 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
- 07Microbot may not meet its development and commercialization objectives in a timely manner or at all24% rewritten
- 08Microbot’s ability to expand its technology platforms for other uses may be limited49% rewritten
- 09Our 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 expectedNew
- 10Microbot has relied on, and intends to continue to rely on, third-party manufacturers to produce its products and product candidates
- 11If 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
- 12Microbot may be subject to penalties and may be precluded from marketing its products and product candidates if Microbot fails to comply with extensive governmental regulations25% rewritten
- 13Microbot products may in the future be subject to mandatory product recalls that could harm its reputation, business and financial results
- 14If 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
- 15Microbot 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
- 16If 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 effectively30% rewritten
- 17Our profitability may be negatively impacted by inflation in the cost of labor, materials, and servicesNew
Risks Relating to International Business
- 18In order for Microbot to market its product candidates in countries other than the United States, it must comply with the safety and quality regulations in such countries21% rewritten
- 19Microbot operations in international markets involve inherent risks that Microbot may not be able to control
- 20Microbot’s financial results may be affected by fluctuations in exchange rates and Microbot’s current currency hedging strategy may not be sufficient to counter such fluctuations
Risks Relating to Microbot’s Intellectual Property
- 21Intellectual property litigation and infringement claims could cause Microbot to incur significant expenses or prevent Microbot from selling certain of its product candidates
- 22If 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
- 23Dependence 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
Risks Relating to Operations in Israel
- 24Existing and historical risks relating to our operations in Israel are being exacerbated by the current military actions and operations, and related activities, following the U.S.-Israel joint attach on Iran75% rewritten
- 25Microbot has facilities located in Israel, and therefore, political conditions in Israel may affect Microbot’s operations and results
- 26Political relations could limit Microbot’s ability to sell or buy internationally
- 27Israel’s economy may become unstable
- 28Exchange rate fluctuations between the U.S. dollar and the NIS currencies may negatively affect Microbot’s operating costs
- 29Funding and other benefits provided by Israeli government programs may be terminated or reduced in the future and the terms of such funding may have an impact on future corporate decisions37% rewritten
- 30In addition, as a result of our 2022 agreement with Nitiloop, we took over the liability to repay Nitiloop’s IIA grants in the amount of approximately $925,000
- 31Some of Microbot’s employees are obligated to perform military reserve duty in Israel
- 32It may be difficult to enforce a non-Israeli judgment against Microbot or its officers and directors
Risks Relating to Microbot’s Securities, Governance and Other Matters
- 33If we fail to comply with the continued listing requirements of The Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
- 34Anti-takeover provisions in the Company’s charter and bylaws under Delaware law may prevent or frustrate attempts by stockholders to change the board of directors or current management and could make a third-party acquisition of the Company difficult
General Risks
- 35Political, social and geopolitical conditions can adversely affect our business
- 36Political uncertainty may have an adverse impact on our operating performance and results of operations
- 37Raising additional capital may cause dilution to the Company’s investors, restrict its operations or require it to relinquish rights to its technologies or product candidates
- 38Information technology failures and data security breaches could harm our business
- 39Our business strategy in part relies on identifying, acquiring and developing complementary technologies and products, which entails risks which could negatively affect our business, operations and financial condition
- 40The market price for our common stock may be volatile
- 41The issuance of shares upon exercise of outstanding warrants and options could cause immediate and substantial dilution to existing stockholders
Other Microbot Medical 10-Ks
- FY2024 10-K risk factors43 risks
Microbot operates as an early-stage medical device company facing continuous operating losses and dependence on the LIBERTY system. Operations and key personnel are heavily concentrated in Israel, creating regional geopolitical and military vulnerabilities. Intellectual property protection, regulatory approvals from the FDA and foreign bodies, and third-party manufacturing partnerships are critical to future commercialization.
Filed Mar 25, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.