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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): January 12, 2026

 

MICROBOT MEDICAL INC.

(Exact name of registrant as specified in its charter)

 

Delaware   000-19871   94-3078125

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

175 Derby St., Bld. 27

Hingham, MA 02043

(Address of Principal Executive Offices) (Zip Code)

 

Registrant’s telephone number, including area code: (781) 875-3605

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

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

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

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. ☐

 

 

 

 

 

 

Item 8.01 Other Events.

 

On January 12, 2026, Microbot Medical Inc. (the “Company”) issued a press release reaffirming its 2025 achievements and announcing its key 2026 anticipated milestones.

 

The press release, which is furnished as Exhibit 99.1 to this Current Report on Form 8-K, is incorporated herein by reference.

 

Forward Looking Statements

 

This Item 8.01 of this Current Report on Form 8-K may contain “forward-looking statements.” Such statements which are not purely historical (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “intends,” “would,” “could” and “estimates”) are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future, including but not limited to, business, regulatory and financial milestones.

 

Actual results could differ from those projected in any forward-looking statements due to numerous factors. These forward-looking statements are made as of the date of this Form 8-K, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Although the Company believes that the beliefs, plans, expectations and intentions contained in this Form 8-K are reasonable, there can be no assurance that such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in the Company’s reports and statements filed from time-to-time with the Securities and Exchange Commission.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
Number
  Description
     
99.1   Press Release
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements 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.

 

  MICROBOT MEDICAL INC.
   
  By: /s/ Harel Gadot
  Name:  Harel Gadot
  Title: Chief Executive Officer, President and Chairman

 

Date: January 12, 2026

 

 

 

Exhibit 99.1

 

 

Microbot Medical Continues its 2025 Momentum; Announces Key 2026 Milestones

 

Limited Market Release (LMR) of the LIBERTY® System is on Schedule

 

Building on Positive Customer Feedback and Growing Market Enthusiasm, the Company Prepares for Full Market Release (FMR) in Q2

 

HINGHAM, Mass., Jan. 12, 2026 — Microbot Medical Inc. (Nasdaq: MBOT), developer and distributor of the innovative LIBERTY® Endovascular Robotic System, is continuing to generate significant market and new customer momentum as it enters 2026. In 2025, the Company met its milestones, including several pivotal achievements such as obtaining FDA 510(k) clearance for LIBERTY, the first single-use, remotely operated robotic system for peripheral endovascular procedures. The Company initiated its limited market release, quickly achieving its first customer to adopt LIBERTY for patient care. The Company is positioning itself to leverage this momentum and commercialize LIBERTY across a targeted U.S. market of 2.5 million peripheral endovascular procedures annually. This progress enables the Company to pursue and strive for the 2026 anticipated milestones listed below.

 

Key 2025 Operational and Business Achievements

 

Received FDA clearance
Launched the Limited Market Release of LIBERTY, strategically introducing LIBERTY into select high procedure volume regions, leveraging early demand to accelerate adoption.
Emory University Hospital, a nationally recognized academic medical center in Atlanta, became the first hospital to adopt the LIBERTY system shortly after the company commenced its commercialization. The Company is collaborating with Emory to establish an Endovascular Robotics Program in interventional radiology to enhance the growing and evolving specialty field.
Established an experienced commercial leadership team, including in key sales and marketing roles, to strengthen the Company’s launch readiness plans.
Expanded the cross-functional team to support launch readiness of LIBERTY.
Presented data from the ACCESS PVI pivotal trial at the Society of Interventional Radiology (SIR) annual meeting, highlighting 100% robotic navigation success, a 92% reduction in radiation exposure and no adverse device events reported.
Attended CIO, the first scientific conference since receiving FDA clearance, with overwhelming positive feedback from attendees.
Partnered with third-party manufacturers and logistics organizations to ensure greater efficiencies and meet expected customer demand.
Advanced Teleintervention™ collaboration with Corewell Health™ as LIBERTY® successfully performed simulated vascular navigation across two sites within the Corewell Health™ system, located five miles apart.
Expanded its IP Portfolio with Global Patent Allowances in the U.S., Japan, Europe and Israel, resulting in a total of 20 patents granted and 52 patent applications pending approval.
Added as a member of the Russell Microcap® Index, which Microbot believes reflects its continued strong execution and progress.
Bolstered the balance sheet, which also included a non-dilutive grant, to further strengthen the company’s commercial capabilities.

 

Anticipated 2026 Operational and Commercial Milestones

 

Commence the Full Market Release (FMR) of the LIBERTY System in Q2 2026, in conjunction with the Society of Interventional Radiology (SIR) conference.
Grow customer base by attracting early adopters and securing new hospitals with medium-to-high volume target procedures.
Validate the LIBERTY System’s significant market opportunity, with the expansion of the types of procedures that are being performed as well as the end user call point to include interventional radiologists, vascular surgeons, and interventional cardiologists.

 

 

 

 

Establish commercial and operational infrastructure to support expansion into markets outside the USA, either under FDA Clerance or other regional and local regulatory approvals.
Enhance the Company’s core capabilities by filling cross-functional roles with the right talent to support execution and future growth.
Maintain a strong presence at key medical societies and conferences, including the Society of Interventional Oncology (SIO) and International Symposium on Endovascular Therapy (ISET) in February, Society of Interventional Radiology (SIR) in April, Global Embolization Symposium and Technologies (GEST) in May and Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in September.
Continue to establish pipeline to allow future growth to other interventional spaces (cardiology, neurovascular) and increase the utilization opportunity within the peripheral space.
Continue collaborations with leading institutions in the areas of teleintervention and autonomous robotics and explore additional opportunities to leverage the innovative LIBERTY technology.
Expand and protect the Company’s global IP portfolio, which creates barriers to entry, and allows the Company to monetize its innovative technology.
Leverage the strong balance sheet to fully execute its near and medium-term commercial strategy in the U.S. and globally, and to support its product development pipeline.

 

About Microbot Medical

 

Microbot Medical Inc. (NASDAQ: MBOT) is a commercial stage medical device company focused on transforming endovascular procedures through advanced robotic technology. Microbot’s LIBERTY® Endovascular Robotic System is the first single-use, remotely operated robotic solution designed for precision, efficiency, and safety. Backed by a strong intellectual property portfolio and a commitment to innovation, Microbot is driving the future of endovascular care.

 

Learn more at www.microbotmedical.com and connect on LinkedIn and X.

 

Safe Harbor

 

Statements to future financial and/or operating results, future growth in research, technology, clinical development, commercialization and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “contemplates,” “continues,” “could,” “forecasts,” “intends,” “may,” “might,” “possible,” “potential,” “predicts,” “projects,” “should,” “would,” “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the commercialization of the LIBERTY® Endovascular Robotic System, and in the development of future versions of or applications for the system, uncertainty in the results of regulatory pathways and regulatory approvals, uncertainty resulting from political, social and geopolitical conditions, particularly any changes in personnel or processes or procedures at the FDA and announcements of tariffs on imports into the U.S., disruptions resulting from new and ongoing hostilities between Israel and the Palestinians, Iran and other neighboring countries, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical® can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical® disclaims any intent or obligation to update these forward-looking statements, except as required by law.

 

Contacts:

 

IR@microbotmedical.com

Media@microbotmedical.com