Microbot Medical (NASDAQ: MBOT) wins FDA 510(k) nod for LIBERTY robotic system

Rhea-AI Filing Summary

Microbot Medical Inc. filed an 8-K to report that the U.S. Food and Drug Administration has granted 510(k) clearance for its LIBERTY® Endovascular Robotic System, described as the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures. This clearance allows the company to move ahead with final commercial activities that depended on marketing clearance and to begin U.S. commercialization, with an aim to address approximately 2.5 million annual U.S. peripheral vascular procedures and later pursue global markets. The company also disclosed that its President, CEO and Chairman, Harel Gadot, is presenting at the H.C. Wainwright Annual Investor Conference in New York on September 9, 2025, with a live webcast available via its website.

Positive

• FDA 510(k) clearance of LIBERTY® Endovascular Robotic System, described as the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures, creating a pathway to U.S. commercialization.
• Large stated procedure opportunity, as the company cites approximately 2.5 million annual U.S. peripheral vascular procedures that LIBERTY® aims to address, alongside plans to pursue global markets.

Negative

• None.

Insights

Medtech and Regulatory Affairs Analyst

FDA 510(k) clearance for LIBERTY positions Microbot Medical to begin U.S. commercialization and target a large peripheral vascular procedure market.

The company reports that the U.S. Food and Drug Administration granted 510(k) clearance for the LIBERTY® Endovascular Robotic System. The device is described as the first FDA-cleared single-use, remotely operated robotic system for peripheral endovascular procedures, signaling that it met FDA requirements for safety and effectiveness relative to a predicate device.

With this clearance, Microbot Medical states it can complete commercial activities that were contingent on marketing clearance and commence commercialization in the U.S. It specifically highlights an addressable base of approximately 2.5 million annual U.S. peripheral vascular procedures and the intention to pursue entry into global markets, indicating a potentially meaningful revenue opportunity if adoption occurs.

The filing emphasizes that FDA clearance is expected to enable accessibility to advanced robotics without traditional capital equipment and infrastructure constraints, which may appeal to a broader set of hospitals and centers. Actual commercial impact will depend on pricing, reimbursement, clinician adoption and competitive responses, which are not detailed here and will likely be clarified in subsequent company communications and filings.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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): September 8, 2025

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 7.01 Regulation FD Disclosure.

On September 8, 2025, Microbot Medical Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has granted 510(k) clearance for the Company’s LIBERTY^® Endovascular Robotic System, the first FDA cleared single-use, remotely operated robotic system for peripheral endovascular procedures.

The press release, which is furnished as Exhibit 99.1 to this Current Report on Form 8-K, is incorporated herein by reference. The information in this Item 7.01 and Exhibit 99.1 is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. This report will not be deemed an admission as to the materiality of any information in this Item 7.01 or Exhibit 99.1.

In addition, the Company announced that it will attend the H.C. Wainwright Annual Investor Conference held in New York, New York, from September 8-10, 2025. Mr. Harel Gadot, the Company’s President, CEO and Chairman, will present live on Tuesday, September 9, 2025 at 9:00 am ET, and a live webcast may be accessed via the ‘Events’ section of the Company’s website at www.microbotmedical.com. Interested parties should reach out to their H.C. Wainwright sales representatives or contact mpolyviou@evcgroup.com to schedule a one-on-one meeting with Microbot Medical’s management team.

Item 8.01 Other Events.

The FDA has granted 510(k) clearance for the Company’s LIBERTY^® Endovascular Robotic System, the first FDA cleared single-use, remotely operated robotic system for peripheral endovascular procedures. The FDA clearance positions the Company to commercialize LIBERTY^® in the U.S., with the goal of transforming the field to enable accessibility to advanced robotics without the traditional constraints of capital equipment and a dedicated infrastructure.

With FDA clearance, the Company expects to complete the final commercial activities that were contingent on marketing clearance, positioning the Company to commence commercialization, penetrate the approximately 2.5 million annual U.S. peripheral vascular procedures, and pursue entry into global markets.

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, regulatory 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: September 8, 2025

FAQ

What did Microbot Medical (MBOT) disclose in this 8-K filing?

Microbot Medical disclosed that the U.S. Food and Drug Administration granted 510(k) clearance for its LIBERTY® Endovascular Robotic System, and that it plans to complete final commercial activities and commence U.S. commercialization. The company also noted its participation in the H.C. Wainwright Annual Investor Conference in New York in September 2025.

What is Microbot Medical’s LIBERTY Endovascular Robotic System?

The LIBERTY® Endovascular Robotic System is described as the first FDA-cleared single-use, remotely operated robotic system designed for peripheral endovascular procedures. The company states that it aims to enable access to advanced robotics without traditional capital equipment and dedicated infrastructure constraints.

What does the FDA 510(k) clearance mean for Microbot Medical (MBOT)?

The company states that FDA 510(k) clearance positions it to commercialize LIBERTY® in the U.S.. With this clearance, it expects to complete final commercial activities that were contingent on marketing clearance and begin commercialization, targeting approximately 2.5 million annual U.S. peripheral vascular procedures and future global market entry.

How large is the market Microbot Medical is targeting with LIBERTY?

Microbot Medical cites approximately 2.5 million annual U.S. peripheral vascular procedures as the opportunity it aims to penetrate with the LIBERTY® system. The company also indicates plans to pursue entry into global markets, though specific international numbers are not provided in this filing.

Is Microbot Medical providing a presentation or webcast related to this news?

The company states that its President, CEO and Chairman, Harel Gadot, will present at the H.C. Wainwright Annual Investor Conference in New York on September 9, 2025 at 9:00 am ET. A live webcast of the presentation may be accessed through the ‘Events’ section of the company’s website at www.microbotmedical.com.

Does this 8-K filing include forward-looking statements from Microbot Medical?

Yes. The company notes that the section discussing LIBERTY® and its commercialization plans may contain forward-looking statements, including beliefs, plans and expectations regarding regulatory milestones and commercialization. It cautions that actual results could differ due to various factors and refers investors to risk factor disclosures in its SEC reports.