エドガーで原本を確認する
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): April 1, 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 April 1, 2025, Microbot Medical Inc. (the “Company”) issued a press release announcing that data from the Company’s ACCESS-PVI trial will be presented by Francois Cornelis, MD, PhD, FCIRSE, Memorial Sloan Kettering Cancer Center, Department of Radiology. This is the first time data from the study will be presented via a podium presentation, to take place on Wednesday, April 2, 2025 at 11:33am CT. The Company also reaffirms that it expects the FDA’s decision with respect to 510(K) clearance of LIBERTY® during the current second quarter.
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.
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: April 1, 2025
Exhibit 99.1
REMINDER: Microbot Medical Announces Data from the Company’s ACCESS-PVI trial will be Presented via Podium Presentation at Society of Interventional Radiology Annual Meeting
Company Reaffirms Expected Timing of FDA Decision With Respect to 510(K) Clearance of LIBERTY® During the Current Second Quarter
BRAINTREE, Mass., April 1, 2025 -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic System, is providing this reminder that data from the Company’s ACCESS-PVI trial will be presented by Francois Cornelis, MD, PhD, FCIRSE, Memorial Sloan Kettering Cancer Center, Department of Radiology. This is the first time data from the study will be presented via a podium presentation, to take place on Wednesday, April 2, 11:33am CT.
ACCESS-PVI trial, a prospective, multicenter, single-arm trial evaluating the performance and safety of LIBERTY® in patients undergoing peripheral vascular interventions.
In conjunction with the data presentation, members of the Company’s executive and clinical teams have been meeting with SIR attendees. The Company reaffirms that it expects the FDA’s decision with respect to 510(K) clearance of LIBERTY® during the current second quarter.
About Microbot Medical®
Microbot Medical Inc. (NASDAQ: MBOT) is a pre-commercial stage medical technology company with a vision to improve the quality of care for millions of patients and providers globally. The Company has developed the world’s first single-use, fully disposable endovascular robotic system, which aims to eliminate traditional barriers to accessing advanced robotic systems.
Further information about Microbot Medical® is available at http://www.microbotmedical.com.
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 “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, the Company’s need for and ability to obtain additional working capital to continue its transition to a commercially focused company, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic System, uncertainty in the results of regulatory pathways and regulatory approvals, including whether the FDA will timely grant 510(k) clearance to commercially market the LIBERTY® Endovascular Robotic System in the United States if at all, uncertainty resulting from political, social and geopolitical conditions, particularly any changes in personnel or processes or procedures at the FDA, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians 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.
Investor Contact: IR@microbotmedical.com