Microbot Medical Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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| Item 7.01 | Regulation FD Disclosure. |
On June 9, 2025, Microbot Medical Inc. (the “Company”) issued a press release announcing the continued expansion of its commercial team with the addition of Michael Lytle as the head of Sales Operations & Analytics, in preparation for the anticipated U.S. launch of the LIBERTY System, which is projected during the third quarter of 2025. The press release further announced that the Company remains engaged with the U.S. Food and Drug Administration (“FDA”), with a 510(k) decision with respect to its LIBERTY® Endovascular Robotic System now expected during the third quarter of 2025. This updated FDA decision timeline remains within the FDA’s original scheduled review window and is not expected to affect the Company’s planned launch upon clearance.
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 8.01 | Other Events. |
The Company announced that a 510(k) decision with respect to its LIBERTY® Endovascular Robotic System is now expected during the third quarter of 2025. This updated FDA decision timeline remains within the FDA’s original scheduled review window and is not expected to affect the Company’s planned launch upon clearance
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 dated June 9, 2025 | |
| 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: June 9, 2025