UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On October 31, 2023, Microbot Medical Inc. (the “Company”) issued a press release announcing additional updates regarding positive outcomes of its previously announced pivotal pre-clinical study using the LIBERTY Robotic Surgical System. Follow up visual examination three days after the procedures using the LIBERTY Robotic Surgical System, confirms 100% success rate in reaching the targets with no visual evidence of vascular injury or any other visual adverse event.
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.
On October 31, 2023, the Company announced additional updates regarding positive outcomes of its previously announced pivotal pre-clinical study using the LIBERTY Robotic Surgical System. Follow up visual examination three days after the procedures using the LIBERTY Robotic Surgical System, confirms 100% success rate in reaching the targets with no visual evidence of vascular injury or any other visual adverse event.
The Company expects to receive the comprehensive final report later this quarter. Subject to the final report, and the completion of the verification and validation process, the Company plans on submitting the Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration, in order to commence its pivotal clinical trial in humans.
Cautionary Statements Regarding Forward-Looking Statements
This Current Report on Form 8-K includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Certain of these forward-looking statements can be identified by the use of words such as “believes,” “expects,” “intends,” “plans,” “estimates,” “assumes,” “may,” “should,” “will,” “seeks,” or other similar expressions. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results, including those under “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023. Most of these factors are outside the Company’s control and are difficult to predict. The Company cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based, except as may be required by law.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description | |
| 99.1 | Press Release dated October 31, 2023 | |
| 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: October 31, 2023 | ||