UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 Other Events.
On October 17, 2023, Microbot Medical Inc. (the “Company”) issued a press release announcing the successful initial outcomes from its pivotal pre- clinical study with the LIBERTY® Robotic Surgical System.
The pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a total of 48 animal targets. A total of 6 LIBERTY Systems were used in the study, and each was used to reach a total of 8 targets. All 6 LIBERTY Systems performed flawlessly, with 100% usability and technical success. No acute adverse events or complications were visually observed intra-operative.
The Company expects to receive the comprehensive final report later this quarter. Subject to the final report, and the completion of a planned verification and validation process, the Company plans on submitting the Investigational Device Exemption application to the FDA, in order to commence its pivotal clinical trial in humans.
The press release, which is filed as Exhibit 99.1 to this Current Report on Form 8-K, is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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. | |
| /s/ Harel Gadot | |
| Harel Gadot | |
| Chairman, President and Chief Executive Officer | |
| Date: October 17, 2023 |