Item 7.01 Regulation FD Disclosure.
On January 27, 2021, Microbot Medical Inc. (the "Company") issued a press
release announcing the completion of successful discussions with the U.S. Food
and Drug Administration (FDA) for its Self-Cleaning Shunt (SCS). After review of
the Company's existing pre-clinical data, the FDA's feedback will allow the
Company to apply for a limited clinical investigation known as an Early
Feasibility Study (EFS), which is designed for novel technologies such as the
SCS. Consequently, the Company reiterates its timeline for the First-in-Human
(FIH) clinical trial under the EFS, expected to commence in the third quarter of
2022.
The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K
is incorporated herein by reference. The information in this report (including
Exhibit 99.1) is being furnished pursuant to Item 7.01 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
herein (including Exhibit 99.1).
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