MICROBOT MEDICAL INC. (NASDAQ:MBOT) Files An 8-K Regulation FD Disclosure
Item 7.01
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 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).
(d) Exhibits
| 99.1 | Press Release |
Microbot Medical Inc. Exhibit
EX-99.1 2 ex99-1.htm Exhibit 99.1 Microbot Medical Announces Successful Outcome of its Discussions with FDA Regarding Regulation of Self-Cleaning Shunt FDA Feedback Reflects Strength of Pre-Clinical Safety Data; Maintains Q3 2022 Projected Commencement of First-in-Human Clinical Trial HINGHAM,…
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About MICROBOT MEDICAL INC. (NASDAQ:MBOT)
Microbot Medical Inc., formerly StemCells, Inc., is a medical device company. The Company specializes in the researching, designing, developing and commercializing transformational micro-robotic medical technologies leveraging the artificial and natural lumens within the human body. It is engaged in developing its two product candidates: the Self Cleaning Shunt (SCS) for the treatment of hydrocephalus and normal pressure hydrocephalus (NPH), and TipCAT, a self-propelling, semi-disposable endoscope that the Company is developing for use in colonoscopy procedures. Its ViRob technology is an autonomous crawling micro-robot, which can be controlled remotely or within the body. The Microbot SCS device is a robotic system designed as the ventricular catheter portion of a cerebrospinal fluid (CSF) shunt system. The Company’s TipCAT is an endoscope that provides see and treat capabilities within tubular lumens in the human body, such as the colon, blood vessels and the urinary tract.
