Benzinga | Jan 27, 2021 08:32AM EST

Microbot Medical Announces Outcome Of Its Discussions With FDA Regarding Regulation Of Self-Cleaning Shunt; FDA To Allow Co. To Apply For Early Feasibility Study

HINGHAM, Mass., Jan. 27, 2021 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (NASDAQ:MBOT) announced 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.