Description of Business
|6 Months Ended
Jun. 30, 2019
|Organization, Consolidation and Presentation of Financial Statements [Abstract]
|Description of Business
Note 1 – Description of Business
Motus GI Holdings, Inc. (the “Company”) was incorporated in Delaware, U.S.A. in September 2016. The Company and its subsidiaries, Motus, Ltd. and Motus, Inc., are collectively referred to as “Motus GI” or the “Company”.
The Company has developed the Pure-Vu System (the “Pure-Vu System”), a medical device that has received 510(k) clearance from the U.S. Food and Drug Administration (the “FDA”). In June 2019, the 510(k) premarket notification for the second-generation of the Pure-Vu System was reviewed and cleared by the FDA. The first-generation of the Pure-Vu System has received CE Mark approval in the European Economic Area, and the Company intends to seek CE Mark approval for the second-generation of its Pure-Vu System. The Pure-Vu System is indicated to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure. The device integrates with standard and slim colonoscopes to enable safe and rapid cleansing during the procedure while preserving established procedural workflow and techniques by irrigating the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter. To date, as part of the limited pilot launch in the U.S. market, the Company has focused on collecting additional clinical and health economic data, as exemplified by the recently completed Reliable Endoscopic Diagnosis Utilizing Cleansing Enhancement Study (the “REDUCE Study”), along with garnering valuable experience in key hospitals on the use of the Pure-Vu System to support a planned launch of the Pure-Vu System in the United States hospital market in the second-half of 2019. The Company does not expect to generate significant revenue from product sales unless and until the Company expands its commercialization efforts.