Quarterly report pursuant to Section 13 or 15(d)

Description of Business

Description of Business
9 Months Ended
Sep. 30, 2020
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 second-generation of the Pure-Vu System has received CE Mark approval in the European Economic Area. 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. The Company began commercialization in the fourth quarter of 2019, with the first commercial placements of its second generation Pure-Vu System as part of its initial U.S. market launch targeting early adopter hospitals. As a result of the COVID-19 pandemic, the initial launch of the Pure-Vu System was impacted, particularly in the second quarter of 2020. In the latter half of the third quarter of 2020, the Company saw  colonoscopy procedural volumes, hospital access and physician availability and engagement begin to improve. The Company does not expect to generate significant revenue from product sales until the Company expands its commercialization efforts for the Pure-Vu System, which is subject to significant uncertainty.