Motus GI Holdings, Inc. announced that it has submitted a special 510(k) to the U.S. Food and Drug Administration ("FDA") for market clearance of its Pure-Vu Gen 4 Gastro and Colon. A special 510(k), according to FDA guidance, has an initial review usually within 30 days of receipt. The Pure-Vu EVS Gen 4 Gastro for upper gastrointestinal (GI) procedures and the improved version for the colon each provide significant benefits compared to previous Pure-Vu models and are designed to potentially open new segments of the GI market by introducing new capabilities while also addressing factors that make it easier to work with commercial partners.

Both products leverage the same workstation to create an effective platform to improve visualization in both the upper and lower GI tract to facilitate use in multiple indications, especially in high acuity patients like GI bleeding. The Pure-Vu Gen 4 Gastro builds off the success of the patented and proprietary pulsed vortex irrigation and smart sense suction used in the colon device and has been enhanced to target blood and blood clots in the upper GI tract. These key enhancements include a larger and more powerful suction channel, more efficient irrigation jets, and a smaller profile distal tip that offers enhanced flexibility during insertion and enhanced navigation, as well as reductions in the cost-of-goods of approximately 50% and the training requirements for the customer from hours to minutes.

Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc. The existence of blood and blood clots in these patients can impair a physician?s view, making it difficult to identify the bleed source. The Company believes removing adherent blood clots from the field of view is a significant need in allowing a physician the ability to identify and treat the bleed source. The mortality rate of this condition can reach up to approximately 10%, as noted in Thad Wilkins, MD, et al., American Family Physician (2012).