Motus GI Holdings, Inc. announced that it has received clearance from the U.S. Food and Drug Administration ("FDA") for the special 510(k) for technological advancements featured in the new Pure-Vu EVS Gastro and Gen 4 Colon system. The Pure-VU EVS Gastro opens the critically important upper gastrointestinal (GI) portion of the market and access to the high acuity patients that suffer from an upper GI bleed where visualization to address this high mortality condition can be a significant issue. Both the Pure Vu EVS Gastro and the improved version for the colon each provide significant benefits compared to previous Pure-Vu models and are designed to potentially open new opportunities in 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, that can provide clinical benefit to patients and efficiencies for hospital systems. The Pure-Vu EVS 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. 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 mortality rate of this condition can reach up to approximately 10%, as noted in Thad Wilkins, MD, et al., American Family Physician (2012).