The Pure-Vu® System – Improving Endoscopy Outcomes

The Company's flagship product is the Pure-Vu® System, a 510(k) U.S. Food and Drug Administration cleared medical device 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 cleaning during the procedure while preserving standard procedural workflow and techniques. The first generation of the Pure-Vu® System has received CE mark approval in Europe, and we intend to seek CE Mark approval for the second generation of our Pure-Vu® System.

Following the recent FDA clearance of the second generation Pure-Vu® System (“Pure-Vu® GEN2”), Motus GI plans to initiate its commercial launch in the U.S. with an initial focus on inpatient colonoscopy, with plans to expand into the high medical need outpatient market. The commercial launch of Pure-Vu® in international markets  will be explored in the future. Challenges with bowel preparation for inpatient colonoscopy represent a significant area of unmet need that directly affects clinical outcomes and increases the cost of care in a market segment that comprises approximately 1.5 million annual procedures in the U.S. and approximately 4 million annual procedures worldwide. Motus GI believes the Pure-Vu® System may improve outcomes and lower costs for hospitals by reducing the time to a successful colonoscopy, minimizing delayed and aborted procedures, and improving the quality of an exam. In clinical studies to date, the Pure-Vu® System significantly increased the number of patients with an adequate cleansing level, according to the Boston Bowel Preparation Scale Score, a validated assessment instrument.