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The abstract entitled, “Performance of the Motus Pure-Vu System – A novel device for achieving adequate bowel prep in poorly prepped patients,” was presented by K. Van Keulen from the Department of Gastroenterology and Hepatology at Radboud University Medical Center in the Netherlands. The multicenter, feasibility study enrolled a total of 47 cases at three clinical sites in Europe. Peter Siersema, Professor of Endoscopic Gastrointestinal Oncology at Radboud University, Helmut Neumann, Professor of Medicine and Director of Endoscopy at the Department of Internal Medicine at the University Medical Center Mainz in Germany, and Dr. Manon Spaander, Associate Professor in Gastroenterology at the Department of Gastroenterology of the Erasmus University Medical Center in Rotterdam, were the key investigators in the study.
“The ability to improve the patient’s experience and the overall quality of the exam is important given that, in as many as 20% of the over 30 million colonoscopies performed worldwide each year, patients are inadequately prepared. Inadequate preparation results in increased rates of missed lesions, earlier repeat procedures, prolonged colonoscopy duration, reduced patient satisfaction and increased costs,” said Professor Siersema. “The clinical data from this study demonstrating Pure-Vu System’s safety and effectiveness in cleansing poorly prepared colons combined with the physician and patient reported outcomes are encouraging, and I believe Pure-Vu System will play a key role in enhancing the colonoscopy procedure’s effectiveness in multiple patient populations.”
Pure-Vu System was used in subjects with a partially prepared colon after 2×10 mg Bisacodyl, diet restrictions, which included no dried fruit, seeds or nuts, starting 2 days before the procedure and an up to 24-hour clear liquid diet prior to the colonoscopy. Indications for colonoscopy included family history of colorectal cancer (“CRC”) and polyp surveillance. The endpoints of the study were safety, improvement of colon cleansing level as per the Boston Bowel Preparation Scoring (“BBPS”) when comparing before and after Pure-Vu System use, Pure-Vu System usability via questionnaire and patients’ satisfaction via questionnaire. BBPS is a 10-point scale assessing bowel preparation after all cleansing maneuvers are completed by the endoscopist. Each region of the colon receives a “segment score” from 0 to 3 and these segment scores are summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon is 9 and the minimum BBPS score for an unprepared colon is 0.
Results from the study show that the Pure-Vu System significantly increased the number of subjects with an adequate cleansing level (BBPS >= 2 for all 3 colon segments) from 19.1%; CI 95% [11%, 43%] at baseline to 100%; CI 95% [89%, 100%] after using the Pure-Vu System and the cecum was reached and visualized in 46 of the 47 study cases. Mean post-treatment BBPS score was 9 vs. 3 prior to Pure-Vu System use.
Physicians were satisfied with the device’s general ease of use. No major difficulties were experienced when performing polypectomy. No serious adverse events were reported.
Mark Pomeranz, Chief Executive Officer of Motus said, “We are very pleased with the results from this study as the data are consistent with our previous clinical findings demonstrating the Pure-Vu System to be safe and effective in cleaning inadequately prepared colons to an adequate level, along with continued effective outcomes and physician and patient satisfaction.”
“Our commercialization strategy has been specifically designed to enhance our growing body of clinical evidence in order to support data-driven market utilization and adoption of the Pure-Vu System in the coming years. We are currently executing the market development phase of this strategy which includes driving clinical and health economic data, developing practice management models and importantly, partnering with multiple thought leaders that are active in the treatment of high-need patient sub-sets that require more frequent colonoscopies or face more significant clinical challenges with respect to adequate bowel preparation. We believe this strategic approach will position the Company to thoughtfully target an initial addressable market of approximately seven million colonoscopy procedures per year in the US alone. We firmly believe the Pure-Vu System will play a significant role in providing a solution for patients with an inadequately prepared colon which we believe will ultimately improve the overall quality of colonoscopies and help to reduce the risk of colorectal cancer and other significant GI disorders,” added Mr. Pomeranz.
Motus GI received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market its Pure-Vu System, and it is currently being introduced on a pilot basis. The Company expects to move to a full commercial launch in the U.S. and international markets in 2019.