Motus GI Holdings announces publication of Pure-Vu system clinical study data.
Motus GI Holdings announced that its manuscript titled, "An intra-procedural endoscopic cleansing device for achieving adequate colon preparation in poorly prepped patients," has been published in the peer-reviewed Journal of Clinical Gastroenterology. The Company's flagship product, the Pure-Vu System, is a U.S. FDA 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 safe and rapid cleansing during the procedure while preserving established procedural workflow and techniques. The Company is currently focused on post-approval clinical trials and market development programs with leading U.S. hospitals that are utilizing the Pure-Vu System on a pilot basis in preparation for a full commercial launch in the U.S. and select international markets in 2019. The Pure-Vu System significantly increased the number of subjects with an adequate cleansing level from 31% at baseline to 98% after use of Pure-Vu. Cecal intubation was achieved in 48/49 patients. The published manuscript includes data from the Company's multicenter feasibility study of the Pure-Vu System, which enrolled a total of 50 patients with poorly prepared colons undergoing colonoscopy to evaluate the Pure-Vu System at 2 clinical sites in Spain and Israel. In this study, the Pure-Vu System was used in subjects with a partially prepared colon after a spilt dose of two tablets of 5mg Bisacodyl / Laxadin diet restrictions starting 2 days before the procedure and a 24- or 18-hour clear liquid diet prior to the colonoscopy. At Days 2 and 14 post procedure a telephone follow-up was conducted to assess patient well-being and capture any adverse events. The endpoints of the study were safety, improvement of colon cleansing level as per the Boston Bowel Preparation Scoring when comparing before and after Pure-Vu System use, Pure-Vu System usability via questionnaire and patients' satisfaction via questionnaire. Patients with an adequate cleansing level increased significantly from 31% at baseline to 98% after use of Pure-Vu. Cecal intubation was achieved in 48/49 patients. Due to a convoluted anatomy in one patient, the colonoscope was unable to reach and therefore clean the cecum. The Pure-Vu System was found to be safe, efficacious, and easy to use in cleansing inadequately prepared colons, enabling the endoscopist to conduct a complete examination. No serious adverse events were reported.
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|Date:||Feb 19, 2019|
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