FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Motus GI Holdings, Inc., (NASDAQ:MOTS) ("Motus GI" or the "Company"), a medical technology company dedicated to improving clinical outcomes and enhancing the cost-efficiency of colonoscopy, announced today that its manuscript titled, “A novel device for intra-colonoscopy cleansing of inadequately prepared colonoscopy patients – a feasibility study,” has been published in the peer-reviewed journal, Endoscopy.
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.
Feasibility Study Data Highlights
- 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%; Confidence interval (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.
“We are pleased to have the data from our European clinical feasibility study selected for publication in this prestigious, peer-reviewed journal. The data bolsters our confidence in the Pure-Vu® System’s ability to successfully cleanse the colon to a high level regardless of the adequacy of the pre-procedural prep,” commented Tim Moran, Chief Executive Officer of Motus GI. “We continue to generate clinical and health economic data that we believe will help drive Pure-Vu® to be the standard of care in the inpatient market and support high need segments in the outpatient market, where patients present with an inadequately prepped colon up to 23% of the time.”
The published manuscript includes data from the Company’s multicenter feasibility study of the Pure-Vu® System, which 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 Pure-Vu® System has consistently shown its ability to improve clinical outcomes while reducing the dependency on conventional purgative-based bowel preps,” said Professor Siersema. “The ability to offer a solution to difficult-to-prep populations fills an important unmet need in colonoscopy. The data from this study suggest that Pure-Vu® could be an important tool for inpatients as well as high medical need outpatient, especially for those that have difficulty with the preparation regimes such as elderly patients, diabetics and patients with motility issues. We are grateful that this important data has been recognized by our peers and has been published in the Endoscopy journal.”
For this feasibility study, the Pure-Vu® System was used in subjects with partially prepared colons after 2x10 mg Bisacodyl, diet restrictions, which included no dried fruit, seeds or nuts, starting two 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. As previously noted the mean BBPS score went from a mean of 3 prior to the use of the Pure-Vu® System and a 9 after the use of the Pure-Vu® System in this study.
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.
About the Journal
Endoscopy is the premier journal for information on the latest technologies and international developments in gastrointestinal endoscopy. Under the expert direction of an international editorial board, this journal presents high-quality content that addresses the needs of endoscopists, surgeons, clinicians, and researchers across the globe.
Publishing 12 issues each year, Endoscopy features top-quality review articles, original contributions, prospective studies, valuable surveys of diagnostic and therapeutic advances, and in-depth coverage of the most important national and international meetings. All articles published in Endoscopy undergo rigorous peer review.
About Motus GI and the Pure-Vu® System
Motus GI Holdings, Inc. is a medical technology company, with subsidiaries in the U.S. and Israel, dedicated to improving clinical outcomes and enhancing the cost-efficiency of colonoscopy. The Company’s flagship product is the Pure-Vu® System, 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 Pure-Vu® System has received CE mark approval in Europe. The Pure-Vu® System is currently being introduced on a pilot basis in the U.S. market, and the Company is planning to initiate a full commercial launch focused on the inpatient colonoscopy market in the U.S. and select international markets in 2019. 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 successful colonoscopy, minimizing delayed and incomplete 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.
This press release contains certain forward-looking statements. Forward-looking statements are based on the Company's current expectations and assumptions. The Private Securities Litigation Reform Act of 1995 provides a safe-harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms, including without limitation, risks inherent in the development and commercialization of potential products, uncertainty in the timing and results of clinical trials or regulatory approvals, maintenance of intellectual property rights or other risks discussed in the Company’s Form 10-K filed on March 28, 2018, and its other filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.