Motus GI(R) Holdings, Inc. Presents Positive Clinical Data from Performance Study of the Pure-Vu(R) System at the 25th United European Gastroenterology Week
Data show Pure-Vu System significantly increased the number of subjects with an adequate cleansing level to 100% from 19.1% at baseline after use of the Pure-Vu System; Pure-Vu System has potential to improve clinical outcomes while reducing costs and complications associated with conventional purgative-based bowel preps in a market encompassing over 30 million annual procedures worldwide
FORT LAUDERDALE, FL -- (Marketwired) -- 11/01/17 -- Motus GI Holdings, Inc. ("Motus" or the "Company"), a medical technology company dedicated to improving endoscopy outcomes and experiences, announced today that positive results from a recently conducted study evaluating the performance of the Pure-Vu® System in cleansing a poorly prepared colon, assessing the system's usability, patient satisfaction and safety, were presented at the 25th United European Gastroenterology ("UEG") Week, held October 28 - November 1, 2017, in Fira Gran Via, Barcelona.
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 2x10 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.
"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," commented Mark Pomeranz, Chief Executive Officer of Motus.
"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.
About UEG Week
UEG Week is the largest and most prestigious gastroenterology meeting in Europe and has developed into a global congress. It attracts over 14,000 participants each year, from more than 120 countries, and numbers are steadily rising. UEG Week provides a forum for basic and clinical scientists from across the globe to present their latest research in digestive and liver diseases, and also features a two-day postgraduate course that brings together top lecturers in their fields for a weekend of interactive learning.
About Colorectal Cancer
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S. with approximately 50,000 deaths and 140,000 new cases of CRC diagnosed each year. The lifetime risk of developing CRC is about 1 in 20 -- or 5%. Through the use of colonoscopies, however, CRC has become one of the most preventable cancers.
About the Pure-Vu® System
The Pure-Vu® System is a 510(k) US Food and Drug Administration cleared medical device indicated for cleaning a poorly prepared colon during the colonoscopy procedure, decreasing the dependency on pre-procedural prep regimens to achieve a thorough colonoscopy. The device integrates with standard colonoscopes, allowing the physician to clean poorly-prepared colons in a safe and effective manner to gain clear visualization of the colon mucosa.
About Motus GI
Motus GI Holdings, Inc. is a medical technology company, with subsidiaries in the U.S. and Israel, dedicated to improving endoscopy outcomes, lowering costs and enhancing patient experiences. The Company is focused on the development and commercialization of the Pure-Vu® System to improve the colonoscopy experience and assist in the early detection and prevention of colorectal cancer and other diseases of the rectum and colon. The Pure-Vu® System has the potential to improve the colonoscopy experience for physicians, patients and payers by diminishing the dependency on pre-procedural preparations, thereby enhancing the quality and cost-effectiveness of the exam. For more information, visit www.motusgi.com.
This press release contains certain forward-looking statements, including those relating to the Company's product development, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. The Company has made every reasonable effort to ensure the information and assumptions on which these statements are based are current, reasonable and complete. However, a variety of factors, many of which are beyond the Company's control, affect the Company's operations, performance, business strategy and results and there can be no assurances that the Company's actual results will not differ materially from those indicated herein. Additional written and oral forward-looking statements may be made by the Company from time to time. 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. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Jenene Thomas Communications, LLC
Source: Motus GI Holdings, Inc.
Released November 1, 2017