FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company dedicated to improving endoscopy outcomes and experiences, announced today that it has appointed Seth A. Gross, MD, to its Medical Advisory Board (“MAB”). Motus GI’s MAB is comprised of leading experts in the gastroenterology and endoscopy field who actively work with the Company to advise, develop and execute the clinical trials and development strategy. In addition, Dr. Gross will serve as principal investigator in the Company’s upcoming Reliable Endoscopic Diagnosis Utilizing Cleansing Enhancement, or “REDUCE,” study, a single-arm multi-center, prospective, study of the Pure-Vu® System.
“In the in-patient hospital setting, the required preparation for a colonoscopy, especially for an emergent patient, not only delays the time to diagnosis but in many cases the prep does not work well which reduces the quality of the exam and leads to repeat procedures and extended lengths of stay,” said Dr. Gross. “I believe the Pure-Vu System offers a powerful new tool to address these challenges and potentially provides a more consistent, effective procedure. I look forward to working with the Motus GI Medical Advisory Board as we look to advance the Pure-Vu System. I am equally excited to take part in the Company’s upcoming REDUCE study, which is designed to evaluate the potential improvement in colonoscopy procedure outcomes with the use of the Pure-Vu System in the in-patient population.”
Dr. Gross is a leading physician with over 17 years of experience as a gastroenterologist and advanced endoscopist. He currently is an Associate Professor of Medicine, NYU School of Medicine. Dr. Gross has authored a number of abstracts and papers in the field of gastroenterology, is active on national committees and has participated in teaching new and advanced techniques in gastroenterology. Dr. Gross serves on the American College of Gastroenterology (ACG) Institute's board of directors and is an ACG Educational Affairs Committee member. Dr. Gross received his MD from the Sackler School of Medicine New York State American Program of Tel Aviv University and completed his residency at Northshore University Hospital and his fellowship in gastroenterology at the Mayo Clinic School of Graduate Medical Education.
“We are very pleased to welcome Dr. Gross, a pioneer in the field of endoscopy, to our Medical Advisory Board. We believe that his knowledge and expertise will be a valuable addition to Motus GI as we work to demonstrate how the Pure-Vu System can address the significant clinical and health economic challenges associated with bowel prep for colonoscopy in the in-patient setting. Dr. Gross is committed to providing the best possible outcomes for his patients, and we have been working closely with him on the design of the REDUCE study, which we remain on track to begin this quarter,” said Mark Pomeranz, CEO of Motus GI.
The REDUCE study, a multi-center in-patient prospective trial, is expected to enroll approximately 100 patients. The primary endpoint of the REDUCE study is improvement of colon cleanliness (Boston Bowel Preparation Scale Score (“BBPS”)), which has been shown to directly correlate to improved outcomes. The Company expects to initiate the REDUCE study in the second quarter and report results in the fourth quarter of this year.
The Pure-Vu System, Motus GI’s flagship product, is currently being introduced on a pilot basis in the U.S. market. The Company is planning to initiate a full commercial launch in the U.S. and select international markets in 2019. Motus GI received CE mark approval for the Pure-Vu System in Europe and expects to continue to involve key European clinical centers, along with a broad range of U.S. clinical centers, in its post-approval in-patient and out-patient clinical trials that it plans to conduct over the course of the next 24 months. The Company’s expected clinical trials are designed to evaluate the Pure-Vu System’s ability to rapidly cleanse poorly prepped patients during colonoscopy with BBPS as the measure of cleanliness, as well as assess the Pure-Vu System’s ability to reduce healthcare costs by reliably and predictably moving patients through the system to a successful examination.
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. 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. 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. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in the Company's filings with the Securities and Exchange Commission, including its registration statement on Form S-1, as amended from time to time, under the caption "Risk Factors."