FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus" or the "Company"), a medical technology company dedicated to improving endoscopy outcomes and experiences, announced today that it has received European CE mark approval for its flagship product, the Pure-Vu® System. The Pure-Vu System works with standard colonoscopes to help facilitate the cleaning of poorly prepped colons during the colonoscopy procedure, while preserving standard procedural workflow and techniques. The Pure-Vu System has previously received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") and is currently being introduced on a pilot basis in the U.S.
“Receiving CE mark approval for the Pure-Vu System is a notable achievement as we work to expand the awareness of the benefits of the Pure-Vu System in key European markets over the next 24 months. CE mark approval enables us to continue to work with expert clinical thought leaders in Europe and begin to lay the foundation for future commercial expansion into Europe,” said Mark Pomeranz, CEO of Motus. “We believe the Pure-Vu System has the potential to improve clinical outcomes while significantly reducing costs, particularly in our initial target market of difficult-to-prep in-patient colonoscopy. While there are 30 million colonoscopy procedures performed annually worldwide, nearly 4 million of these procedures are performed for in-patients where reliance on conventional purgative-based bowel preps remains a serious challenge and leads to delayed diagnoses, extended hospital stays, and other increased costs due to repeat procedures and readmissions.”
Peter D. Siersema, MD, PhD, Professor of Endoscopic Gastrointestinal Oncology at the Radboud University Medical Center, Nijmegen, The Netherlands, and Medical Advisor of Motus, commented, “I believe the Pure-Vu System has tremendous potential to provide physicians with an easy-to-use device that enables a quality exam for patients, especially those who experience difficulty with the prep, and may minimize the possibility of a repeat procedure. The Pure-Vu System has the potential to make a real difference for patients undergoing a colonoscopy and may be an important tool in addressing colorectal cancer and other serious GI disorders.”
In November 2017, Motus reported positive results from its most recent European clinical study evaluating the performance of the Pure-Vu® System in cleansing a poorly prepared colon at the 25th United European Gastroenterology (“UEG”) Week conference in Fira Gran Via, Barcelona. Results from the 47-patient study showed 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% at baseline to 100% after using the Pure-Vu System. Mean post-treatment BBPS score was 9 vs. 3 prior to Pure-Vu System use. Motus expects to continue to involve select European clinical centers in post-approval clinical trials of the Pure-Vu System it plans to conduct during the next 12 months and beyond.
About the Pure-Vu® System
The Pure-Vu® System is a 510(k) U.S. Food and Drug Administration cleared medical device indicated to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure. The device integrates with standard colonoscopes to enable cleaning during the procedure while preserving standard procedural workflow and techniques. The Pure-Vu System has received CE mark approval in Europe.
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.
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."