FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, today announced receiving CE (Conformité Européene) Mark approval for the GEN2 Pure-Vu System. The Company is assessing potential strategic partnership opportunities for the Pure-Vu System with established medical device companies and distributors with commercial operations across the EU.
The CE Mark signifies that the Pure-Vu System meets the essential requirements of all relevant European Medical Device Directives. The directives outline the safety and performance requirements for medical devices in the European Union (EU). Receiving this regulatory clearance allows Motus GI to commercialize the Pure-Vu System and disposable sleeves across the EU and other CE Mark geographies.
“This is an important step in our commercialization strategy for the Pure-Vu system in Europe. We estimate that there are approximately 1.2 million inpatient colonoscopies conducted annually in the EU, making it one of the largest potential markets for our system,” stated Tim Moran, Chief Executive Officer of Motus GI. “The next step in our plan to enter the European market with the Pure-Vu System is to assess potential distribution agreements with companies that offer proven sales capabilities in the GI space and working knowledge of each country’s regulations. We believe a partnership could be the most efficient and effective method to bring the clinical and economic benefits of our Pure-Vu® System to physicians and patients across Europe.”
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 improve visualization during a colonoscopy while preserving established procedural workflow by irrigating the colon and evacuating debris to provide a better quality exam. 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. 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 enhancing 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.
Motus GI estimates that approximately 1.5 million inpatient procedures take place in the U.S. annually and approximately 4 million procedures take place worldwide each year.
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, providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions.
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 26, 2019, 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.