Motus GI Receives Approval from the Israeli Ministry of Health to Initiate Commercial Sales of its GEN2 Pure-Vu® System in Israel
Company assessing strategic partnership opportunities in Israel and throughout Europe following key regulatory approvals
FORT LAUDERDALE, Fla., April 07, 2020 (GLOBE NEWSWIRE) -- 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 it has received approval from the Israeli Ministry of Health, Medical Device Division (known as "AMAR") to initiate commercial sales of the GEN2 Pure-Vu® System in Israel. This regulatory clearance gives Motus GI access to the Israeli medical device market – one of the largest in the Middle East.
“The AMAR approval, in addition to the recent CE Mark approval in the EU, positions us well to continue strategic discussions with medical device companies and distributors who have a commercial footprint in Israel and across Europe,” said Tim Moran, chief executive officer of Motus GI. “Given the large unmet need associated with insufficient bowel prep that exists throughout the world, we plan on continuing to assess potential partners who may be able to assist in scaling and accelerating our commercial footprint. We continue to expand our network of influential GI’s that can benefit from the Pure-Vu System in addressing inadequate bowel prep for inpatient colonoscopies – a key factor behind rescheduled, delayed or incomplete colonoscopies.”
The Pure-Vu System is cleared by the U.S. Food and Drug Administration 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 improve visualization enhancing the quality of an exam. In multiple clinical studies to date, involving challenging inpatient and outpatient cases, the Pure-Vu System has consistently helped achieve adequate bowel cleanliness rates greater than 95% following a reduced prep regimen.
Motus GI estimates that approximately four million inpatient colonoscopy procedures take place worldwide each year.
About Motus GI
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 30, 2020 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.
Released April 7, 2020