Motus GI Submits 510(k) Application to FDA for the Pure-Vu System for Upper GI Endoscopy
FORT LAUDERDALE, Fla., April 06, 2021 (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, announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (“FDA”) for a version of the Pure-Vu® System that is compatible with gastroscopes used during upper gastrointestinal (GI) endoscopy procedures to remove blood, blood clots and debris in order to provide a clear field-of-view for the endoscopist. The device is designed to integrate with therapeutic gastroscopes to enable safe and rapid cleansing during the procedure, while preserving established procedural workflow and techniques.
“We are excited to announce the filing of the 510(k) with the FDA for our new Pure-Vu System compatible with gastroscopes used during upper GI endoscopies. Our potential entry into the upper GI market is a natural next step in our growth strategy for the Pure-Vu System. If approved, this product will expand our total addressable market, and we see potential synergies for our commercial team as we intend to target the same population of GI physicians,” stated Tim Moran, Chief Executive Officer of Motus GI. “Launching a version of Pure-Vu designed for use during upper GI endoscopy is the result of collaboration between our R&D team working directly with key physicians using the Pure-Vu System who saw the potential for leveraging our technology for another significant unmet need in the GI space.”
Upper GI bleeds occurred in the U.S. at a rate of approximately 400,000 cases per year in 2019, according to iData Research Inc. The mortality rate of this condition can reach up to approximately 10%, as noted in Thad Wilkins, MD, et al., American Family Physician (2012). Removing adherent blood clots from the field of view is a significant need in allowing the physician the ability to identify and treat the bleed source.
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 related to the Company’s cost reduction plan, the cost savings and the cash expenses related to the implementation of the plan, risks related to the continued impact of the COVID-19 pandemic, 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 16, 2021, 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 6, 2021