Motus GI Submits Special 510(k) to FDA for Pure-Vu EVS Gen 4 Gastro and Colon
– A special 510(k), according to FDA guidance, is usually reviewed within 30 days of receipt –
– Pure-Vu Gen 4 platform opens up the Upper GI market, reduces the cost-of-goods by approximately 50% and minimizes the need for onsite support to new accounts –
FORT LAUDERDALE, Fla., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc., (NASDAQ: MOTS) (“Motus GI” or the “Company”), a medical technology company focused on improving endoscopic outcomes and experiences, announced today that it has submitted a special 510(k) to the U.S. Food and Drug Administration ("FDA") for market clearance of its Pure-Vu Gen 4 Gastro and Colon. A special 510(k), according to FDA guidance, has an initial review usually within 30 days of receipt.
The Pure-Vu EVS Gen 4 Gastro for upper gastrointestinal (GI) procedures and the improved version for the colon each provide significant benefits compared to previous Pure-Vu models and are designed to potentially open new segments of the GI market by introducing new capabilities while also addressing factors that make it easier to work with commercial partners. Both products leverage the same workstation to create an effective platform to improve visualization in both the upper and lower GI tract to facilitate use in multiple indications, especially in high acuity patients like GI bleeding.
The Pure-Vu Gen 4 Gastro builds off the success of the patented and proprietary pulsed vortex irrigation and smart sense suction used in the colon device and has been enhanced to target blood and blood clots in the upper GI tract. These key enhancements include a larger and more powerful suction channel, more efficient irrigation jets, and a smaller profile distal tip that offers enhanced flexibility during insertion and enhanced navigation, as well as reductions in the cost-of-goods of approximately 50% and the training requirements for the customer from hours to minutes.
“The submission of this special 510(k) to the FDA brings us one step closer to being able to commercially launch our next generation system in the U.S. market. Expanding the Pure-Vu platform’s capabilities into supporting upper GI procedures, an area of high unmet patient need, should accelerate the adoption of the Pure-Vu system in the market,” commented Mark Pomeranz, Chief Executive Officer. “Our submission for 510(k) clearance of the Pure-Vu Gen 4 Gastro and Colon is supported by positive preclinical and clinical data collected by some of the top key opinion leaders in both the U.S. and abroad. These data show the value our new platform offers hospitals and patients suffering from a number of indications.”
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 existence of blood and blood clots in these patients can impair a physician’s view, making it difficult to identify the bleed source. The Company believes removing adherent blood clots from the field of view is a significant need in allowing a physician the ability to identify and treat the bleed source. The mortality rate of this condition can reach up to approximately 10%, as noted in Thad Wilkins, MD, et al., American Family Physician (2012).
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.
For more information, visit www.motusgi.com and connect with the Company on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
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, statements relating to risks related to market and other conditions, risks inherent in the development and commercialization of potential products, possible or assumed future results of operations, business strategies, potential grow opportunities, 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 quarterly and annual reports filed with the Securities and Exchange Commission, 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, except as required by law.
Investor Contact:
Troy Williams
LifeSci Advisors
(518) 221-0106
twilliams@lifesciadvisors.com
