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 received clearance from the U.S. Food and Drug Administration (“FDA”) for the special 510(k) for technological advancements featured in the new Pure-Vu EVS Gastro and Gen 4 Colon system.
– Clearance opens up the potential breakthrough opportunity in the Upper GI market, an area of high unmet clinical need –
– Technological advancements featured in new generation of the Pure-Vu platform, enhance the performance of the system, improve the ease of use and minimizes the need for onsite support to new accounts –
– Expect to initiate market introduction of the new Pure-Vu EVS platform by year-end for both the Upper GI and Colon indications –
FORT LAUDERDALE, Fla., Oct. 24, 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 received clearance from the U.S. Food and Drug Administration (“FDA”) for the special 510(k) for technological advancements featured in the new Pure-Vu EVS Gastro and Gen 4 Colon system. The Pure-Vu EVS Gastro opens the critically important upper gastrointestinal (GI) portion of the market and access to the high acuity patients that suffer from an upper GI bleed where visualization to address this high mortality condition can be a significant issue. Both the Pure Vu EVS Gastro and the improved version for the colon each provide significant benefits compared to previous Pure-Vu models and are designed to potentially open new opportunities in 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, that can provide clinical benefit to patients and efficiencies for hospital systems.
“We are excited to receive FDA clearance for our next generation system, which features key enhancements such as 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. In addition to offering new capabilities, this latest version of our platform reduces the cost-of-goods by approximately 50% and the training requirements for the customer from hours to minutes. Based on physician feedback, we expect the Upper GI indication and these enhancements to be well received by the GI community and we believe will drive greater market adoption of the Pure-Vu EVS platform,” commented Mark Pomeranz, Chief Executive Officer. “We look forward to initiating market introduction of the Pure-Vu EVS Gastro and Gen 4 Colon in the U.S. by the end of the year. Currently, we are planning to ramp up manufacturing supply and expect to have supply of both new products to customers in the coming months.”
The Pure-Vu EVS 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.
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 acceptance of the Pure-Vu EVS Gastro and Gen 4 Colon system 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
