Motus GI Submits 510(k) Application to FDA for the Pure-Vu System for Upper GI Endoscopy

Rhea-AI Summary

Motus GI Holdings has submitted a 510(k) application to the FDA for a new version of the Pure-Vu System, compatible with gastroscopes for upper GI endoscopy. This innovation aims to improve efficiency in treating upper GI bleeds, which affect approximately 400,000 patients annually in the U.S. The product enhances visibility by removing blood and debris during procedures, potentially expanding Motus GI's market share and operational synergies. CEO Tim Moran expressed optimism about the application, as it aligns with the company's growth strategy.

Positive

• Submission of 510(k) application for Pure-Vu System compatible with gastroscopes.
• Potential market expansion targeting upper GI procedures.
• Addresses significant clinical need in treating upper GI bleeds.

Negative

• None.

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.

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, 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.

Investor Contact:
Bob Yedid
LifeSci Advisors
(646) 597-6989
bob@lifesciadvisors.com

FAQ

What is the recent FDA application by Motus GI Holdings?

Motus GI submitted a 510(k) application for the Pure-Vu System that is compatible with gastroscopes for upper GI endoscopy.

How does the new Pure-Vu System benefit upper GI endoscopy?

It improves visibility by clearing blood, blood clots, and debris during procedures, enhancing treatment outcomes.

What is the potential market impact of Motus GI's new device?

The new device could expand Motus GI's addressable market and streamline operations with existing GI physician targets.

How many upper GI bleeds occur annually in the U.S.?

Approximately 400,000 cases of upper GI bleeds are reported each year in the U.S.

What is the significance of the Pure-Vu System in treating upper GI conditions?

The Pure-Vu System addresses a critical need by allowing physicians to identify and treat sources of upper GI bleeds effectively.