Motus GI Receives Approval from the Israeli Ministry of Health to Initiate Commercial Sales of its Pure-Vu® EVS System

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Motus GI receives approval to initiate commercial sales of Pure-Vu EVS System in Israel

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• Motus GI has received approval from the Israeli Ministry of Health to sell the Pure-Vu EVS System in Israel, one of the largest markets in the region. This supports the company's strategy to form global partnerships with medical device companies.

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FORT LAUDERDALE, Fla., Aug. 10, 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, today announced that it has received approval from the Israeli Ministry of Health, Medical Device Division (known as "AMAR") to initiate commercial sales of the Pure-Vu^® EVS System in Israel.

“We are pleased to secure regulatory clearance for the Pure-Vu EVS System in Israel, which is considered an advanced medical system globally and one of the largest markets in this region. Leading healthcare systems in a number of regions in the U.S. and the Veterans Health Administration (VHA) are currently utilizing the Pure-Vu EVS System. Gaining regulatory approval in various regions of the world supports our strategy to enable strategic partnerships with medical device companies on a global basis,” stated Mark Pomeranz, Chief Executive Officer of Motus GI.

The Pure-Vu System EVS integrates with standard and slim colonoscopes, to improve visualization during colonoscopy while preserving established procedural workflow and techniques. Through irrigation and evacuation of debris, the Pure-Vu System is designed to provide better-quality exams. Challenges exist for inpatient colonoscopy and endoscopy, particularly for patients who are elderly, with comorbidities, or active bleeds, where the ability to visualize, diagnose and treat is often compromised due to debris, including fecal matter, blood, or blood clots. Motus GI believes this is especially true in high acuity patients, like upper GI bleeds where the existence of blood and blood clots can impair a physician’s view and removing them can be critical in allowing a physician the ability to identify and treat the source of bleeding on a timely basis.

Patients struggling to get a high-quality prep prior to their colonoscopy can lead to delayed, aborted and repeat procedures, which puts a burden on the healthcare system and the patient, both from a clinical and economic perspective. According to the literature, early repeat exams happen between 10% and 20% of the time in outpatient colonoscopies and many patients don't come back as prescribed, which leaves them at a higher risk for an interval cancer, especially for patients at high risk for CRC.

The Pure-Vu EVS is already cleared by the U.S. Food and Drug Administration (FDA) to help facilitate the cleansing of a poorly prepared gastrointestinal tract during colonoscopy.

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

FAQ

What approval did Motus GI receive?

Motus GI received approval from the Israeli Ministry of Health to sell the Pure-Vu EVS System in Israel.

What is the Pure-Vu EVS System?

The Pure-Vu EVS System is a medical device that improves visualization during colonoscopy by irrigating and evacuating debris.

What are the benefits of the Pure-Vu EVS System?

The Pure-Vu EVS System provides better-quality exams and helps physicians identify and treat the source of bleeding.

Is the Pure-Vu EVS System already approved in the US?

Yes, the Pure-Vu EVS System is already cleared by the U.S. FDA.