Motus GI Announces First Patient Enrolled in a Pilot Study Using the Pure-Vu® System for Patients with Lower GI Bleeding Being Conducted by a Leading U.S. Medical Center

Rhea-AI Summary

Motus GI Holdings, Inc. (NASDAQ: MOTS) announced the enrollment of the first patient in a pilot study for the Pure-Vu® System, aimed at improving clinical outcomes for patients with emergent lower gastrointestinal bleeding. The study will enroll up to 20 patients and assess bowel preparation success during urgent colonoscopies using minimal prep. The Pure-Vu System, FDA-cleared, enhances visualization and is expected to lower costs while expediting diagnoses. The company anticipates that over 4.8 million inpatient colonoscopies will occur globally in 2021, underlining the system's potential impact.

Positive

• Enrollment of the first patient in a pilot study for the Pure-Vu® System.
• Potential to improve clinical and economic outcomes in urgent colonoscopy cases.
• Pure-Vu System's FDA clearance may enhance marketability and adoption.
• Estimates of 4.8 million inpatient colonoscopies worldwide in 2021 highlight demand.

Negative

• None.

FORT LAUDERDALE, Fla., March 15, 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 today the enrollment of the first patient in a pilot study of the Pure-Vu® System. The study is evaluating the clinical and economic outcomes using the Pure-Vu System in patients with emergent lower gastrointestinal bleeding that are evaluated and treated in the Intensive Care Unit (ICU) or the rapid inpatient endoscopy suite.

The study, which is being conducted at a leading a non-profit, academic medical center in the U.S., is expected to enroll up to 20 patients with acute lower GI bleeding, who are undergoing urgent colonoscopy under monitored anesthesia care or conscious sedation. The colonoscopies will be performed using the Pure-Vu System after the patient has received minimal to no purgative preparation and two enemas. Cleansing success will be attained if a Boston Bowel Preparation Scale (BBPS) of ≥2 is achieved in all three colonic segments. The primary outcome of the study will be the proportion of patients who achieve an adequate bowel preparation to identify bleeding lesions in all three colonic segments. Additional information on the study is available at ClinicalTrials.gov (click here).

“We are excited to work with a well-known U.S. medical institution to evaluate how the Pure-Vu System may be able to improve the clinical and economic outcomes for patients with lower gastrointestinal bleeding. In addition, this study is designed for patients to undergo minimal bowel prep – just two enemas over a 30-minute period – with a goal of providing patients a much faster diagnosis as compared to the 24-hours usually required to do a full bowel prep,” said Tim Moran, chief executive officer of Motus GI. “This study builds upon a number of patient case studies presented to us over the past year that show how treating physicians were able to rapidly diagnose and treat bleeds in patients due to the improved visualization the Pure-Vu System provides during colonoscopy.”

In May 2019, the U.S. Food and Drug Administration (FDA) issued 510(k) clearance for the Pure-Vu GEN2 System. The system is approved to connect to standard or slim colonoscopes to help facilitate intraprocedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.

About the Pure-Vu System
The Pure-Vu System integrates with standard and slim colonoscopes to improve visualization during a colonoscopy while preserving established procedural workflow by irrigating the colon and evacuating debris to provide a better-quality exam. Challenges with bowel preparation for inpatient colonoscopy, particularly patients who are elderly, with comorbidities, or active bleeds, represent a significant area of unmet need that directly affects clinical outcomes and increases the cost of care. Motus GI believes the Pure-Vu System may lead to positive outcomes and lower costs for hospitals by safely and quickly improving visualization of the colon for a quality exam the first time. In multiple clinical studies to date, involving the treatment of challenging inpatient and outpatient cases, the Pure-Vu System has consistently helped achieve adequate bowel cleanliness rates greater than 95% following a reduced prep regimen. Motus GI estimates that in 2021 approximately 4.8 million inpatient colonoscopy procedures will take place worldwide.

The Pure-Vu System has received a CE Mark in the EU and is cleared by the U.S. Food and Drug Administration to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure.

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 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 30, 2020 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 purpose of the pilot study for the Pure-Vu® System?

The study aims to evaluate the clinical and economic outcomes using the Pure-Vu System in patients with emergent lower gastrointestinal bleeding.

How many patients are expected to be enrolled in the Pure-Vu® System study?

The study is expected to enroll up to 20 patients.

What are the anticipated benefits of the Pure-Vu® System?

The system is designed to improve visualization during colonoscopy and reduce bowel preparation time, potentially leading to faster diagnoses.

What is the significance of the FDA clearance for the Pure-Vu System?

FDA clearance allows the Pure-Vu System to be marketed and used to facilitate intraprocedural cleaning during colonoscopy, enhancing its commercial potential.

How many inpatient colonoscopy procedures are expected in 2021?

Approximately 4.8 million inpatient colonoscopy procedures are anticipated to take place worldwide in 2021.