FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Motus GI Holdings, Inc., (NASDAQ:MOTS) ("Motus GI" or the "Company"), a medical technology company dedicated to improving endoscopy outcomes and experiences, announced today that it has enrolled the first patient in its REDUCE (Reliable Endoscopic Diagnosis Utilizing Cleansing Enhancement) study. The REDUCE study is a single-arm multi-center, prospective study that will utilize the Pure-Vu® System to facilitate bowel cleansing in approximately 100 hospitalized patients who are indicated for a diagnostic colonoscopy procedure. The Pure-Vu® System is a medical device that cleans the colon intra-procedurally to facilitate improved visualization during a colonoscopy procedure to enable a quality exam and has demonstrated effective cleaning in hundreds of procedures. Challenges with bowel preparation for inpatient colonscopy represent a significant area of unmet need that directly affects clinical outcomes and the cost of care in a market that comprises over 1.5 million annual procedures in the U.S. and over 4 million annual procedures worldwide.
“Hospitalized patients are generally very difficult to prep for colonoscopy procedures due to serious emergent conditions, such as undiagnosed GI bleeding, and other factors such as ongoing illnesses, comorbidities and new medications,” said Seth A. Gross, MD, FACG, FASGE, AGAF, Associate Professor of Medicine, NYU Langone Health, Principal Investigator of the REDUCE study. “This is a serious challenge, as inadequate bowel preparation is a major impediment to achieving a quality colonoscopy and can lead to long procedure times, the need to repeat procedures, extended hospital stays and delayed diagnoses, all of which significantly increase costs for hospitals and interfere with quality care for patients.”
The REDUCE study is a multi-center study designed to evaluate the Pure-Vu® System’s ability to consistently and reliably cleanse the colon to facilitate a successful colonoscopy in a timely manner in patients who are indicated for a diagnostic colonoscopy procedure. The primary endpoint of the study is to determine the Pure-Vu® System’s rate of improved bowel cleansing level using the Boston Bowel Preparation Scale (BBPS) index, a validated and commonly used method of scoring bowel cleanliness for colonoscopy. Other key data to be collected as part of the study include the proportion of patients who receive a successful colonoscopy for the intended indication in the first attempt and the time to successful colonoscopy compared to current care algorithms, both key data in evaluating speed and quality of diagnosis as well as evaluating hospital costs and length of stay.
“The initiation of the REDUCE study represents a significant step in our strategic approach to continue to build a robust set of clinical and health economic data to support the commercial launch and drive adoption of the Pure-Vu® System in the key segment of inpatient colonoscopy,” said Mark Pomeranz, CEO of Motus. “We are hopeful the data from this study, which we expect to report in the fourth quarter of this year, will demonstrate the ability of the Pure-Vu® System to reduce the time to achieve a quality exam as well as eliminate excess hospital expenses. Since most of inpatient colonoscopies are currently covered under the bundled payment of a Diagnosis-Related Group (“DRG”) reimbursement, we believe the Pure-Vu® System has the potential to offer a new standard of care which may enhance hospital efficiency by improving quality of care, reducing the length of stay and direct costs, as well as accelerating bed turn-over for new patients.”
About the Pure-Vu® System
The Pure-Vu® System is a 510(k) U.S. Food and Drug Administration cleared medical device indicated to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure. The device integrates with standard colonoscopes to enable cleaning during the procedure while preserving standard procedural workflow and techniques. The Pure-Vu® System has received CE mark approval in Europe. The Pure-Vu® System is currently being introduced on a pilot basis in the U.S. market, and the Company is planning to initiate a full commercial launch focused on the inpatient colonscopy market in the U.S. and select international markets in 2019.
About Motus GI
Motus GI Holdings, Inc. is a medical technology company, with subsidiaries in the U.S. and Israel, dedicated to improving endoscopy outcomes, lowering costs and enhancing patient experiences. The Company is focused on the development and commercialization of the Pure-Vu® System to improve the colonoscopy experience and assist in the early detection and prevention of colorectal cancer and other diseases of the rectum and colon. In clinical studies to date, the Pure-Vu® System significantly increased the number of patients with an adequate cleansing level, according to the Boston Bowel Preparation Scale Score, a validated assessment instrument.
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. Forward-Looking statements involve risks and uncertainties, including, without limitation, risk 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 28, 2018, 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 of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.