FORT LAUDERDALE, Fla., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc. (Nasdaq: MOTS, or "Motus GI" or "the Company"), a medical technology company focused on improving endoscopic outcomes and experiences, announced today the publication of positive data from a study of the second generation Pure-Vu System in a manuscript titled, "An intraprocedural bowel cleansing system for difficult-to-prepare patients-A multicenter prospective feasibility study," in the peer-reviewed journal, United European Gastroenterology (UGE). The Company's Pure-Vu System is an FDA-approved and CE-certified bowel cleansing system (BCS) intended to increase visualization in inadequately prepared colons by offering intraprocedural cleansing.
"We are excited to see the positive results from this European study published in the UGE Journal, further building upon the extensive portfolio of study data and user experiences for the second generation Pure-Vu System. This study concluded that adequate bowel cleaning can be achieved in patients with a history of inadequate bowel preparation by using the Pure-Vu System. As a result, patients and hospitals would benefit from a reduced number of repeat colonoscopies and clinical admissions for bowel preparation," commented Mark Pomeranz, Chief Executive Officer. "It is worth noting that since this study was initiated, the Motus GI team secured 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. These enhancements address many of the limitations of our previous model and may make it even more effective in patients with a complicated anatomy."
The single arm, international, multicenter colonoscopy study evaluated if an adequate level of bowel cleansing could be achieved with the Pure-Vu System in patients with previous poor bowel preparation (Boston Bowel Preparation Scale (BBPS)<6). The study enrolled a total of 44 patients with previous poor bowel preparation (BBPS<6) within the last 2 years. Typically patients with a history of poor bowel prep are prescribed a more aggressive prep regime on their follow up colonoscopy, whereas in this study all patients received a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System. The BBPS was assessed before and after segmental washing by the endoscopist who performed the procedure and later by an independent endoscopist (photos). The study exclusion criteria included previous colon resection, previous colorectal cancer, colitis, lower gastrointestinal bleeding with hemodynamic instability, ASA>3, insufficiently corrected anticoagulation disorders, inability to provide informed consent.
Results from the study met the primary endpoint, showing a median BBPS increase from 1-2-2 (IQR 1-2) to 3-3-3 (IQR) (p < 0.0001), with 31.8% and 88.6% of patients adequately prepared before and after using the Pure-Vu System, respectively (p < 0.0001). The study also met its key secondary endpoints. The study reported a cecal intubation rate was 88.6%, and, in patients with complete colonoscopy, the adequate cleansing rate was 97.5%. Median total procedure time was 26 minutes, of which 5.3 minutes were spent on cleaning. General ease of use was scored with a median of 4 out of 5, representing "as good as conventional colonoscopy." No serious adverse events occurred.
The UGE article is available at the Wiley online library (click here).
About Motus GI Holdings, Inc.
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.
Cautionary Statement Regarding 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 the satisfaction of customary closing conditions related to the offering and uncertainties related to the offering and the use of proceeds from the offering, 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
