Motus GI Holdings Publishes Positive Results from a European Study of the Second Generation Pure-Vu System in Improving Visualization for Colonoscopy in Patients with a History of Poor Bowel Preparation
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The publication of the study on the Pure-Vu System signifies a notable advancement in the field of endoscopic procedures, particularly colonoscopy. The data indicating a significant increase in the Boston Bowel Preparation Scale (BBPS) from pre to post-use of the system demonstrates a marked improvement in bowel cleansing efficacy. This is critical as inadequate bowel preparation can lead to missed lesions and increased rates of repeat procedures, which are costly and inconvenient for patients and healthcare systems alike.
From a research perspective, the adoption of such technology could potentially reduce the number of incomplete colonoscopies and improve diagnostic accuracy. The improvement in BBPS scores from a median of 1-2-2 to 3-3-3 is statistically significant and clinically relevant, as a score of 3 across all colon segments indicates an excellent level of cleanliness, which is ideal for thorough examination.
Furthermore, the reported ease of use and the absence of serious adverse events suggest that the Pure-Vu System could be integrated into routine clinical practice with minimal disruption. This could translate into better patient outcomes and reduced healthcare costs associated with repeat procedures.
The economic implications of the Pure-Vu System's enhanced bowel cleansing capabilities are substantial. With the study reporting a 97.5% adequate cleansing rate in patients with complete colonoscopies, there is potential for significant reductions in the number of repeat colonoscopies. This not only improves patient experience but also alleviates the financial burden on healthcare facilities.
Repeat procedures can be a significant cost driver in endoscopy units. By potentially decreasing these repeat procedures, the Pure-Vu System could contribute to more efficient use of healthcare resources. Moreover, the median total procedure time of 26 minutes, with only an additional 5.3 minutes required for cleaning, indicates that the system can be incorporated into the workflow without substantial increases in procedure time, which is a crucial factor in healthcare economics where efficiency and throughput are key performance indicators.
It's important to note that the upfront costs of the Pure-Vu System and the training required for its use could offset some of these savings. However, if the system leads to fewer repeat procedures and improved patient throughput, the long-term cost savings could be significant.
This positive data could potentially impact Motus GI's market position. The Pure-Vu System addresses a clear need in the gastroenterology field for better bowel preparation in difficult-to-prepare patients. The enhancements mentioned, such as a larger suction channel and more efficient irrigation jets, suggest that the company is actively responding to user feedback and improving their product to meet clinical needs.
Given that the system is already FDA-approved and CE-certified, the publication of this data in a peer-reviewed journal serves as a strong marketing tool and could facilitate increased adoption of the system. The company's ability to innovate and secure FDA clearance for the next-generation system could attract investors' attention, potentially influencing Motus GI's stock performance.
However, it's important to consider the competitive landscape and reimbursement policies, which can affect the rate of adoption. If the system is not covered or poorly reimbursed by insurance companies, this could hinder its market penetration despite its clinical benefits.
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
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
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