Motus GI Presents Positive Clinical Data from U.S. Prospective Study of the Pure-Vu® System at the 2018 American College of Gastroenterology (ACG) Annual Meeting
Gerald Bertiger, MD, Gastroenterologist, at Hillmont GI, in Flourtown, PA, presented the poster titled, “Optimizing the Preparation Regimen Prior to Colonoscopy Procedure with the Pure-Vu® System,” from a U.S. prospective clinical study that enrolled a total of 46 subjects and sought to evaluate the performance of the Pure-Vu® System in cleansing colons in patients requiring a colonoscopy that were allowed to consume solid food the day before the procedure and only required to consume a minimal bowel preparation regimen.
The use of the Pure-Vu® System enabled intraprocedural cleansing of the colon and enabled 100% successful completion of all colonoscopies performed. The primary endpoint of the study was evaluation of the quality of colon visualization using the Boston Bowel Preparation Scale (BBPS), a validated and widely used measure with a 0 to 9 point scale. Patients in the study had an average baseline BBPS of 3.67±2.86 which was improved to an average of 8.91±0.35 (p value <0.0001) following use of the Pure-Vu® System. The post-cleansing BBPS score is meaningfully higher than results generally seen with standard liquid diet plus purgative-based bowel prep regimens. The mean total procedure time for all arms was 26.61 minutes with the Mag Citrate arms trending lower at 25.03 minutes which is nearing the time of a standard colonoscopy.
“The data from this study support the safety and effectiveness of the Pure-Vu® System in patients with very dirty colons,” commented Dr. Bertiger. “Usability of the Pure-Vu® System was also easy and enabled a 100% success rate in the completion of the colonoscopies performed with successful intraprocedural cleansing of the colon. This study gives us solid insight into how the Pure-Vu® System can support patients that need a colonoscopy for urgent reasons in an inpatient environment as well as patients with medical issues that have significant issues with tolerating current preparation regimes.”
“This data along with my experience using the Pure-Vu® System in the inpatient setting gives me confidence this product can address the significant number of delayed and incomplete procedures associated with inpatients,” commented, Jason B. Samarasena MD FACG, Associate Clinical Professor of Medicine, Division of Gastroenterology School of Medicine, University of California Irvine. “The Pure-Vu® System has the potential to quicken the time to diagnosis, reduce cost and improve bed turnover which are important with the current reimbursement landscape.”
This prospective study was designed to compare two different minimal bowel preparation regimens. Initially patients were randomized to receive one of two minimal bowel preparations: three doses of 17gr MiraLAX each mixed in 8.5 oz of clear liquids or two doses of 7.5oz Magnesium Citrate (MgC) each taken with 19.5oz of clear liquid. A study amendment early on replaced the MiraLAX arm, due to obvious inferior BBPS results from the outset. The replacement arm consisted of two doses of 5oz MgC taken with 16oz of clear liquid. All patients were allowed a low residue diet (consisting of chicken, pasta, eggs, etc.) on the day prior and were asked to avoid seeds and nuts for five days prior to their procedure. Regardless of the minimal preparation regime, there was a significant difference (p value <0.0001) between the baseline preparation and that seen post cleansing with the Pure Vu® System (baseline BBPS of 3.673.67±2.86 was improved to 8.91±0.35 post Pure-Vu® use). No serious adverse events related to the device were reported.
“We continue to be encouraged by the clinical results being produced by the Pure-Vu® System. Its ability to consistently demonstrate the safe and efficient cleansing of insufficiently prepped colons during colonoscopy positions the Pure-Vu® System to potentially become a new standard of care, especially for inpatients whose diagnosis and treatment is often delayed due to the current preparation requirements. The data from this study also provides valuable insight into our ongoing REDUCE and upcoming EXPEDITE studies, both of which utilize the BBPS as a measure of colon cleanliness as a primary endpoint,” commented Tim Moran, Chief Executive Officer of Motus GI. “The successful execution of these studies is an important step in our ongoing market development activities, which we believe will help to accelerate initial market adoption for the upcoming commercial launch of the Pure-Vu® System in 2019.”
The Pure-Vu® System fits on commercially available standard and slim colonoscopes and generates a proprietary pulsed vortex™ mixture of water and air to safely remove debris while simultaneously evacuating the bowel contents, allowing the endoscopist to perform a quality examination even when the patient does not or is not able to complete a successful prep on his or her own. Motus GI’s clinical trials, such as the ongoing REDUCE study and its upcoming EXPEDITE study, are designed to evaluate the Pure-Vu System’s ability to address delays and inefficiencies in the inpatient population. The Pure-Vu® System and Pure-Vu® Slim have received 510(k) clearance from the U.S. Food and Drug Administration and the Pure-Vu® System has received CE mark approval in Europe and is currently being introduced on a pilot basis in the U.S.
The presented poster is available on the Motus GI website and can be accessed by clicking here.
Motus GI also has a booth at ACG and can be found in the Exhibit Hall at Booth #245.
About Motus GI and the Pure-Vu® System
Motus GI Holdings, Inc. is a medical technology company, with subsidiaries in the U.S. and Israel, dedicated to improving clinical outcomes and enhancing the cost-efficiency of colonoscopy. The Company’s flagship product is the Pure-Vu® System, a U.S. FDA cleared medical device indicated to help facilitate the cleaning of a poorly prepared colon during the colonoscopy procedure. The device integrates with standard and slim colonoscopes to enable safe and rapid cleansing during the procedure while preserving established 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 colonoscopy market in the U.S. and select international markets in 2019. Challenges with bowel preparation for inpatient colonoscopy represent a significant area of unmet need that directly affects clinical outcomes and increases the cost of care in a market segment that comprises approximately 1.5 million annual procedures in the U.S. and approximately 4 million annual procedures worldwide. Motus GI believes the Pure-Vu® System may improve outcomes and lower costs for hospitals by reducing the time to successful colonoscopy, minimizing delayed and aborted procedures, and improving the quality of an exam. 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, 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 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 hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Source: Motus GI Holdings, Inc.