FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Motus GI Holdings, Inc., (NASDAQ:MOTS) ("Motus GI" or the "Company"), a medical technology company dedicated to improving clinical outcomes and enhancing the cost-efficiency of colonoscopy, announced today the first successful clinical cases were completed in late October with the Company’s Pure-Vu® Slim Sleeve, a compatible extension to the Pure-Vu® System for slim colonoscopes. The Company recently announced that the Pure-Vu® Slim Sleeve had received special 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Pure-Vu® Slim Sleeve has the same cleansing performance as the standard Pure-Vu® Sleeve and both versions work with the same Pure-Vu® workstation control system. The Pure-Vu® Slim Sleeve has been designed to be compatible with smaller diameter and more flexible slim colonoscopes with additional enhancements to the Company’s low friction lubricious coating technology to aid in navigation through the colon. The Pure-Vu® Slim Sleeve enables access to the full colonoscopy market where Motus GI estimates, through consultation with colonoscope manufacturing companies, approximately 30% of procedures are performed with a slim colonoscope. In total, 15 colonoscopies were completed in the last few weeks of October at select hospitals using Pure-Vu® Slim Sleeve.
“Based on my initial experience, I am impressed with the usability and effectiveness of the Pure-Vu® Slim Sleeve, especially the fact that the cleaning performance of the Pure-Vu® Slim Sleeve is just as powerful as the Pure-Vu® Sleeve. Being able to utilize the Pure-Vu® System in critically ill inpatients to improve and expedite care is where I have found the slim colonoscope most advantageous,” noted Melissa Latorre, M.D. from NYU Langone Health in NY.
“We are excited by the early clinical use feedback on the Pure-Vu® Slim Sleeve, which was designed with the same stringent standards used for the Pure-Vu® System. The Pure-Vu® System has demonstrated the ability to rapidly cleanse the colon and overcome the high rates of insufficient bowel prep in the inpatient setting. With the addition of the Pure-Vu® Slim Sleeve, we are able to target the full range of inpatient procedures,” commented Tim Moran, Chief Executive Officer of Motus GI. “Our focus remains on the successful execution of our ongoing REDUCE clinical trial, launch of our EXPEDITE study, and our expanding market development programs with leading U.S. hospitals that are utilizing the Pure-Vu® System on a pilot basis. We will continue to drive the completion of these key activities and milestones in advance of our commercial launch in 2019.”
The Pure-Vu® System generates a proprietary pulsed vortex™ mixture of water and air to safely remove debris from the colon mucosa while simultaneously evacuating the bowel contents, clearing the way for 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. The Pure-Vu® System consists of a disposable sleeve, now available in standard and slim versions, which fits over a colonoscope without interfering with the working channel, as well a workstation controller.
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 rapidly cleanse the colon intra-procedurally during emergent colonoscopies done on an inpatient basis in hospitals, and to assess the Pure-Vu® System’s ability to reduce the time to successful diagnosis and eliminate delays, costs and complications associated with conventional bowel preparation requirements.
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 incomplete 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.