Motus GI Announces EXPEDITE Study Initiated by Boston Medical Center to Evaluate Clinical Effectiveness of Pure-Vu® System for Improving Bowel Preparation Rates
- Investigator-Initiated study will assess the ability of the Pure-Vu System to accelerate time to a successful colonoscopy in a real-world setting
- Study to enroll up to 100 hospital inpatient and outpatient participants in need of a diagnostic colonoscopy
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)-- Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, announced today that the Boston Medical Center (BMC) has initiated the EXPEDITE clinical study to evaluate the effectiveness of the Pure-Vu System on bowel preparation rates.
“There is a great need for a solution like the Pure-Vu System that helps care providers overcome challenges with conventional bowel preparation regimens. One of the key things we will look at in this study is how effectively this system can accelerate time to colonoscopy and diagnosis for high-risk inpatient cases, such as GI bleeds. This will include performing same day colonoscopy with no preparation in critical inpatient populations,” said Brian C. Jacobson, MD, associate professor of medicine, Boston University School of Medicine, Section of Gastroenterology, Boston Medical Center. “The EXPEDITE study will also evaluate how the Pure-Vu System can help address the impact of inadequate preparation on outpatient cases performed in the hospital. Inadequate bowel preparation often leads to cancellation and rescheduling of outpatient cases. Despite the patient support system we have in place at our hospital, many patients that have outpatient procedures canceled due to inadequate preparation fail to have an adequate colonoscopy within the next six months. We need solutions to make sure these patients don’t lose the benefits of diagnostic colonoscopy due to challenges with conventional bowel preparation.”
Tim Moran, chief executive officer of Motus GI, commented, “We are excited to be part of this investigator-initiated study with a leading team of gastroenterologists at BMC to gather further insights on the benefits of the Pure-Vu System for inpatient and outpatient colonoscopies. BMC has initiated this study because insufficient bowel prep rates continue to be a burden on patients and the healthcare system, leading to longer hospital stays, delayed diagnosis, and additional costs to the patient and hospital. In multiple clinical trials involving challenging inpatient and outpatient cases, the Pure-Vu System has consistently helped achieve adequate bowel cleanliness rates greater than 95% following a reduced prep regimen. We believe expanding clinical and commercial experience will further demonstrate the Pure-Vu System’s capability to help physicians address insufficient bowel prep and reduce inefficiencies, delays, procedure cancellations and repeat procedures.”
The EXPEDITE study will enroll up to 50 inpatients and 50 outpatients over a 12-month study period. The study will evaluate bowel preparation adequacy in the 100 patients undergoing a colonoscopy with the Pure-Vu System against inpatient and outpatient populations that had a colonoscopy over the prior 24 months preceding availability of the Pure-Vu System. The rate of bowel preparation adequacy will be measured before and after Pure-Vu System using the Boston Bowel Preparation Scale (BBPS), a validated assessment instrument that is used broadly by gastroenterologists on a scale of 0 to 3 per segment, requiring a minimum score of 2 to be considered adequately prepped. The BBPS scale has been used in all Pure-Vu System clinical studies performed to date including the REDUCE inpatient colonoscopy study for which results were presented at Digestive Disease Week in May 2019. Findings from the REDUCE study, showed per segment BBPS improved from an average baseline of 1.74, 1.74 and 1.5 to 2.89, 2.91 and 2.86, respectively, with a statistically significant p value of .001 for all three segments of the colon after Pure-Vu System use.
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, providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions. 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. 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 26, 2019, 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.
Released November 11, 2019