Motus intends to present the full positive clinical results of the REDUCE study titled “Evaluation of Bowel Cleansing Efficacy in Hospitalized Patient Population Using the Pure-Vu System” at Digestive Disease Week 2019 (DDW).
The company said that its REDUCE study is a multi-center inpatient prospective trial designed to evaluate Pure-Vu System’s ability to improve bowel preparation to facilitate colonoscopy in timely manner in patients who were indicated for a diagnostic colonoscopy.
The study enrolled 95 hospitalized patients on schedule regardless of their level of pre-procedural bowel preparation. Improvement of bowel preparation from baseline to post procedure was set as the primary endpoint for the study, as assessed by the Boston Bowel Preparation Scale (BBPS).
Motus said that BBPS measures the cleanliness of each of the three segments of the colon on a scale of 0 to 3, where a minimum score of 2 or better per segment is required to be considered adequately prepped.
The analysis from the REDUCE study has showed statistical improvement in each colon segment after Pure-Vu System use, where the BBPS rating per segment was improved from an average baseline of 1.74, 1.74 and 1.5 to 2.89, 2.91 and 2.86, respectively, with a p value of .001 for all three segments of the colon.
Furthermore, the study showed that in patients receiving Pure-Vu System, adequate bowel preparation was improved from a baseline of 38% to 96% in segments evaluated.
Motus GI chief executive officer Tim Moran said: “We are excited about the results from the REDUCE study. The data further validates that the Pure-Vu System has the potential to provide a paradigm shifting solution for patients with insufficient bowel prep, enabling physicians and hospital administrators to improve patient care and reduce costs.
“We are on track for the commercial launch of Pure-Vu GEN2 in 2019. We anticipate the results of the REDUCE study will be an essential part of driving early adoption in the market.”