Motus GI Holdings, Inc. has announced today that its manuscript titled, “An intra-procedural endoscopic cleansing device for achieving adequate colon preparation in poorly prepped patients,” has been published in the peer-reviewed Journal of Clinical Gastroenterology.
The Company’s flagship product, the Pure-Vu® System, is 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 Company is currently focused on post-approval clinical trials and market development programs with leading U.S. hospitals that are utilizing the Pure-Vu® System on a pilot basis in preparation for a full commercial launch in the U.S. and select international markets in 2019.
Feasibility Study Data Highlights
- The Pure-Vu® System significantly increased the number of subjects with an adequate cleansing level (BBPS >= 2 for all 3 colon segments) from 31% (15/49) at baseline to 98% (48/49) after use of Pure-Vu (P<0.001). Cecal intubation was achieved in 48/49 (98%) patients.
“We are very pleased with the data from this multi-center clinical study and delighted it has been selected for publication in the prestigious Journal of Clinical Gastroenterology. The Pure-Vu® System has consistently shown its ability to improve clinical outcomes while reducing the dependency on conventional purgative-based bowel preps. The data also further supports our confidence in the Pure-Vu® System’s ability to successfully cleanse the colon and reduce the number of failed and repeat procedures. It will continue to be an important focus for us to generate clinical and health economic data that we believe will help drive adoption when we officially launch later this year,” commented Tim Moran, Chief Executive Officer of Motus GI.
The published manuscript includes data from the Company’s multicenter feasibility study of the Pure-Vu® System, which enrolled a total of 50 patients with poorly prepared colons undergoing colonoscopy to evaluate the Pure-Vu® System at 2 clinical sites in Spain and Israel. Javier Pérez-Jimenez, M.D., Medical Director of San Rafael Hospital in Cadiz, Spain was the primary investigator in the study.
“The clinical data from this study demonstrating Pure-Vu® System’s safety and effectiveness in cleansing poorly prepared colons combined with the physician and patient reported outcomes were very encouraging and we’re pleased to have it published in the Journal of Clinical Gastroenterology,” said Dr. Pérez-Jimenez. “The Pure-Vu® System has the potential to play a key role in enhancing the colonoscopy procedure’s effectiveness in multiple patient populations. The ability to improve the patient’s experience and the overall quality of the exam is an area of great importance as inadequate preparation can lead to increased rates of missed lesions, earlier repeat procedures, prolonged colonoscopy duration, reduced patient satisfaction and increased costs.”
In this study, the Pure-Vu® System was used in subjects with a partially prepared colon after a spilt dose of two tablets of 5mg Bisacodyl / Laxadin (DulcolaxR) diet restrictions (no dried fruit, seeds or nuts) starting 2 days before the procedure and a 24- or 18-hour clear liquid diet prior to the colonoscopy. At Days 2 and 14 post procedure a telephone follow-up was conducted to assess patient well-being and capture any adverse events. The endpoints of the study were safety, improvement of colon cleansing level as per the Boston Bowel Preparation Scoring (“BBPS”) when comparing before and after Pure-Vu® System use, Pure-Vu® System usability via questionnaire and patients’ satisfaction via questionnaire.
Patients with an adequate cleansing level (BBPS ≥ 2 in each colon segment) increased significantly from 31% (15/49) at baseline to 98% (48/49) after use of Pure-Vu (P<0.001). Cecal intubation was achieved in 48/49 (98%) patients. Due to a convoluted anatomy in one patient, the colonoscope was unable to reach and therefore clean the cecum.
The Pure-Vu® System was found to be safe, efficacious, and easy to use in cleansing inadequately prepared colons, enabling the endoscopist to conduct a complete examination. No serious adverse events were reported.