Motus Climbs on FDA Nod for GEN2

Motus GI Holdings, Inc. (NASDAQ:MOTS) rose in early Tuesday trading after the company received Food and Drug Administration clearance to market its Pure-Vu GEN2 system.

The Fort Lauderdale-based Motus, a medical technology company dedicated to improving clinical outcomes and enhancing the cost-efficiency of colonoscopy, says the system helps 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.

Medical experts point up the need for such a system in patients, saying "Inadequate bowel preparation prior to colonoscopy remains an unmet need that affects a significant percentage of patients’ ability to receive a complete and high-quality exam.

"This often leads to canceled, delayed and aborted procedures, resulting in prolonged hospitalizations and increased costs for both patients and providers."

CEO Tim Moran says "Receiving FDA clearance for our Pure-Vu® GEN2 represents a major milestone for the Company. The Pure-Vu® System continues to demonstrate outstanding cleansing performance in poorly prepped colons, including the statistically significant improvement in colon cleanliness in hospitalized patients as recently demonstrated by the positive outcome of our REDUCE (Reliable Endoscopic Diagnosis Utilizing Cleansing Enhancement study."

The REDUCE study was a multi-center inpatient prospective trial designed to evaluate Pure-Vu® System’s ability to consistently and reliably improve bowel preparation to facilitate a successful colonoscopy in a timely manner in patients who were indicated for a diagnostic colonoscopy.

Shares in MOTS gained 63 cents, or 16.2%, to $4.53