Could Revita DMR be an Alternative to Insulin Use?

Fractyl Laboratories made a pretty bold statement with its interim data from the INSPIRE trial at the American Diabetes Association's 79th Scientific Sessions in San Francisco this past weekend. The investigator-initiated INSPIRE clinical study showed that Fractyl’s Revita Duodenal Mucosal Resurfacing (DMR) System can help eliminate the need for daily insulin injections for type 2 diabetes patients. “[Revita DMR] … is now showing real promising efficacy in patients who are taking daily injections for their type 2 diabetes already,” Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl told MD+DI. “Unlike our prior trials, which have focused on the cusp of patients needing insulin, where the question is can Revita DMR help improve glucose control and delay or prevent the need for insulin – [INSPIRE] is a trial for people already on insulin, asking can patients discontinue insulin successfully after our procedure.” Revita DMR is a same-day, outpatient endoscopic treatment that uses heat to resurface the lining of the upper intestine (duodenum) in a minimally invasive, outpatient procedure. The INSPIRE study completed enrollment at 16 patients, out of which 13 patients have reached the six-month follow-up, and 11 of 13 (85%) are insulin-free. The remaining three patients are still in the trial but have not reached their six-month follow-up for this...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news