Life Medical Sciences' Repel
This article was originally published in The Gray Sheet
Executive Summary
Pivotal trial in the U.S. employing the bioresorbable copolymer gel for prevention or reduction of adhesions following gynecological surgery will include 140 patients at roughly 14 sites and is slated to begin in the third quarter. Edison, New Jersey-based LMS announced investigational device exemption clearance April 30. Pilot study data show the product to be twice as effective in reducing adhesion formation compared to the control of standard surgical treatment; the device was particularly effective in treating adhesion formation on the posterior surface of the uterus ("The Gray Sheet" Dec. 22, In Brief). LMS is conducting a pilot study for Repel-CV for prevention of adhesions following cardiovascular surgery ("The Gray Sheet" March 30, p. 24) and has completed preclinical studies on Resolve, a bioresorbable viscous solution for reducing post-operative adhesions in gynecological and general abdominal surgeries. Preclinical studies are ongoing for Relieve gel for orthopedic use