Biomimetics gets FDA Pre-Market Approval
BY JOHN MCCORMICK, NOVEMBER 21, 2005
Biomimetic Therapeutics, Inc. announced today that it has received approval from the FDA for GEM 21S, a fully synthetic regeneration system for the treatment of periodontal bone defects.
According to the management, this is the first totally synthetic product combining a purified recombinant growth factor with a synthetic bone matrix to be approved by the FDA for human application.
GEM 21S approval was based on results from a pivotal 180 patient double-blind, randomized, controlled multicenter, pivotal clinical trial. The study assessed both soft-tissue attachment levels and bone regeneration and found statistically significant benefits in bone growth and accelerated tissue attachment level gain. The Company has posted scientific literature on its products here.
Biomemetics has additional product candidates in development for trauma, spine, and sports medicine applications such as cartilage, tendon and ligament repair.
