India, July 7 -- Organogenesis Holdings Inc. (ORGO) announced that the U.S. FDA has accepted its Biologics License Application (BLA) for ReNu, a cryopreserved amniotic suspension allograft designed to manage pain in patients with symptomatic knee osteoarthritis.
Knee osteoarthritis (OA) is a degenerative disease affecting nearly 31 million Americans, with projections rising to more than 34 million by 2027. It is one of the leading causes of disability, often culminating in total knee replacement when other treatments fail.
ReNu combines amniotic fluid cells and micronized amniotic membrane, delivering cellular, growth factor, and extracellular matrix components. The therapy has been evaluated in three large randomized controlled trials in...