Organogenesis Holdings Inc.'s ReNu Receives FDA Regenerative Medicine Advanced Therapy Designation For Osteoarthritis of the Knee
January 11, 2021 at 07:31 pm IST
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Organogenesis Holdings Inc. announced that the U.S. Food and Drug Administration has granted ReNu®, a cryopreserved amniotic suspension allograft for the management of symptoms associated with knee osteoarthritis, Regenerative Medicine Advanced Therapy designation. The FDA created the RMAT designation program to expedite development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious or life-threatening disease or condition. To qualify for RMAT designation, a therapy must also be supported by preliminary clinical evidence indicating the potential to address unmet medical needs related to the serious condition. RMAT designation includes all of the benefits of the Fast Track and Breakthrough Therapy designation programs. It also provides the advantage of early interactions and intensive guidance from the FDA on development of the therapy, including potential priority review of the biologics license application and potential ways to support accelerated approval and satisfy post-approval requirements. The FDA granted RMAT designation for ReNu based on clinical evidence from a 200 patient multicenter single-blinded randomized controlled trial demonstrating at 6 months that patients with knee OA treated with ReNu experienced a statistically significant reduction in pain and improvement in function compared with hyaluronic acid, a commercially available therapy commonly used to treat knee OA, and saline. OA is a degenerative joint disease affecting more than 30 million Americans and accounts for more than $185 billion in annual expenditures. Knee OA has been estimated to affect approximately 14 million Americans ages 25 and older, with nearly 8 million under the age of 65. The number of knee replacement surgeries is growing every year, and expected to rise from approximately 680,000 Americans in 2014 to 1.28 million Americans in 2030.
Organogenesis Holdings Inc. is a regenerative medicine company focused on the development, manufacture and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. It offers a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Its advanced wound care products include Apligraf for the treatment of venous leg ulcers and diabetic foot ulcers (DFUs); Dermagraft for the treatment of DFUs; PuraPly AM as an antimicrobial barrier and native, cross-linked extracellular matrix scaffold for a variety of wound types; and Affinity, Novachor and NuShield placental allografts to address a variety of wound sizes and types. Sports Medicine products include NuShield as a surgical barrier and PuraForce as a reinforcement matrix in targeted soft tissue repairs; and Affinity, Novachor, PuraPly MZ, PuraPly AM and PuraPly SX for management of open wounds in the surgical setting.