Organogenesis Holdings Inc. announced that the study demonstrated a statistically significant reduction in knee OA pain at six months as assessed by the Western Ontario and McMaster Universities Arthritis Index pain scale compared with subjects treated with saline control. ReNu showed a favorable safety profile consistent with prior studies. Knee OA is a degenerative joint disease that is estimated to affect nearly 31.1 million Americans and projected to grow to 34.4 million Americans by 2027.

In addition to improving knee OA pain symptoms, ReNu maintained patient function compared to saline control (p < 0.0001). Complete analysis of the Phase 3 prospective, double-blind, multicenter, saline-controlled, parallel group clinical trial is expected in May. A second multi-center clinical trial for ReNu is actively enrolling with full enrollment expected this year, ahead of earlier expectations.

ReNu is a cryopreserved, amniotic suspension allograft (ASA) developed for the management of symptomatic knee osteoarthritis. ReNu consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and extracellular matrix components. ReNu received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Knee OA in 2021.