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APR 24 2027
UPCOMING · 207 DAYS TO PDUFA

Organogenesis Holdings — ReNu (cryopreserved amniotic suspension allograft) $ORGO

for management of pain in symptomatic knee osteoarthritis

BLA · Standard Review

Accepted JUL 6 2026.

About

Knee osteoarthritis is a degenerative joint disease in which the cushioning cartilage inside the joint wears down over time, leading to bone changes, inflammation, and pain that can make everyday movement difficult. ReNu is a cryopreserved amniotic suspension allograft — donated amniotic tissue processed and preserved as a liquid — that is injected directly into the knee joint, where it delivers a mix of natural tissue components that appear to calm joint inflammation. Because knee osteoarthritis pain is driven partly by that inflammation, ReNu may help ease symptoms and could potentially support joint comfort, though its benefits are still being tested.

Pivotal trial

NCT04636229 Phase 3 completed NCT04636229

This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

Source: ClinicalTrials.gov

Also in development