Organogenesis completes FDA submission for knee arthritis treatment

Organogenesis Holdings Inc. (NASDAQ: ORGO) completed its rolling Biologics License Application submission to the Food and Drug Administration for ReNu, a treatment for symptomatic knee osteoarthritis, according to a company statement.

The company initiated the rolling BLA submission in December 2025 with non-clinical modules and has now completed the application with clinical and chemistry, manufacturing, and controls modules.

"We are pleased to complete the BLA submission for ReNu, which represents a significant milestone in our drive to bring a new regenerative therapy to knee OA patients," said Patrick Bilbo, Chief Operating Officer of Organogenesis.

ReNu is a cryopreserved, amniotic suspension allograft that contains amniotic fluid cells and micronized amniotic membrane. The treatment has been studied in three randomized controlled trials involving more than 1,300 patients and received FDA Regenerative Medicine Advanced Therapy designation for knee osteoarthritis in 2021.

The product was previously marketed under Section 361 of the Public Health Service Act and was commercially available for approximately six years before requiring BLA approval.

Knee osteoarthritis affects an estimated 31.1 million Americans and is projected to impact 34.4 million Americans by 2027, according to the company. The degenerative joint disease is characterized by pain and functionality deficits, with total knee replacement typically serving as end-stage treatment when other options are exhausted.

Organogenesis develops, manufactures and commercializes regenerative medicine products for advanced wound care and surgical and sports medicine markets.

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