CANTON, Mass., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (NASDAQ: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced that the second Phase 3 randomized controlled trial (RCT) of ReNu, a cryopreserved amniotic suspension allograft (ASA) for the management of symptoms associated with knee osteoarthritis (OA), did not achieve statistical significance for its primary endpoint, despite the ReNu results demonstrating a numerical improvement in baseline pain reduction over the first Phase 3 trial. Baseline pain reduction at six months for ReNu was -6.9 for the second Phase 3 study compared to -6.0 in the first Phase 3 study. Additionally, the ReNu results continued to demonstrate a favorable safety profile.

The primary endpoint for the study is the difference between ReNu and Saline groups in the reduction in knee pain at six months assessed by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale. The study demonstrated a numerical improvement of -0.51 favoring ReNu (p=0.0393 one-sided p-value, compared to p=0.023 target threshold). The first Phase 3 trial achieved improvement of -0.72 favoring ReNu, which was statistically significant (p=0.0177, one sided p-value, compared to p=0.023 target threshold).

"Given the first Phase 3 trial achieved a statistically significant reduction in pain compared to Saline and the second Phase 3 trial demonstrated a numerical improvement in baseline pain reduction over the first Phase 3, we believe these results support the potential approval of ReNu for pain symptoms associated with knee OA, including those patients classified as most severe," said Patrick Bilbo, Chief Operating Officer of Organogenesis. "As a next step, we will request a pre-BLA meeting with the FDA by the end of October to discuss the submission pathway, including using the combined efficacy analysis from both Phase 3 studies to support a BLA approval."

ReNu has now been studied in three large RCTs of more than 1,300 patients combined. Organogenesis believes the totality of this data is compelling evidence for the FDA to review in a Biologics License Application (BLA). Additionally, the FDA granted ReNu Regenerative Medicine Advanced Therapy (RMAT) designation based on ReNu demonstrating the potential to treat an unmet medical need related to a serious condition.

"The results for ReNu support our continued confidence in the potential of ReNu as an innovative pain management product," said Gary S. Gillheeney, Sr., President, Chief Executive Officer and Chair of the Board for Organogenesis. "We believe ReNu, if approved, will address a significant unmet medical need for the millions of Americans suffering from symptomatic knee OA."

Knee OA is a degenerative joint disease that is estimated to affect more than 30 million Americans. It is ranked among the most common causes of disability and poor quality of life, generally characterized by pain and functionality deficits. End stage management of the disease in these patients is typically a total knee replacement when all other treatment options are exhausted.

The fully enrolled 594 patient second Phase 3 trial is a prospective, double-blind, multicenter, saline-controlled, parallel group, RCT of ReNu ASA, for the treatment of subjects with mild to severe symptomatic knee OA. Patients were randomized to receive a single intra-articular (IA) injection of either saline control or ReNu.

Additional top-line data tables from both Phase 3 studies are available in a Current Report on Form 8-K, which the Company filed today with the SEC and can be found at SEC.gov.

About ReNu®

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.