Ryan Zimmerman

Ross Osborn

Aaron Wukmir

Brooks O'Neil

Matthew Park

- Organogenesis Holdings Inc. announced that its **second Phase 3 randomized controlled trial of ReNu did not achieve statistical significance for its primary endpoint**.  **[1661181_0001193125-25-217810_d870311dex991.htm:1]** **[1661181_0001193125-25-217810_d870311d8k.htm:2]** 
- The primary endpoint, reduction in knee pain at six months, showed a **numerical improvement of -0.5 favoring ReNu** (p=0.0393), which was below the p=0.023 target threshold for statistical significance.  **[1661181_0001193125-25-217810_d870311dex991.htm:1]** **[1661181_0001193125-25-217810_d870311d8k.htm:2]** 
- Despite this, the company noted a **favorable safety profile** and **statistically significant maintenance of function** (p<0.0001) for ReNu.  **[1661181_0001193125-25-217810_d870311dex991.htm:1]** **[1661181_0001193125-25-217810_d870311d8k.htm:2]** 
- Organogenesis plans to **request a pre-Biologics License Application (BLA) meeting with the FDA by the end of October 2025** to discuss the submission pathway, including potentially using combined efficacy analysis from both Phase 3 studies.  **[1661181_0001193125-25-217810_d870311dex991.htm:1]** **[1661181_0001193125-25-217810_d870311d8k.htm:2]**

Organogenesis Provides Update on Second Phase 3 ReNu Study

- Organogenesis anticipates the proposed Physician Fee Schedule (PFS) changes, effective **January 1, 2026**, will be a significant positive for the industry, bringing **consistent reimbursement across sites of care** and recognizing **PMA products as clinically differentiated**.  **[1661181_tx_380334_0]** 
- The company is relaunching **Dermograph** and manufacturing **Transite** at its new Smithfield, Rhode Island facility.  **[1661181_tx_380334_1]**  The surgical and sports medicine segment demonstrated strong growth, **up 16% in Q2 2025 and 13% for the first half of 2025**, driven by the PuraPly brand and new product launches.  **[1661181_tx_380334_1]** 
- For its Renew product, Organogenesis completed the **second phase three trial** and expects **top-line data by the end of September 2025**. If successful, a **BLA application is anticipated by the end of 2025**, with **approval expected in 2026** and commercialization in 2027.  **[1661181_tx_380334_2]** 
- Organogenesis ended the first half of 2025 with **over $70 million in cash** and expects a **stronger second half of 2025** with anticipated profit generation, despite some expected pricing pressure at the end of Q4 2025.  **[1661181_tx_380334_1]** **[1661181_tx_380334_2]**

Organogenesis Holdings (ORGO)