Organogenesis Holdings, Inc. is a regenerative medical company, which engages in the development, manufacture, and commercialization of product solutions for the advanced wound care, surgical and sports medicine markets. The company was founded in 1985 and is headquartered in Canton, MA.
相关临床试验
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0 进行中
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53.9%
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- PuraPly AM combined with standard care demonstrated statistically significant superiority over standard care alone in treating diabetic foot ulcers in a randomized controlled trial of approximately 170 patients. - The trial achieved wound closure at 12 weeks as a key efficacy endpoint, highlighting the product's therapeutic potential for this challenging patient population. - Organogenesis has completed a Type-B meeting with the FDA and plans to initiate a rolling Biologics License Application for ReNu by the end of December. - Despite positive clinical results, the company faces projected revenue declines of 25-38% in 2026 due to CMS reimbursement changes, though the trial data may help de-risk coverage decisions.
- Organogenesis Holdings Inc. received FDA confirmation to initiate a rolling Biologics License Application (BLA) for ReNu, a cryopreserved amniotic suspension allograft for knee osteoarthritis treatment. - The FDA determined that ReNu's clinical development program, including two large Phase 3 randomized controlled trials and over 1,300 patients studied, is appropriate for BLA submission expected by end of 2025. - ReNu targets knee osteoarthritis, a degenerative joint disease affecting 31.1 million Americans and projected to grow to 34.4 million by 2027. - The treatment received FDA Regenerative Medicine Advanced Therapy (RMAT) designation in 2021 and was previously commercially available for approximately six years under Section 361 regulations.
- Organogenesis announced that ReNu, a cryopreserved amniotic suspension allograft, did not achieve statistical significance for its primary endpoint in the second Phase 3 trial for knee osteoarthritis pain management. - Despite missing the primary endpoint, ReNu demonstrated numerical improvement in baseline pain reduction (-6.9) compared to the first Phase 3 study (-6.0) and maintained statistically significant functional benefits (p<0.0001). - The company plans to request a pre-BLA meeting with FDA by end of October to discuss submission pathway using combined efficacy data from both Phase 3 studies. - ReNu has been studied in three large randomized controlled trials involving more than 1,300 patients combined and holds FDA Regenerative Medicine Advanced Therapy designation for knee osteoarthritis.
- The Centers for Medicare & Medicaid Services (CMS) has proposed a new per-square-centimeter payment methodology for skin substitutes based on FDA classification under the CY 2026 Physician Fee Schedule. - Leading regenerative medicine companies Organogenesis and BioStem Technologies applaud the reform, believing it will curb abuse and reduce rapid escalation in Medicare spending while ensuring consistent payment across care sites. - The proposed changes recognize clinical differentiation of PMA products and aim to expand access to innovative wound healing technologies that have been proven to reduce life-threatening amputations. - Companies view the reform as promoting long-term stability in the wound care market while encouraging investment in innovation and improving patient outcomes.
- Organogenesis Holdings reports positive interim analysis from its Phase 3 trial of ReNu for knee osteoarthritis, covering 50% of 474 planned patients. - The Data Monitoring Committee recommended the trial proceed without modifications, confirming favorable results and a consistent safety profile for ReNu. - The fully enrolled trial with 594 patients evaluates ReNu versus saline control via intra-articular injection, measuring knee pain reduction using the WOMAC pain scale. - Knee osteoarthritis affects approximately 31.1 million Americans, with projections estimating a rise to 34.4 million cases by 2027.
