This section highlights FDA-related milestones and regulatory updates for drugs developed by Organogenesis (ORGO).
Over the past two years, Organogenesis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ReNu and NuShield. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ReNu FDA Regulatory Events
ReNu is a drug developed by Organogenesis for the following indication: for Knee Osteoarthritis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ReNu
- Announced Date:
- September 25, 2025
- Indication:
- for Knee Osteoarthritis
Announcement
Organogenesis Holdings 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.
AI Summary
Organogenesis Holdings announced that its second Phase 3 randomized controlled trial of ReNu, a cryopreserved amniotic suspension allograft for knee osteoarthritis, did not meet its primary endpoint despite showing a numerical improvement over the first trial.
At six months, baseline pain reduction with ReNu was –6.9 compared to –6.0 in the first Phase 3 study. The difference versus saline was –0.51 favoring ReNu (one-sided p=0.0393), missing the company’s p=0.023 target. In the first trial, ReNu achieved a –0.72 improvement (p=0.0177). The second trial did show statistically significant maintenance of function (p<0.0001).
Organogenesis said it remains confident in ReNu’s potential as an innovative pain management therapy. The company plans to request a pre-BLA meeting with the FDA by the end of October to discuss using combined data from both Phase 3 studies in its Biologics License Application.
ReNu has now been studied in three large trials involving over 1,300 patients and continues to demonstrate a favorable safety profile.
Read Announcement- Drug:
- ReNu
- Announced Date:
- May 2, 2024
- Indication:
- for Knee Osteoarthritis
Announcement
Organogenesis Holdings Inc. announced that its Phase 3 randomized control trial evaluating the safety and efficacy of ReNu, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee osteoarthritis (OA) achieved its primary endpoint upon the analysis of positive top line data.
AI Summary
Organogenesis Holdings Inc. announced positive top-line results from its Phase 3 randomized control trial for ReNu, a cryopreserved amniotic suspension allograft (ASA), designed to treat symptoms of knee osteoarthritis (OA). The trial met its primary endpoint, showing a statistically significant reduction in knee pain at six months compared to saline control (p=0.0177), along with significant preservation of joint function (p<0.0001).
The study involved 515 patients with moderate to severe knee OA and demonstrated that ReNu maintained a favorable safety profile similar to prior research. These results provide strong evidence that ReNu could offer a much-needed non-surgical treatment option for knee OA patients, including those with severe symptoms. Organogenesis now plans to engage with the FDA to discuss the next steps in the regulatory process.
Read Announcement
NuShield FDA Regulatory Events
NuShield is a drug developed by Organogenesis for the following indication: For Diabetic Foot Ulcers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NuShield
- Announced Date:
- October 1, 2024
- Indication:
- For Diabetic Foot Ulcers
Announcement
Organogenesis Holdings Inc. announced the publication of "Dehydrated Amnion Chorion Membrane Versus Standard of Care for Diabetic Foot Ulcers: A Randomised Controlled Trial" in the Journal of Wound Care.
AI Summary
Organogenesis Holdings Inc. announced the publication of its study, "Dehydrated Amnion Chorion Membrane Versus Standard of Care for Diabetic Foot Ulcers: A Randomised Controlled Trial," in the Journal of Wound Care. The research involved 218 patients with diabetic foot ulcers and compared treatment with NuShield—the company’s dehydrated amnion chorion membrane—plus standard care against standard care alone. Results showed that the NuShield group experienced a 48% greater chance of wound closure, achieving faster healing times over a 12‐week period. The study’s findings, demonstrating statistically significant improvements compared to the standard of care (p=0.04), support the potential for NuShield to meet Medicare coverage requirements under proposed Local Coverage Determinations. This publication strengthens Organogenesis’ position in developing advanced wound care therapies aimed at reducing complications and amputations in patients with diabetic foot ulcers.
Read Announcement
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