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
NuShield and ReNu. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NuShield - FDA Regulatory Timeline and 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.
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ReNu - FDA Regulatory Timeline and 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:
- 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.
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