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Organogenesis Announces Publication of Randomized Clinical Trial Results Demonstrating the Safety and Efficacy of NuShield for Diabetic Foot Ulcers
• Robust 218-patient RCT demonstrates statistically superior frequency of wound closure at 12 weeks compared to standard of care (p=.04)
• Organogenesis believes published study satisfies requirements for Medicare coverage under proposed Local Coverage Determination (LCDs)
CANTON, Mass., Oct. 01, 2024 (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 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.
NuShield, a dehydrated amnion chorion membrane, demonstrated statistically superior frequency of wound closure (p=0.04) compared to standard of care (SoC) at weeks 4, 6, 8, 10, and 12 as determined by a Cox analysis that adjusted for both wound duration and wound area in a challenging patient population with complex diabetic foot ulcers (DFUs). A total of 218 patients with Wagner 1 or 2 grade DFUs were randomized into two treatment groups: NuShield plus SoC or SoC alone. The NuShield group demonstrated a 48% greater probability of wound closure and decreased median time to complete wound closure when compared to SoC alone.
• Organogenesis believes published study satisfies requirements for Medicare coverage under proposed Local Coverage Determination (LCDs)
CANTON, Mass., Oct. 01, 2024 (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 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.
NuShield, a dehydrated amnion chorion membrane, demonstrated statistically superior frequency of wound closure (p=0.04) compared to standard of care (SoC) at weeks 4, 6, 8, 10, and 12 as determined by a Cox analysis that adjusted for both wound duration and wound area in a challenging patient population with complex diabetic foot ulcers (DFUs). A total of 218 patients with Wagner 1 or 2 grade DFUs were randomized into two treatment groups: NuShield plus SoC or SoC alone. The NuShield group demonstrated a 48% greater probability of wound closure and decreased median time to complete wound closure when compared to SoC alone.
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