FDA Accepted Biologics Application for SkinTE Therapy
The regulatory review process has begun for a new treatment designed to assist in healing diabetic foot ulcers.
Updated on Sept. 22, 2026 in Diabetes
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The FDA has accepted the Biologics License Application for SkinTE, a potential new therapy for treating Wagner grade 1 diabetic foot ulcers. This regulatory milestone follows clinical trial findings indicating the treatment may improve wound closure outcomes for patients in the United States.
Why it matters
If approved, this therapy could offer a new approach to treating chronic foot ulcers that have persisted for at least four weeks. By potentially increasing closure rates, it may provide a meaningful alternative to existing standard-of-care protocols for this patient population.
In the COVER DFUS II study, 120 patients with Wagner grade 1 diabetic foot ulcers were evaluated to measure complete wound closure within 12 weeks. Findings showed that participants treated with SkinTE plus standard care achieved higher rates of closure compared to those using standard care alone.
The players
FDA
The federal agency responsible for regulating food, tobacco, and medical products in the United States.
PolarityBio
A biotechnology company focused on developing regenerative medicine therapies including SkinTE.
The details
SkinTE functions by utilizing healthy full-thickness skin harvested directly from the patient. This tissue is processed into multicellular segments—including keratinocytes, dermal fibroblasts, endothelial cells, and follicular cells—which are then combined with standard wound dressings to support the natural healing of ulcers ranging from 1cm2 to 15cm2.
Timeline
September 15, 2026: PolarityBio announced the FDA's acceptance of the Biologics License Application.
March 16, 2027: The Prescription Drug User Fee Act target date for an FDA decision.
Health Landscape
The application follows the completion of the COVER DFUS II study, which evaluated regenerative approaches to addressing chronic wounds. This development signals a continued shift in the treatment landscape toward autologous tissue-based therapies for managing diabetic complications.
If you are managing diabetic foot ulcers, discuss the potential emergence of new regenerative therapies with your doctor to understand how they might fit into your long-term care plan. Tracking the healing progress of any existing wounds remains a vital preventive habit for this condition.
The takeaway
The FDA’s acceptance of this application initiates a formal review that may expand future treatment options for chronic diabetic foot ulcers. Patients should continue working with their physicians to monitor wound status and discuss ongoing advancements in clinical care.
What happens next
The FDA is expected to reach a decision on the application by the Prescription Drug User Fee Act target date of March 16, 2027.
Further reading
For more information on current management strategies, see Diabetes.
More information
View the details in the PolarityBio news release.
Source note: This article includes information reported by Renal and Urology News.
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