FDA Granted Priority Review to SkinTE for Diabetic Ulcers
The FDA has accepted a Biologics License Application for a skin-based treatment targeting 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 therapy designed to treat Wagner grade 1 diabetic foot ulcers. The agency has granted the application Priority Review status, moving the treatment closer to potential market availability.
Why it matters
SkinTE provides a novel approach to wound healing by using a patient's own healthy full-thickness skin cells to encourage recovery. The therapy aims to improve healing outcomes for patients struggling with chronic diabetic foot ulcers.
The COVER DFUS II study evaluated 120 patients with ulcers ranging from 1cm2 to 15cm2. The trial measured complete wound closure as a primary endpoint within a 12-week duration.
The players
FDA
The Food and Drug Administration is the federal agency responsible for protecting public health by regulating the safety and efficacy of biological products and medical devices.
PolarityBio
PolarityBio is a biotechnology company focused on developing regenerative medicine therapies for complex tissue repair.
The details
SkinTE utilizes multicellular segments, including keratinocytes, dermal fibroblasts, endothelial cells, and follicular cells, to assist in closing difficult wounds. When combined with standard of care dressings, the therapy has shown superior rates of complete wound closure in clinical testing.
Timeline
September 15, 2026: PolarityBio announced the FDA's acceptance of the BLA.
March 16, 2027: FDA Prescription Drug User Fee Act target date.
The Big Picture
This story follows a pattern set by the COVER DFUS II clinical trial. It marks the regulatory progression of the regenerative medicine therapy evaluated in that research program.
Patients suffering from chronic diabetic foot ulcers may soon have a new regenerative treatment option if the FDA approves the therapy. This could potentially reduce the time required for wound closure and improve long-term healing outcomes for those with Wagner grade 1 ulcers.
The takeaway
Regenerative therapies that utilize a patient's own tissue are becoming a focal point for treating non-healing diabetic wounds. Patients and providers should look for upcoming peer-reviewed publications to better understand the long-term efficacy of these multicellular treatments.
What happens next
The FDA has set a Prescription Drug User Fee Act target date of March 16, 2027, for its final decision on the SkinTE application.
Further reading
For more information on current treatment trends, visit the Diabetes section.
More information
Read the full details in the PolarityBio news release.
Source note: This article includes information reported by Renal and Urology News.
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