PolarityBio wins FDA Priority Review for SkinTE BLA in DFUs
PolarityBio has secured FDA acceptance of its Biologics License Application for SkinTE, an autologous cutaneous multicellular therapy for Wagner Grade 1 diabetic foot ulcers, with the agency granting Priority Review and setting a PDUFA target action date of 16 March 2027.
Priority Review compresses the FDA's review goal from ten months to six, and is reserved for products that, if approved, would offer a meaningful improvement in safety or effectiveness for a serious condition. SkinTE already holds two earlier FDA designations, Regenerative Medicine Advanced Therapy and Breakthrough Therapy, both for the same indication, giving the programme an unusually strong regulatory tailwind heading into its final review period.
Trial data underpinning the filing
The BLA is supported by COVER DFUS II (NCT06140303), a pivotal Phase III randomised controlled trial that enrolled 120 patients across multiple US sites over 14 months. Participants were randomised equally to receive SkinTE added to standard of care, or standard of care alone, and were followed for 24 weeks. The study met its primary endpoint: complete wound closure within 12 weeks.
Robert Kirsner, chair of the trial, noted that the benefit extended beyond closure rates. "In COVER DFUS II, adding SkinTE to standard of care both improved complete wound closure at 12 weeks and reduced adverse events," he said. "Closure paired with better overall outcomes for patients is the combination clinicians managing difficult-to-heal diabetic foot ulcers need." Full infection and safety data are being prepared for peer-reviewed publication, meaning the complete dataset is not yet in the public domain.
Market and reimbursement context
Diabetic foot ulcers represent a substantial and growing clinical problem, with an estimated 15–25% of people with diabetes developing a foot ulcer during their lifetime. Chronic non-healing ulcers carry serious downstream consequences, including hospitalisation and lower-limb amputation, and existing standard-of-care options, which include advanced wound dressings and growth-factor therapies, leave a significant proportion of patients without durable closure.
The reimbursement landscape for skin substitute products has shifted materially following Medicare payment changes that took effect in January 2026. Under current Centers for Medicare and Medicaid Services policy, wound therapies approved via a BLA pathway retain separate payment as biological products under Medicare Part B, a distinction that may give BLA-approved products a structural reimbursement advantage over certain device-pathway competitors. PolarityBio has flagged this explicitly, noting it has been building commercial, medical affairs and market access infrastructure in parallel with its clinical programme.
The autologous cell-based wound care space has attracted increasing interest from both specialist biotechs and larger wound-care groups. SkinTE's autologous design, deriving tissue from the patient's own skin, differentiates it mechanistically from allogeneic and synthetic alternatives, though it also introduces manufacturing and logistics complexity at commercial scale. PolarityBio said it has built manufacturing capabilities in anticipation of a potential approval, and investors will be watching whether that infrastructure can support a commercial launch in the months following a positive PDUFA outcome. Beyond diabetic foot ulcers, the company is advancing SkinTE into venous leg ulcers and pressure injuries, both large indications where unmet need remains high.