SALT LAKE CITY, Sept. 02, 2025 (GLOBE NEWSWIRE) -- PolarityBio, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous regenerative skin multicellular therapy, today announced the launch of an Expanded Access Treatment Protocol (EAP) to provide continued access to SkinTE® for patients with Wagner 1 diabetic foot ulcers (DFUs). The FDA cleared PolarityBio to initiate this protocol following the successful completion of enrollment in the company’s pivotal Phase III study, COVER DFUs II.
“Completing enrollment in our Phase III trial represents an important milestone for PolarityBio and a critical step toward bringing SkinTE to the patients who need it most,” said John Stetson, Chief Executive Officer of PolarityBio. “Through this expanded access program, we are now able to make SkinTE available to patients who have exhausted other treatment options and face the serious risks associated with non-healing DFUs.”
Under the protocol, patients may be eligible if they have Wagner 1 DFUs that have not healed after four weeks of standard care. The eligibility criteria for the EAP are intentionally broader than those for the COVER DFUs II study, enabling treatment of larger and more complex wounds, better reflecting real-world clinical practice and broadening patient access.
Consistent with PolarityBio’s evidence-based mission, the company will collect both efficacy and safety data from patients enrolled in the EAP, further contributing to the clinical understanding of SkinTE.
Wound care providers and sites interested in learning more about the SkinTE Expanded Access Treatment Protocol for patients with Wagner 1 DFUs and determining if it could benefit their patients can contact PolarityBio at EAP@PolarityBio.com for additional information.
About PolarityBio
PolarityBio, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative biologics. PolarityBio’s first regenerative biologic is SkinTE®, an autologous skin multicellular therapy. PolarityBio has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and is now pursuing the final pivotal study on SkinTE® needed to support a biologics license application (BLA) for a Wagner 1 diabetic foot ulcer indication. SkinTE® is available for investigational use only. Learn more at www.polaritybio.com.
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