Salt Lake City, Utah — September 2, 2025 — Leads & Copy — PolarityBio, a clinical-stage biotechnology firm specializing in autologous regenerative skin multicellular therapy for wound healing, has initiated 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 start this protocol following completion of enrollment in the COVER DFUs II Phase III study.
John Stetson, CEO of PolarityBio, stated that completing enrollment in the Phase III trial marks a step toward providing SkinTE to patients in need, and that the expanded access program allows them to offer SkinTE to patients who have exhausted other treatment options and face risks from non-healing DFUs.
The protocol allows patients to be eligible if they have Wagner 1 DFUs that have not healed after four weeks of standard care. The eligibility criteria are intentionally broader than those for the COVER DFUs II study, enabling treatment of larger and more complex wounds.
PolarityBio will collect efficacy and safety data from patients enrolled in the EAP, further contributing to the clinical understanding of SkinTE.
Wound care providers and sites can contact PolarityBio at EAP@PolarityBio.com for more information.
Contact: Parker Scott, IR@polaritybio.com, 801-455-1440; Jessica Starman, MBA, media@elev8newmedia.com
Source: PolarityBio
