PolarityBio Announces Launch of Expanded Access Treatment Protocol to Provide Continued Access to SkinTE® for Patients with Wagner 1 Diabetic Foot UlcersSALT 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.
PolarityBio to Share Regenerative Wound Healing Expertise at SAWC Fall 2025SALT LAKE CITY, Aug. 28, 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 its participation in the Symposium on Advanced Wound Care (SAWC) Fall 2025, taking place September 3-6, 2025, in Las Vegas, Nevada.
PolarityBio Completes Enrollment in the Phase III Pivotal Study of SkinTE for Diabetic Foot UlcersSALT LAKE CITY, Aug. 26, 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 completion of patient enrollment in COVER DFUS II, a Pivotal Phase III Multicenter Randomized Controlled Trial (RCT) investigating SkinTE® in the treatment of Wagner 1 Diabetic Foot Ulcers (DFUs). Final trial results are anticipated in the first quarter of 2026.
PolarityBio Receives U.S. FDA Breakthrough Therapy Designation for Treatment of Wagner Grade I Diabetic Foot Ulcers (DFU)SALT LAKE CITY, Feb. 20, 2025 (GLOBE NEWSWIRE) -- PolarityBio, a clinical-stage biotechnology company developing regenerative tissue products, announced today that SkinTE has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of Wagner Grade 1 Diabetic Foot Ulcers (DFU). The FDA grants BTD to drug candidates for serious or life-threatening conditions that have preliminary clinical evidence demonstrating potential to provide substantial improvement over existing therapies. The designation provides enhanced regulatory support, increased engagement with the FDA and additional opportunities to engage with the FDA and access to expedited development pathways, including features of the Fast Track program.
PolarityBio Announces Interim Enrollment Achieved in SkinTE’s Phase III Pivotal StudySALT LAKE CITY, Dec. 03, 2024 (GLOBE NEWSWIRE) -- PolarityBio, a clinical-stage biotechnology company developing regenerative tissue products, today announced that it has surpassed the interim enrollment target for SkinTE’s Phase III Pivotal Study in the treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II). The company has enrolled 65 subjects toward the target of 120 subjects for performing interim analysis on the trial’s 12-week primary endpoint.
