Applied Biologics Receives Central IRB Approval for Phase 3 BIOxHEAL™ Clinical Trial
Clinical site activation and patient enrollment expected to begin in the coming weeks
SCOTTSDALE, Ariz., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Applied Biologics, a biopharmaceutical company advancing novel biologic therapies for serious diseases with significant unmet medical needs, today announced that the Advarra Institutional Review Board (Advarra IRB) has approved the Company’s randomized, controlled, multicenter Phase 3 clinical trial evaluating BIOxHEAL™ for the treatment of nonhealing diabetic foot ulcers.
The approval follows the U.S. Food and Drug Administration’s earlier clearance of the Company’s Investigational New Drug (IND) application and represents another important milestone as Applied Biologics advances the BIOxHEAL clinical development program toward patient enrollment.
The Phase 3 study is designed as a randomized, controlled, multicenter clinical trial evaluating BIOxHEAL plus standard of care compared with standard of care alone in patients with nonhealing diabetic foot ulcers.
With central IRB approval now complete, Applied Biologics is advancing clinical site activation activities, with patient enrollment expected to begin in the coming weeks.
“Central IRB approval represents another significant milestone in the advancement of BIOxHEAL,” said Edward Britt, Chief Executive Officer of Applied Biologics. “Following FDA clearance of our Phase 3 program, successful GMP manufacturing of our initial clinical lot, and now central IRB approval, we are transitioning into active clinical execution. Our focus is on activating clinical sites and initiating patient enrollment as efficiently and responsibly as possible.”
Britt continued, “Patients living with chronic diabetic foot ulcers face a substantial risk of infection, hospitalization, amputation, and diminished quality of life. We believe these patients deserve therapies developed through rigorous scientific research, pharmaceutical-quality manufacturing, and well-controlled clinical studies. We are excited to take this next step in advancing BIOxHEAL toward potential regulatory approval.”
Applied Biologics expects to provide additional updates as clinical sites are activated, the first patients are enrolled, and the Phase 3 clinical program continues to advance.
About BIOxHEAL™
BIOxHEAL is an investigational biologic being developed for the treatment of chronic wounds. BIOxHEAL has not been approved by the U.S. Food and Drug Administration, and its safety and effectiveness have not been established.
About Applied Biologics
Applied Biologics is a biopharmaceutical company advancing novel biologic therapies for serious diseases with significant unmet medical needs.
The Company’s pipeline includes programs focused on chronic wounds, degenerative diseases, immunology, and regenerative medicine.
Applied Biologics is committed to advancing innovative therapies through rigorous scientific development, clinical validation, and regulatory excellence.
Forward-Looking Statements
This press release contains forward-looking statements regarding clinical site activation, patient enrollment, clinical development, regulatory activities, investigational products, and future business prospects. Actual results may differ materially from those expressed or implied due to various risks and uncertainties.
MEDIA CONTACT: Molly Murphy Executive Assistant Applied Biologics, LLC molly.murphy@appliedbiologics.com
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