Applied Biologics Activates First Clinical Site in Phase 3 BIOxHEAL™ Trial
Milestone marks transition to active site-level execution with patient screening and enrollment expected to begin
Press Release Disclaimer: This is a press release distributed through the XPR Media network. It has not been independently verified by our newsroom.
SCOTTSDALE, Ariz., Sept. 01, 2026 (GLOBE NEWSWIRE) — Applied Biologics, a biopharmaceutical company advancing novel therapies for serious diseases with significant unmet medical needs, today announced activation of the first clinical research site in its Phase 3 clinical trial evaluating BIOxHEAL™, the Company’s investigational biologic for the treatment of chronic diabetic foot ulcers.
The milestone follows FDA clearance of the Company’s Investigational New Drug (IND) application, completion of initial GMP clinical manufacturing activities, and central Institutional Review Board approval for the Phase 3 program. With the first clinical site now activated, BIOxHEAL has transitioned into active site-level clinical execution, with patient screening and enrollment expected to begin shortly.
The randomized, controlled, multicenter Phase 3 study is designed to evaluate BIOxHEAL plus standard of care compared with standard of care alone in patients with nonhealing diabetic foot ulcers. Additional clinical sites are progressing through activation as the study expands across its planned research network.
“Activating our first Phase 3 clinical site is an important milestone because BIOxHEAL is now moving from clinical preparation into execution at the investigator level,” said Edward Britt, Chief Executive Officer of Applied Biologics. “Following FDA clearance, GMP manufacturing, and central IRB approval, our focus has shifted to activating our investigator network and beginning patient enrollment. This is another meaningful step forward in the development of BIOxHEAL.”
David G. Armstrong, DPM, MD, PhD, Study Chair for the BIOxHEAL Phase 3 clinical trial, commented, “Diabetic foot ulcers remain among the most serious and challenging complications of diabetes, with consequences that can include infection, hospitalization, amputation, and loss of mobility. Well-designed randomized clinical trials are essential to determining whether new therapies can meaningfully improve outcomes for these patients. Activation of the first clinical site marks the beginning of that important next stage for the program.”
Charles M. Zelen, DPM, Founder and President of the Professional Education and Research Institute (PERI), the contract research organization supporting execution of the study, added, “Site activation represents the point at which extensive protocol development, regulatory preparation, investigator selection, training, and clinical operations come together at the research site. Our team is focused on rigorous study execution, protocol compliance, data quality, and efficient activation of the remaining sites as patient screening and enrollment begin.”
The BIOxHEAL Phase 3 program is being conducted through a multicenter network of clinical investigators experienced in diabetic wound care and clinical research. Applied Biologics and its clinical research partners will continue activating participating sites as the study moves into enrollment.
“Our objective with BIOxHEAL has always been to develop a biologic for chronic wounds according to the rigorous scientific, manufacturing, regulatory, and clinical standards expected of modern biopharmaceutical development,” Britt added. “We are grateful to Dr. Armstrong, our Study Chair, Dr. Zelen, our participating investigators, and the clinical teams who are helping us advance this program for patients with difficult-to-heal wounds.”
Applied Biologics expects to provide an additional update upon enrollment of the first patient in the Phase 3 study.
About BIOxHEAL™
BIOxHEAL is an investigational biologic being developed for the treatment of chronic wounds under Section 351 of the Public Health Service Act. 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 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 screening and enrollment, clinical development, BIOxHEAL, regulatory activities, 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
