SCOTTSDALE, Ariz., Oct. 13, 2026 (GLOBE NEWSWIRE) -- Applied Biologics, LLC, a biopharmaceutical company advancing novel therapies for serious diseases with significant unmet medical needs, today announced that the first patient has been enrolled and treated with BIOxHEAL™, the Company’s investigational biologic, in its Phase 3 clinical trial for the treatment of chronic diabetic foot ulcers.
The milestone marks the initiation of investigational product administration in the randomized, controlled, multicenter Phase 3 study and represents an important advancement in BIOxHEAL’s clinical development program.
The study is designed to evaluate the efficacy of BIOxHEAL administered in conjunction with standard of care compared with standard of care alone in patients with chronic, nonhealing diabetic foot ulcers. The trial will evaluate complete wound closure over a 12-week treatment period, with participating clinical research sites continuing patient screening and enrollment.
First patient treatment follows a series of important development milestones for BIOxHEAL, including successful Good Manufacturing Practice (GMP) manufacturing of initial clinical lots, clearance of the Company’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA), central Institutional Review Board approval, and activation of clinical research sites.
BIOxHEAL is being developed under Section 351 of the Public Health Service Act, with the objective of advancing a novel biologic therapy for chronic wounds through the rigorous scientific, manufacturing, regulatory, and clinical standards applicable to FDA-licensed biologics.
Diabetic foot ulcers represent a serious complication of diabetes and remain a significant clinical challenge, particularly among patients whose wounds fail to heal with conventional treatment. Chronic diabetic foot ulcers can lead to infection, hospitalization, amputation, and substantial healthcare utilization, underscoring the need for innovative therapies supported by well-controlled clinical evidence.
The BIOxHEAL Phase 3 program is part of Applied Biologics’ broader investment in clinical research and development. The Company recently completed Last Patient, Last Visit in its CAMPX multicenter randomized controlled trial evaluating XWRAP® in diabetic foot ulcers and is advancing that study toward final database lock and statistical analysis.
In parallel, Applied Biologics continues advancing its investigational gene therapy pipeline, including APPB-515, a preclinical disease-modifying osteoarthritis gene therapy program, and APPB-429, a preclinical gene therapy program targeting diabetic peripheral neuropathy. Both programs reflect the Company’s growing investment in computational protein engineering, gene-delivery technologies, and the development of innovative therapies for serious diseases with significant unmet medical needs.
With BIOxHEAL now actively enrolling and treating patients, CAMPX progressing toward final analysis, and multiple preclinical programs advancing, Applied Biologics continues expanding its capabilities across biologic development, clinical research, gene therapy, and regenerative medicine.
The Company expects to continue activating clinical research sites and enrolling patients as the BIOxHEAL Phase 3 program progresses.
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 FDA, 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 combines commercial-stage advanced wound care technologies with a growing pipeline of investigational biologic and gene therapy programs, including BIOxHEAL™, in Phase 3 clinical development for chronic wounds; APPB-515, a preclinical disease-modifying osteoarthritis gene therapy program; and APPB-429, a preclinical gene therapy program targeting diabetic peripheral neuropathy.
Applied Biologics continues to invest in rigorous clinical research, pharmaceutical-quality manufacturing, protein engineering, gene-delivery technologies, and scientific innovation.
Forward-Looking Statements
This press release contains forward-looking statements regarding BIOxHEAL, patient enrollment, clinical site activation, clinical development, regulatory activities, CAMPX, APPB-515, APPB-429, and future business prospects. BIOxHEAL is investigational and has not been approved by the FDA. Forward-looking statements are subject to clinical, scientific, regulatory, operational, and other risks and uncertainties, and actual results may differ materially from those expressed or implied.
