Applied Biologics Announces Full Enrollment of BIOxHEAL™ Phase 3 Sentinel Safety Cohort

Completion of sentinel cohort enrollment triggers independent Data and Safety Monitoring Board review, a required milestone before initiation of the 243-patient randomized controlled phase

SCOTTSDALE, Ariz., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Applied Biologics, LLC, a biopharmaceutical company advancing novel therapies for serious diseases with significant unmet medical needs, today announced the completion of enrollment into the sentinel safety cohort of its Phase 3 randomized controlled clinical trial evaluating BIOxHEAL^™ in patients with chronic, nonhealing diabetic foot ulcers (study AB BIOH-26-001).

AB BIOH-26-001 is a multicenter, open-label, randomized controlled clinical trial designed to evaluate the efficacy of BIOxHEAL plus standard of care (SOC) compared with SOC alone in patients with chronic, nonhealing diabetic foot ulcers. The study will enroll 243 randomized participants across up to 30 investigational sites, with participants allocated 2:1 to BIOxHEAL plus SOC or SOC alone. The primary endpoint is the proportion of target ulcers achieving complete wound closure at 12 weeks, confirmed by blinded, independent wound evaluators.

Per protocol, the trial requires an initial non-randomized sentinel safety cohort, in which all enrolled participants receive BIOxHEAL plus SOC. Completion of the sentinel cohort triggers an independent safety review by the Data and Safety Monitoring Board (DSMB). Applied Biologics will not advance to the randomized phase of the trial until the DSMB has completed its review, issued a recommendation to the Sponsor, and FDA authorization to proceed has been obtained.

David G Armstrong, DPM MD PhD, Distinguished Professor of Surgery at the University of Southern California Keck School of Medicine and Study Chair for AB BIOH-26-001, said, “The completion of sentinel cohort enrollment is an important protocol milestone that reflects well on the operational quality of this program. The sentinel phase was designed specifically to generate early safety data in this patient population before broader randomization, and its completion brings us meaningfully closer to the data that will define the clinical profile of BIOxHEAL.”

Chronic nonhealing diabetic foot ulcers represent a serious and underserved medical condition affecting millions of patients with diabetes. Patients who develop diabetic foot ulcers face significant risk of amputation, prolonged hospitalization, and diminished quality of life. Despite the availability of standard wound care, many ulcers fail to achieve complete closure under current treatment approaches, underscoring the need for effective advanced therapies supported by rigorous clinical evidence.

BIOxHEAL is a sterile, single-use, topically applied biologic derived from human amniotic membrane that retains native extracellular matrix architecture and biologically active factors implicated in wound healing. Applied Biologics is conducting AB BIOH-26-001 with the Professional Education and Research Institute (PERI) as the clinical research organization. The study is registered on ClinicalTrials.gov.

Applied Biologics expects the DSMB to conduct its review of the sentinel cohort safety data and issue its recommendation in the coming weeks. Subject to DSMB recommendation and FDA authorization, the Company anticipates initiating randomized enrollment thereafter. The Company will provide further updates on study progress as milestones are achieved.

About BIOxHEAL^™
BIOxHEAL^™ is a sterile, single-use, topically applied biologic derived from human amniotic membrane. BIOxHEAL retains the native tissue extracellular matrix architecture and complex of biologically active factors implicated in wound healing. BIOxHEAL is currently under clinical investigation for the treatment of nonhealing diabetic foot ulcers.

Applied Biologics continues to expand the clinical and scientific evidence base for BIOxHEAL through rigorous, prospective, randomized controlled clinical development.

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^™, currently in Phase 3 clinical development for chronic wounds, and preclinical programs focused on degenerative diseases and peripheral nerve regeneration.

Applied Biologics continues to invest in rigorous clinical research, pharmaceutical-quality manufacturing, scientific innovation and national market access.

Forward-Looking Statements
This press release contains forward-looking statements regarding AB BIOH-26-001, the DSMB review, the timing of FDA authorization, the initiation of the randomized phase, and future development of BIOxHEAL. Actual results and timing may differ materially from those expressed or implied due to clinical, regulatory, operational, safety, and other risks and uncertainties. Clinical trial enrollment and regulatory processes are subject to factors outside the Company’s control, and there can be no assurance that the study will proceed on any particular timeline or that BIOxHEAL will receive regulatory approval.

MEDIA CONTACT:
Molly Murphy
Executive Assistant
Applied Biologics, LLC
molly.murphy@appliedbiologics.com