SCOTTSDALE, Ariz., Oct. 20, 2026 (GLOBE NEWSWIRE) -- Applied Biologics, LLC, a biopharmaceutical company advancing novel therapies for serious diseases with significant unmet medical needs, today announced that interim results from the CAMPX randomized controlled clinical trial evaluating XWRAP® in the management of chronic diabetic foot ulcers have been accepted for publication in the Journal of Chronic Wound Care Management & Research.
The manuscript, “Interim Analysis of Single-Layer Amniotic Membrane for the Management of Chronic Diabetic Foot Ulcers in the CAMPX Trial,” reports results from a planned interim analysis of the multicenter, randomized controlled trial comparing XWRAP plus standard of care (SOC) with SOC alone.
The interim analysis was based on a December 2025 data lock and included 129 randomized patients. Fifteen patients remained actively enrolled at the time of the interim analysis and were conservatively classified as not healed for purposes of the intention-to-treat analysis.
The interim analysis demonstrated a consistent directional benefit favoring XWRAP across complete wound closure and wound-area reduction:
- In the intention-to-treat population, complete wound closure was achieved in 17.9% of patients receiving XWRAP plus SOC compared with 11.3% receiving SOC alone, representing a 59% higher relative rate of closure.
- In the per-protocol population, complete wound closure was achieved in 31.2% of patients receiving XWRAP plus SOC compared with 21.4% receiving SOC alone, representing a 46% higher relative rate of closure.
- Patients receiving XWRAP plus SOC also demonstrated greater mean and median percent area reduction (PAR) compared with SOC alone in both the intention-to-treat and per-protocol populations.
Complete wound closure was independently assessed using de-identified wound images reviewed by blinded wound-care specialists, providing an objective assessment of the study’s primary clinical endpoint.
The accepted manuscript appropriately characterizes the findings as preliminary and notes that efficacy requires confirmation through analysis of the completed study population.
Since the interim data cut reported in the accepted manuscript, CAMPX has completed patient enrollment and Last Patient, Last Visit, concluding the patient-facing phase of the randomized controlled trial. Applied Biologics is now advancing the completed study through final data reconciliation, database lock and final statistical analysis.
Acceptance of the interim CAMPX results for peer-reviewed publication represents another milestone in Applied Biologics’ broader evidence-development strategy for XWRAP. The Company continues to invest in prospective randomized controlled clinical trials, translational research, real-world evidence, health economic research and scientific publication to further characterize the clinical and biological performance of XWRAP.
Applied Biologics expects to separately report results from the completed CAMPX study following database lock and finalization of the full statistical analysis.
About XWRAP®
XWRAP is a single-layer amniotic membrane allograft used as a wound cover in the management of chronic wounds and as a tissue-plane barrier during surgical procedures. XWRAP is manufactured from donated human tissue subject to donor screening and testing and is regulated as a human cell, tissue, and cellular and tissue-based product (HCT/P) under FDA regulations at 21 CFR Part 1271.
Applied Biologics continues to expand the scientific evidence supporting XWRAP through randomized controlled clinical trials, translational research, real-world evidence, health economic research and scientific publication.
About the CAMPX Trial
CAMPX is a multicenter, randomized controlled clinical trial evaluating XWRAP plus standard of care compared with standard of care alone in patients with chronic, nonhealing diabetic foot ulcers. The study’s primary endpoint is the percentage of target ulcers achieving complete wound closure over 12 weeks. The trial is registered on ClinicalTrials.gov as NCT06564831.
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 APPB-515, a preclinical disease-modifying osteoarthritis gene therapy program.
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 CAMPX, final statistical analyses, clinical research, scientific publication, XWRAP and future business prospects. Interim clinical results are preliminary and may differ from results observed in the completed study population. Actual results may differ materially from those expressed or implied due to clinical, scientific, regulatory, operational and other risks and uncertainties.
