SCOTTSDALE, Ariz., Oct. 28, 2026 (GLOBE NEWSWIRE) -- Applied Biologics, LLC, a biopharmaceutical company advancing novel therapies for serious diseases with significant unmet medical needs, today announced the publication of peer-reviewed interim results from the CAMPX randomized controlled clinical trial 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,” was authored by Thomas Serena, MD; Brianna Tramelli, BS; Emily Cook, MS; Dereck Shi, MS; Gregory Bohn, MD; and Ryan Breisinger, BS, from SerenaGroup, Inc., and is available online at https://doi.org/10.67702/IYDY9245.
CAMPX is a multicenter, randomized controlled clinical trial evaluating XWRAP® plus standard of care (SOC) compared with SOC alone in patients with chronic, nonhealing diabetic foot ulcers. The published interim analysis was based on a December 2025 data lock and included 129 randomized patients enrolled across 19 research sites.
In the intention-to-treat (ITT) population, complete wound closure was achieved in 17.9% of patients receiving XWRAP plus SOC compared with 11.3% receiving SOC alone, representing a risk ratio of 1.59 (95% CI: 0.67–3.77). In the per-protocol (PP) population, complete wound closure was achieved in 31.2% of patients receiving XWRAP plus SOC compared with 21.4% receiving SOC alone (RR 1.46; 95% CI: 0.61–3.50).
Patients receiving XWRAP plus SOC also demonstrated greater mean and median percent area reduction (PAR) compared with SOC alone in both the ITT and PP populations. In the ITT population, mean PAR was 28.5% with XWRAP plus SOC compared with 24.3% with SOC alone, with a median PAR of 31.6% versus 20.0%, respectively.
Complete wound closure was independently assessed using de-identified wound images evaluated by two blinded wound care specialists unaffiliated with the trial. In cases of discordant assessment, a third independent medical lead’s determination was used, providing rigorous, objective evaluation of the study’s primary clinical endpoint.
Thomas Serena, MD, lead author and a nationally recognized wound care physician, said, “Peer-reviewed publication of the CAMPX interim results represents an important contribution to the clinical evidence base for amniotic membrane-based wound care products. The study was designed with rigorous clinical methodology, and the results demonstrate a consistent directional benefit favoring XWRAP across both complete wound closure and wound area reduction. We look forward to evaluating the complete dataset following database lock and final analysis.”
Since the interim data cut, Applied Biologics has completed Last Patient, Last Visit in CAMPX and is advancing the study through final data reconciliation toward database lock and final statistical analysis. The published manuscript appropriately characterizes the interim findings as preliminary; the Company will report complete study results following final analysis.
Applied Biologics continues to expand its XWRAP evidence-development program through prospective randomized controlled trials, translational research, real-world evidence, health economic research and scientific publication. The CAMPX publication represents the Company’s ongoing investment in generating the peer-reviewed clinical evidence that physicians, patients, healthcare systems and payers should expect from companies participating in advanced wound care.
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 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 CAMPX, database lock, final statistical analyses, study results, clinical research, 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.
MEDIA CONTACT: Molly Murphy Executive Assistant Applied Biologics, LLC molly.murphy@appliedbiologics.com
