Applied Biologics Reports Statistically Significant Improvement in Wound Closure Outcomes in Updated Analyses of the CAMPX Randomized Controlled Trial Evaluating XWRAP®
SCOTTSDALE, Ariz., June 15, 2026 (GLOBE NEWSWIRE) -- Applied Biologics, a biopharmaceutical company advancing novel biologic therapies for serious diseases with significant unmet medical needs, today announced positive findings from updated analyses of the ongoing CAMPX randomized controlled clinical trial evaluating XWRAP® in the treatment of chronic diabetic foot ulcers.
The updated Intent-to-Treat (ITT) analysis demonstrated a statistically significant improvement in complete wound closure among patients treated with XWRAP plus standard of care compared to patients receiving standard of care alone. In the ITT analysis, 31% of patients treated with XWRAP plus standard of care achieved complete wound closure compared to 18% of patients treated with standard of care alone, representing a 13% absolute improvement in healing outcomes (p=0.023).
Consistent with the ITT findings, the updated Per-Protocol (PP) analysis also demonstrated a statistically significant improvement in complete wound closure among patients treated with XWRAP plus standard of care. In the PP analysis, 33% of patients treated with XWRAP plus standard of care achieved complete wound closure compared to 17% of patients receiving standard of care alone, representing a 16% absolute improvement in healing outcomes (p=0.039).
The CAMPX Trial is a prospective, randomized, controlled, multicenter study conducted across 23 SerenaGroup and affiliated research sites throughout the United States. The study enrolled patients with both Wagner Grade 1 and Wagner Grade 2 diabetic foot ulcers, representing a broad patient population commonly encountered in clinical practice.
“These findings represent an important milestone in the clinical development of XWRAP,” said Edward Britt, Chief Executive Officer of Applied Biologics. “We are particularly encouraged by both the magnitude and consistency of the treatment benefit observed across the Intent-to-Treat and Per-Protocol analyses. The improvement in wound closure outcomes observed in these updated analyses reinforces our belief that biologic therapies have the potential to meaningfully improve outcomes for patients suffering from chronic diabetic foot ulcers.”
Britt continued, “Chronic wounds remain a significant healthcare challenge for patients, providers, and healthcare systems worldwide. We believe these findings further support our commitment to advancing innovative biologic therapies designed to address serious diseases with significant unmet medical needs.”
The CAMPX Trial is being conducted in collaboration with SerenaGroup®, one of the nation’s leading wound care research organizations and a recognized leader in chronic wound research.
“The favorable outcomes observed across both the Intent-to-Treat and Per-Protocol populations are encouraging,” said Thomas Serena, MD, founder of SerenaGroup and Principal Investigator of the CAMPX Trial. “The consistency of these findings, together with the magnitude of the treatment effect observed among patients treated with XWRAP, supports continued evaluation of this therapy in the management of chronic diabetic foot ulcers. Importantly, the inclusion of both Wagner Grade 1 and Wagner Grade 2 ulcers provides insight into clinical outcomes across a patient population representative of real-world clinical practice.”
The Company noted that enrollment completion, database review, and final study closeout activities remain ongoing. Additional analyses are planned following final database lock, and the Company intends to pursue publication of the study findings in a peer-reviewed medical journal.
About XWRAP®
XWRAP is a placental-derived wound covering intended for the management of chronic wounds. Applied Biologics continues to evaluate XWRAP through prospective clinical research programs designed to generate meaningful clinical evidence regarding patient outcomes.
About Applied Biologics
Applied Biologics is a biopharmaceutical company advancing novel biologic 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 biologic therapies through rigorous scientific development, clinical validation, and regulatory excellence.
Forward-Looking Statements
This press release contains forward-looking statements regarding clinical trial progress, future analyses, enrollment completion, publication activities, product development programs, and future business prospects. Actual results may differ materially from those expressed or implied due to various risks and uncertainties, including clinical, regulatory, operational, and market-related factors.
MEDIA CONTACT: Molly Murphy Executive Assistant Applied Biologics, LLC molly.murphy@appliedbiologics.com
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