Applied Biologics Announces Successful GMP Manufacturing of Initial Clinical Lots of BIOxHEAL™
Manufacturing milestone supports planned clinical development of the Company’s lead investigational biologic for chronic wounds
SCOTTSDALE, Ariz., July 30, 2026 (GLOBE NEWSWIRE) -- Applied Biologics, a biopharmaceutical company advancing novel biologic therapies for serious diseases with significant unmet medical needs, today announced the successful completion of Good Manufacturing Practice (GMP) manufacturing of the initial clinical lots of BIOxHEAL™, the Company’s lead investigational biologic being developed for the treatment of chronic wounds.
The successful manufacture of the initial clinical lots represents a significant operational milestone for the BIOxHEAL development program and reflects the Company’s continued progress in advancing BIOxHEAL from product development into clinical-stage manufacturing. The clinical lots are expected to support the Company’s planned clinical development activities and ongoing regulatory program.
BIOxHEAL is an investigational biologic being developed as a short-course biologic therapy for the treatment of chronic wounds. The program incorporates Applied Biologics’ proprietary manufacturing processes together with a comprehensive quality system designed to produce consistent clinical-grade product.
“Successfully completing GMP manufacturing of our initial clinical lots is an important milestone for Applied Biologics and reflects years of investment in manufacturing science, process development, and quality systems,” said Edward Britt, Chief Executive Officer of Applied Biologics. “The ability to consistently manufacture high-quality investigational biologics is fundamental to advancing innovative therapies through clinical development. This achievement represents another important step in the advancement of BIOxHEAL and further strengthens the manufacturing foundation supporting our broader regenerative medicine pipeline.”
Taylor Carson, Director of Manufacturing Operations, added, “Manufacturing an investigational biologic requires disciplined process control, rigorous quality oversight, and careful execution at every stage of production. Successfully completing these initial GMP clinical lots demonstrates the strength of our manufacturing systems and the dedication of our manufacturing and quality teams as we continue supporting the advancement of BIOxHEAL.”
The BIOxHEAL program is supported by ongoing research focused on product characterization, manufacturing consistency, potency, and clinical development. Applied Biologics continues to advance the program through the regulatory process while expanding the scientific evidence supporting BIOxHEAL.
The Company believes the manufacturing capabilities established through the BIOxHEAL program provide a strong operational foundation for future biologic programs across its regenerative medicine pipeline.
About BIOxHEAL™
BIOxHEAL is an investigational biologic being developed as a short-course biologic therapy for the treatment of chronic wounds. BIOxHEAL has not been approved by the U.S. Food and Drug Administration, and its safety and effectiveness have not been established.
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 therapies through rigorous scientific development, clinical validation, and regulatory excellence.
Forward-Looking Statements
This press release contains forward-looking statements regarding BIOxHEAL, manufacturing activities, clinical development, regulatory submissions, commercialization plans, pipeline programs, and future business prospects. Actual results may differ materially from those expressed or implied due to various risks and uncertainties.
MEDIA CONTACT: Molly Murphy Executive Assistant Applied Biologics, LLC molly.murphy@appliedbiologics.com
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