CMS Proposed 2027 Medicare Policy Continues Recognition of the FDA’s Section 351 Biologic Pathway

Applied Biologics believes rigorous scientific development and regulatory standards are essential to advancing innovation in chronic wound care

SCOTTSDALE, Ariz., Aug. 10, 2026 (GLOBE NEWSWIRE) -- Applied Biologics, a biopharmaceutical company advancing novel biologic therapies for serious diseases with significant unmet medical needs, today highlighted the Centers for Medicare & Medicaid Services’ (CMS) recently released Calendar Year 2027 Medicare Physician Fee Schedule (PFS) Proposed Rule, which continues to recognize the distinct regulatory framework applicable to FDA-licensed biologics developed under Section 351 of the Public Health Service Act.

Applied Biologics believes the proposed policy appropriately recognizes the significant scientific, manufacturing, and clinical distinctions associated with FDA-licensed biologics and reinforces the importance of rigorous product development in advancing innovative therapies for patients with chronic wounds.

The Company’s lead investigational product, BIOxHEAL™, is an investigational biologic being developed under Section 351 of the Public Health Service Act 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.

“Applied Biologics made the strategic decision several years ago to pursue the FDA’s Section 351 biologics pathway because we believed chronic wound care deserved the same rigorous scientific, manufacturing, and clinical standards expected of other biologic therapies,” said Edward Britt, Chief Executive Officer of Applied Biologics.

“Developing an FDA-licensed biologic requires substantial investment in pharmaceutical-quality manufacturing, analytical characterization, quality systems, potency testing, and well-controlled clinical trials. We are encouraged to see CMS continue recognizing the distinct regulatory framework applicable to FDA-licensed biologics because those standards ultimately benefit physicians and the patients they serve.”

Britt continued, “Our objective has never been to pursue the easiest regulatory pathway. Our objective has been to develop the highest-quality biologic we can for patients living with chronic wounds. We believe rigorous science, rigorous manufacturing, and rigorous clinical evidence are the foundation for meaningful innovation.”

Applied Biologics continues to advance BIOxHEAL through its Phase 3 clinical development program while expanding its broader pipeline of investigational biologic therapies focused on chronic wounds, degenerative diseases, immunology, and regenerative medicine.

The Company believes continued alignment between FDA regulatory standards and Medicare policy helps reinforce the importance of scientific rigor, product quality, and clinical evidence as the foundation for innovation in advanced wound care.

About BIOxHEAL™
BIOxHEAL is an investigational biologic being developed for the treatment of chronic wounds under Section 351 of the Public Health Service Act. 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 investigational programs focused on chronic wounds, degenerative diseases, immunology, and regenerative medicine.

Applied Biologics is committed to advancing innovative therapies through rigorous scientific development, pharmaceutical-quality manufacturing, clinical validation, and regulatory excellence.

Forward-Looking Statements
This press release contains forward-looking statements regarding proposed Medicare policies, regulatory developments, clinical development, investigational products, commercialization, 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