SCOTTSDALE, Ariz., Sept. 08, 2026 (GLOBE NEWSWIRE) — Applied Biologics, a biopharmaceutical company advancing novel therapies for serious diseases with significant unmet medical needs, today welcomed a new proposed pathway from the Centers for Medicare & Medicaid Services (CMS) designed to increase coordination with the U.S. Food and Drug Administration (FDA) and accelerate Medicare beneficiary access to certain innovative medical technologies.
CMS recently issued a proposed procedural notice outlining the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, which would create earlier and more frequent engagement among CMS, FDA, and manufacturers of certain FDA-designated Breakthrough Devices during product development.
Under the proposed framework, CMS would participate earlier in the development process to help manufacturers understand which clinical outcomes are particularly relevant to Medicare beneficiaries. By increasing alignment between FDA regulatory requirements and CMS evidence expectations before pivotal clinical studies are completed, the pathway is intended to reduce delays between FDA market authorization and subsequent Medicare coverage decisions.
Although RAPID is specifically designed for eligible medical devices and does not apply to Applied Biologics’ drug or biologic development programs, the Company believes the underlying model of earlier coordination among CMS, FDA, and innovators has broader relevance across medical product development.
Applied Biologics is currently advancing multiple investigational development programs, including BIOxHEAL™, an investigational biologic entering Phase 3 clinical development for chronic wounds, and a preclinical Disease-Modifying Osteoarthritis (DMOAD) Gene Therapy Program. As the Company expands its drug and biologic pipeline, Applied Biologics believes earlier visibility into both FDA regulatory requirements and CMS evidence expectations could help developers design clinical programs that generate evidence meaningful not only for regulatory approval, but ultimately for patient access.
“As a biopharmaceutical company developing novel biologic and gene therapies, we think about the entire path from scientific discovery to patient access,” said Edward Britt, Chief Executive Officer of Applied Biologics. “Developing an innovative therapy is not simply about obtaining FDA approval; it is about generating the right evidence throughout development so that, if approved, the therapy can ultimately reach the patients who need it. CMS and FDA have different statutory responsibilities, and those standards should remain rigorous and independent. But having those agencies engage with innovators earlier in development can help companies design smarter clinical programs, reduce unnecessary duplication, and potentially shorten the path from scientific innovation to patient access.”
Britt continued, “That is particularly relevant as we build our disease-modifying osteoarthritis gene therapy program. Osteoarthritis disproportionately affects older Americans, and Medicare beneficiaries could ultimately be among the populations with the greatest need for truly disease-modifying therapies. Understanding the evidence expectations of both FDA and CMS earlier in development could be enormously valuable in designing efficient clinical programs that answer the questions important to regulators, physicians, payers, and patients.”
The RAPID proposal builds upon previous CMS initiatives designed to encourage earlier engagement regarding evidence development and Medicare coverage considerations. Applied Biologics believes continued evolution toward greater coordination among regulatory agencies, coverage authorities, manufacturers, physicians, and patients can help create a more predictable environment for medical innovation while maintaining rigorous scientific and evidentiary standards.
“Drug development is extraordinarily complex, expensive, and time-consuming,” Britt added. “Government agencies should maintain rigorous and independent standards, but there is tremendous value in those agencies communicating early enough that innovators understand the evidence they will ultimately need. We believe thoughtful government coordination can help the biotechnology industry develop important therapies more efficiently while maintaining the scientific standards necessary to protect patients and the healthcare system.”
Applied Biologics supports continued exploration of mechanisms that facilitate earlier communication among FDA, CMS, innovators, physicians, and patients while preserving the independent statutory responsibilities of each agency.
The Company believes greater regulatory and coverage alignment has the potential to reduce unnecessary development inefficiencies, improve predictability, and ultimately accelerate access to meaningful new therapies for Medicare beneficiaries and other patients.
About Applied Biologics
Applied Biologics is a biopharmaceutical company advancing novel 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 currently advancing BIOxHEAL™, an investigational biologic entering Phase 3 clinical development for chronic wounds, as well as a preclinical Disease-Modifying Osteoarthritis Gene Therapy Program focused on developing a potential disease-modifying treatment for osteoarthritis.
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 government policy, regulatory and reimbursement processes, research and development activities, preclinical and clinical development, investigational therapies, patient access, and future business prospects. The RAPID pathway described herein is a proposed CMS pathway for certain eligible medical devices and does not apply to Applied Biologics’ current drug or biologic development programs. 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
