SCOTTSDALE, Ariz., June 09, 2026 (GLOBE NEWSWIRE) -- Applied Biologics, a biopharmaceutical company developing novel biologic therapies for chronic wounds, tissue repair, and degenerative disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for BIOxHEAL, enabling advancement into Phase 3 clinical development for the treatment of diabetic foot ulcers (DFU).
BIOxHEAL is Applied Biologics’ lead clinical asset, an investigational biologic therapy targeting diabetic foot ulcers—a serious and prevalent complication of diabetes associated with infection, hospitalization, lower-extremity amputation, diminished quality of life, and substantial healthcare expenditures. Despite the significant burden DFUs place on patients and healthcare systems, a critical unmet need persists for therapies supported by robust clinical evidence and modern biologic development standards.
“FDA clearance of our IND for BIOxHEAL is a defining milestone for Applied Biologics and the culmination of years of scientific, manufacturing, and regulatory work,” said Edward Britt, Chief Executive Officer of Applied Biologics. “We believe patients living with chronic wounds deserve therapies backed by rigorous clinical evidence, reproducible manufacturing processes, and clearly defined quality standards. This clearance represents a meaningful step toward bringing a novel biologic therapy to patients facing significant unmet medical needs.”
Britt continued: “Biologic and tissue-based therapies have long demonstrated the potential to improve outcomes for patients with chronic wounds. The future of this field lies in combining that biological potential with the development rigor, manufacturing standards, and clinical validation that define modern biopharmaceutical innovation. BIOxHEAL was developed to advance that vision, and we are proud to reach this milestone as we prepare to initiate Phase 3 enrollment.”
The IND clearance reflects the Company’s sustained investment across biologic manufacturing, analytical characterization, clinical development infrastructure, quality systems, and regulatory science. Applied Biologics is currently advancing manufacturing activities, clinical site preparation, and operational readiness initiatives in support of patient enrollment.
In parallel, Applied Biologics continues to advance a broader pipeline of biologic therapies and technologies across chronic wounds, tissue repair, and degenerative disease, including translational science initiatives and next-generation therapeutic programs designed to address unmet medical needs across multiple indications.
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 within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding product development, clinical trial plans, regulatory activities, manufacturing operations, commercialization strategy, and future business prospects. These statements are based on the Company’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied, including risks related to regulatory review and approval, clinical trial design and execution, manufacturing scale-up, market adoption, and competitive dynamics. The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this release.
MEDIA CONTACT: Molly Murphy Executive Assistant Applied Biologics, LLC molly.murphy@appliedbiologics.com
