INTENT Biologics, a clinical-stage biotechnology company developing first-in-class exosome-based biologic therapies for serious conditions with significant unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for PEP Biologic™ for the treatment of diabetic foot ulcers (DFU) under IND 019567.

FDA Fast Track designation is designed to facilitate the development and expedite the review of drugs and biologics intended to treat serious conditions and address unmet medical needs, including the potential to dramatically improve patient outcomes compared to existing therapies. Under the Fast Track program, PEP Biologic is now eligible for more frequent interactions with the FDA, rolling submission of portions of its Biologics License Application (BLA) and potentially accelerated or priority review in the future. PEP Biologic is being advanced into pivotal clinical development in 2026 in diabetic foot ulcers, recognized as a serious complication of diabetes with significant unmet medical need.

“FAST TRACK designation from FDA is a meaningful milestone confirming our belief that patients suffering serious burns, ulcers and other complicated wounds continue to suffer from high unmet medical need that current therapies do not adequately address,” said Suneet Varma, Chief Executive Officer of INTENT Biologics. “If approved, PEP Biologic would be the first FDA-approved biologic for diabetic foot ulcers in nearly 30 years and the first exosome-based biologic ever approved. We look forward to more frequent interactions and rolling reviews of certain data with FDA. We are more excited than ever as we have completed our Phase II trial and advanced PEP Biologic into pivotal Phase III clinical development in 2026 and prepare for registration and commercialization in the near future.”

Diabetic foot ulcers affect an estimated 19–34% of patients with diabetes during their lifetime and are a leading cause of lower-extremity amputations and a major driver of healthcare costs. Many patients fail to achieve durable healing with currently available treatment options resulting in increased mortality.

PEP Biologic is a platelet-derived exosome biologic designed to deliver regenerative signaling messages that modulate immune responses and promote tissue repair, supporting resolution of inflammation and tissue regeneration. INTENT Biologics is advancing PEP Biologic into clinical development for diabetic foot ulcers based on a proprietary exosome platform originating from RION and Mayo Clinic.

About PEP Biologic™

PEP Biologic (Purified Exosome Product) is a first-in-class exosome therapeutic discovered through Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program and developed on RION’s industry-leading platelet-derived exosome biomanufacturing platform. Packaged as a shelf-stable lyophilized powder, each dose contains regenerative exosomes that deliver polyvalent biologic signals to induce tissue regeneration and regulate immune responses for accelerated healing. With a novel mechanism of action that reduces hyper-inflammation, regulates immune response and repairs & regenerates tissue, PEP Biologic is being advanced by INTENT Biologics into pivotal clinical trials for a range of advanced wound care indications where current treatments fail to address the underlying biology.

About INTENT Biologics

INTENT Biologics is a clinical-stage biotechnology company dedicated to developing first-in-class exosome-based therapeutics in Advanced Wound Care. Spun out of RION, a global leader in regenerative exosome science, and built on more than two decades of research at the Mayo Clinic, INTENT is advancing PEP Biologic into pivotal clinical development for multiple indications in advanced wound care conditions. Headquartered in Minnesota, the company is focused on “revolutionizing and replacing” standards of care in chronic wounds by harnessing regenerative exosomes to treat diseases with significant unmet need. More information can be found at www.intent.bio.

About RION

RION is a clinical-stage regenerative medicine company founded out of the Mayo Clinic after two decades of stem cell and exosome research and innovation. RION is the global leader in isolating and mass-producing platelet-derived regenerative exosomes into a proprietary therapeutic platform to produce Purified Exosome Product (PEP), a shelf-stable biologic designed to activate the body’s natural healing processes. RION is advancing a deep pipeline with clinical and preclinical programs in diabetic foot ulcers, knee osteoarthritis, musculoskeletal injury, dermatologic conditions, pulmonary disease, cardiovascular health, and women’s health. RION’s regenerative PEP technology will be integral to the therapeutic exosome revolution. More information can be found at www.riontx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260108991993/en/