INTENT Biologics Receives FDA Agreement Granting a Full Waiver for its Pediatric Study Plan for PEP Biologic™ in Advanced Wound Care

ROCHESTER, Minn.--(BUSINESS WIRE)--INTENT Biologics, a clinical-stage biotechnology company developing PEP Biologic as the 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 agreed to INTENT’s Initial Pediatric Study Plan (iPSP) for PEP Biologic™ under IND 019567, supporting the company’s request for a full pediatric waiver for its forthcoming Biologics License Application (BLA).

FDA’s agreement reflects alignment that pediatric studies are not required for PEP Biologic’s flagship indication, diabetic foot ulcers (DFU) which is initiating a pivotal trial in 2026. The agreed iPSP provides regulatory clarity and removes the requirement to conduct clinical studies in the pediatric population as part of the DFU development program, contingent upon biologic licensure.

“FDA alignment on our pediatric study plan is another important regulatory milestone achieved as we advance PEP Biologic toward late-stage clinical development and eventual BLA submission,” said Suneet Varma, Chief Executive Officer of INTENT Biologics. “This agreement allows us to remain fully focused on delivering a first-in-class biologic therapy for adult patients suffering from DFU, one of many different chronic, non-healing wounds with significant unmet medical need, while maintaining a clear and efficient regulatory pathway.”

The pediatric waiver agreement follows the FDA’s recent Fast Track designation for PEP Biologic in diabetic foot ulcers and further strengthens INTENT’s regulatory position as the company prepares for late-stage clinical development and registration-enabling studies. Together, these achieved regulatory milestones support an efficient development strategy aligned with FDA expectations for serious adult-onset conditions where pediatric studies are impossible or highly impractical.

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, chronic radiation ulcers, and advanced wound care indications based on a proprietary exosome platform originating from RION.

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 late-stage clinical development for multiple indications in advanced tissue regeneration. 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.