If you know someone with diabetes, you likely know someone who has struggled with a foot ulcer. More than 1.6 million Americans develop diabetic foot ulcers each year and many face wounds that simply won’t heal — often leading to infection, hospitalization, or amputation.
A Rochester‑based biotech company, INTENT Biologics, is working to change that. The company has received FDA Breakthrough Therapy designation for PEP Biologic, a first‑in‑class exosome treatment designed to activate the body’s own healing mechanisms.
Breakthrough designation is rare and reserved for therapies showing early evidence of being significantly more effective than current options. Combined with previously granted Fast Track status, PEP Biologic now moves forward on an accelerated path toward pivotal clinical trials.
PEP Biologic uses platelet‑derived exosomes — tiny biological messengers — to reduce inflammation and trigger tissue repair. Rather than covering a wound or providing temporary protection, the therapy aims to correct the underlying regenerative failure that keeps chronic wounds from healing.
“This is a transformational milestone for INTENT Biologics and for advanced wound care,” said CEO Suneet Varma in a news release. “Patients with diabetic foot ulcers continue to face high rates of non‑healing and amputation. FDA’s decision recognizes the potential of PEP Biologic to meaningfully improve outcomes.”
INTENT Biologics was spun out of RION, Mayo Clinic’s regenerative medicine partner and has been funded through a combination of private venture capital, strategic investment from RION and non‑dilutive support tied to Mayo Clinic’s underlying research programs. While the company has not disclosed exact totals, industry sources indicate INTENT has raised tens of millions in early‑stage capital to advance PEP Biologic through Phase 1 and Phase 2 studies. Moving into pivotal trials and commercial manufacturing will require substantially more funding — often $50–100 million or more for a novel biologic — positioning INTENT for additional venture rounds or strategic partnerships.
The advanced wound‑care market includes national players such as Organogenesis, Smith+Nephew and MiMedx, all of which offer biologic dressings or amniotic‑derived products. However, none have FDA Breakthrough designation for diabetic foot ulcers and none are developing platelet‑derived exosome therapeutics at INTENT’s clinical stage. RION, also headquartered in Rochester and the scientific originator of PEP Biologic, is advancing additional exosome programs but remains earlier in development.
With pivotal trials ahead, PEP Biologic stands out as one of Minnesota’s most promising biotech innovations — offering new hope to thousands living with chronic, non‑healing diabetic wounds.
(Source here.)
