- RION's Phase 2A clinical trial focuses on evaluating the safety and efficacy of Platelet Exosome Product™ (PEP™) combined with TISSEEL fibrin sealant for treating Diabetic Foot Ulcers (DFU).
- Diabetic Foot Ulcers, affecting 18.6 million people worldwide each year, significantly impact quality of life and impose substantial economic burdens on healthcare systems.
- The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU.
January 30, 2024 - ROCHESTER, Minn.--RION, a clinical-stage regenerative medicine company, at the forefront of the exosome therapeutic revolution, has officially commenced a Phase 2A study aimed at assessing the efficacy and safety of its exclusive exosome regenerative therapeutic, known as Purified Exosome Product™ (PEP™), for the management of Diabetic Foot Ulcers (DFU).
Diabetic Foot Ulcers affect approximately 18.6 million people worldwide each year1 and are associated with increasing rates of amputation and death. The economic burden of DFUs is substantial, imposing $13 billion in cost on the US public and private healthcare systems.2 The trial is a key part of RION's broader efforts in regenerative medicine, aiming to address unmet needs in the treatment of chronic conditions such as DFU.
Building on the success of the Phase 1B study conducted at Mayo Clinic, RION's Phase 2A trial represents a significant step forward in the development of a regenerative biologic for Diabetic Foot Ulcers. This prospective, randomized, multi-center study will involve 40 patients across the United States. Patients will be divided into two cohorts: one receiving standard care and the other treated with PEP™ exosomes, enabling a thorough comparison of outcomes.
A positive outcome in the Phase 2A trial has the potential to pave the way for a pivotal study followed by the submission of a Biologics License Application (BLA). PEP™ addresses a significant unmet medical need in the realm of diabetic wound care... RION's Press Release -
