Exciting to be progressing to Phase 2 for Diabetic Foot Ulcers (DFU) with our Purified Exosome Product (PEP) #diabeticfootulcer #woundhealing #exosomes #biologics #regenerativemedicine #clinicaltrials
We are proud to announce the initiation of our Phase 2A study, which aims to assess the efficacy and safety of our novel regenerative exosome therapeutic, Purified Exosome Product™ (PEP™), in managing Diabetic Foot Ulcers (DFU). This significant milestone highlights our commitment to revolutionizing regenerative medicine and addressing critical unmet healthcare needs in chronic diseases like DFUs. Building upon our Phase 1B study's success at Mayo Clinic, RION's Phase 2A trial marks a pivotal advancement in creating regenerative biologics for Diabetic Foot Ulcers. This rigorous, randomized, multi-center study is set to enroll 40 participants throughout the United States, carefully stratified into two groups to compare the standard of care against the innovative topical treatment with PEP™ exosomes. The findings will be instrumental, shaping the trajectory for future clinical research and laying the groundwork for a Biologics License Application (BLA)—a critical step in meeting the urgent need for new therapeutic options in diabetic wound care. For more information about our trial and deeper insight into our breakthrough regenerative exosome technology, please read our press release by clicking the link below. https://lnkd.in/ervYnYQU #Rion #RegenerativeMedicine #Exosomes #DiabeticFootUlcer #Diabetes