- Phase 1 investigator-initiated trial evaluating the safety of intradermally injected Purified Exosome Product™ (PEP™) in healthy adults
- Rion Aesthetics, a regenerative aesthetics company, provides investigational product and research support
- Trial intended to generate safety data and support future scientific exploration
ROCHESTER, Minn.--(BUSINESS WIRE)--Rion Aesthetics, an internationally recognized regenerative aesthetics company, today announced that the U.S. Food and Drug Administration (FDA) has allowed an Investigational New Drug (IND) application to proceed for a Phase 1 investigator-initiated trial evaluating Purified Exosome Product™ (PEP™) injected into the dermis. The study is sponsored and independently conducted by Clinical Testing Center of Beverly Hills and is being led by Dr. John H. Joseph, a double board-certified facial plastic surgeon based in California.
PEP™, a shelf-stable lyophilized powder derived from human platelets, is an investigational product, developed by RION, a clinical-stage regenerative medicine company. PEP™ is being evaluated in research for its potential effects on cellular processes relating to tissue repair, including cell growth, angiogenesis, inflammation modulation, and cellular protection.
The investigator-initiated trial will evaluate the safety and tolerability of PEP™ when injected intradermally into healthy adults undergoing planned elective abdominoplasty surgery. Rion Aesthetics is providing PEP™, the investigational product, and research support for this independent trial. Following FDA allowance of the IND application, dosing of the first participants began this month.
“This trial marks an important step in expanding the scientific understanding of PEP™ exosomes,” said Alisa Lask, CEO of Rion Aesthetics. “We’re proud to support independent scientific research into PEP™ as part of our commitment to advancing innovation in regenerative aesthetics.”
The study (NCT06429033) is a Phase 1 clinical trial that will enroll up to nine healthy adult participants undergoing abdominoplasty surgery. This trial is designed to evaluate the safety and tolerability of intradermally administered, platelet-derived PEP™ exosomes in healthy volunteers. Additional endpoints will include tissue analyses to assess PEP™’s regenerative potential on biological markers such as collagen and elastin.
About Rion Aesthetics
Rion Aesthetics, a regenerative aesthetics company founded in Rochester, MN, and backed by over 15 years of visionary science, is at the forefront of platelet-derived exosome innovation. Rion Aesthetics is advancing research into potential aesthetic applications of exosome-based platforms through translational science, rigorous preclinical research and early-stage clinical investigation.
About RION
RION was established out of the Mayo Clinic after two decades of research and innovation. RION is located in Rochester, MN, and is internationally recognized for its pioneering advancements in isolating and mass-producing platelet-derived regenerative exosomes into shelf-stable PEP™.
RION is rewriting the regenerative medicine playbook. Their cutting-edge proprietary biomanufacturing platform crafts the future of regenerative therapy, unlocking the potent secrets within these tiny cellular messengers.
In addition to medical aesthetics, RION is actively studying PEP™ across multiple areas of regenerative medicine, including cardiovascular disease, musculoskeletal injury, pulmonary disease, wound healing, and women’s health disorders.
About PEP™
RION's Purified Exosome Product™ (PEP™) is a shelf-stable product in a lyophilized powder derived from human platelets that contains stabilized platelet-derived regenerative exosomes. Discovered by the Mayo Clinic Van Cleve Cardiac Regenerative Medicine Program, PEP™ is an investigational exosome platform being studied for its potential to support cellular processes related to tissue repair and regeneration.
RION and its scientific collaborators have conducted extensive preclinical and translational research, supported by over 30 peer-reviewed publications and multiple FDA IND-enabling studies across major therapeutic areas. The company is currently evaluating PEP™ in preclinical and clinical studies, including wound healing and exploratory efforts in musculoskeletal, cardiovascular, pulmonary, and women’s health research. These efforts aim to contribute to the scientific understanding of PEP™ exosome-based approaches in areas with significant unmet clinical needs.
About Clinical Testing Center of Beverly Hills
The Clinical Testing Center of Beverly Hills (CTC), directed by Dr. John Joseph, specializes in conducting Phase II, III, and IV FDA clinical trials for innovative aesthetic devices, topical treatments, and pre/post-treatment applications. The CTC provides comprehensive clinical services, including phlebotomy, 12-lead ECG, digital patient photography, and temperature-controlled storage. The experienced and certified team ensures adherence to high-quality clinical research standards and facilitates rapid patient enrollment through discreet access to an extensive patient database.
About Dr. John H. Joseph
Dr. John H. Joseph is a renowned, double board-certified facial plastic surgeon based in Encino, California, with extensive expertise in aesthetics. Known for his innovative approach to advancing aesthetic medicine, Dr. Joseph has led significant clinical research across biologics, medical devices, and skincare. His work focuses on the development of new aesthetic devices and products, topical drugs, and pre/post treatment applications.
Contacts
Franco Botta (botta@rionax.com)
