Rochester, Minn.– Rion Aesthetics has announced its support for the first U.S. investigator-initiated clinical trial evaluating the safety of dermal injections using its investigational Purified Exosome Product™ (PEP™), a platelet-derived exosome formulation developed for regenerative aesthetic applications.
The Phase 1 trial, now underway following approval from the U.S. Food and Drug Administration (FDA) to proceed under an Investigational New Drug (IND) application, is being conducted independently by the Clinical Testing Center of Beverly Hills. The study is led by Dr. John H. Joseph, a double board-certified facial plastic surgeon based in California.
Designed to assess safety and tolerability, the trial involves intradermal injections of PEP™ in healthy adults undergoing elective abdominoplasty surgery. Rion Aesthetics is supplying the investigational product and providing research support for the study, which is expected to enroll up to nine participants.
PEP™, a shelf-stable lyophilized exosome powder derived from human platelets, is being explored for its potential to influence biological processes tied to tissue regeneration—such as cell growth, inflammation modulation, angiogenesis, and cellular repair.
“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 this independent research as part of our broader mission to advance innovation in regenerative aesthetics.”
In addition to safety, researchers will evaluate biological markers such as collagen and elastin to gauge PEP™’s potential for promoting tissue repair and rejuvenation. The study, registered under ClinicalTrials.gov identifier NCT06429033, could help lay the groundwork for future trials and clinical applications involving regenerative therapies in aesthetic medicine.
