At Lengea Law, we stay at the forefront of legal and regulatory developments in aesthetics and regenerative medicine—and the latest milestone from Rion Aesthetics is one we’re watching closely.
Rion Aesthetics has officially launched the first U.S. investigator-initiated clinical trial of intradermally injected exosomes, using their proprietary Purified Exosome Product™ (PEP™). This Phase 1 trial, approved by the FDA and conducted by the Clinical Testing Center of Beverly Hills, marks a pivotal moment in the scientific validation of exosome-based treatments in the aesthetic space.
So what does this mean for providers?
It signals a shift toward greater clinical scrutiny and regulatory alignment—a trend Lengea has long prepared our clients for. As the leading law firm serving over 1,300 aesthetic businesses, we understand the fine line between innovation and compliance. While exosomes have been used topically in many U.S. med spas under vague regulatory gray zones, injectable use has never been FDA-approved—until now, for clinical research only.
At Lengea, we are advising clients on:
- How to talk about exosomes in marketing without triggering FDA enforcement.
- Whether your exosome supplier meets evolving regulatory expectations.
- What this trial could mean for the future legality of injectable use.
- How to structure informed consent and patient education around regenerative therapies.
We commend Rion Aesthetics for taking the rigorous, science-driven path. Their commitment to investigator-led research not only supports the field—it sets a precedent. As the FDA continues to tighten its oversight of regenerative products, compliance isn’t just advisable—it’s non-negotiable.
Whether you’re already offering exosome facials or exploring regenerative injectables for the future, Lengea is here to guide you through this fast-changing legal terrain with clarity and confidence.
Want help ensuring your regenerative aesthetic offerings are compliant?
Let’s talk. Contact us to book a compliance consultation with our team.