Pluri Inc., a biotechnology company pioneering 3D cell-expansion technology to power scalable cell-based products across therapeutics, regenerative aesthetics, longevity and agri-food tech, announced that its consumer-health and aesthetics subsidiary, Cellav Health and Aesthetics Ltd., has completed the development and U.S. cosmetic product listings of two flagship regenerative aesthetic products – Regenativo+ and Placento+, clearing the path for commercial launch in the United States.
With the U.S. commercial launch and its professional portfolio now listed under the U.S. cosmetic framework and pursuant to U.S. Food and Drug Administration (FDA) regulation, Cellav is in active discussions with U.S. distributors, clinic networks and advancing commercial discussions with strategic partners across the United States, United Kingdom and additional international markets. The Company is focused on securing initial commercial orders, expanding adoption among licensed aesthetic professionals and building a scalable commercial platform for future growth.
The products, Regenativo+, a plant-derived treatment, and Placento+, a placenta-derived formulation, are supplied in Cellav’s signature DUO format: a vial of lyophilized powder paired with a booster vial, designed for topical, professional use following aesthetic procedures.
Clinical validation of Cellav’s ingredients underscores commercial readiness: statistically significant improvements (p<0.05) in skin distensibility, elasticity, firmness and the skin-fatigue index, using plant-based extra cellular vesicles (EV) ingredients. Another study using placenta-based secretome and exosomes, demonstrated significant improvements (p<0.05) in vascular tone (redness) and brown discoloration, with additional improvements in pigmented spots observed in subjects with higher baseline values, and favorable trend observed in skin texture. The tested ingredients were well tolerated, with no clinically meaningful adverse events reported, supporting Cellav’s premium positioning in the professional regenerative and longevity channel.
“We believe that Pluri has built the most advanced cell-expansion platforms in the industry. Today, that technology moves from the lab to the market,” said Yaky Yanay, President and Chief Executive Officer of Pluri. “Our first U.S. commercial launch through Cellav opens access to one of the fastest-growing and highest-margin segments in consumer health. With a clinically validated, scalable portfolio in hand, we believe that we are positioned to capture meaningful share and translate our technology leadership into shareholder value. It also deepens Pluri’s foothold in the longevity field, one of the most strategically important and capital-attractive frontiers in biotech today, where we believe that our proprietary cell-expansion platform is uniquely positioned to lead.”
“This milestone represents the transition of Cellav from product development to commercialization,” said Katty Dowery, Chief Executive Officer of Cellav. “Over the past several years, we have focused on building the scientific, manufacturing, clinical and regulatory foundations required to enter the aesthetics market responsibly and at scale. With our first professional products now listed in the U.S., we are focused on establishing strategic partnerships, building a meaningful commercial presence, and expanding our pipeline of next-generation regenerative aesthetics solutions.”
