Celularity Inc. (Nasdaq: CELU), a regenerative and cellular medicine company, announced a strategic partnership with Fountain Life to supply stem cell therapy products under Florida's newly enacted legislation. The collaboration leverages Florida Statute § 458.3245, which became effective July 1, 2025, allowing qualified physicians to administer autologous or allogeneic adult stem cell products for specific medical conditions without requiring investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA).
Regulatory Framework Enables Immediate Deployment
The new Florida law authorizes licensed physicians to treat patients with stem cell therapies for orthopedic conditions, wound healing, and pain management. This regulatory framework provides a pathway for real-world deployment of investigational stem cell therapies while maintaining stringent safety and sourcing standards.
Fountain Life currently operates four state-of-the-art longevity centers across the United States, including facilities in Naples and Lake Nona-Orlando, Florida, with a Miami location opening soon. These centers are strategically positioned to implement Florida's new legal framework and deliver physician-directed regenerative cellular therapies to eligible patients.
Placental-Derived Stem Cell Technology
Celularity specializes in cell therapies sourced ethically from the postpartum placenta. The company's pipeline includes human placental-derived stem cells and mesenchymal stem cell-like product candidates, supported by extensive clinical datasets across multiple therapeutic areas that align with the use cases permitted under the new Florida statute.
The company maintains a substantial inventory of investigational cell therapies at its FDA-registered, accredited GMP facility in Florham Park, New Jersey, which are immediately available for physician-directed use under the new legislation.
Leadership Perspectives on Partnership
"Celularity's ability today to supply clinical-grade, ethically-sourced stem cells ensures 'Day One' readiness under the new Florida law to partners like Fountain Life," said Robert J. Hariri, M.D., Ph.D., CEO and Chairman of Celularity. "We applaud Florida's proactive, data-driven approach to advancing investigational stem cell therapies and improving patient outcomes, for which Fountain Life, a leading science-backed longevity center, powered by AI, is an ideal partner."
Hariri emphasized Celularity's unique position in the market: "Celularity is unique in our ability to also deliver placental-derived biomaterials for many of the indications targeted in the Florida legislation and we are committed to meeting the high standards laid out in this important new healthcare law."
Dr. William Kapp, CEO and co-founder of Fountain Life, highlighted the alignment between the companies' standards and Florida's requirements. "Cellular medicine is at the core of Fountain Life's mission to transform healthcare and extend human longevity," Kapp said. "We apply the most rigorous standards to every regenerative therapy we offer, ensuring it meets the highest benchmarks for safety, efficacy, and scalability. Florida's stringent criteria for stem cell sourcing align perfectly with our uncompromising commitment to clinical excellence."
Strategic Positioning in Longevity Medicine
Fountain Life, founded in 2019, positions itself as a science-backed longevity company committed to proactive and data-driven healthcare. The company combines advanced AI diagnostics, cutting-edge therapeutics, restorative therapies, and its proprietary health intelligence engine, Zori AI, to help members live longer, healthier lives.
The partnership represents a significant step in Celularity's mission to expand access to regenerative cellular therapies while providing a regulated framework for the deployment of its placental-based technologies. This collaboration addresses the growing demand for regenerative medicine solutions in the longevity and preventative healthcare sectors.
