Celularity makes cell therapy available in Florida under new state law

Celularity Inc. (NASDAQ: CELU) announced the availability of cenplacel-L, a placental-derived cell therapy, for investigational use by licensed physicians in Florida under recently enacted state legislation. The company partnered with Fountain Life Management to provide the therapy through the new regulatory framework.

Florida Statutes § 458.3245 and § 459.0127, effective July 1, 2025, authorize licensed physicians to perform certain cell therapies not yet approved by the Food and Drug Administration, provided the treatments comply with sourcing, manufacturing, accreditation and patient consent requirements.

Cenplacel-L, also designated as PDA-001 or PDA-002 in clinical research, is manufactured at Celularity's FDA-registered, GMP-compliant facility. The therapy targets inflammation, degeneration and age-related conditions through what the company describes as immunomodulatory and regenerative properties demonstrated in clinical studies.

"By making cenplacel-L available to qualified physicians in Florida, we aim to advance access to innovations that may address unmet needs in wound care, orthopedics and other therapeutic areas permitted under state law," said Robert J. Hariri, Celularity's chairman and chief executive officer.

The collaboration with Fountain Life provides clinical implementation through advanced diagnostics, patient selection and physician oversight within a preventive care model. Fountain Life operates longevity-focused healthcare services combining diagnostics and therapeutics.

Celularity maintains inventory of the cell therapy at its manufacturing facility and stated it can support physician-directed investigational use consistent with Florida law requirements. The therapy has not received FDA approval for any indication.

The company described this as establishing one of the first state-level frameworks in the United States enabling physician-directed use of allogeneic cellular therapies outside traditional federal approval pathways.

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