• New law goes into effect on July 1 st authorizing Florida physicians to provide stem cell therapies to their patients for orthopedics, wound care, and pain management

FLORHAM PARK, N.J., July 01, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a regenerative and cellular medicine company, today hailed a new Florida law taking effect today that opens the door to physicians’ use of investigational stem cell therapies in the state in orthopedics, wound care, and pain management.

“Today, a groundbreaking new law takes effect in Florida authorizing physicians to provide stem cell therapies to their patients subject to strict requirements ensuring patient safety and ethical standards,” said Robert J. Hariri, M.D., Ph.D., Celularity CEO and Chairman. “Celularity is fully prepared to supply the ethically sourced stem cells which enable these treatments, and we look forward to working with Florida physicians to make these innovative therapies available to patients.”

The new law authorizes Florida physicians to provide stem cell therapies that have not yet been approved by the US Food and Drug Administration, or FDA, and imposes strict limits on the permissible sources of the stem cells used, which must be manufactured, stored and retrieved in facilities that are FDA registered and certified or accredited by approved organizations. Approved facilities must comply with Good Manufacturing Practices, which are FDA-established standards that mandate strict controls on facilities, processes, and quality control. Additionally, physicians must obtain patient informed consent prior to administering treatments authorized under the new law.

“We applaud Florida’s intention to advance medical treatments and improve patient outcomes with this balanced approach to fostering medical innovation while upholding ethical standards,” said Dr. Hariri. “Celularity is the long-standing leader in the field of ethically sourced stem cell therapies with extensive knowledge and real world data obtained from multiple clinical trials, including wound care and other therapeutic targets authorized under the new Florida law.” In 2001, Celularity’s predecessor organization, Anthrogenesis Corporation (later Celgene Cellular Therapeutics) announced a groundbreaking discovery of a method to recover a then-novel kind of stem cell from the postpartum human placenta. President George W. Bush acknowledged this transformational discovery around ethically sourced stem cells in his landmark August 2001 speech on stem cell research.

“We believe Florida’s physician-focused approach is a model for other states, insofar as physicians are ideally positioned to assess which therapeutic approach is in a patient’s best interest, including investigational stem cell therapies,” said Dr. Hariri, noting the Florida Medical Association’s statement that it “was extensively involved in the crafting of this legislation and sought to ensure that a proper balance was struck between protecting the public from bogus therapies and preventing physician overregulation.”

Celularity operates a purpose-built cell therapy manufacturing and storage/retrieval facility with hundreds of units of placenta-derived stem cells in inventory for use in investigational therapies including those authorized under the new Florida law. Celularity’s facility is FDA registered and certified/accredited as required by the new Florida law. “Celularity is positioned right now to supply the stem cells necessary to fulfill the objectives of the new Florida law and we look forward to working with Florida physicians to ensure their patients have access to stem cell therapies,” said Dr. Hariri.

About Celularity

Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it can develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies. For more information about Celularity and its cutting-edge regenerative medicine solutions, please visit www.celularity.com.

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Carlos Ramirez
Senior Vice President, Celularity Inc.
[email protected]