Celularity Hails New Florida Law Opening Patient Access to Stem Cell Therapies

Rhea-AI Summary

Celularity (Nasdaq: CELU), a regenerative and cellular medicine company, welcomes a new Florida law effective July 1, 2025, that authorizes physicians to provide investigational stem cell therapies for orthopedics, wound care, and pain management. The legislation permits the use of non-FDA approved stem cell treatments under strict safety and ethical guidelines.

The law requires stem cells to be sourced from FDA-registered and certified/accredited facilities that comply with Good Manufacturing Practices. Physicians must obtain patient informed consent before administering treatments. Celularity, operating an FDA-registered facility with extensive stem cell inventory, is positioned to supply ethically sourced placenta-derived stem cells for these authorized therapies.

The company, through its predecessor Anthrogenesis Corporation, pioneered the discovery of placental stem cell recovery methods in 2001, which was acknowledged by President George W. Bush. The Florida Medical Association was actively involved in crafting the legislation to balance public protection and physician regulation.

Positive

• New Florida law creates market opportunity for Celularity's stem cell therapies
• Company's facility already meets FDA registration and certification requirements of the new law
• Celularity has existing inventory of placenta-derived stem cells ready for immediate supply
• Law expands potential treatment applications to orthopedics, wound care, and pain management

Negative

• Stem cell therapies authorized under the law are not yet FDA-approved
• Success depends on physician adoption and implementation of the new program

• 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.

Forward Looking Statements
Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding: (i) our future sales or sales growth; (ii) our expectations for future financial results, including levels of net sales; (iii) our expectations regarding new products including our 510K products; and (iv) future demand for our products. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “improving,” “may,” “observed,” “potential,” “promise,” “should,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Celularity’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K and Form 10-K/A for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC) on May 8, 2025 and May 21, 2025, respectively, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com

FAQ

What does the new Florida stem cell law mean for Celularity (CELU)?

The law allows Celularity to supply ethically sourced stem cells to Florida physicians for treatments in orthopedics, wound care, and pain management, creating a new market opportunity for the company.

When does the Florida stem cell therapy law take effect?

The law takes effect on July 1, 2025, allowing physicians to provide certain investigational stem cell therapies under strict safety and ethical guidelines.

What requirements must Celularity meet under the new Florida stem cell law?

Celularity must maintain an FDA-registered and certified/accredited facility that complies with Good Manufacturing Practices for stem cell manufacturing, storage, and retrieval.

What medical conditions can be treated under Florida's new stem cell law?

The law authorizes stem cell treatments for orthopedics, wound care, and pain management applications.

Are the stem cell treatments under the Florida law FDA-approved?

No, the law specifically authorizes physicians to provide stem cell therapies that have not yet been approved by the FDA, subject to strict safety and ethical requirements.