Celularity & Fountain Life Announce Partnership to Deliver Stem Cell Therapies Under New Florida Law
Rhea-AI Summary
Celularity (Nasdaq: CELU) has formed a strategic partnership with Fountain Life to provide stem cell therapy products in Florida, leveraging a new state law effective July 1, 2025. The legislation allows qualified physicians to administer stem cell treatments for orthopedic conditions, wound healing, and pain management without FDA IND approval.
Fountain Life operates four longevity centers, including two in Florida (Naples and Lake Nona-Orlando), with Miami opening soon. Celularity will supply clinical-grade, placental-derived stem cells from its FDA-registered facility in New Jersey, offering immediate availability for physician-directed use under the new regulatory framework.
Positive
- Strategic partnership enables immediate market access in Florida for stem cell therapies
- Celularity's FDA-registered facility ensures ready-to-use stem cell inventory
- New Florida law creates regulatory pathway without requiring FDA IND approval
- Multiple deployment centers available through Fountain Life's established network
Negative
- Limited geographic scope restricted to Florida state
- Regulatory framework differs from standard FDA approval process
- Treatment applications limited to specific conditions (orthopedics, wound care, pain management)
Insights
Celularity's partnership with Fountain Life leverages Florida's new stem cell law, creating immediate revenue opportunities and regulatory precedent.
This partnership represents a significant regulatory and commercial opportunity for Celularity. The new Florida statute (§ 458.3245) creates a state-level regulatory pathway that circumvents traditional FDA approval requirements for certain stem cell therapies - specifically in orthopedics, wound healing, and pain management.
The deal provides Celularity immediate access to Fountain Life's established centers in Florida (Naples, Lake Nona-Orlando, and soon Miami), enabling commercialization of their placental-derived stem cell products without completing the lengthy FDA approval process. This represents a critical market validation of Celularity's technology and manufacturing capabilities.
From a business perspective, this partnership addresses a fundamental challenge facing regenerative medicine companies - the lengthy timeline to revenue generation. Celularity's existing inventory of investigational cell therapies can now be deployed commercially in Florida, potentially creating near-term revenue streams while their traditional FDA pathways continue.
The partnership also establishes a precedent for state-level regulation of regenerative therapies that could expand to other states. This regulatory bifurcation could accelerate commercialization timelines in selective geographic markets while companies simultaneously pursue federal approvals.
For Celularity investors, this represents both opportunity and risk. While accelerating revenue generation, the company must still demonstrate clinical efficacy and safety in these real-world applications or risk reputational damage that could impact broader regulatory strategy.
- Fountain Life operates four flagship longevity centers, including two in Florida, where a new state law effective July 1, 2025, authorizes licensed physicians to administer stem cell therapies to members with conditions in orthopedics, wound care, and pain management.
FLORHAM PARK, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company focused on addressing age-related and degenerative diseases, announced today that it entered into a strategic partnership with Fountain Life, a global leader in science-backed longevity and preventative health company, to supply stem cell therapy products manufactured and distributed by Celularity.
Fountain Life intends to deploy Celularity’s technology in accordance with Florida Statute § 458.3245, which became effective July 1, 2025. The law authorizes qualified physicians in the state of Florida to treat patients with autologous or allogeneic adult stem cell products under specific conditions, including the treatment of orthopedic conditions, wound healing, and pain management, without requiring investigational new drug (IND) approval by the U.S. Food and Drug Administration (FDA).
Fountain Life currently operates four state-of-the-art longevity centers across the United States, including Naples, and Lake Nona-Orlando, Florida and soon to open in Miami. These centers are well-positioned to implement Florida’s new legal framework and deliver innovative, physician-directed regenerative cellular therapies to eligible patients.
Celularity is a pioneer in the field of cell therapies sourced ethically from the postpartum placenta. Its pipeline includes human placental-derived stems cells and mesenchymal stem cell-like product candidates, supported by extensive clinical datasets across multiple therapeutic areas aligned with the use cases permitted under the new Florida statute. Celularity maintains a substantial inventory of investigational cell therapies, which are immediately available for physician-directed use, at its FDA-registered, accredited GMP facility in Florham Park, New Jersey.
This collaboration aligns with Celularity’s mission to expand access to regenerative cellular therapies and provides a regulated framework for real-world deployment of its placental-based technologies.
“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. “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 added, “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.”
“Cellular medicine is at the core of Fountain Life’s mission to transform healthcare and extend human longevity,” said Dr. William Kapp, CEO and co-founder of Fountain Life. “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. We chose to partner with Celularity because of their proven ability to meet and exceed those standards, providing our members access to the most vetted, advanced cellular therapeutics.”
About Celularity
Celularity Inc. (Nasdaq: CELU) is a regenerative and cellular medicine company developing and commercializing advanced biomaterial products and cryopreserved allogeneic 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
About Fountain Life
Fountain Life is the leading science-backed longevity company, committed to proactive and data-driven global healthcare. Founded in 2019, it is the world’s first fully integrated destination for proactive health and longevity—combining advanced AI diagnostics, cutting-edge therapeutics, restorative therapies, and Zori AI, its proprietary health intelligence engine. Through continuous optimization, Fountain Life helps members live longer, healthier lives. Built to shift healthcare from reactive to preventive, Fountain Life offers scalable access through its tiered membership model: CORE, APEX, and EPIC. Fountain Life is redefining the future of medicine. Discover more at www.fountainlife.com.
Isabel Coscia
Chief Marketing Officer, Fountain Life.
Isabel.coscia@fountainlife.com
FAQ
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