Celularity Hails New Florida Law Opening Patient Access to Stem Cell Therapies
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.
Celularity (Nasdaq: CELU), un'azienda specializzata in medicina rigenerativa e cellulare, accoglie con favore una nuova legge della Florida che entrerà in vigore il 1° luglio 2025 e autorizza i medici a fornire terapie sperimentali con cellule staminali per ortopedia, cura delle ferite e gestione del dolore. La normativa consente l'uso di trattamenti con cellule staminali non ancora approvati dalla FDA, purché rispettino rigorose linee guida di sicurezza ed etica.
La legge richiede che le cellule staminali provengano da strutture registrate e certificate/accreditate dalla FDA che osservino le Buone Pratiche di Fabbricazione. I medici devono ottenere il consenso informato dei pazienti prima di somministrare i trattamenti. Celularity, che gestisce una struttura registrata dalla FDA con un ampio inventario di cellule staminali, è pronta a fornire cellule staminali derivate dalla placenta ottenute in modo etico per queste terapie autorizzate.
L'azienda, tramite la sua predecessora Anthrogenesis Corporation, ha pionieristicamente scoperto i metodi per il recupero delle cellule staminali placentari nel 2001, riconosciuto anche dall'allora Presidente George W. Bush. L'Associazione Medica della Florida ha partecipato attivamente alla stesura della legge per bilanciare la protezione del pubblico e la regolamentazione dei medici.
Celularity (Nasdaq: CELU), una empresa de medicina regenerativa y celular, da la bienvenida a una nueva ley de Florida que entrará en vigor el 1 de julio de 2025 y que autoriza a los médicos a ofrecer terapias experimentales con células madre para ortopedia, cuidado de heridas y manejo del dolor. La legislación permite el uso de tratamientos con células madre no aprobados por la FDA bajo estrictas normas de seguridad y ética.
La ley exige que las células madre provengan de instalaciones registradas y certificadas/acreditadas por la FDA que cumplan con las Buenas Prácticas de Manufactura. Los médicos deben obtener el consentimiento informado del paciente antes de administrar los tratamientos. Celularity, que opera una instalación registrada por la FDA con un extenso inventario de células madre, está preparada para suministrar células madre derivadas de la placenta obtenidas éticamente para estas terapias autorizadas.
La compañía, a través de su predecesora Anthrogenesis Corporation, fue pionera en el descubrimiento de métodos para la recuperación de células madre placentarias en 2001, reconocimiento otorgado por el presidente George W. Bush. La Asociación Médica de Florida participó activamente en la elaboración de la legislación para equilibrar la protección pública y la regulación médica.
Celularity (나스닥: CELU)는 재생 및 세포 의학 회사로서 2025년 7월 1일부터 발효되는 플로리다주의 새로운 법률을 환영합니다. 이 법은 정형외과, 상처 치료 및 통증 관리를 위한 임상 시험 단계의 줄기세포 치료를 의사들이 제공할 수 있도록 허용합니다. 해당 법안은 엄격한 안전 및 윤리 지침 하에 FDA 승인을 받지 않은 줄기세포 치료의 사용을 허용합니다.
법률은 줄기세포가 FDA에 등록되고 인증/인정된 시설에서 조달되어야 하며 우수 제조 기준을 준수해야 한다고 규정합니다. 의사들은 치료를 시행하기 전에 환자의 사전 동의를 받아야 합니다. Celularity는 광범위한 줄기세포 재고를 보유한 FDA 등록 시설을 운영하며, 윤리적으로 조달된 태반 유래 줄기세포를 이 승인된 치료에 공급할 준비가 되어 있습니다.
이 회사는 전신인 Anthrogenesis Corporation을 통해 2001년에 태반 줄기세포 회복 방법을 선구적으로 발견했으며, 이는 조지 W. 부시 대통령에게도 인정받았습니다. 플로리다 의학 협회는 공공 보호와 의사 규제의 균형을 맞추기 위해 법안 제정에 적극 참여했습니다.
Celularity (Nasdaq : CELU), une société de médecine régénérative et cellulaire, accueille favorablement une nouvelle loi en Floride qui entrera en vigueur le 1er juillet 2025, autorisant les médecins à fournir des thérapies expérimentales à base de cellules souches pour l’orthopédie, les soins des plaies et la gestion de la douleur. Cette législation permet l’utilisation de traitements à base de cellules souches non approuvés par la FDA, sous des directives strictes de sécurité et d’éthique.
La loi exige que les cellules souches proviennent de structures enregistrées et certifiées/accréditées par la FDA respectant les Bonnes Pratiques de Fabrication. Les médecins doivent obtenir le consentement éclairé des patients avant d’administrer les traitements. Celularity, qui exploite une installation enregistrée auprès de la FDA avec un large stock de cellules souches, est positionnée pour fournir des cellules souches dérivées du placenta, obtenues de manière éthique, pour ces thérapies autorisées.
La société, par l’intermédiaire de sa prédécesseure Anthrogenesis Corporation, a été pionnière dans la découverte des méthodes de récupération des cellules souches placentaires en 2001, reconnue par le président George W. Bush. L’Association médicale de Floride a activement participé à l’élaboration de la loi afin de concilier protection du public et régulation des médecins.
Celularity (Nasdaq: CELU), ein Unternehmen für regenerative und zelluläre Medizin, begrüßt ein neues Gesetz in Florida, das am 1. Juli 2025 in Kraft tritt und Ärzten die Erlaubnis gibt, experimentelle Stammzelltherapien für Orthopädie, Wundversorgung und Schmerzmanagement anzubieten. Die Gesetzgebung erlaubt die Verwendung von nicht von der FDA zugelassenen Stammzellbehandlungen unter strengen Sicherheits- und Ethikrichtlinien.
Das Gesetz verlangt, dass Stammzellen aus FDA-registrierten und zertifizierten/akkreditierten Einrichtungen stammen, die den Guten Herstellungspraxen entsprechen. Ärzte müssen vor der Behandlung die informierte Einwilligung der Patienten einholen. Celularity betreibt eine von der FDA registrierte Einrichtung mit umfangreichem Stammzellbestand und ist bereit, ethisch gewonnene, plazentabestandene Stammzellen für diese zugelassenen Therapien bereitzustellen.
Das Unternehmen, über seinen Vorgänger Anthrogenesis Corporation, war Pionier bei der Entdeckung von Methoden zur Gewinnung plazentabestandener Stammzellen im Jahr 2001, was von Präsident George W. Bush anerkannt wurde. Die Florida Medical Association war aktiv an der Ausarbeitung der Gesetzgebung beteiligt, um den Schutz der Öffentlichkeit und die Regulierung der Ärzte in Einklang zu bringen.
- 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
- Stem cell therapies authorized under the law are not yet FDA-approved
- Success depends on physician adoption and implementation of the new program
Insights
Florida's new stem cell law creates revenue opportunity for Celularity's placenta-derived therapies in orthopedics, wound care, and pain management.
A new Florida law effective July 1st represents a significant regulatory shift, authorizing physicians to provide non-FDA approved stem cell therapies for orthopedics, wound care, and pain management. This legislation creates an immediate market opportunity for Celularity, which is strategically positioned to capitalize on this development with its inventory of placenta-derived stem cells.
The regulatory framework is carefully constructed with patient safeguards, requiring stem cells to be sourced from facilities that are FDA-registered and certified/accredited, with mandatory Good Manufacturing Practices compliance. Celularity confirms their facilities already meet these requirements, eliminating barriers to market entry.
This development is particularly valuable for Celularity given their historical position in ethical stem cell sourcing. The company pioneered placenta-derived stem cell recovery methods back in 2001 through predecessor Anthrogenesis Corporation, giving them over two decades of expertise in this specific field. Their existing inventory and purpose-built manufacturing infrastructure means they can immediately supply products without additional capital investment or development time.
Florida's approach could serve as a regulatory template for other states, potentially creating a domino effect that would significantly expand Celularity's addressable market beyond Florida. The physician-centric model aligns with Celularity's go-to-market strategy, as doctors will determine which patients receive these therapies. While revenue impact remains to be seen, this represents a clear path to commercialization for therapies that would otherwise require lengthy FDA approval processes.
- New law goes into effect on July 1st 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
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