Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft™ Wound Care Products
Celularity Inc. (Nasdaq: CELU) has received recommendation letters from the FDA Tissue Reference Group confirming that its Natalin and Acelagraft™ wound care products meet criteria to be regulated solely under section 361 of the PHS Act as human cell, tissue and cellular and tissue-based products (HCT/P).
Natalin is a decellularized dehydrated amnion derived tri-layer graft, while Acelagraft™ is a decellularized dehydrated amnion derived bi-layer graft. Both products are indicated for use in partial and full thickness acute and chronic wounds.
According to Nova One Advisor, the global Biological Skin Substitutes market was valued at $347.75 million in 2024 and is projected to grow at a CAGR of 8.83% through 2034, reaching $810.50 million. The chronic wounds segment is expected to grow fastest at 9.13% CAGR, with North America representing 42% of the global market.
Celularity Inc. (Nasdaq: CELU) ha ricevuto lettere di raccomandazione dal Gruppo di Riferimento per i Tessuti della FDA che confermano che i suoi prodotti per la cura delle ferite Natalin e Acelagraft™ soddisfano i criteri per essere regolati esclusivamente ai sensi della sezione 361 del PHS Act come prodotti umani a base di cellule, tessuti e prodotti cellulari e basati su tessuti (HCT/P).
Natalin è un innesto tri-strato decellularizzato e disidratato derivato dall'amnios, mentre Acelagraft™ è un innesto bi-strato decellularizzato e disidratato derivato dall'amnios. Entrambi i prodotti sono indicati per l'uso in ferite acute e croniche di spessore parziale e totale.
Secondo Nova One Advisor, il mercato globale dei Sostituti Cutanei Biologici è stato valutato 347,75 milioni di dollari nel 2024 e si prevede che cresca a un CAGR dell'8,83% fino al 2034, raggiungendo 810,50 milioni di dollari. Si prevede che il segmento delle ferite croniche cresca più rapidamente con un CAGR del 9,13%, con il Nord America che rappresenta il 42% del mercato globale.
Celularity Inc. (Nasdaq: CELU) ha recibido cartas de recomendación del Grupo de Referencia de Tejidos de la FDA que confirman que sus productos para el cuidado de heridas Natalin y Acelagraft™ cumplen con los criterios para ser regulados únicamente bajo la sección 361 de la Ley PHS como productos humanos basados en células, tejidos y productos celulares y basados en tejidos (HCT/P).
Natalin es un injerto tri-capa descelularizado y deshidratado derivado del amnios, mientras que Acelagraft™ es un injerto bi-capa descelularizado y deshidratado derivado del amnios. Ambos productos están indicados para su uso en heridas agudas y crónicas de grosor parcial y total.
Según Nova One Advisor, el mercado global de Sustitutos Biológicos de Piel fue valorado en 347,75 millones de dólares en 2024 y se proyecta que crecerá a una tasa compuesta anual (CAGR) del 8,83% hasta 2034, alcanzando 810,50 millones de dólares. Se espera que el segmento de heridas crónicas crezca más rápido con un CAGR del 9,13%, siendo América del Norte el 42% del mercado global.
Celularity Inc. (Nasdaq: CELU)는 FDA 조직 참고 그룹으로부터 Natalin 및 Acelagraft™ 상처 치료 제품이 인간 세포, 조직 및 세포 및 조직 기반 제품(HCT/P)으로서 PHS 법 제361조에 따라 단독 규제를 받을 수 있다는 확인 서신을 받았습니다.
Natalin은 탈세포화된 탈수된 양막에서 유래한 3층 이식편이며, Acelagraft™는 탈세포화된 탈수된 양막에서 유래한 2층 이식편입니다. 두 제품 모두 부분 및 전체 두께의 급성 및 만성 상처에 사용하도록 지시되어 있습니다.
Nova One Advisor에 따르면, 글로벌 생물학적 피부 대체물 시장은 2024년에 3억 4,775만 달러로 평가되었으며, 2034년까지 연평균 성장률(CAGR) 8.83%로 성장할 것으로 예상되며, 8억 1,050만 달러에 이를 것으로 보입니다. 만성 상처 부문은 9.13% CAGR로 가장 빠르게 성장할 것으로 예상되며, 북미가 글로벌 시장의 42%를 차지하고 있습니다.
Celularity Inc. (Nasdaq: CELU) a reçu des lettres de recommandation du Groupe de Référence des Tissus de la FDA confirmant que ses produits de soins des plaies Natalin et Acelagraft™ répondent aux critères pour être réglementés uniquement en vertu de la section 361 de la loi PHS en tant que produits humains basés sur des cellules, des tissus et des produits cellulaires et tissulaires (HCT/P).
Natalin est un greffon tri-couche décellularisé et déshydraté dérivé de l'amnios, tandis qu'Acelagraft™ est un greffon bi-couche décellularisé et déshydraté dérivé de l'amnios. Les deux produits sont indiqués pour une utilisation dans des plaies aiguës et chroniques de l'épaisseur partielle et totale.
Selon Nova One Advisor, le marché mondial des substituts cutanés biologiques était évalué à 347,75 millions de dollars en 2024 et devrait croître à un taux de croissance annuel composé (CAGR) de 8,83% jusqu'en 2034, atteignant 810,50 millions de dollars. Le segment des plaies chroniques devrait croître le plus rapidement avec un CAGR de 9,13%, l'Amérique du Nord représentant 42% du marché mondial.
Celularity Inc. (Nasdaq: CELU) hat Empfehlungsschreiben von der FDA Tissue Reference Group erhalten, die bestätigen, dass ihre Natalin und Acelagraft™ Wundpflegeprodukte die Kriterien erfüllen, um ausschließlich nach Abschnitt 361 des PHS-Gesetzes als menschliche Zell-, Gewebe- und zelluläre sowie gewebebasierte Produkte (HCT/P) reguliert zu werden.
Natalin ist ein dekellulisiertes, dehydriertes Amnion, das als Dreischicht-Transplantat dient, während Acelagraft™ ein dekellulisiertes, dehydriertes Amnion ist, das als Zweischicht-Transplantat dient. Beide Produkte sind zur Anwendung bei teilweisen und vollständigen akuten und chronischen Wunden vorgesehen.
Laut Nova One Advisor wurde der globale Markt für biologische Hautersatzprodukte im Jahr 2024 auf 347,75 Millionen Dollar geschätzt und wird voraussichtlich bis 2034 mit einer jährlichen Wachstumsrate (CAGR) von 8,83% auf 810,50 Millionen Dollar wachsen. Der Bereich chronische Wunden wird voraussichtlich mit einer CAGR von 9,13% am schnellsten wachsen, wobei Nordamerika 42% des globalen Marktes ausmacht.
- FDA granted HCT/P 361 regulatory status for Natalin and Acelagraft™ wound care products
- Products target the $347.75M global Biological Skin Substitutes market
- Target market projected to grow to $810.50M by 2034 (8.83% CAGR)
- Chronic wounds segment growing at 9.13% CAGR - fastest in the sector
- North America represents 42% of the global market, positioning CELU favorably
- Highly competitive wound care market with established players
- No mention of revenue projections or market share expectations
- No timeline provided for commercial launch or sales strategy
Insights
Celularity's receipt of FDA Tissue Reference Group recommendation letters for its Natalin and Acelagraft™ wound care products represents a significant regulatory milestone with material commercial implications for this micro-cap regenerative medicine company.
The 361 HCT/P designation (Human Cells, Tissues, and Cellular and Tissue-Based Products) is particularly valuable as it allows these products to reach market without the lengthy and expensive premarket approval process required for drugs or biologics. This regulatory pathway typically reduces time-to-market by 12-24 months and can save tens of millions in development costs compared to traditional FDA approval routes.
These additions to Celularity's wound care portfolio target the $347.75 million global biological skin substitutes market, which is projected to grow at nearly 9% CAGR through 2034. Most importantly, these products address the chronic wound segment—including diabetic foot ulcers, pressure ulcers, and venous leg ulcers—which is growing even faster at 9.13% CAGR, driven by increasing diabetes prevalence and an aging population.
For context, with Celularity's current $38 million market capitalization, even capturing a modest 1-2% of the North American wound care market (approximately $146 million) could significantly impact the company's financial trajectory. The placental-derived biomaterials used in these products typically command premium pricing in the wound care space, with similar products generating $1,500-$3,000 per application.
The commercial potential must be balanced against execution risks. While the CEO references "commercial momentum," investors should note that Celularity reported just $3.8 million in total revenue for Q3 2024, indicating these new products need to gain significant traction to materially improve financial performance. The company's cash runway and commercialization capabilities will be critical factors determining whether this regulatory win translates to shareholder value.
This development strengthens Celularity's competitive positioning against larger wound care players like Organogenesis, MiMedx, and Smith & Nephew, though the company will need to demonstrate clinical differentiation and establish distribution channels to gain meaningful market share. The timing of this regulatory milestone aligns well with increasing clinical adoption of advanced biological dressings for chronic wounds, where traditional treatments often show efficacy.
Natalin and Acelagraft™ are the latest additions to Celularity’s portfolio of HCT/P 361 products for use in the treatment of partial and full thickness acute and chronic wounds
FLORHAM PARK, N.J., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity” or the “Company”), a regenerative and cellular medicine company, today announced that on December 19, 2024, it received recommendation letters from the US Food and Drug Administration, or FDA, Tissue Reference Group, or TRG, in response to the Company’s requests regarding its Natalin and Acelagraft™ products confirming that each product “appears to meet all the criteria for regulation solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271.” FDA’s recommendations reflect that each meets the criteria to be regulated solely under section 361 (21 CRFR Part 1271.10(a)) as a human cell, tissue and cellular and tissue-based product, or HCT/P, for given indication for use.
Natalin is a decellularized dehydrated amnion derived tri-layer graft and Acelagraft™ is a decellularized dehydrated amnion derived bi-layer graft. Both Natalin and Acelagraft™ are indicated for use in partial and full thickness acute and chronic wounds.
According to Nova One Advisor, the 2024 global Biological Skin Substitutes market was
“We are extremely pleased to receive these TRG recommendation letters on important additions to our portfolio of human placental-derived biomaterials, which serves as a further testament to our commitment to innovate in the wound care sector and will further enable us to build on our commercial momentum,” commented Dr. Robert Hariri, Chairman and CEO of Celularity.
About the Tissue Reference Group
The Tissue Reference Group, or TRG, is a working group within the FDA that responds to inquiries from manufacturers and sponsors regarding their existing, investigational, or proposed products containing or consisting of HCT/Ps. The TRG provides recommendation letters to inquiring stakeholders concerning, among other things, the application of the criteria in 21 CFR 1271.10(a) to the regulation of human cells, tissues and cellular and tissue-based products, or HCT/P, for given indication(s) for use and whether a submitted product appears to meet HCT/P regulatory requirements. A TRG recommendation letter referencing Section 361 of the Public Health Service Act is used by the Centers for Medicare and Medicaid Services, or CMS, and other agencies to confirm the regulatory status of an HCT/P and that it meets the criteria for regulation solely under Section 361 of the Public Health Services Act, versus requiring premarket approval as a drug or biologic.
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, visit www.celularity.com.
Forward Looking Statements
This press release includes “forward-looking statements” (as defined under Federal securities laws). 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,” “expect,” “forecast,” “may,” “plan,” “project,” “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 filed with the Securities and Exchange Commission (SEC) on July 30, 2024, 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 FDA recommendation did Celularity (CELU) receive for Natalin and Acelagraft™ products?
What are the specific uses for Celularity's Natalin and Acelagraft™ products?
How large is the market for biological skin substitutes that CELU's new products will compete in?
What is the difference between Celularity's Natalin and Acelagraft™ wound care products?
Which wound care market segment is growing fastest that CELU's products target?
