Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft™ Wound Care Products
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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
News Market Reaction
On the day this news was published, CELU declined 9.38%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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?
