Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft™ Wound Care Products
Celularity Inc. - Class A (CELU)
Company Research
Source: GlobeNewswire
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
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CELU
Sec Filings
- 12/5/25 - Form 8-K
- 11/21/25 - Form 4
- 11/21/25 - Form 4
- CELU's page on the SEC website