Celularity gets 361 nod from FDA for its amniotic derived wound care products, Natalin and Acelagraft™ 

Celularity Inc. (Nasdaq: CELU), a regenerative and cellular medicine company, announced that it received recommendation letters from the FDA’s Tissue Reference Group (TRG), 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.”

This recommendation from the FDA means that the products may 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. English? 361 is considered an easier regulatory environment when compared to 351, which requires a Biologics License Application (BLA) and clinical trials for approval.

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 $347.75 million and projected to grow at a compound annual growth rate, or CAGR, of 8.83% through 2034 to reach $810.50 million. The chronic wounds segment, which includes diabetic foot ulcers, pressure ulcers and venous leg ulcers, is anticipated to grow at a 9.13% CAGR over the forecast period, the fastest of any segment. North America was the largest market accounting for 42.0% of the 2024 global market according to Nova One Advisor.

“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 http://www.celularity.com.