Celularity’s Natalin and Acelagraft™ Receive FDA TRG Recommendations

Celularity Inc. has received key recommendation letters from the FDA’s Tissue Reference Group (TRG) confirming that its regenerative medicine products, Natalin and Acelagraft™, meet the criteria for regulation solely under section 361 of the Public Health Service Act. This designation allows the company to market these human cell and tissue-based products (HCT/Ps) for use in treating acute and chronic wounds, reinforcing Celularity’s position in the rapidly growing wound care market.

Dr. Robert Hariri, Celularity’s Chairman and CEO, expressed enthusiasm for the regulatory milestone, calling it a testament to the company’s commitment to innovation in placental-derived biomaterials. With the global biological skin substitutes market expected to reach $810.5 million by 2034, Celularity is well-positioned to capitalize on the expanding demand, particularly in North America, which currently holds the largest market share.