Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft™ Wound Care Products

Core Insights - Celularity Inc. has received recommendation letters from the FDA's Tissue Reference Group for its products Natalin and Acelagraft™, confirming they meet the criteria for regulation under section 361 of the PHS Act [1][5] - Natalin is a tri-layer graft and Acelagraft™ is a bi-layer graft, both indicated for treating partial and full thickness acute and chronic wounds [2] - 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$810.50 million by 2034, with the chronic wounds segment expected to grow at a 9.13% CAGR [3] Company Overview - Celularity Inc. specializes in regenerative and cellular medicine, focusing on advanced biomaterial products and placental-derived cell therapies [6] - The company aims to leverage the unique biology of the placenta to develop effective and affordable therapeutic solutions for unmet global health needs [6] Market Context - North America accounted for 42.0% of the global Biological Skin Substitutes market in 2024, indicating a significant market presence [3]