Vericel Gets FDA Nod for NexoBrid in Severe Pediatric Burns

Vericel Corporation, a key player in advanced therapies for sports medicine and severe burn care, recently announced that the U.S. Food and Drug Administration (FDA) has approved the use of NexoBrid® (anacaulase-bcdb) for pediatric patients. This new indication allows for the use of NexoBrid for eschar removal in children suffering from deep partial-thickness and full-thickness thermal burns.

Nick Colangelo, President and CEO of Vericel, expressed his satisfaction with the FDA's decision, highlighting the importance of NexoBrid as a non-surgical treatment option for severe burn injuries in children. He emphasized the potential of NexoBrid to become the standard care method for eschar removal, thus making a significant difference in the lives of both adult and pediatric burn patients. Colangelo also mentioned the company's dedication to advancing the commercial launch of NexoBrid.

The FDA's approval of the pediatric indication for NexoBrid is grounded in the findings of a comprehensive global Phase 3 clinical trial known as the Children Innovation Debridement Study (CIDS). This trial assessed the safety and efficacy of NexoBrid in pediatric burn patients. Additional supportive data from Phase 2 and Phase 3 studies conducted during NexoBrid's clinical development also played a crucial role in securing this approval. With this new indication, Vericel aims to expand its customer base to include approximately 20 pediatric burn centers across the United States, anticipating a significant boost in NexoBrid's overall uptake over time.

Dr. Steven Kahn, Chief of Burn Surgery at MUSC, University Hospital, and Shawn Jenkins Children’s Hospital, endorsed the FDA's decision, noting that NexoBrid offers a less invasive alternative to traditional burn treatment methods. He highlighted the approval as a milestone that ensures children now have access to a non-surgical option for the effective and rapid treatment of severe thermal burns.

NexoBrid, which contains proteolytic enzymes, was initially approved by the FDA on December 28, 2022, for eschar removal in adults with deep partial-thickness and full-thickness thermal burns. The product is now available commercially in the United States.

Vericel Corporation is renowned for its advanced therapies designed for the sports medicine and severe burn care markets. The company's portfolio includes innovative cell therapies and specialty biologics that aim to repair injuries and restore lives. Vericel markets three primary products in the United States. These include MACI® (autologous cultured chondrocytes on porcine collagen membrane), which is used for repairing symptomatic cartilage defects in the knee; Epicel® (cultured epidermal autografts), a permanent skin replacement for patients with severe burns covering at least 30% of their body surface area; and NexoBrid®. Vericel holds exclusive North American rights for NexoBrid, a biological orphan product formulated with proteolytic enzymes for eschar removal in both adults and pediatric patients suffering from deep partial-thickness and full-thickness thermal burns.

Each of these products underscores Vericel's commitment to leveraging biological innovations and medical technology to provide highly effective treatment options. The company continues to focus on delivering advanced therapeutic solutions that significantly improve patient outcomes in their respective markets.