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Vericel Announces FDA Approval of NexoBrid for the Treatment of Pediatric Patients with Severe Thermal Burns
Approval Expands NexoBrid Target Customer Base to Include Approximately 20 Pediatric Burn Centers CAMBRIDGE, Mass., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Vericel
About this update from Vericel Corporation
[{"type":"text","content":"Approval Expands NexoBrid Target Customer Base to Include Approximately 20 Pediatric Burn Centers CAMBRIDGE, Mass., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness and/or full-thickness thermal burns. “We are pleased that the FDA approved NexoBrid for pediatric use as it provides a novel non-surgical solution for managing severe burn injuries in this vulnerable pediatric patient population,” said Nick Colangelo, President and CEO of Vericel. “We believe NexoBrid is poised to become the new standard of care for eschar removal and make a meaningful impact on the lives of adult and pediatric burn patients, and we look forward to further executing on our NexoBrid commercial launch.” The FDA approval of the pediatric indication for NexoBrid is based on the results of a global Phase 3 clinical trial, Children Innovation Debridement Study (CIDS), which evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients, as well as additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid. Vericel is expanding its target customer base to include the approximately 20 pediatric burn centers in the United States, which the Company expects will have a meaningful impact on overall NexoBrid uptake over time. “For pediatric burn patients, NexoBrid represents a less invasive alternative to traditional methods and the approval ensures that children will now have access to this innovative non-surgical option to quickly and effectively treat severe thermal burns,” said Steven Kahn, MD, Chief of Burn Surgery at MUSC, University Hospital and Shawn Jenkins Children’s Hospital. NexoBrid was initially approved for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns by the FDA on December 28, 2022, and is commercially available in the United States. About NexoBridNexoBrid (anacaulase-bcdb) is a biologic product containing proteolytic enzymes indicated for eschar removal in adults and pediatric patients with deep partial- and/or full-thick...