Vericel Announces FDA Approval of NexoBrid for the Treatment of Pediatric Patients with Severe Thermal Burns

Core Insights - The FDA has approved NexoBrid for pediatric use, expanding its target customer base to approximately 20 pediatric burn centers in the U.S. [1][2] - NexoBrid is positioned as a novel non-surgical solution for managing severe burn injuries in pediatric patients, potentially becoming the new standard of care [2][3] - The approval is based on the results of the global Phase 3 clinical trial, Children Innovation Debridement Study (CIDS), which assessed the safety and efficacy of NexoBrid in hospitalized pediatric patients [2] Company Overview - Vericel Corporation is a leader in advanced therapies for sports medicine and severe burn care markets, with a differentiated portfolio of innovative cell therapies and specialty biologics [7] - The company markets three products in the U.S.: MACI, Epicel, and NexoBrid, the latter being a biological orphan product indicated for eschar removal in both adults and pediatric patients [7] - NexoBrid was initially approved for adult use on December 28, 2022, and is now commercially available in the U.S. [4] Product Information - NexoBrid (anacaulase-bcdb) is indicated for eschar removal in patients with deep partial-thickness and/or full-thickness thermal burns [5] - The product contains proteolytic enzymes and offers a less invasive alternative to traditional burn treatment methods [3][5] - Limitations of use include contraindications for certain types of burns and specific patient conditions [5][6]