An Expanded Access Program with NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries in Adult and Pediatric Patients

Following global Phase III trials, a single-arm expanded access program at 23 burn centers in the United States (2019-2024) provided centers with additional experience treating adult and pediatric burn patients with NexoBrid and maintaining burn care preparedness for mass casualty incidents. Eligible patients included children (<18 years old) and adults (≥18 years old) with deep thermal burns covering up to 30% total body surface area. NexoBrid application was followed by standard care. Patients were monitored weekly until wound closure, and again after 3 and 12 months. Outcomes included incidence and time to eschar removal, need for surgical excision or escharotomy, length of hospital stay, wound closure, and Modified Vancouver Scar Scale. A total of 239 patients (215 adult, 24 pediatric) received NexoBrid, with 142 (131 adult, 11 pediatric) completing the 12-month follow-up. Mean ages were 41 and 11 years, respectively. Mean treated target wound area was approximately 6% of total body surface area, with 38 circumferential burns. Eschar removal was achieved in 95% of adults and 100% of pediatric patients within 4 hours. Surgical excision was performed in 4% of adults, but not in pediatric cases. No escharotomies were needed. Median length of stay was 10 days. Wound closure occurred by 22 days (adults) and 28 days (pediatric). Safety data were consistent with previous trials. NexoBrid demonstrated comparable outcomes versus previous Phase III trials and potential efficacy in preventing burn-induced compartment syndrome.