CAMBRIDGE, Mass. and YAVNE, Israel, Oct. 02, 2019 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ: VCEL) and MediWound Ltd. (NASDAQ: MDWD) today announced initiation of the NexoBrid® expanded access treatment protocol (NEXT) to treat burn patients with deep partial- and full-thickness burns in the U.S. during the preparation and review of the NexoBrid Biologics License Application (BLA).
“We are excited to initiate NEXT in the U.S. in tandem with preparations with Vericel for the BLA filing,” said Sharon Malka, MediWound’s Chief Executive Officer. “NEXT, which is supported and funded by the Biomedical Advanced Research and Development Authority (BARDA), allows for the continued clinical use as well as non-declared emergency use of NexoBrid for U.S. patients prior to NexoBrid approval by the FDA. We believe NEXT will enhance national preparedness for burn mass casualty incidences, where it has the potential to meaningfully impact patients’ lives.”
Nick Colangelo, president and CEO of Vericel said, “After a successful pre-BLA meeting with the FDA, we remain on track for the BLA submission in the second quarter of 2020. NEXT will further extend the number of NexoBrid-trained physicians and healthcare providers in the U.S. and generate additional awareness, advocacy and use at U.S. burn centers prior to commercialization of NexoBrid.”
NEXT is an open-label, single-arm treatment protocol which allows for the treatment of up to 150 burn patients with deep partial- and full-thickness thermal burns up to 30% of total body surface area. NEXT has been designed to be consistent with current real-life burn treatment practices in the U.S. and up to 30 U.S. burn centers will participate. The increased number of burn centers trained and familiar with NexoBrid prior to FDA approval will improve national readiness for potential burn mass casualty events. To further promote national readiness, the FDA has agreed that in the event of a burn mass casualty event that is not a nationally declared emergency, additional patients could be treated under the NEXT treatment protocol.
