MediWound Ltd. announced that it has met its primary and all secondary endpoints in its pivotal U.S. Phase 3 clinical study (DETECT) with NexoBrid to treat patients with deep partial thickness (DPT) and full thickness (FT) thermal burns intended for submission for Biological License Application (BLA) from U.S. Food and Drug Administration (FDA). The NexoBrid DETECT study is a prospective, controlled, multi-center, multi-national, assessor blinded Phase 3 study in 175 patients randomized to either NexoBrid, Standard of Care (SOC), or the Gel Vehicle placebo at a ratio of 3:3:1, with 12- and 24-month long-term safety follow-up. The study involves 44 burn centers. The study objectives are to evaluate the efficacy and safety of NexoBrid by removing burn eschar earlier and reducing surgical burden and related blood loss in hospitalized patients with severe burns. Complete eschar removal was the primary endpoint of the study and was tested against the Gel Vehicle control arm. The primary analysis was based on whether complete eschar removal was achieved in all target wounds of a patient. The analysis compared all randomized patients to the NexoBrid arm to all randomized patients to the Gel Vehicle control arm. Secondary endpoints included reduction in the need for surgical eschar removal (surgical burden), earlier eschar removal, and blood loss, which were tested against the SOC control arm. All secondary endpoints were analyzed and compared all patients randomized to the NexoBrid arm to all patients randomized to the SOC control arm. Time to complete wound closure (non-inferiority) and other standard safety measurements were also compared with the SOC control arm. Funding and support for this pivotal U.S. Phase 3 clinical study (DETECT) with NexoBrid is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract.