Mallinckrodt plc announced publication of results from the pivotal Phase 3 STRATA2016 clinical trial of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat), which is approved for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).  The data were published in Burns, a peer-reviewed journal of the International Society for Burn Injuries. The trial, which evaluated the efficacy and safety of a single application of StrataGraft in adult patients with deep partial-thickness thermal burns, achieved both co-primary efficacy endpoints. Please see Important Safety Information for StrataGraft below. The Phase 3 clinical trial was supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). BARDA is providing funding and technical support for the continued development of StrataGraft under Project BioShield Contract No. HHSO100201500027C. The published data showed that 96% of the burn sites treated with StrataGraft did not require autografting, and 83.1% of patients achieved durable wound closure of the StrataGraft treatment site without autografting by three months. As a reference, 86% of patients achieved durable wound closure of the autograft control sites. The significant reduction in use of autograft in patients treated with StrataGraft resulted in favorable outcomes in the secondary efficacy endpoints of donor site pain and donor site cosmesis (preservation or restoration of physical appearance). Additionally, cosmesis at the StrataGraft and autograft treatment sites was clinically similar at 12 months. Safety results showed the most common treatment-emergent adverse event (TEAE) was pruritus (itching) at the treatment site, which occurred in 36.6% (26 of 71) of patients and was causally related to StrataGraft treatment in 11 patients. All TEAEs related to StrataGraft treatment were mild to moderate in severity. Hypertrophic scarring (HTS) occurred at the StrataGraft treatment site in 12.7% (9 of 71) of patients, and 4.2% (3 of 71) of patients had HTS determined by the investigator to be causally related to StrataGraft treatment. Each year, approximately 40,000 patients in the United States require hospitalization for the treatment of severe burns.1 Autograft is the current standard of care for deep partial-thickness burns – complex skin injuries in which the damage extends through the entire epidermis (outermost layer of skin) and into the lower part of the dermis (innermost layer of skin). Autograft involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, creating a donor site wound and leaving the patient with more wounded areas requiring care. Data from the Phase 3 trial supported the U.S. Food and Drug Administration approval of StrataGraft on June 15, 2021. The open-label, controlled, randomized, multicenter Phase 3 clinical trial evaluated the efficacy and safety of a single application of StrataGraft in the treatment of deep partial-thickness thermal burns. The trial enrolled 71 patients (55 males and 16 females; 78% white and 20% African American) at 12 burn centers across the United States. Eligible patients were age 18 years and older and had thermal burns comprising 3% to 49% total body surface area involving the torso or upper or lower extremities for which surgical excision and autografting were clinically indicated. The study design used an intra-patient comparator, in which two similar areas of burn injury on the same patient were randomly assigned to either StrataGraft treatment or autograft. The co-primary endpoints were the difference in the percent area of the StrataGraft treatment site and the control autograft treatment site that was autografted by three months and the proportion of patients achieving durable wound closure of the StrataGraft treatment site without autograft placement at three months. Secondary endpoints assessed donor site pain, donor site cosmesis and treatment site cosmesis. Results published in Burns showed the study met its co-primary efficacy endpoints of autograft sparing and durable wound closure by three months. A significantly smaller area of burn wounds treated with StrataGraft required autografting by three months compared to the area of burn wounds treated exclusively with autograft (p<0.0001). Additionally, 96% (68 of 71) of the burn sites treated with StrataGraft did not require autografting. By three months, 83.1% of patients achieved durable wound closure of the StrataGraft treatment site without autografting (95% CI: 74.4, 91.8), which was clinically similar to that of the autograft control site (86% [95% CI: 77.8, 94.0%]). Secondary efficacy endpoint data also showed favorable outcomes with StrataGraft. In all but three patients, the StrataGraft treatment site did not need to be autografted, and the donor sites were therefore not harvested. As a result, significantly lower mean donor site pain intensity was observed through Day 14 at StrataGraft donor sites compared with autograft donor sites, as measured by the Wong-Baker FACES pain rating scale (p<0.0001). At three months, cosmesis data showed the mean donor site Patient and Observer Scar Assessment Scale (POSAS) observer total score was significantly lower (more like normal skin) for StrataGraft donor sites compared with autograft donor sites (p<0.0001). At 12 months, cosmesis at the StrataGraft and autograft treatment sites was clinically similar, as measured by POSAS total scores by observer. A molecular analysis of patient biopsies at the StrataGraft treatment site at three months demonstrated that DNA from cells of StrataGraft was not detectable in any patients evaluated, which is consistent with wound healing by the patients' own cells. Safety results showed the most common TEAE was pruritus (itching) at the treatment site, which occurred in 36.6% (26 of 71) of patients and was causally related to StrataGraft treatment in 11 patients. All TEAEs related to StrataGraft treatment were mild to moderate in severity. HTS occurred at the StrataGraft treatment site in 12.7% (9 of 71) of patients, and 4.2% (3 of 71) of patients had HTS determined by the investigator to be causally related to StrataGraft treatment. StrataGraft is a viable, bioengineered, allogeneic, cellularized scaffold product derived from keratinocytes grown on gelled collagen containing dermal fibroblasts.