PHMB-Impregnated Acellular Biologic Grafts for Treatment of Third-Degree Burns

PROJECT SUMMARY BioAesthetics is developing a novel acellular graft for improved burn wound healing. Our patent- pending drug-loaded, polymer-integrated acellular biologic graft (PCT/US19/25306) will act as a barrier to pathogens, deliver anti-infectives to the wound site during healing, and provide an optimal regenerative scaffold. This will allow for a single-stage wound reconstruction, without the need for additional patient-derived tissue, of full-thickness burns (e.g., second- and third-degree burns). Our predicate STTR Phase 1 grant is geared towards providing proof-of-concept that our grafts are capable of promoting wound healing and preventing infection in burn wounds in vivo. The goal of this proposal is to enroll in the NIH I-corps program, which will help BioAesthetics validate customer needs and commercialize this technology. Our objective within the NIH I-corps program is to understand the larger ecosystem surrounding tissue graft use, including clinician product preference in treatment of burns, pricing and reimbursement through hospitals and insurer networks, and antimicrobial use. In the US, burns requiring medical treatment affect nearly 500,000 people each year, causing approximately 40,000 hospitalizations and 3,400 deaths. A 2010 Healthcare Cost and Utilization Project brief reported that approximately $1.5B was spent in the US on burn-related injuries, with an additional $5B linked to lost work. Many clinical challenges exist related to burn treatment including infection, time to wound closure, and time to functional recovery, which can result in long hospital stays, high treatment costs, and an increased risk of contracting a drug-resistant infection. There is a significant unmet need to identify novel, innovative approaches to safely treat patients with serious burn wounds. We believe that our enhanced acellular graft will be able to rapidly heal infected burn wounds, reduce the need for antibiotics, not require additional surgeries, and improve patient quality of life.PROJECT NARRATIVE BioAesthetics has received an NIH STTR Phase I grant to generate and test an enhanced acellular graft for treatment of second and third degree burn wounds. Our enhanced grafts have the potential to rapidly heal infected burn wounds by acting as a pro-regenerative scaffold and delivering anti-infectives at the wound site, improving patient health and quality of life. This proposal will provide BioAesthetics with training through the NIH I-corps program in how to best approach commercialization, allowing our graft to have a greater impact on the health of patients with burn wounds.