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

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SUMMARY To improve patient outcomes, BioAesthetics is developing a drug-eluting acellular dermal graft for single-stage reconstruction of full-thickness burns. Nearly half a million Americans are affected each year by burns requiring medical treatment, with nearly 40,000 patients needing to be hospitalized. The annual medical cost of burns is $1.5 billion. Burn wounds have a long- lasting impact on health-related quality of life and affect both physical and mental health. Infections are the most frequent wound healing complication, with up to a third of patients with burns developing infections, and are the leading cause of death. Our innovation lies in creating a transformative acellular biologic graft (ABG) that enables sustained, local release of therapeutic agents at the burn site. Our novel approach simultaneously provides a native dermal scaffold for patient-mediated tissue regeneration, while countering the onset of complications due to infection during the course of wound healing. Donor tissue processed with BioAesthetics’ patent-pending method to remove cells and immunogens (i.e., ABGs) have been show to support host-mediated tissue recellularization. To create ABGs that enable therapeutic agent release, BioAesthetics has developed a patent-pending polymer impregnation technique that generates hydrogel-based drug delivery systems within ABGs. In our Phase I project, BioAesthetics assessed the feasibility of this innovative product for treating third-degree burns and demonstrated that the ABGs are efficacious in porcine third-degree burn wound healing and infection barrier models. In this Phase II project, we propose further product development, related to clinical manufacturing of the graft, including evaluating donor tissue variability and terminal sterilization effects, and expansion of the preclinical testing to include porcine third-degree burn infected and uninfected wound healing and barrier function models. Following completion of these studies, the product will be poised for FDA regulatory filings. Ultimately, our goal is to improve clinical outcomes for patients by reducing complications that arise from burn wounds.