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 40,000patients 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 mostfrequent wound healing complication, with up to a third of patients with burns developing infections, and are theleading cause of death.Our innovation lies in creating a transformative acellular biologic graft (ABG) that enables sustained, local releaseof therapeutic agents at the burn site. Our novel approach simultaneously provides a native dermal scaffold forpatient-mediated tissue regeneration, while countering the onset of complications due to infection during thecourse of wound healing. Donor tissue processed with BioAesthetics' patent-pending method to remove cellsand immunogens (i.e., ABGs) have been show to support host-mediated tissue recellularization. To create ABGsthat enable therapeutic agent release, BioAesthetics has developed a patent-pending polymer impregnationtechnique 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-degreeburns and demonstrated that the ABGs are efficacious in porcine third-degree burn wound healing and infectionbarrier models. In this Phase II project, we propose further product development, related to clinical manufacturingof the graft, including evaluating donor tissue variability and terminal sterilization effects, and expansion of thepreclinical testing to include porcine third-degree burn infected and uninfected wound healing and barrier functionmodels. 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.
Public Health Relevance Statement: NARRATIVE
BioAesthetics seeks to improve outcomes for patients with full-thickness burn wounds by creating a dermal
acellular biologic graft with a biocompatible, biodegradable, tunable hydrogel-based drug delivery system that
provides sustained, local release of therapeutic agents. Our novel approach simultaneously provides a natural,
biologic scaffold for patient-mediated tissue regeneration while countering the onset of complications due to
infection during the course of wound healing. This Phase II project focuses on advancing our R&D efforts in a
porcine burn model.
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