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

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.

Grant Number: 5R44GM140660-03
NIH Institute/Center: NIH
Principal Investigator: Juliana Blum