To improve patient outcomes, BioAesthetics is developing an acellular human dermal substitute 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 an allogeneic 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 tissue recellularization with the host's own cells. 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 this STTR Phase I project, BioAesthetics is assessing the feasibility of this innovative product for treating third-degree burns. Porcine ABGs will be impregnated with silk fibroin polymer loaded with the antiseptic polyhexamethylene biguanide (PHMB) (PHMB+silkABGs). We will 1) characterize PHMB release, therapeutic efficacy against Pseudomonas aeruginosa, and cytotoxicity in vitro and 2) assess in vivo efficacy in porcine third- degree burn and infection barrier models. Successful completion of this project will validate the feasibility of our product and generate proof-of-concept data to serve as a foundation for future efforts. A subsequent Phase II project will focus on further developing the product (e.g. testing different drugs, polymers, etc.), expanding the preclinical testing of the product, and performing necessary biocompatibility work for an FDA submission. Ultimately, our goal is to improve clinical outcomes for patients by reducing complications that arise from burn wounds.
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 I project focuses on demonstrating feasibility by characterizing in vitro drug release and activity as well as demonstrating in vivo efficacy in a porcine burn model.
