SBIR-STTR Award

Thermal injury is common in military conflicts due to primarily to the widespread use of explosive devices. Burns can produce scars that are excessive, physically debilitating and functionally damaging. There is a critical need for an effective product that can control bacterial contamination and prevent colonization, mitigate inflammation, and diffuse to or reach necrotic and damaged tissue resulting from a blast or traumatic thermal wound to reduce the formation of fibrotic scars. Synedgen has developed a biocompatible polysaccharide derivative (PAAG) that has been demonstrated in vivo and in vitro to reduce inflammation and provide enhanced healing with the reduction of scarring. This Phase 1 study will demonstrate the extent to which PAAG mitigates scar reduction in full thickness burns in a porcine model, and provide an opportunity to examine innate immune responses, inflammatory cytokines and healing pathways.

Thermal injury is common in military conflicts due primarily to the widespread use of explosive devices. Though scar formation is a natural process of wound healing, burns can produce scars that are excessive, physically debilitating and functionally damaging. Synedgen has demonstrated the efficacy of a safe topical treatment to reduce inflammation, prevent infection in, improve the healing rate of and reduce the magnitude of scar formation in burns. Synedgen uses a derivative of a natural biopolymer to prevent the initial stages of inflammation due to damage and necrotic tissue. Consequently, the burn healing process shifts to a regenerative phase earlier and is stimulated to heal, without the complications of unmitigated inflammation. This product can be used alone or in combination with other products to provide better management of burn wounds. This Phase II proposal will accelerate the development of this product into the clinic by completing studies of preclinical efficacy in animal models, complete the molecular validation of the polymer active ingredient and provide detailed steps and timelines for bringing this product to clinical trials.