SBIR Phase I: Creation of antimicrobial MyoMatrix for functional muscle regeneration in a porcine model of volumetric muscle loss

Genassist Inc, Cape Girardeau MO

Investigators

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop an antimicrobial muscle-regenerating biomaterial into a commercial-ready product and address volumetric muscle loss injuries. In the context of defense medicine, severe muscle trauma often occurs in environments where external factors such as sterility are not well-controlled. This project is expected to demonstrate antimicrobial properties of this novel muscle-regenerating biomaterial to enable use in these environments. If successful, the broader societal and economic impacts of antimicrobial muscle-regenerating biomaterials are staggering. Volumetric muscle loss affects tens of millions of victims each year. Sixty percent of patients are left untreated, 30% receive a muscle flap transplant, and 10% of injured limbs are amputated. Total average lifetime costs for amputation now total over $700,000. Improved clinical outcomes resulting from the implementation of this technology could lead to hundreds of thousands of dollars in savings over the course of each recipient's lifetime. This Small Business Innovation Research (SBIR) Phase I project demonstrates significant advances over the existing standard of care for the treatment of volumetric muscle loss, for which no treatment currently exists. The joint loss of cells and extracellular matrix creates an environment where muscle regeneration cannot occur, leading to muscle collapse and atrophy over time. This project effectively replaces the extracellular matrix lost in volumetric muscle loss and creates an environment where satellite cells may proliferate and differentiate into new muscle tissue. A technical concern raised by clinicians, especially those who work in austere environments in military medicine, is the risk of infection caused by implanting a foreign substance into a wound bed. To address this, Technical Objective 1 will focus on incorporating antibacterial agents to optimize the scaffold’s ability to promote muscle regeneration while also having an antibacterial effect. Structural and mechanical properties will be assessed, cellular viability ensured, muscle cell quality evaluated, and antibacterial properties measured. Technical Objective 2 aims to investigate these outcomes with a pilot porcine model of muscle trauma. It is anticipated that the proposed antimicrobial biomaterial will both combat the risk of infection and effectively regenerate functional muscle in traumatic muscle injuries. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.