SBIR Phase II: Development and Validation of Clinic-Ready MyoSponge

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to address the urgent unmet medical need for effective treatments of volumetric muscle loss. This project has the potential to significantly improve health outcomes and reduce long-term rehabilitation costs. This Small Business Innovation Research (SBIR) Phase II project will focus on developing and testing an off-the-shelf, clinic-ready acellular biomimetic scaffold. The engineered biomimetic scaffold significantly increased muscle function and improved muscle architecture. Also, this project will optimize manufacturing processes to ensure consistency and scalability, perform comprehensive preclinical safety and efficacy studies following regulatory guidance, and refine the material’s properties to maximize functional recovery. The anticipated result of this work is to deliver a clinic-ready regenerative scaffold that could serve as the foundation for future innovations in musculoskeletal and soft tissue repair. 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.