SBIR Phase II: An Injectable Protein Matrix to Enhance the Stability of Autologous Fat Grafts

Insoma Bio Inc, Durham NC

Investigators

Abstract

The broader impact of this Small Business Innovation and Research (SBIR) Phase II Project will improve clinical outcomes for the thousands of patients globally who undergo craniofacial repair surgery each year. Facial disfigurement, whether congenital or acquired, can have profound physical and psychosocial implications including altered body image, reduced quality of life, and poor societal integration. Fat grafting is one of the most rapidly growing procedures in facial reconstructive surgery due to its lack of reliance on foreign or synthetic materials, safe harvest, and minimal surgical risk. While fat grafting has potential to make groundbreaking strides in facial reconstruction, the technique is held back by unreliable volume and shape loss. Craniofacial repairs are particularly challenging for surgeons given the requirement for exquisite control of graft shape and volume. The product supported by this proposal has the capacity to dramatically improve the shape, volume, and survivability of grafted fat. This technology has the potential to not only provide a novel and innovative option for clinicians facing challenging craniofacial cases, but success in this beachhead market will also support the rapidly growing utility of fat grafting in other procedures such as breast reconstruction, amputation site bulking, and hand/foot pad repair. The proposed project is focused on the development and commercialization of a recombinant, protein-based biopolymer engineered from human elastin to enhance the use of fat grafting in craniofacial reconstruction. This product is one of the first materials to make use of a new paradigm in understanding protein engineering: that highly disordered proteins with defined 3D structure play key roles in the mechanical and biological activity of the body. Using iterative design and molecular engineering of specific protein ordered and disordered domains, the team has generated a new class of biomaterials that are uniquely suited to meet the key criteria for a fat grafting support matrix including: (1) a temperature-dependent phase transition from a liquid to a moldable solid at body temperature, (2) a porous matrix that allows cellular infiltration and supports long-term viability of the tissue in vivo as well as the vascularization required for tissue viability, and (3) enhanced protein stability that allows simple use at the point-of-care with minimal modification to current clinical practice. This Phase II project will focus on core needs for scale-up, toxicity studies, biocompatibility, and large animal efficacy evaluations in preparation for regulatory submission, clinical evaluation, and commercial approval. 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.