An off the shelf alternative to fat transfer for soft tissue repair

Project Summary The goal of this Phase I SBIR program is the development of an optimized, off-the-shelf alternative to autologous fat grafting for soft tissue repair. Fat grafting is commonly used as a minimally invasive alternative to synthetic implants or major reconstructive surgery (e.g., free flaps) for the repair of damaged, lost, or surgically resected soft tissue, with particular focus on craniofacial, breast, and extremity reconstruction. It is one of the fastest growing procedures in plastic surgery with an estimated 80% of reconstructive surgeons already incorporating the procedure in their practice. However, fat grafting requires liposuction, an operation which liquifies the fat, exposing it to shear forces which limit the capacity of fat to survive and retain shape once re-injected. A product which can deliver the same results as an autologous graft in an office procedure without the need to process and harvest tissue would be poised for rapid market adoption in this expanding field. To this end, this Phase I grant will evaluate the collaborative combination of inSoma Bio’s tissue repair matrix – FractomerTM – with Renuva®, an industry-leading adipose allograft material marketed through the Musculoskeletal Transplant Foundation (MTF Biologics) as an off-the-shelf alternative to autologous fat transfer. Renuva is marketed to restore volume in the face, hands, and body, and has shown significant clinical outcomes, restoring the adipocyte population at the site of injection; however, cadaver-based products across the board are inherently limited by scale and donor sourcing. As a result, access to markets for larger repairs such as facial reconstruction, surgical sites such as lumpectomy defects, and regions of tissue wasting (e.g., lipodystrophy) are limited. Fractomer, on the other hand, is a biosynthetic protein scaffold which can be produced at large scale using simple fermentation and is designed to replicate the extracellular matrix. Fractomer has been shown to support long-term viability, vascularization, and shape-retention when co-injected with human lipoaspirate. A product composed of both Fractomer and Renuva has clear potential to supply both the scaffold and cellular cues needed without the need to harvest tissue from the patient as well as significantly increase the maximum repair volume capacity, allowing access to previously unreachable markets. Preliminary studies have already confirmed the capacity for these two products to complement one another, and this SBIR will allow optimization of a commercially viable formulation. Phase I studies will include testing mixtures of Fractomer and Renuva for injectability, thermally- induced phase transition, shape retention, and support for cellular viability. In vivo studies will then be undertaken to monitor cellular composition, adipogenesis, and signs of any adverse effect from inflammation or necrosis. The resulting product would expand the range of surgical procedures suited to fat grafting, and provide a safer, cost-effective, and off-the-shelf product which eliminates the need for painful fat harvesting surgeries.