SBIR Phase II: Regenerative Tissue Filler for Breast Conserving Surgery and Other Soft Tissue Restoration Needs

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is its potential to lower healthcare costs and enhance the quality of life for breast cancer survivors, along with those suffering from traumatic injuries, skin ulcers, and other surgical wounds. For breast conserving surgery (BCS), which represents the standard of care for early-stage breast cancer, the most assured way of achieving satisfactory outcomes is complete tumor removal and preservation of breast cosmesis in a single surgery. Unfortunately, the rates of BCS-related complications, deformities, and secondary surgeries remain high (20-40%), which increases healthcare costs and negatively impacts patient quality of life. To address these problems, this project furthers development of an in-situ, scaffold-forming collagen designed as a conformable and regenerative filler for soft tissue defects and voids. This soft-tissue filler has the potential to improve breast surgeons’ ability to provide predictable and pleasing outcomes to their patients. Further, the versatility of this collagen polymer means that it can be used for a variety of other clinical applications (e.g., vocal fold medialization, therapeutic cells, and drug delivery) and to create regenerative tissue products for other areas of major unmet clinical need (e.g., cartilage, skeletal muscle). This Small Business Innovation Research (SBIR) Phase II project seeks to complete the final technical hurdles to commercialize the novel collagen polymer referred to above. Recognizing the significance of collagen as the body’s primary tissue building material, this patented biomaterial platform was designed to be highly purified and to retain collagen’s natural fibril-forming (polymerization) capacity. While this technology offers a broad range of customization potential, this project focuses on development of an in-situ, scaffold-forming collagen to accelerate and improve healing outcomes of complex cavity, tunneling, and deep penetrating tissue defects. The collagen is applied as a conformable liquid, which rapidly transitions to a fibrillar scaffold with soft tissue consistency. Preclinical studies evaluating this product as a breast tissue filler following lumpectomy have documented the following: 1) ease of use, 2) conformability to patient-specific voids, 3) noninflammatory regenerative healing, and 4) compatibility with standard clinical procedures. This SBIR project seeks to achieve key commercialization milestones associated with establishing pilot-scale manufacturing and achieving relevant product regulatory clearance and approval. Specifically, work will include development and validation of scalable processing steps for collagen purification, sterilization, and viral inactivation. This project will also complete most of the non-clinical bench performance and biocompatibility testing necessary for regulatory filings.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.