SBIR-STTR Award

This SBIR Phase I project will address key hurdles for commercialization of an injectable breast tissue replacement for use immediately following breast conserving surgery, otherwise known as lumpectomy. Surgeons using this procedure today have limited options for predictably restoring normal breast size, shape, and consistency following tumor removal. Because of this, many women are left with breast deformities or must undergo multiple surgical procedures. These issues compromise their psychological well-being and quality of life and increase healthcare costs. With these challenges in mind, this project will evaluate the ability of a patented, liquid, fibril-forming collagen to serve as an injectable, breast tissue replacement. Upon injection, this liquid biopolymer self-assembles into a physically stable and persistent natural fibrillar scaffold, meaning it can be used to fill patient-specific tissue voids. Project results will provide early-stage preclinical evidence of this biopolymer's effectiveness for filling and regenerating breast tissue in a large animal lumpectomy model. If successfully translated to the clinic, this therapy would provide breast cancer surgeons with a much-needed regenerative breast tissue solution. This in turn, would boost surgeons' confidence when working to achieve complete tumor removal, improve quality of life for breast cancer survivors, and decrease overall costs of care. The liquid collagen polymers evaluated in this proposal preserve several natural features of the collagen protein as it exists in the body, thus giving rise to three key advantages. First, this biomaterial has the ability to rapidly transition from liquid to solid, forming natural collagen-fibril scaffolds just like those in the body's tissues. Second, it is amenable to customization and advanced biofabrication with tailorable geometries, fibril architectures, and mechanical properties. And finally, these scaffolds stably integrate and persist in vivo, inducing site-appropriate tissue generation without evoking immune or inflammatory response. This project seeks to overcome technical hurdles associated with identifying compatible and scalable sterilization and manufacturing processes for this unique, liquid biomaterial. Additionally, project activities will seek to specify biopolymer formulations that support surgeon ease-of-use, provide efficacy for breast tissue replacement, and do not interfere with standard clinical practices (e.g. radiation and re-excision procedures). The outcomes of this proposal will provide valuable proof-of-concept for a viable medical-grade manufacturing process and early preclinical validation that these collagen polymers can address breast cancer patient-specific needs. Finally, this project will lay the foundation for this natural collagen polymer to serve as an enabling tool for next generation personalized regenerative medicine therapies. 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.

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.