SBIR Phase I: Biofabrication of a collagen fabric by scaled-up electrochemical compaction

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is in the development of a highly biocompatible implant material made from collagen that can be used to treat a variety of medical conditions, including stress urinary incontinence, pelvic organ prolapse, hernias, and orthopedic injuries. Many people suffer from these conditions, but the current treatments are suboptimal. Most current implants for the repair or support of these soft tissue problems are made from polypropylene, which has significant clinical problems, including chronic inflammation and pain. The FDA recently ordered the removal of all synthetic implants for pelvic organ prolapse from sale in the US due to patient safety issues. Stress urinary incontinence affects 22% of women aged 45-64 years, and an estimated 9.2 million women in the US alone will have pelvic organ prolapse by 2050. These women have life-altering disorders, often limiting them from working, caring for their families, exercising, traveling, etc. New technology to safely treat these disorders is urgently needed. The current project will advance the development of a safe, natural, and effective implant material presently not available to these women. Reimbursement for these procedures under Medicare and private insurance are in place. This Small Business Innovation Research (SBIR) Phase I project seeks to advance the manufacturing of electrocompacted collagen threads which can be used for a variety of medical implants. The existing lab-scale manufacturing process for the production of the collagen threads will be developed into a scaled-up commercial ready process. Key goals include speeding up the thread production, decreasing the need for operator intervention, and improving the efficiency of converting the collagen feedstock into thread, all while maintaining thread strength and process repeatability. This is critical to ensuring that products developed from this technology can be produced in commercial volume and will be priced within existing medical insurance reimbursements. Achieving these goals will greatly de-risk this technology, enabling the attraction of further investment capital and the continuation of product development. 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.