Project Summary/Abstract Prospective evaluation of a surgical solution for breast cancer-associated lymphedema The proposed project will complete remaining key research and technology requirements that are needed to commercialize a ground-breaking interventional device for treating secondary lymphedema -- a chronic and debilitating disease that currently has no cure and impacts an estimated 15-30% of breast cancer survivors. Breast cancer staging and cure typically necessitates surgery, with or without adjunctive radiation therapy. These interventions, while life-saving, sometimes destroy enough lymphatic function that the breast cancer survivor is left with a condition in the arm that can include painful swelling, frequent infections that can be life-threatening and, ultimately, irreversible structural changes in the tissues that result in severe deformity, and serious reduction in function and quality-of-life. BioBridge is a novel, thread-like collagen scaffold designed to support the regeneration of new healthy lymphatic vessels that will repair diseased tissue in patients that are suffering from breast cancer related lymphedema. Based on results from an earlier, successful large animal study, it is hypothesize that this novel device will provide the first ever treatment to measurably restore lymphatic function, reduce swelling, and improve the patient’s quality of life. A primary goal of this project is evaluate BioBridge efficacy in human subjects. A defined protocol has been developed that will be used to test 120 subjects that have Stage I or Stage II breast cancer-related lymphedema in a multi-site clinical study and led by Stanford University. When successfully completed, the study will have generated critical quantitative data that will confirm the ability of the BioBridge to reverse disease and compare its efficacy to the existing treatment strategies for lymphedema. Another goal is to scale up the fabrication technology to support commercial production of BioBridge devices. A proprietary manufacturing process has already been successfully developed and deployed for lower volume production. This project will now focus on developing and scaling the next generation deposition technology to enable larger commercial volumes. The final goal of this project is to prepare and submit the clinical results for regulatory approval and reimbursement consideration for using BioBridge as an interventional device for treating lymphedema. Having a successful outcome at the completion of this study would provide a viable, safe and much needed treatment approach to this common disease that so heavily impacts breast cancer survivorship. It will also provide the framework for better comprehension of this disease and the role that regenerative medicine can play in future strategies to treat and prevent lymphedema.

NARRATIVE Secondary lymphedema is a chronic and debilitating disease that currently has no cure and impacts an estimated 15-30% of breast cancer survivors. This project will conduct a multi-site clinical study with a new interventional device comprised of a novel nano- patterned collagen scaffold that has shown in large animal studies to promote new lymphatic vessel formation. If successful, this device will innovate the treatment approaches for patients suffering this horrible disease by providing the means to restore lymphatic function.