Implantable Lymph Node Substitute for Prevention of Surgically-Induced Lymphoedema

Lymphoedema is a common adverse side-effect of cancer surgeries performed in the NHS. Most commonly, it causes an incurably swollen arm in breast cancer patients, leading to a lifetime of disability, disfigurement and mental health issues. Caring for these patients (compared to breast cancer patients who do not develop lymphoedema) is estimated to cost the NHS £1344m per year. There are currently no treatments available for this condition, but there are pharmaceutical strategies in clinical trials. We have developed a permanent implant that would be deployed at the time of surgery to reconnect lymphatic vessel pathways disrupted by cancer surgeons. The implant is designed to replicate the fluid mechanical characteristics of natural lymph nodes, and will elute a growth factor specific to lymphatic vessel cells (VEGFC). The proposed three-year development project will take the implant from early feasibility studies (we have demonstrated success with early-stage in vivo research) to being fully ready for subsequent preclinical testing in vivo. This requires strict adherence to regulatory-compliant design and testing procedures. We will develop Standard Operating Procedures for all aspects of implant manufacturing and testing. This will include development of sterilisation procedures, determination of implant shelf life, and finalisation of design details (mechanical stability and optimisation of VEGFC release kinetics). We will also update our existing business plans, which will include externally supplied analyses of Freedom-to-Operate, Health Care Economics, Regulatory Compliance, and Trial Design. Following the proposed project, we will pursue separate funding for preclinical and clinical trials. While the challenges to bringing a permanently implantable medical device to the market are considerable, the proposed work presents an opportunity to prevent adding to the total of 168,000 women in England currently living with incurable lymphoedema.