720690Development of an innovative medical device to promote healthy blood flow in bypass surgeryClosedGRD Development of PrototypeInnovate UKCardiovascular diseases (CVD) account for ~31% of all global deaths. Atherosclerosis - hardening & narrowing of the arteries thus restricting blood supply to essential organs - is the dominant cause of CVD responsible for ~75% of all cardiovascular deaths. Surgeons perform complex bypass graft surgery using sections of a patient’s own healthy vessels or synthetic grafts to reconnect the blood supply when blood flow is restricted, however bypass graft failure rates are staggeringly high (~50%). The primary cause is Smooth Muscle Cell Neointimal Hyperplasia (SMCNIH), an overreaction of a natural healing process for the vessel wall in response to the trauma of surgery. The severe overgrowth of scar tissue causes the vessel lumen to narrow & constrain at the join thus restricting/blocking the blood flow - resulting in a high risk of clot formation. ~2M vascular grafts are implanted globally p.a. at >$8k/patient. Revision surgery after graft failure is expensive, carries further morbidity/mortality risk & causes severe distress to patients. Newtec recognises the major business opportunity that exists for a cost effective medical device that addresses this problem. The novel patented technology is a metal-free, drug-free device designed to support a vascular join & promote healthy healing following arterial or venous bypass surgery, promoting optimal healing of the joined vessels through its unique bilayered structure. PoC trials showed that the intimal hyperplasia (causing vessel lumen narrowing) reduced by a significant 30-50% - demonstrating the potential for routine use. This project will advance the tech to develop a validated ‘works-like’ ‘looks-like’ prototype to be used in a first in man trial prior to commercialisation. The device will be targeted towards the cardiovascular surgical device mkt (est. globally to reach ~$47.2bn by 2018) with initial applications in vascular grafts, peripheral grafts & subsequently coronary artery bypass grafts.