710778Proof of concept study on a novel manufacturing process and design features for a coronary artery liquid biopsy systemClosedGRD Proof of ConceptInnovate UKProof of Concept application for R&D on the design and manufacture of a novel, intra-arterial catheter used to sample biomarkers associated with coronary artery disease (CAD). Initial clinical studies with the device have uniquely shown that high concentrations of biomarkers exist at sites of CAD. These biomarkers allow biological processes underlying the progression of CAD to be better understood. PlaqueTec’s business model is to sell access to its coronary biomarker IP & to provide bespoke studies to Pharmaceutical companies as a tool to a) discover new drug targets and b) greatly de-risk the development of both novel and in pipeline CVD drug therapies. The applicant has regulatory approval to market its catheter in Europe and currently manufactures the catheter using a short run batch release process. This is a largely manual process that results in high production costs & limited throughput and this restricts broader market uptake. The applicant seeks to simplify the production process using innovative design & manufacturing technologies but at this stage the concepts are unproven. The enclosed project seeks to provide the body of R&D needed to identify design/process improvements that can deliver significant improvements in cost and throughput without compromising compliance with medical device regulations. This project is a study on the most safety critical element of the catheter, the deployable mixing structures (termed “baffles”). It will explore latest innovations in biomaterials, plasma treatment, micromachining, joining & other manufacturing technologies to address three main challenges 1 – can design improvements deliver equivalent clinical performance to current baffles at lower cost/higher throughput; 2 – Can technology and process improvements (e.g. semi automation) deliver the current baffle design more efficiently and 3 – Can methods be developed to demonstrate equivalence in baffle performance (post changes) without requiring clinical trials.