Proof of concept study on a novel manufacturing process and design features for a coronary artery liquid biopsy system

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Proof of Concept application for R&D on the design and manufacture of a novel, intra-arterialcatheter used to sample biomarkers associated with coronary artery disease (CAD). Initialclinical studies with the device have uniquely shown that high concentrations of biomarkersexist at sites of CAD. These biomarkers allow biological processes underlying the progressionof CAD to be better understood. PlaqueTec’s business model is to sell access to its coronarybiomarker 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 pipelineCVD drug therapies.The applicant has regulatory approval to market its catheter in Europe and currentlymanufactures the catheter using a short run batch release process. This is a largely manualprocess that results in high production costs & limited throughput and this restricts broadermarket uptake. The applicant seeks to simplify the production process using innovative design& manufacturing technologies but at this stage the concepts are unproven. The enclosedproject seeks to provide the body of R&D needed to identify design/process improvementsthat can deliver significant improvements in cost and throughput without compromisingcompliance with medical device regulations.This project is a study on the most safety critical element of the catheter, the deployablemixing structures (termed “baffles”). It will explore latest innovations in biomaterials, plasmatreatment, micromachining, joining & other manufacturing technologies to address threemain challenges 1 – can design improvements deliver equivalent clinical performance tocurrent baffles at lower cost/higher throughput; 2 – Can technology and processimprovements (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.