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

用于冠状动脉疾病（CAD）相关生物标志物采样的新型动脉内导管设计和制造的研发概念验证申请。使用该设备的初步临床研究独特地表明，在CAD部位高浓度的生物标志物存在。这些生物标记物可以更好地理解CAD进展的生物学过程。PlaqueTec的商业模式是出售其冠状动脉生物标志物知识产权，并为制药公司提供定制研究，作为一种工具，a)发现新的药物靶点；b)大大降低开发新的和正在研发的ecvd药物治疗的风险。申请人已获得在欧洲销售其导管的监管批准，目前使用短期批放行工艺生产导管。这是一个很大程度上的手工过程，导致高生产成本和有限的吞吐量，这限制了更广泛的市场吸收。申请人试图使用创新的设计和制造技术来简化生产过程，但在这个阶段，这些概念尚未得到证实。所附项目旨在提供所需的研发机构，以确定设计/工艺改进，这些改进可以在不损害医疗器械法规合规性的情况下显著改善成本和吞吐量。这个项目是对导管最安全的关键元素的研究，可展开的混合结构（称为“挡板”）。它将探索生物材料、等离子体处理、微加工、连接和其他制造技术的最新创新，以解决三个主要挑战：1 .设计改进能否以更低的成本/更高的产量提供与当前挡板相同的临床性能；2 -技术和工艺改进（如半自动化）能否更有效地提供当前挡板设计？ 3 -能否开发方法来证明挡板性能的等效性（更改后），而无需临床试验。

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.