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

概念验证申请，用于设计和制造一种新型动脉内导管，用于对与冠状动脉疾病（CAD）相关的生物标志物进行采样。该装置的初步临床研究已经独特地表明，CAD部位存在高浓度的生物标志物。这些生物标志物使CAD进展的生物学过程得到更好的理解。PlaqueTec的商业模式是出售其冠状动脉生物标志物知识产权的使用权，并向制药公司提供定制研究，作为一种工具，以a）发现新的药物靶点，B）大大降低新型和管道CVD药物疗法开发的风险。申请人已获得监管机构批准，在欧洲销售其导管，目前使用短期批量释放过程制造导管。这是一个主要的手工过程，导致高生产成本和有限的吞吐量，这限制了更广泛的市场占有率。申请人试图使用创新的设计和制造技术来简化生产过程，但在现阶段，这些概念尚未得到证实。该项目旨在提供所需的研发机构，以确定设计/工艺改进，可以在不影响医疗器械法规的情况下显著提高成本和产量。该项目是对导管最安全的关键元件-可展开混合结构（称为“挡板”）的研究。它将探索生物材料、等离子体治疗、微机械加工、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 -罐技术和工艺改进（例如半自动化）更有效地提供当前的挡板设计，并且可以开发方法来证明挡板性能的等效性（变更后）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.