The MedManu project aims to develop and commercialize PyCath, an innovative medical device for comprehensive coronary and microvascular physiology assessment during angiography. PyCath integrates a fiber-optic pressure sensor and a proprietary blood flow velocity (BFV) sensor into a single microcatheter, enabling fast and accurate diagnosis of both Coronary Artery Disease (CAD) and Ischemia with Non-Obstructive Coronary Artery (INOCA)

 

The project addresses the unmet clinical need for precise diagnosis of INOCA, which affects 50-70% of women and 30-50% of men undergoing angiography. By combining pressure and flow velocity measurements, PyCath provides a full spectrum of tools to assess both epicardial and microvascular functionality, empowering interventional cardiologists to measure what is not visible

 

MedManu brings together three key partners: Medyria AG, the technology owner and main industrial partner; ME Electronics S.R.L., an electronic manufacturing company; Agile MV experts in caheter manufacturing, Incite Medical Engineering expert in medical device engineering. The collaboration aims to develop an industrial process for automating sensor and catheter assembly, ensuring low production costs and high-quality control

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The project's innovation extends beyond the medical device itself to the manufacturing process. It focuses on creating new technologies for assembling microsensors in medical devices, addressing challenges in integration, reliability, and cost-effectiveness. The automated assembly system will include innovations in BFV sensor subassembly, wire manipulation, and catheter integration.

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MedManu aligns with sustainable development goals by improving health outcomes, addressing gender disparities in cardiovascular disease diagnosis, and advancing industrial innovation. The project aims to obtain regulatory clearance, gain market traction, and secure funding to bring PyCath to market, potentially revolutionizing the diagnosis and treatment of cardiovascular diseases.