Novel Catheter for the Diagnosis of Cardiovascular Disease

Project Information

Wirecath

Grant agreement ID: 878216

DOI

10.3030/878216

Project closed

EC signature date 11 July 2019

Start date 1 August 2019

End date 31 January 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

CAVIS TECHNOLOGIES AB
Sweden

Periodic Reporting for period 1 - Wirecath (Novel Catheter for the Diagnosis of Cardiovascular Disease)

Reporting period: 2019-08-01 to 2020-01-31

Summary of the context and overall objectives of the project

Cavis Technologies has an objective to clinically validate and commercialise Wirecath® – its novel medical device for assessing the severity of narrowing in the coronary arteries. It has the potential to substantially reduce management costs in coronary artery disease by improving its diagnosis, and thus, increasing opportunity for timely prevention of disease progression and its severe complications, such as angina, shortness of breath and heart attack. Wirecath® has several premium features over competing solutions. These are high accuracy, superior manoeuvrability and cost-effectiveness. It’s simple and robust design is based on a unique position of the pressure sensor and resistance to hydrostatic error, that standard pressure wires are liable to.
With this project, Cavis intends to plan further product development and large-scale clinical evaluation studies that will follow the first-in-man study. Cavis’ current research and development activities are supported by investment from shareholders and numerous innovation grants.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The concluded SME Instrument Phase I project highlighted a strong technical and commercial viability of the product. Cavis conducted numerous interviews with cardiologists from Sweden, the Netherlands and the UK in order to gather feedback on Wirecath®. The overall response was very positive and concerned mostly with the device’s superior wire manoeuvrability as well as measurement accuracy.
The company has also confirmed that its further clinical strategy will consist of three serial studies. In this respect, the team together with KOLS and cardiologist have developed two large-scale clinical study synopsis.

The strategic business review allowed for further study of the competitive landscape and led to strengthening Cavis strategy for market entry. Cavis have identified several important partners and distributors. The established strategy on how to engage with external partners will support the product’s international expansion and the company’s growth.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

With 1.9 million deaths a year, cardiovascular diseases are the leading cause of death in the EU and place a considerable burden on healthcare systems and government budgets. As the prevention and treatment of various cardiovascular diseases, including coronary artery disease, is of a high strategic priority across the EU, Cavis foresees the enormous potential for Wirecath to improve the diagnosis of this condition and contribute to the prevention and management of cardiovascular disease problem. Cavis’ vision is that all patients should receive a diagnosis of their problems that will enable them to be treated effectively. Wirecath® will contribute to improvement in the CAD diagnosis, optimising appropriate treatment. It will bring long-lasting benefits to medical professionals and patients with coronary artery disease. It will also contribute to substantial cost savings in the healthcare budgets.

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