The first heart failure therapy management point-of-care device with multiplex and multimodal sensor

Project Information

CardioCap

Grant agreement ID: 101188828

DOI

10.3030/101188828

EC signature date 22 November 2024

Start date 1 January 2025

End date 31 December 2026

Funded under

• The European Innovation Council (EIC)

Total cost

No data

EU contribution

€ 2 499 999,00

Coordinated by

OMINI
France

Periodic Reporting for period 1 - CardioCap (The first heart failure therapy management point-of-care device with multiplex and multimodal sensor)

Reporting period: 2025-01-01 to 2025-12-31

Summary of the context and overall objectives of the project

Chronic diseases represent one of the main challenges facing healthcare systems worldwide, both in terms of patient outcomes and economic sustainability. Among them, heart failure is a leading cause of hospitalisation in elderly populations and a major driver of healthcare costs. Despite significant therapeutic advances, heart failure management still relies heavily on symptoms and infrequent laboratory testing, resulting in delayed treatment adjustments, avoidable hospital readmissions, and increased strain on healthcare systems.

Effective heart failure management requires the regular monitoring of multiple blood biomarkers reflecting cardiac function, kidney function, and electrolyte balance. However, today’s solutions are largely hospital-based, expensive, and poorly adapted to decentralized or community care settings. As a result, most patients are managed outside hospitals without access to timely, actionable biological information, forcing clinicians to balance treatment efficacy against safety with limited data.

The CardioCap project addresses this unmet need by developing the first portable, multiplex point-of-care blood testing platform designed for heart failure therapy management. Using a single finger-prick blood sample, CardioCap is designed to simultaneously measure four key blood biomarkers required for clinical decision-making. By providing results in under ten minutes, the platform enables faster and more precise treatment adjustments in community and home-care settings.

The project’s overall objective is to develop, validate, and prepare for regulatory approval a scalable point-of-care diagnostic device that enables frequent, affordable, and decentralized biomarker monitoring. CardioCap is built on a proprietary sensor technology that integrates proteins, ions, and metabolites on a single disposable strip, combined with a reusable reader and a connected data infrastructure. This approach aims to replicate, for complex chronic diseases, the impact that glucose meters had on diabetes management.

Beyond heart failure, the project lays the foundation for a broader diagnostic platform capable of expanding to other chronic conditions requiring multiplex biomarker monitoring. By shifting biological testing closer to patients and caregivers, CardioCap contributes to improved clinical outcomes, reduced hospitalizations, and more sustainable healthcare delivery, in line with European priorities on innovation, digital health, and decentralized care.

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

During the first reporting period, the project focused on the development and validation of the core technical components required for clinical evaluation and regulatory readiness.

Key activities included the design freeze and optimization of the multiplex biosensor strip, enabling the simultaneous measurement of four clinically relevant biomarkers from a single blood sample. The fabrication process was standardized and optimized to improve reproducibility and reduce variability. Analytical performance targets were achieved through testing on human plasma samples obtained from blood banks.

In parallel, a functional reader device was developed, manufactured, and validated. Multiple reader prototypes were produced and tested, demonstrating reliable signal acquisition, data transmission, and compatibility with the multiplex sensor strips. These devices are now ready for use in clinical studies.

The project also successfully completed a retrospective clinical validation phase, demonstrating that CardioCap achieves the required analytical performance when compared to standard laboratory methods. Target measurement ranges and precision were met for all four biomarkers, confirming the suitability of the platform for heart failure monitoring in a clinically relevant environment.

In addition to technical development, major progress was made in regulatory and quality preparedness. Key quality management system processes aligned with ISO 13485 were implemented, and a white audit was successfully passed, validating the robustness of the company’s core quality processes and supporting future regulatory submissions.

Overall, the first reporting period resulted in a clinically ready prototype, validated analytical performance, and a solid regulatory and quality foundation for the next stages of clinical evaluation and industrialization.

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)

The CardioCap project delivers results that go beyond the current state of the art in point-of-care diagnostics by combining multiplex capability, affordability, and portability within a single platform. Existing point-of-care solutions typically focus on single biomarkers, require multiple tests, or rely on expensive and complex instrumentation unsuitable for decentralized care.

CardioCap introduces a novel sensor architecture that enables the simultaneous detection of proteins, ions, and metabolites on a single disposable strip. This multi-chemistry integration allows clinically actionable biomarker panels to be measured from a single drop of blood, reducing complexity and enabling frequent monitoring.

From an economic perspective, the project demonstrates that multiplex diagnostics can be delivered at a cost comparable to single-analyte tests, making large-scale deployment feasible in community and home-care settings. This represents a significant step toward democratizing access to advanced diagnostics.

The platform architecture is designed for scalability and extension beyond heart failure, supporting future applications in other chronic diseases where multiplex biomarker monitoring is essential.

Certificate of participation of the project’s CEO in the EIC Women Leadership Programme

Recognition of the project’s CEO as one of Sifted’s 100 Women in Tech in Europe 2025

Prototype of the CardioCap portable reader and multiplex biosensor strip under development