"The NIMBLE System: A novel non-invasive and non-ionizing medical device for the continous monitoring of patients with implanted cardiovascular stents"""

Project Information

NIMBLE System

Grant agreement ID: 101145249

DOI

10.3030/101145249

EC signature date 15 January 2024

Start date 1 February 2024

End date 31 July 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 295 000,00

EU contribution

€ 2 306 500,00

Coordinated by

NIMBLE DIAGNOSTICS SL
Spain

Periodic Reporting for period 1 - NIMBLE System (The NIMBLE System: A novel non-invasive and non-ionizing medical device for the continous monitoring of patients with implanted cardiovascular stents")

Reporting period: 2024-02-01 to 2025-01-31

Summary of the context and overall objectives of the project

NIMBLE Diagnostics is a MedTech company developing a first-in-class microwave-based medical device for continuous, non-invasive, non-ionizing monitoring of patients with implanted stents. Stents restore blood flow but can become blocked or damaged in 30% of cases. Symptoms only appear when a stent is 90% dysfunctional, increasing the risk of severe complications, including strokes, heart attacks, and sudden death. The current standard-of-care relies on invasive catheter angiography, involving anesthesia, X-ray exposure, and 24-hour hospitalization, making it unsuitable for regular monitoring.
The WAEVE System reads the stent’s electromagnetic signature non-invasively, detecting malfunctions and correlating them with clinical outcomes. This enables early treatment, preventing complications and allowing personalized therapy, shifting care from reactive to proactive.

Our technology is at TRL6, with a validated prototype showing excellent results. The EIC Accelerator project aims to optimize software and hardware, establish pre-series manufacturing, complete a pivotal European clinical trial, secure regulatory approvals, disseminate findings, and develop a robust reimbursement strategy while engaging Key Opinion Leaders in cardiology.

The project aligns with trends in cardiovascular care, addressing the increasing need for stent monitoring due to aging populations and rising coronary artery disease cases. While advancements in sensors and implants improve treatments, failures remain unmonitored. No company currently focuses on tracking these devices' performance, creating a critical gap that NIMBLE aims to fill.

Thus, our purpose is to fill this gap in the sector and support cardiovascular patients and clinicians by developing non-invasive diagnostics technologies. With the WAEVE System, we aim to establish a new standard of value-based treatment for patients with implanted stents.

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

NIMBLE Diagnostics has made significant progress under the EIC Accelerator grant. Main achievements are:

1) WAEVE System product development-progressed towards a market ready product:
- Near completion of the commercial and regulatory software.
- Commenced in-house development of a proprietary Vector Network Analyzer (VNA) to reduce manufacturing costs and reliance on third-party suppliers.
- New antennas/transducers to improve usability and contact with the patient's skin.
- Supplier agreement in place to manufacture the WAEVE System units for the pivotal clinical trial.

2) Preparation for Pivotal clinical trial:
- Preliminary data from the First in Human clinical trial: demonstrated high correlation (R=0.82) in 15 patients between the NIMBLE System and OCT, confirming accuracy. Achieved fast and reliable measurements (<5 minutes per patient) with excellent patient tolerance with no adverse events. Hardware and software improvements identified and incorporated in the WAEVE System prototype.
- Agreement signed with the Clinical Research Organization (CRO) for the Pivotal clinical trial. The CRO has experience in medical devices, cardiovascular products, diagnostics, and multicentric and multi-country trials.
- Pivotal clinical trial design in place. Evaluating which centres will participate in the clinical study in coordination with the CRO responsible for monitoring the study.
- Training programme for end-users of the technology established: we have started workshops with interventional cardiologists participating in the pivotal clinical study to identify areas of future development to improve the capabilities of our device.

3) Enhanced the company’s IPR Strategy:
- Secured the first patent in the EU and submitted additional patents (divisional patent, a priority European patent, and a near-final draft for a fourth patent).
- Submitted and granted 3 trademarks for NIMBLE Diagnostics as a company TM, NIMBLE as a company and product TM, and WAEVE as a product TM.

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)

Results & Impact:

-Clinical Impact: The first in human clinical trial’s preliminary outcomes have already demonstrated the system’s accuracy (R=0.82 correlation with OCT), speed (measurements under 5 minutes per patient), and safety (no adverse events reported).
These results validate the core functionality of the technology and establish a strong foundation for:
1) regulatory process (data for CE mark and FDA approval)
2) market confidence (credibility among stakeholders - potential investors, strategic partners, and early adopters)
3) scale up to larger multicentric clinical trials

-Manufacturing/Economic Impact: Improved manufacturing efficiency through proprietary VNA development, enhancing scalability and affordability.

-Innovation Impact: A strong patent portfolio safeguards innovation while fostering future advancements in medical diagnosis. The research conducted advances knowledge in the use of microwaves for diagnostic medical applications.

Several critical needs identified for achieving success.

- Clear Communication Channels and Stakeholder Engagement: incorporate diverse perspectives to ensure that the product meets both clinical and market needs through:
1) maintain continuous dialogue among clinicians, researchers, industry and regulatory bodies
2) participation in medical congresses, organisation of workshops and informative webinars

- Evidence Generation and Key Partnerships: validate the technology in different regions and populations to strengthen clinical evidence, which is crucial not only for regulatory purposes, but also for market acceptance. As well as, forming strategic partnerships with hospitals/distributors and stablishing a commercial team to ensure smooth adoption and widespread use. Moreover, collaboration with health technology assessment bodies is key to implement the WAEVE System into healthcare systems and secure reimbursement codes, ensuring financial viability and accessibility.

- Continued Funding and Scaling: Secure additional funding to support commercialization, internationalization, and pipeline expansion, which is vital for the project’s growth and sustainability.

The WAEVE System in the outpatient setting during the first clinical trial