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.
