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

Introduction

At NIMBLE Diagnostics, we are developing a first-in-class microwave-based medical device for the non-invasive and non-ionizing monitoring of patients with implanted stents.

Background

Stents are one of the most implanted devices worldwide and are used to re-open blocked arteries and restore the correct flow of blood or other fluids. They are especially useful to prevent heart attacks or to treat their lasting symptoms. However, after implantation, stents become blocked or damaged in 30% of cases. Symptoms only appear after a stent is already 90% dysfunctional, which increases the incidence of serious complications, including strokes, heart attacks, or sudden death.

Current Diagnosis Methods

Diagnosis of malfunctioning stents is still symptom-driven and is based on an invasive procedure called catheter angiography. This procedure involves:

1. Anesthesia
2. X-ray exposure
3. 24-hour hospitalization recovery

This complex, costly, and invasive procedure is not appropriate for ongoing monitoring, which is why the standard of care only reacts when patients already have potentially life-threatening symptoms.

NIMBLE System

The NIMBLE System can read the electromagnetic signature of any stent non-invasively in less than 5 seconds. It can be used to provide information on stent status and malfunction during regular clinical visits. Thus, NIMBLE enables early treatments to prevent negative outcomes and personalization of therapy, shifting from reactive to proactive care.

Current Status

Our technology is currently at TRL5/6, with an MVP that has shown excellent results in pre-clinical validations. We have also started the first-in-human testing in a pilot study of 30 patients that will finish in early 2024.

Future Plans

The EIC Accelerator program will allow us to bridge the biggest risk of our project by performing the regulatory clinical trial to obtain the CE mark. Additionally, it will support us in creating and accessing a multi-billion blue ocean market opportunity. This will allow us to establish NIMBLE as a European leader in the future of implant diagnostics and aid millions of patients worldwide.