An AI powered turn-key solution for MRI based interventional cardiology

Project Information

TRACKR

Grant agreement ID: 190140779

DOI

10.3030/190140779

Project closed

EC signature date 8 March 2023

Start date 1 April 2023

End date 31 December 2025

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 546 727,50

EU contribution

€ 2 482 709,00

Coordinated by

NANO4IMAGING GMBH
Germany

Periodic Reporting for period 1 - TRACKR (An AI powered turn-key solution for MRI based interventional cardiology)

Reporting period: 2023-04-01 to 2024-03-31

Summary of the context and overall objectives of the project

Nano4Imaging (N4I) is a MedTech company specialized in MR based interventional procedures. We have previously successfully commercialized EmeryGlide, an MR compatible guidewire for cardiovascular procedures. In this project, we will deliver TRACKR – a ‘turn-key’ platform that provides the currently missing technologies for MRI guided interventional radiology. The TRACKR technology consists of: a) a coating platform based on proprietary MagnaFy technology. This nano-coating can be applied on any commercial interventional device (catheter, guide-wire, balloon) and enable their MR visibility. b) A REAL-TIME TRACKING SOFTWARE based on novel deep learning algorithms that allows real-time tracking of the MagnaFy coated devices during an interventions. Over 700million patients worldwide will benefit from our treatment without radiation and contrast agents.

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

We have conducted animal studies in the United States, Ohio State University (OSU) to generate training data for our algorithm. We have successfully developed the first version of the TRACKR software prototype which is currently undergoing the clinical input & feedback process. This is crucial and serves as a basis for the further development of the required functionalities while performing the interventional MRI procedures.

Finally we are preparing to use clinical data from application of our current EmeryGlide in cardiovascular indications as a validation set for our algorithm, which will be required before FDA submission of the software.
Regarding the coating platform as part of TRACKR we have printed different marker patterns on catheters from Numed, Biotronik, Terumo and others. These devices have been used in procedures in animals (OSU), including abdominal stenting, PTA and genicular artery embolization. Markers have been interrogated at different MRI sequences in low-field (0.5T) up to 3T Siemens scanners. Finally a series of markers have been printed on a new exchange wire prototype by N4I and evaluated in phantom and animal experiments.

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)

We have signed a letter of intent (LoI) with Siemens Healthineers AG which enables us to develop a second generation version of our TRACKR Software that can be integrated into the MAGNETOM Application Platform of the market leader Siemens’ MRI Scanner Systems and gives us a broad market access. At the same we are elaborating with Philips a collaboration to train and test different marker profiles to explore guidance using their existing overlay system, which is used by some of our major customers.
The impact of our project potentially reaches beyond the immediate benefot for patients. By enabling interventions in the MRI suite, we will contribute to the breakthrough developments in the medical imaging industry such as the increased utilization of environmentally friendly MRI scanners.

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