PROJECT TITLE

Development of the TOTAL PLAQUE system, enabling automated and precise analysis of atherosclerotic plaques in the coronary arteries in cardiac CT scans using new medical algorithms

Priority: 1. Support for entrepreneurs
Measure: 1.1 SMART Pathway
Intermediary Body: Polish Agency for Enterprise Development
Call for proposals: FENG.01.01-IP.02-002/25
Grant agreement: FENG.01.01-IP.02-0421/25
Total project cost: 9,206,040.00 PLN
Total amount of eligible expenditure: 9 206 040 PLN
The total amount of funding: 6 857 861 PLN

THE AIM OF THE PROJECT

The project aims to develop the Total Plaque system to help doctors diagnose coronary artery disease more precisely. The project aims to address three key research challenges that currently pose a barrier to the precise diagnosis of coronary artery disease:

  • The lack of tools/algorithms utilising both phases of the cardiac cycle
  • Insufficient accuracy of automatic segmentation for identifying atherosclerotic plaques (with particular emphasis on LAP plaques)
  • Low effectiveness of automatic identification of high-risk plaque features

PROJECT DESCRIPTION

Subject of the project

The scope of the project is to implement the R&D Module, under which a new product – the TOTAL PLAQUE system – will be developed. This solution will improve diagnostic accuracy in the early detection of atherosclerosis, thereby enabling more effective identification of the disease in its early stages. The system will be a Class IIa medical device.

Identified need

According to available data, the high incidence and mortality associated with coronary heart disease mean that accurate diagnosis and effective treatment are crucial, both from a societal and a market perspective. Research findings confirm the need to improve the diagnostic process, showing that some patients considered low risk or apparently healthy have atherosclerotic plaques with high-risk characteristics. This phenomenon highlights a significant diagnostic gap and a growing need for tools that enable precise assessment of non-calcified plaques.

The response to this challenge will be the development of a fully automated IT system for detailed analysis of cardiac CT scans. This solution will provide doctors with accurate information on the presence and characteristics of non-calcified atherosclerotic plaques, which are one of the most common causes of heart attacks. As a result, it will be possible to detect the risk at an earlier stage and initiate appropriate treatment for coronary artery disease more quickly, even before life-threatening events occur.

System components

The system will consist of two components:

1. The main component of the solution will be machine learning (ML) algorithms designed to analyse computed tomography (CT) images of the heart. Based on the processed data, the system will enable precise detection and characterisation of pathologically altered plaques (including high-risk atherosclerotic plaques), accounting for four plaque characteristics. In addition, the algorithms will quantitatively measure the volume of low-attenuation plaque (LAP).

2. An additional/supporting component will comprise a set of tools enabling:

  • the display of machine learning (ML) algorithm results alongside the computed tomography (CT) image
  • correction of analysis results by a doctor, with automatic recalculation of the final quantitative parameters
  • approval of examination results by a doctor

CT image processing will take place automatically – after retrieval from the healthcare facility’s PACS – or manually upon initiation by a doctor. This solution will ensure operational flexibility and seamless integration with medical facilities’ existing IT infrastructure.

Project scope

It covers the implementation of both industrial research and development work.

Features and specifications of the solution

Improving diagnostic accuracy through:

  • the ability to co-register images from two phases of the cardiac cycle with minimal permissible error
  • an almost twofold increase in the quantitative measurement of the volume of low-attenuation LAP plaques
  • more than a twofold improvement in the quality of detection of high-risk atherosclerotic plaques

Target groups

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