Project description
Advancing PET measurement of myocardial blood flow
The assessment of myocardial blood flow is carried out by positron emission tomography (PET) using 15O-water, a radioactive variation of regular water as a tracer. However, the short half-life of 15O-water alongside difficulties in image analysis have prohibited its widespread clinical use. Scientists of the EU-funded EU-CAD project are working on a new hardware and analytical software combination to aid clinicians all over the world with 15O-water PET images. The project aims to further develop the current prototype and validate it in patients before obtaining regulatory approval to operate in Europe. Given the implication of myocardial blood flow in coronary heart disease, a robust measurement approach will help patient outcomes.
Objective
Coronary artery disease (CAD) is a disease blocking blood flow to the heart. Identifying patients with limited blood flow is key in improving patient outcomes. 15O-water is the undisputed gold standard tracer for blood flow assessment, with more than 450 publications on the topic. However, the ultra-short half-life of 15O -water, the difficult image analysis and the lack of regulatory approved equipment have limited its use in clinical practice. This limits the transition from current practice (SPECT, with poor accuracy and low throughput) to PET. With MedTrace’s solution of hardware and analytical software, clinicians all over the world will get routine access to 15O-water PET, achieving unrivalled accuracy at a low-cost while increasing patients’ comfort.
MedTrace’s addressable market potential draws on the installed base of current PET scanners (>500,000 worldwide in 2017), tapping into a multi-billion-euro opportunity for every 1% that starts using 15O-water. This market is even larger as we further build the evidence that 15O-water PET scans are safer and more cost-effective than current clinical practice.
We are asking for grant funding to further mature our working prototype solution, validate it in a small cohort of patients in three different EU sites, and obtain CE approval to operate in Europe. We also ask for equity funding to scale in the US by conducting a phase III clinical trial for regulatory approval in the US. This will allow us to overcome all the remaining regulatory barriers and improve cardiac imaging worldwide.
Fields of science
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Programme(s)
Funding Scheme
SME-2 - SME instrument phase 2Coordinator
2970 HORSHOLM
Denmark
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.