Caristo Diagnostics announces EU approval for AI technology which can predict heart attacks years in advance

March 29, 2021

Congratulations to our portfolio company, Caristo Diagnostics, who today announced that its first product, CaRi-Heart, has received a CE mark under the new European Medical Device Regulations (MDR).

CaRi-Heart will fundamentally disrupt the approach to diagnosis and treatment of coronary artery disease, by predicting heart attacks years before they happen with the measurement of coronary inflammation from a routine coronary CT scan.

Caristo’s mission is to transform health outcomes through clinical and scientific innovation, using scientific breakthroughs made by Cardiologists at the University of Oxford on cardiovascular risk prediction as its cornerstone. Providing physicians with unique information related to coronary artery inflammation, CaRi-Heart allows individualised treatment decisions to be made for patients to reduce future heart attack risk.

Caristo is thrilled to have the endorsement of the British Heart Foundation, who have supported the company throughout its journey. You can read the full press release released today from the British Heart Foundation below.

 

BHF researchers secure EU approval for new AI heart attack prediction technology

Research funded by us has led to EU-approved artificial intelligence (AI) technology that can identify people at high risk of a fatal heart attack years before it strikes.

The first-of-its-kind technology, CaRi-Heart, was developed by spinout company Caristo Diagnostics and has the power to detect ‘invisible’ risk in people with possible heart disease by using routine heart scans already performed in clinical practice. CaRi-Heart has now received it’s CE mark accreditation, meaning it can be used by doctors across the UK and Europe, and can be rolled out across the NHS.

Those identified at high risk of a future heart attack can be given personalised medication and monitored more closely to prevent a life-threatening event.

Each year in the UK there are hundreds of thousands of hospital visits for people experiencing chest pain. A coronary CT angiogram (CCTA) scan is the first-line test for patients with angina and is used to check for any narrowed or blocked segments in blood vessels that supply the heart. Every year around 350,000 people in the UK have a CCTA scan. However, 75 per cent of these scans do not show significant narrowing of the arteries and so people are sent home without treatment, yet some of them will have a heart attack at some point in the future. Until now, there has been no way for doctors to detect all the underlying red flags that could lead to a future heart attack.

Finding ‘ticking time bomb’ arteries

CaRi-Heart is a new technology that performs a deeper dive into the CCTA scans to reveal the ‘red flags’ beneath their surface, identifying the ‘ticking time bomb’ arteries that cause heart attacks. It works by using AI and deep-learning technology to produce a Fat Attenuation Index Score (FAI-Score), which accurately measures inflammation of blood vessels in and around the heart.

The scientific work that underpins Caristo Diagnostics was initially carried out by BHF researchers at the University of Oxford. We supported the work through a number of translational awards, aimed at developing new technologies for direct patient benefit.

The technology was validated in a landmark BHF-funded study involving around 4,000 patients who were followed up for nine years after their original CCTA scan. They found that people with an abnormal FAI were up to nine times more likely to die of a heart attack in the next nine years than those with normal FAI readings. The study also showed that at least one third of patients who underwent a routine CCTA and were initially considered low risk had a much higher risk after CaRi-Heart was applied to their scan. The patients would have therefore received a more targeted treatment based on the new technology.

Now, the researchers are looking at ways to use this ground-breaking technology to better predict an individual’s risk of developing stroke and diabetes by analysing routine CT scans. They are also directing their expertise towards the Covid-19 pandemic by developing an AI tool to specifically identify Covid-19 patients who are at high risk of having a future heart attack or stroke.

Major success story

Professor James Leiper, our Associate Medical Director, said: “The development and approval of this new AI tool is a major success story. It’s a prime example of how BHF-funded research can lay the foundations for a truly transformational advance in the diagnosis and prevention of heart and circulatory diseases.

“This research exemplifies the fundamental role medical research charities play in the translation of scientific research into the commercial and clinical sectors, which ultimately benefits the UK’s scientific ecosystem and patients with cardiovascular disease. Sadly, the pandemic has had a devastating blow to the BHF’s research spend, cutting it in half by £50 million this year alone. We need the kind support of the public more than ever to continue our life-saving research so more projects like this can get off the ground.”

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