Every year, over 100,000 people die from a heart attack or related stroke in the UK alone, and heart disease and stroke remain the two biggest overall causes of death worldwide. Heart attacks are often caused by inflamed plaques dislodging from the coronary artery and blocking blood getting to the heart. Yet there is no method that allows for early detection of a potentially fatal build-up of plaque that could trigger a heart attack. Caristo’s technology, which has been developed as part of a research collaboration led by Oxford University academics, is based on the novel scientific discovery that the fat tissue surrounding the coronary arteries senses the presence of inflammation in the coronary artery. This change can be detected by analysis of routine coronary CT angiograms (CCTA) using Caristo’s proprietary technology, producing a new measure called the Fat Attenuation Index (FAI) which accurately quantifies the extent of inflammation in the coronary arteries supplying the heart.
 
The FAI can be combined with other known risk factors and imaging characteristics to create a new Cardiac Risk score (CaRi), which provides a greater level of prognostic insight compared with any existing risk-assessment biomarker. With Caristo’s technology, clinicians would be able to identify early those people who are at risk of having a heart attack and take preventative steps, such as lifestyle modification and initiating preventive medication, before it strikes.
 
Caristo’s technology is hardware agnostic and can be assessed on any standard CCTA. This includes existing CCTAs, giving clinicians the opportunity to re-evaluate a patient’s future risk of having a heart attack. By offering the technology on a SaaS basis, the technology can be deployed into hospitals without any changes to hospital infrastructure. This new technology can be used by healthcare providers and the biopharmaceutical industry, as a companion diagnostic to guide deployment of treatments in primary and secondary prevention.  
 
The company’s launch comes shortly after a study into FAI, which is based on analysis of over 3,900 patients in both Europe and the United States and includes follow up data for up to a decade, was published in The Lancet in August. At the same time, Professor Charalambos Antoniades, inventor of the FAI technology who led the study, presented his findings at the European Society of Cardiology Congress.
 
Caristo Diagnostics has raised £2m in seed financing, in a round backed by a consortium of investors, including Oxford Technology Investment Fund, Longwall Ventures, and Oxford Sciences Innovation. The development and launch of Caristo has been supported by Oxford University Innovation. The underpinning research into FAI was conducted collaboratively with partners including the Cleveland Clinic and the University of Erlangen and funded in part by the British Heart Foundation. The funding will be used together with a recently awarded Innovate UK grant for £1.9m, to further develop and then deploy Caristo’s underpinning technology.
 
Professor Charalambos Antoniades, of the Oxford University Division of Cardiovascular Medicine, and founder of Caristo Diagnostics, said: “This new technology may prove transformative for primary and secondary prevention. For the first time, we have a set of biomarkers, derived from a routine test used anyway as part of everyday clinical practice, that measures what we call ‘the residual cardiovascular risk’, currently missed by all risk scores and non-invasive tests. Knowing who is at high risk for a heart attack could allow us to intervene early enough to prevent it. I expect these biomarkers to become an essential part of standard coronary CT angiography reporting in the coming years.”
 
Dr. Victoria Sanchez, Senior Licensing and Ventures Manager at Oxford University Innovation, added: “Heart disease remains the world’s biggest killer—claiming over a hundred thousand lives every year in the UK alone. In many cases, these deaths could be avoided, yet instead are treated reactively after the damage has been done. This technology has the potential to give doctors unparalleled insight into their patients’ prognosis, and make informed treatment decisions with a greater level of confidence. Caristo turns the battle against heart disease from reactive to preventative, increasing chances of avoiding a fatal cardiac incident and saving billions in cardiac care while being relatively inexpensive for hospitals to implement.”
 
Professor Milind Desai, staff cardiologist at the Cleveland Clinic, added: “This is an exciting new technology which has the potential for providing a simple, non-invasive answer to detect patients at risk for future fatal heart attacks. More importantly, it highlights the incredible value of cross-continent collaboration to validate the findings in different populations.”
 
Professor Metin Avkiran, Associate Medical Director at the British Heart Foundation, which funded the research that developed FAI, added: “Most heart scans are good at spotting blockages caused by large plaques, but not the smaller, high-risk plaques that are likely to rupture and cause a heart attack. This new technique could be a game changer—allowing doctors to spot those 'ticking time bomb' patients who are most at risk of a heart attack, and getting them on to intensive treatment. This would undoubtedly save lives. By using this non-invasive scan, we could prevent a lurking heart attack that might occur down the road. But it also potentially gives us a real-time window into tracking the effect of drugs on inflamed arteries, helping us to identify new life-saving therapies.”