Caristo Diagnostics Piloting New Cardiac Disease Diagnostic Technology in UK NHS Hospitals

Latest CaRi-Heart® Technology Raises the Bar for CAD Management by Quantifying Both Coronary Inflammation and Plaque

OXFORD, England, July 12, 2023 /PRNewswire/ -- Caristo Diagnostics Limited, a global leader in cardiac and vascular disease diagnostics and risk prediction, announces today that it is deploying its latest CaRi-Heart® technology in National Health Service (NHS) hospitals as part of a new coronary artery disease (CAD) management pathway pilot.

The new pilot supported by NHS England will involve five NHS trusts, including University Hospitals of Leicester NHS Trust, Liverpool Heart and Chest Hospitals NHS Foundation Trust, Milton Keynes University Hospital NHS Foundation Trust, Oxford University Hospitals NHS Foundation Trust, and Royal Wolverhampton NHS Trust. As part of the pilot, patients visiting Rapid Access Chest Pain Clinics (RACPCs) who undergo a CCTA scan as per NICE guidance, will have their scan analysed by the CaRi-Heart platform in order to help healthcare professionals better assess patients' cardiac risk to optimise medical management.

The latest CaRi-Heart platform was released recently for UK and EU markets and can detect both coronary inflammation and atherosclerosis (plaque), based on routine cardiac CT scans. CaRi-Heart's newest product component, the CaRi-Plaque^TM module, is a web-based software medical device designed for trained operators to analyse cardiac computed tomography angiography (CCTA) data for characterisation and quantification of coronary plaque components. Trained operators can use the CaRi-Plaque module to generate a report describing the physical characteristics of coronary plaque powered by artificial intelligence (AI) algorithms.

The CaRi-Heart report quantifies coronary inflammation via the patient-specific Fat Attenuation Index Score^TM (FAI Score^TM), which is a novel and patented biomarker for the measurement of coronary inflammation, measured for each coronary artery. The CaRi-Heart report also provides the CaRi-Heart Risk, which assesses the overall 8-year risk of a fatal heart attack (based on coronary inflammation status, plaque, and clinical risks factors). Research studies have shown that abnormal FAI is associated with a 6-9 times higher risk for fatal heart attacks and 5 times higher risk for non-fatal heart attacks¹.

"Inflammation plays an important part in the development of atherosclerosis and is a strong predictor of cardiovascular disease progression and events", said Professor Keith Channon, Caristo Diagnostics Chief Medical Officer, "Previously, chest pain clinics have returned most patients back to primary care without a defined prevention or treatment pathway. With coronary inflammation and plaque evaluation provided by the CaRi-Heart analysis, the clinical team will be able to use the additional information to identify at-risk patients more effectively and optimize their treatment, so future cardiac events can be prevented."

"Caristo and our clinical partners are excited about this ground-breaking clinical initiative supported by NHS England", said Frank Cheng, Caristo Diagnostics CEO, "We anticipate that this real-world implementation will pave the way for the CaRi-Heart technology to be broadly adopted both across the NHS and around the world".

About Caristo Diagnostics Limited

Caristo Diagnostics Limited is a global leader in cardiac and vascular disease diagnostics and risk prediction. Founded in 2018 as a spin-out company from the University of Oxford, the world's #1 research university, Caristo has developed a portfolio of imaging-based and AI-assisted platforms that can be applied to aid the prediction and diagnosis of heart attack, stroke, and diabetes. Caristo was highlighted by Nature in 2020 as one of the most exciting science-based companies to have emerged from academic labs. To-date Caristo has attracted over £23 million in venture capital investment (nearly US$30 million). Find Caristo online on its website, LinkedIn and Twitter.

About the CaRi-Heart® Technology

Named first of "7 Technologies That Could Change Heart Healthcare Forevermore" by the Robb Report, the CaRi-Heart technology is Caristo's flagship offering which aids coronary artery disease diagnosis with improved risk prediction. It applies advanced AI algorithms to routine cardiac CT scans to visualize and quantify coronary inflammation, which is the previously invisible root cause of the disease. Each patient's CaRi-Heart report includes several clinical results: (1) the patient specific Fat Attenuation Index Score^TM (FAI Score^TM), a novel and patented biomarker for the measurement of coronary inflammation, which indicates the patient's risk in % relative to a matched peer group; (2) CaRi-Heart Risk, which assesses the absolute 8-year risk of a fatal heart attack (based on both coronary inflammation status and standard clinical risks factors); and (3) coronary plaque-specific characterization and quantification. The CaRi-Heart Analysis is supported by the CaRi-Heart software, which is cloud-based and agnostic to the type of scanner generating the routine cardiac CT images. The CaRi-Heart technology is CE Mark certified under the latest EU MDR with UKCA marking being received in September 2022. The CaRi-Heart technology is limited to research use in the U.S. before the FDA grants marketing authorization.

Multiple patents underpinning CaRi-Heart technologies have been granted in major jurisdictions around the world. In addition, exceptional validation results showing CaRi-Heart technology's ability to aid the prediction of heart attacks have been published in leading medical journals including the Lancet, JACC, European Heart Journal, and Cardiovascular Research. CaRi-Heart validation and implementation projects have been supported by multiple UK government grants and awards, including the NHS AI Stage 3 Award for real-world evaluation and implementation of CaRi-Heart care pathway in multiple NHS hospitals. With its deep clinical insights, proven validity and implementation readiness, the CaRi-Heart Analysis Service and the resulting new care pathway can transform cardiac care around the world by aiding in better prediction and prevention of future heart attacks.

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Contact: Frank Cheng, Caristo Diagnostics CEO, frank.cheng@caristo.com