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Caristo Diagnostics applauds the FDA's approval of Colchicine as the first cardiovascular disease anti-inflammatory.

Caristo Diagnostics applauds the FDA's approval of Colchicine as the first cardiovascular disease anti-inflammatory.

The FDA's decision to approve colchicine as the first anti-inflammatory drug for cardiovascular disease is commended by Caristo Diagnostics Limited, a global leader in the diagnosis and risk prediction of cardiac and vascular diseases. Caristo reaffirms its commitment to leading CCTA-based coronary inflammation detection and cardiovascular risk prediction innovations so that every coronary inflammation patient can be identified and treated with the appropriate therapy, including the FDA-approved anti-inflammatory drug.

The U.S. Food and Drug Administration (FDA) has approved LODOCO® (Colchicine 0.5 mg), the first anti-inflammatory atheroprotective cardiovascular treatment shown to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or multiple risk factors for cardiovascular disease, according to the June 20 press release from AGEPHA Pharma USA. When combined with high-intensity statins and other cardiovascular prevention therapies, 0.5 mg colchicine significantly reduces the overall risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization by 31% compared to the placebo group in a multi-national, randomized, double-blind, placebo-controlled clinical trial.

According to Professor Charalambos Antoniades, Caristo Diagnostics Chief Scientific Officer and British Heart Foundation Professor of Cardiovascular Medicine at the University of Oxford, "inflammation plays an important part in the development of atherosclerosis and is a strong predictor of cardiovascular disease progression." "Colchicine's approval by the FDA is an important tool for us to reduce coronary inflammation, which is a major cause of heart attacks," says the FDA.

The measurement of circulating levels of inflammatory biomarkers like C-reactive protein (CRP), for example, is currently used to assess inflammation; however, these methods are not specific for coronary artery inflammation. Anatomic high-risk plaque (HRP) features can be seen with coronary computed tomography angiography (CCTA), but plaque inflammation is not visible. Ca-Ri Heart® technology, on the other hand, uses cutting-edge AI-driven methods to detect and quantify coronary artery inflammation using the Fat Attenuation Index (FAI) Score on CCTA scans. Patients at high risk of coronary inflammation can be identified using this technology, and treatment priorities and monitoring can be prioritized. "To achieve maximum patient benefit from newly approved anti-inflammatory drugs, it will be crucial to identify patients with coronary artery inflammation at highest risk, independent of other clinical or CCTA features," stated Professor Keith Channon, Chief Medical Officer of Caristo Diagnostics.

Common biomarkers of vascular inflammation were looked at for their prognostic value in a meta-analysis that was published in JACC Cardiovascular Imaging1. These biomarkers included arterial positron emission tomography and computed tomography-derived biomarkers of vascular inflammation, such as anatomical high-risk plaque features and perivascular adipose tissue (PVAT), as well as common circulating inflammatory biomarkers (CRP, interleukin-6, and tumor necrosis factor-a). PVAT was found to have the greatest prognostic value and the highest level of specificity among all biomarkers for predicting cardiovascular events.

In order to bring the exclusive CaRi-Heart® coronary inflammation diagnostic technology, which is based on PVAT quantification, to market, Caristo Diagnostics was established in 2018. Using Caristo's Fat Attenuation Index (FAI) technology, trained medical professionals can use the AI algorithms in CaRi-Heart to obtain measures of coronary inflammation from routine cardiac computed tomography angiography (CCTA) scans. The resulting FAI Score measures the coronary inflammatory mortality risk. By combining coronary inflammation with standard clinic risk factors and the presence of coronary plaques, CaRi-Heart also provides a long-term cardiac mortality risk.

Caristo Diagnostics Limited

Caristo Diagnostics Limited is a world leader in the prediction and diagnosis of cardiac and vascular diseases. Caristo, a portfolio of imaging-based and AI-assisted platforms that can be used to aid in the prediction and diagnosis of heart attack, stroke, and diabetes, was established in 2018 as a spin-off company from the world's leading research university, the University of Oxford. In 2020, Nature featured Caristo as one of the most exciting science-based businesses to emerge from academic labs. Caristo has attracted venture capital investments totaling over £23 million (nearly US$30 million) thus far. Caristo can be found on LinkedIn, Twitter, and its website.

Regarding the CaRi-Heart® Technology

Caristo's flagship product, the CaRi-Heart technology, improves risk prediction for coronary artery disease diagnosis and was named one of the "7 Technologies That Could Change Heart Healthcare Forevermore" by the Robb Report. It uses cutting-edge artificial intelligence algorithms to visualize and quantify coronary inflammation, which was the disease's underlying cause until now. The CaRi-Heart Report for each patient includes the following clinical findings: 1) the patient-specific Fat Attenuation Index (FAI), a novel and patent-pending biomarker for measuring coronary inflammation that shows the patient's risk in percentage terms compared to a group of peers who are similar to them; 2) CaRi-Heart Risk, which measures the absolute 8-year risk of a fatal heart attack using standard clinical risk factors and coronary inflammation status; characterization and quantification of coronary plaque-specific characteristics The cloud-based CaRi-Heart software supports the CaRi-Heart Analysis and is independent of the type of cardiac CT scanner that generates the routine images. Under the most recent EU MDR, the CaRi-Heart technology is CE Mark certified, and UKCA marking will be received in September 2022. Before the FDA grants marketing authorization, CaRi-Heart can only be used for research purposes in the United States.

In major jurisdictions all over the world, numerous patents supporting CaRi-Heart technologies have been granted. In addition, leading medical journals such as the Lancet, JACC, European Heart Journal, and Cardiovascular Research have published exceptional validation results demonstrating CaRi-Heart's capacity to assist in the prediction of heart attacks. Multiple grants and awards from the UK government have supported CaRi-Heart validation and implementation projects, including the NHS AI Stage 3 Award for the real-world evaluation and implementation of the CaRi-Heart care pathway in multiple NHS hospitals. The CaRi-Heart Analysis Service and the resulting new care pathway can help improve the prediction and prevention of future heart attacks by utilizing their in-depth clinical insights, demonstrated validity, and readiness for implementation.

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