Cleerly® Announces CERTAIN Multicenter Clinical Trial Results

Study Results Demonstrate the Prominent Effects of Cleerly’s Products on Changing Clinical Management for Patients Suspected of Coronary Artery Disease

Cleerly, the company working to create a new standard of care to aid in the diagnosis of heart disease, announced continued strong scientific evidence supporting the clinical utility of its products.

A study published online on January 25, 2024 in the European Heart Journal Cardiovascular Imaging¹ demonstrated the independent and strong incremental impact of Cleerly’s products in the prospective multicenter CERTAIN trial of 750 patients conducted at five sites in the U.S. Cleerly’s products were compared to the conventional standard of care interpretation of coronary CT angiography (CCTA) by expert level III imaging physicians. As compared to conventional CCTA interpretation alone, the use of Cleerly’s products led to a significant change in clinical decision making and patient management in more than 57% of patients, and increased physicians’ diagnostic confidence five-fold as compared with standard of care assessment of CCTA.

Use of Cleerly, which performs a comprehensive evaluation of coronary atherosclerosis (plaque), stenosis (narrowing) and ischemia (impaired blood flow), resulted in a 39% change in the assessment of coronary stenosis, a 37% reduction in the need for further invasive and non-invasive testing, and a 28% increase in the use of preventive medications. These results underscore the strong and positive effect of the Cleerly products on clinical utility for patients with suspected coronary artery disease.

“We are excited that our multicenter evidence supports what our rapidly growing customer base has been telling us for some time, namely, that use of Cleerly improves diagnostic accuracy and certainty, while reducing unnecessary downstream resource utilization and potentially harmful invasive testing, and increases the use of preventative medical therapy,” said James P. Earls, MD, Chief Medical Officer of Cleerly.

In all multicenter and single clinical studies performed to date, Cleerly’s products have consistently demonstrated robust clinical utility, including higher diagnostic accuracy and stronger prognostic risk stratification over such historical tests as nuclear SPECT stress testing and FFRCT^2-7.

About Cleerly^®

Cleerly is the company on a mission to eliminate heart attacks by creating a new standard of care for heart disease. Through its FDA-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced non-invasive CT imaging. Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period in landmark, multi-center clinical trials. Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway. For more information, please visit: www.cleerlyhealth.com.

1. Nurmohamed N, Cole J, Budoff M et al Impact of Atherosclerosis Imaging-Quantitative Computed Tomography on Diagnostic Certainty, Downstream Testing, Coronary Revascularization and Medical Therapy: The CERTAIN Study. In Press European Heart Journal CV Imag 2024. This study was sponsored by Cleerly, Inc. and journal article authors Udo Hoffman, M.D., James Min, M.D. and James Earls, M.D. are employees of Cleerly, Inc.
2. Nurmohamed NS, Danad I, Jukema R. High Diagnostic Accuracy Of AI-Ischemia in Comparison To PET, FFR-CT, SPECT, and Invasive FFR: A PACIFIC Sub-Study. Presented at the American College of Cardiology Annual Scientific Meeting New Orleans LA 2023.
3. van Rosendael A, Danad I, CREDENCE study group, PACIFIC study group. Derivation, Validation and Prognostic Assessment of an AI-Based Algorithm for Determination of Coronary Ischemia: The CREDENCE and PACIFIC Trial. in European Association of Cardiovascular Imaging: Late Breaking Clinical Research and Trials. 2023. Barcelona, Spain.
4. Chiou A, Hermel M, Miller G et al. Cleerly™ Vs. Heartflow™ vs. Site Read in The Per-Vessel Prediction of Adenosine FFR ≤0.80 With Plaque Features Associated with False Positives. Presented at the American College of Cardiology Annual Scientific Meeting New Orleans LA 2023
5. Karlsberg RP, Gonzalez Quesada C, Samuels B et al. High diagnostic accuracy of a novel artificial intelligence guided quantitative coronary computed tomography algorithm for predicting myocardial ischemia. Presented at the Society of Cardiovascular Computed Tomography Annual Scientific Meeting Boston MA 2023. Journal of Cardiovascular Computed Tomography Vol. 17 Issue 4 Supplement S28–S29 Published in issue: July, 2023
6. Lipkin I, Telluri A, Kim Y, et al. Coronary CTA With AI-QCT Interpretation: Comparison With Myocardial Perfusion Imaging for Detection of Obstructive Stenosis Using Invasive Angiography as Reference Standard. AJR Am J Roentgenol 2022 Sep;219(3):407-419.
7. Bär S, Nabeta T, Maaniitty T.. Prognostic Value of a Novel Artificial Intelligence-Based Coronary Computed Tomography Angiography-Derived Ischemia Algorithm for Patients with Suspected Coronary Artery Disease. Eur Heart J Cardiovasc Imaging. 2023 Dec 12:jead339. Epub ahead of print. PMID: 38084894.

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