Ischemia.
Reinvented.

Precision heart care at the nexus of vascular biology and artificial intelligence.

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Power of Cleerly

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Dr. Kern's Biography and Video Transcript

Morton J. Kern, MD, MSCAI, FACC, FAHA, is a professor of medicine at the University of California, Irvine, and former Chief of Cardiology and Chief of Medicine at the Long Beach Veterans Administration Medical Center. He practices interventional cardiology and teaches cardiology fellows cardiac catheterization and percutaneous coronary interventions.

Kern is the author of several major textbooks, including The Cardiac Catheterization Handbook, which is used nationally and internationally to train physicians in the subject, and published the second edition of the SCAI Interventional Cardiology Board Review.

His research interests include coronary physiology, hemodynamics, and invulnerable plaque.

Transcript

I think we've entered a time in the treatment of coronary artery disease (CAD) that moves well beyond routine stress testing and into our advanced assessment of the vessel, the wall, the myocardium and the potential for future risk in a noninvasive approach.

So in patients who are suspected of having ischemia due to coronary artery disease, we have a number of modalities to test for limited blood flow. Commonly used every day in every clinical practice around the world. And they are markers of limited blood flow in most circumstances. However, they have a high rate of false positives and a modestly high rate of false negatives. So they are not a standard that we can rely on 100%.

Computed tomography angiography (CTA) coupled with physiology, has become very important to the decision making before we come into the cath lab.

For several years there's been involvement of CT FFR generated through a number of mathematical models and provide us with anatomy and ischemia for that vessel and a map of the heart.

Cleerly has used another method to get that similar type of result. So we have the anatomy, we have an ischemic potential of that vessel, but we also have more features. It incorporates many more variables than any of our other tools and it comes out with a refined decision point for us. We can use the Cleerly tool to talk to us about anatomy and physiology, and have our answer in one test.

The role that artificial intelligence plays in the generation of the information that comes out of that Cleerly tool is unique in that it encompasses an entire array of variable inputs. It processes them, couples them with the information on the vessel wall, and information we get from CT and we get a refined response to ischemia.

We find out through this model that we're going to be able to predict ischemia. And it's not the AI itself, it's the net result of having all this available to us in an ischemia tool. Which make the risk in that individual more easily identified and result in an outcome, when tested through the Cleerly modality, that gives us some information we may not have through any of the other modalities.

When we look at some of the preliminary data and early studies with the Cleerly product, it looks like there is increased specificity with the method of Cleerly to give us risk of a major adverse event in our patients going forward. This is something that is not as strongly developed or available in other modalities.

The Cleerly method for looking at the CTA provides more information than almost any of the other CTAs do. And with that, we're able to look at different aspects of the vessel that would change the way we would treat it. And I think this makes the Cleerly product a potential game changer.

End-to-end artificial intelligence applied to non-invasive CT scans of the heart arteries, Cleerly^® ISCHEMIA™ is a first-of-its-kind, FDA-cleared heart disease evaluation device that integrates novel heart disease features to determine likelihood of coronary artery ischemia in a manner that advances a new paradigm of personalized care.

Informed Decision Making.

When used in conjunction with Cleerly LABS, Cleerly ISCHEMIA findings impact and change physician decision making in nearly 60% patients.⁵

Personalized Assessment.

By applying advanced AI to novel measurements of heart disease, Cleerly ISCHEMIA enables a modern approach to personalized heart disease assessment that doesn’t rely upon population-based assumptions.

Clinical Validation

We tested and validated the Cleerly ISCHEMIA device in the largest clinical trial to date.
And then it validated again. And again. And again.

Cleerly ISCHEMIA’s ability to determine a likely invasive FFR was validated through multiple clinical trials with invasive FFR as the gold standard. Cleerly ISCHEMIA performed consistently well across all studies, having either outperformed or equivalent to other noninvasive measures of ischemia — specifically FFR_CT, myocardial perfusion imaging (SPECT), and PET.^1-4

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Main clinical validation study

CREDENCE Trial

In the prospective, multicenter CREDENCE trial, Cleerly ISCHEMIA demonstrated higher diagnostic accuracy and area under the curve compared to FFR_CT and stress testing, as referenced to 868 invasive measurements by fractional flow reserve (FFR), the ‘gold standard’ for determining ischemia.¹

Cleerly ISCHEMIA - Clinical Validation, CREDENCE trial

External validation study #1

PACIFIC Trial

In a post-hoc analysis of the PACIFIC study, Cleerly ISCHEMIA was compared to FFR_CT, 15O-H2O PET and SPECT to predict invasive FFR≤0.8 as reference standard. On a per-patient basis Cleerly ISCHEMIA (AUC 0.91), FFR_CT (AUC 0.90) and PET (AUC 0.88) performed similarly, outperforming SPECT (AUC 0.71) in predicting ischemia.²

"The Cleerly method for looking at the CTA provides more information than almost any of the other CTAs do. And with that, we're able to look at different aspects of the vessel that would change the way we would treat it. And I think this makes the Cleerly product a potential game changer."

Morton J. Kern, MD, MSCAI, FACC, FAHA
Interventional Cardiologist Professor of Medicine, University of California, Irvine

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Cleerly Billing Guide

Download our 2024 CPT^® coding guide to learn about Cleerly's ISCHEMIA and PLAQUE analysis billing options.

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How Cleerly ISCHEMIA Works

A Cleerly ISCHEMIA Index (CII) is provided for all analyzable coronary vessels as a part of the Cleerly analysis. The CII is a binary indication of ischemia either being unlikely present or likely present based on the threshold equivalent to invasive fractional flow reserve (FFR) measures of >0.80 vs. ≤0.80, respectively. The Cleerly ISCHEMIA binary output is consistent with that used in professional societal practice guidelines, including the ACC/AHA Chest Pain Guidelines.⁶

Through integrating coronary atherosclerosis and vascular morphology characteristics into a single physiologic measure that identifies likely coronary ischemia, the Cleerly ISCHEMIA analysis provides actionable information to the physician to assess a patient's heart health.^1-4

Applying the Category I CPT^® Code 75580 to Cleerly ISCHEMIA

Category 1 CPT^® Code 75580: “Noninvasive estimate of coronary fractional flow reserve derived from augmentative software analysis of the data set from a coronary computed tomography angiography, with interpretation and report by a physician or other qualified healthcare professional.”

With any new CPT^® Code, there is a need to understand how to apply it to FDA-cleared and commercially available technologies. In this regard, the determination of whether a CPT^® code applies to a given technology or service is based solely on the CPT^® Code description, and not on the clinical vignettes that describe the technology or service.

Cleerly ISCHEMIA Provides a Non-Invasive Estimate of Coronary Fractional Flow Reserve

In prior landmark clinical trials, the use of invasive FFR has been demonstrated to guide clinical decision making in a manner that improves patient health outcomes. This improvement in clinical outcomes was observed in these studies when stenting procedures were performed for invasive FFR ranges <0.80 (ischemia likely) and deferred for invasive FFR ranges >0.80 (ischemia unlikely). Based upon the results of these randomized controlled trials, the American Heart Association / American College of Cardiology professional societal guidelines advocate for the use of FFR ranges at the 0.80 threshold to be used to guide clinical decision making for determining appropriateness of coronary revascularization.⁶

Cleerly ISCHEMIA is a novel, artificial intelligence-enabled method applied to typically acquired CCTA to determine ranges of FFR values that categorize a vessel’s likelihood of exhibiting ischemia. The FFR ranges that non-invasive Cleerly ISCHEMIA device was developed and validated upon were those invasive FFR values <0.80 (ischemia likely) versus those values >0.80 (ischemia unlikely). As the determination of ischemia within a given coronary artery vessel is dependent upon all of the disease from the start to end of the vessel, the Cleerly ISCHEMIA device provides output at the vessel level and for all vessels within a patient’s coronary artery tree.
Cleerly ISCHEMIA Provides Results Derived from Augmentative Software Analysis of the Data Set from a CCTA

The American Medical Association (AMA), who creates CPT^® Codes, has developed accepted language used in CPT^® descriptions related to AI and published it under Appendix S: Artificial Intelligence Taxonomy for Medical Services and Procedures, in the AMA/CPT^® Coding Book. They define the term augmentative as “the work performed by the machine for the physician or other QHP is augmentative when the machine analyzes and/or quantifies data to yield clinically meaningful output. Requires physician or other QHP interpretation and report.”

Cleerly ISCHEMIA provides analysis of the likelihood of ischemia in binary fashion that is determined by the FFR ranges of <0.80 and >0.80, respectively, across the entire patient’s coronary artery tree. A physician or other qualified healthcare professional then assesses the data on a vessel by vessel level to determine what, if any, intervention is needed, which meets the AMA definition of augmentative related to AI.
Cleerly ISCHEMIA is Designed for Interpretation and Report by a Physician or Other Qualified Health Care Professional

When utilized by a qualified interpreting healthcare provider, Cleerly ISCHEMIA provides information that may be useful in detecting the likelihood of ischemia associated with coronary artery disease. The Cleerly ISCHEMIA device not only outputs the likelihood of ischemia at the vessel level, it also allows for direct non-invasive interrogation of each individual lesion within a vessel to determine the severity of stenosis and severity of atherosclerosis. The ability for Cleerly ISCHEMIA to provide this comprehensive lesion-by-lesion mapping within a vessel for the the clinically actionable features of coronary artery disease can be used to support the care team in determining whether there may be a lesion to be considered for coronary revascularization and if so, to guide the care team to such relevant factors as ischemia, stenosis and atherosclerosis.
Disclaimer

This communication is provided for informational purposes only and does not constitute a recommendation, representation, warranty, statement or guarantee by Cleerly, Inc. concerning appropriate coding or levels of payment for services rendered. This communication is not intended to increase, maximize, or otherwise adjust payment for the provider nor indicate coverage from any payor. Providers should consult with their reimbursement professional, as well as legal counsel, to ensure all legal and regulatory requirements have been met to support appropriate coding as required by payors for services rendered.

References

¹ Nurmohamed N, Danad I, Jukema R, et al. Development and validation of a quantitative coronary CT angiography model for diagnosis of vessel-specific coronary ischemia. In Press JACC CV Imaging. 2024.
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 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.
⁴ 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.
⁵ Nurmohamed NS, Cole J, Budoff M et al. Changes in CAD Diagnosis, Imaging, Intervention and Medication with AI-QCT: the CERTAIN trial. Presented at the Society of Cardiovascular Computed Tomography Annual Scientific Meeting Boston MA 2023. In Submission (invited) Circulation Cardiovascular Imaging. Journal of Cardiovascular Computed Tomography Vol. 17 Issue 4 Supplement S56–S57 Published in issue: July, 2023.
⁶ Gulati M, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain. ⇱ J Am Coll Cardiol. 2021.

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Contact us for a one-on-one software demonstration with a Cleerly expert to see how bringing Cleerly’s AI‑driven CCTA analysis to your organization can empower you to provide personalized treatment decisions for your patients.

Cleerly® ISCHEMIA™ analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly® LABS™ software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis. Rx Only.

Patents

Cleerly continues to revolutionize heart attack and cardiovascular disease prevention and treatment everyday by inventing world-class technology. Cleerly invests significant time and resources in research and development towards this goal. To protect Cleerly’s research and development efforts, Cleerly has vigorously developed a robust intellectual property portfolio – all part of a strategy for protecting the innovations that make Cleerly an industry leader in cardiovascular disease prevention and treatment.

Cleerly’s products and services may be covered by or for use under one or more of U.S. Patent Nos. 11,922,627, 11,948,301, 12,023,190, 11,861,833, 11,967,078, 11,832,982, 11,690,586, 11,779,292, 11,730,437, 11,672,497, 11,737,718, 11,751,826, 11,660,058, 11,896,415, 11,751,830, 11,751,829, 11,302,001, 11,308,617, 11,238,587, 11,302,002, 11,321,840, 11,341,644, 11,244,451, 11,288,799, 11,276,170, 11,210,786, 11,232,564, 11,367,190, 11,315,247, 11,969,280, 11,094,060, 11,120,550, 11,120,549, 11,132,796, 11,094,061, 11,113,811, 11,501,436, 11,751,831, 11,642,092, 11,759,161, 11,317,883, 11,350,899, 11,766,230, 11,766,229, and 10,813,612, as well as other patents that are pending.

For additional information, please contact legal@cleerlyhealth.com.

Ischemia.
Reinvented.

Precision heart care at the nexus of vascular biology and artificial intelligence.

Discover the
Power of Cleerly

Dr. Kern's Biography and Video Transcript

Transcript

Informed Decision Making.

Personalized Assessment.

Clinical Validation

CREDENCE Trial

PACIFIC Trial

Request your N-of-1 demo

Discover the power of Cleerly

Cleerly Billing Guide

How Cleerly ISCHEMIA Works

Clinical Workflow

Applying the Category I CPT^® Code 75580 to Cleerly ISCHEMIA

Cleerly ISCHEMIA Provides a Non-Invasive Estimate of Coronary Fractional Flow Reserve

Cleerly ISCHEMIA Provides Results Derived from Augmentative Software Analysis of the Data Set from a CCTA

Cleerly ISCHEMIA is Designed for Interpretation and Report by a Physician or Other Qualified Health Care Professional

Disclaimer

References

Request your N-of-1 Cleerly ISCHEMIA Demo

Patents

Solutions

About

Ischemia.Reinvented.

Precision heart care at the nexus of vascular biology and artificial intelligence.

Discover thePower of Cleerly

Dr. Kern's Biography and Video Transcript

Informed Decision Making.

Personalized Assessment.

Clinical Validation