as clinical guidelines shift, heart disease screening startup pulls in $43m series b

AI-Powered Imaging Secures $43 Million for Enhanced Heart Scan Analysis

Cleerly Coronary, a company specializing in artificial intelligence-driven analysis of cardiac imaging, has announced a $43 million Series B funding round this week. This investment arrives as innovative approaches to heart disease screening gain momentum.

Company Origins and Growth

Founded in 2017 by cardiologist James K. Min, also the director of the Dalio Institute for Cardiac Imaging at New York Presbyterian Hospital/Weill Cornell Medical College, Cleerly leverages AI to meticulously analyze detailed CT scans of the heart. The company currently employs 60 individuals and has accumulated $54 million in total funding.

The Series B funding was spearheaded by Vensana Capital, with participation from LVR Health, New Leaf Venture Partners, DigiTx Partners, and Cigna Ventures.

Focus on Detailed Cardiac Analysis

Cleerly’s core objective is to deliver comprehensive analysis of detailed heart imagery, processed through artificial intelligence. This analysis centers on images obtained via Cardiac Computer Tomography Angiogram (CTA), a relatively new, yet rapidly expanding, method for detecting arterial plaques.

“Our focus encompasses the entire heart – every artery and its branches – with detailed characterization and quantification of atherosclerosis,” explains Min. “We assess all plaque accumulation within the arteries and their walls, something traditional cardiology methods haven’t previously been capable of achieving.”

The platform operates as a web application, requiring a specific CTA image – the type the AI is trained to interpret – to be captured during patient checkups.

CTA as a Growing Diagnostic Tool

When a patient presents with symptoms such as chest pain, several screening options are available. These include stress tests, echocardiograms (ECG), and coronary angiograms – a catheter and x-ray-based procedure. CTA represents a more recent imaging technique, utilizing a scanner to create detailed heart images enhanced by an injected dye.

Cleerly’s platform is engineered to analyze these CTA images in depth. CTA has recently become a primary diagnostic test when patients exhibit potential heart issues. The European Society of Cardiology updated guidelines to designate CTA as a first-line test for evaluating chronic coronary disease. The UK adopted CTA as a first-line test for chest pain evaluation in 2016.

While already utilized in the US, guidelines may broaden the frequency of CTA usage. A review on CTA published by the American College of Cardiology highlights its “extraordinary potential.”

Insurance Coverage and Adoption

Positive developments are also occurring regarding insurance coverage. In 2020, United Healthcare announced reimbursement for CTA scans when ordered for low-to medium-risk patients experiencing chest pain. Reimbursement is a significant catalyst for wider adoption.

CTA imaging may not be optimal for patients with existing stents or those undergoing routine checkups (due to the low-dose radiation involved). Cleerly will concentrate on patients exhibiting symptoms or considered at high risk for heart disease.

Prevalence of Heart Disease and Risk Factors

The CDC estimates that currently 18.2 million adults have coronary artery heart disease, the most prevalent form. Furthermore, 47 percent of Americans possess at least one of the three primary risk factors: high blood pressure, high cholesterol, or a smoking habit.

These evolving (and anticipated) guideline changes suggest an increase in CTA scans for high-risk patients, and Cleerly is actively working to extract further insights from these scans through extensive clinical trials.

Understanding Plaque and Heart Attack Risk

Numerous risk factors contribute to heart disease, but the fundamental understanding is that heart attacks occur when plaques accumulate in the arteries, narrowing them and restricting blood flow. Research indicates that the composition of these plaques may provide insights into the level of risk associated with specific blockages, beyond simply their size.

A trial involving 25,251 patients demonstrated that the degree of constriction in arteries correlates with heart attack risk. However, the type of plaque present within those arteries proved to be a more accurate indicator of high-risk patients. Individuals who subsequently experienced sudden heart attacks tended to have higher levels of fibrofatty or necrotic core plaque.

These findings underscore the value of detailed plaque analysis in the heart. It is important to note that Min is an author of this study, which was also conducted across 13 different medical centers.

AI Accuracy and Clinical Validation

A key consideration with all AI-based diagnostic tools is their accuracy in recognizing features within scans.

Currently, FDA documentation emphasizes that the tool is not intended to replace a qualified medical professional’s interpretation of scan results. However, testing suggests promising performance.

A June 2021 study compared Cleerly’s AI analysis of CTA scans to assessments by three expert readers, revealing a diagnostic accuracy of approximately 99.7 percent in evaluating patients with severe arterial narrowing. Three of the nine study authors have equity in Cleerly.

Future Outlook and Expansion

With this latest funding, Min intends to forge more commercial partnerships and scale operations to meet growing demand. “We’ve largely operated under the radar, but we’re now prepared to fulfill demand and become more visible,” he states.

The product will continue to undergo rigorous testing and refinement. Cleerly is currently engaged in seven performance indication studies to assess the software’s ability to identify the diverse range of plaques that can develop in the heart.