Heartflow Plaque Analysis Now Supported by Scientific Statements From American College of Cardiology and American Heart Association for Personalized Management of Patients with Suspected CAD

Rhea-AI Summary

Heartflow (Nasdaq: HTFL) announced that the American College of Cardiology and American Heart Association published scientific statements endorsing the prognostic value of quantitative coronary plaque assessment and highlighting the coronary CTA + Heartflow pathway for personalized CAD management on Dec 18, 2025.

Heartflow said its Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with 95% agreement to IVUS using blinded core-lab adjudication. The company cited real-world evidence including the DECIDE registry, where Plaque Analysis changed medical management in more than 50% of patients, and a FISH&CHIPS cohort validation presented at AHA 2025.

Positive

• FDA-cleared AI-powered plaque quantification
• 95% agreement to IVUS in blinded core-lab adjudication
• DECIDE registry: medical management changed in over 50% of patients
• Endorsement by ACC and AHA scientific statements (Dec 2025)

Negative

• None.

Key Figures

IVUS agreement 95% Agreement of Heartflow Plaque Analysis with IVUS using blinded core lab adjudication

Management change rate more than 50% of patients Patients with medical management changed when Plaque Analysis with Plaque Staging was added in DECIDE registry

Market Reality Check

$30.50 Last Close

Volume Volume 544,278 is close to the 20-day average of 554,441, indicating typical trading activity ahead of this news. normal

Technical Shares trade below the 200-day MA of 32.38 and sit 36.23% under the 52-week high, only 3.59% above the 52-week low.

Peers on Argus

HTFL was down 0.68% while sector peers showed mixed moves (e.g., PRVA up 0.93%, WAY down 2.06%). With no peers in the momentum scanner, today’s setup looked more stock-specific than a broad sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 11	Clinical outcomes data	Positive	+1.0%	Large FISH&CHIPS analyses showed prognostic and cost benefits for FFRCT.
Nov 19	Conference participation	Neutral	-0.3%	Piper Sandler healthcare conference fireside chat announcement and webcast details.
Nov 12	Q3 2025 earnings	Positive	+4.6%	Strong revenue growth, IPO proceeds and initial full‑year 2025 revenue guidance.
Nov 03	AHA data preview	Positive	-8.4%	Planned late‑breaking AHA 2025 presentations on AI‑driven plaque analysis.
Oct 23	Earnings date notice	Neutral	-5.1%	Announcement of Q3 results release timing and investor conference call details.

Pattern Detected

News tied to clinical and economic validation often aligned positively with price, while conference and scheduling headlines sometimes coincided with notable downside moves.

Recent Company History

Over the past few months, Heartflow reported strong Q3 2025 growth with revenue of $46.3 million and initiated full‑year guidance, while remaining loss‑making. Subsequent analyses from the FISH&CHIPS program highlighted prognostic and cost benefits for FFRCT in over 90,000 patients. Conference‑related headlines around AHA and other events saw mixed to negative price reactions, including an 8.38% decline on Nov 3. Today’s ACC/AHA-backed plaque analysis recognition extends the clinical risk‑stratification story seen in recent data updates and the DECIDE registry findings.

Market Pulse Summary

The stock moved +6.5% in the session following this news. A strong positive reaction aligns with the ACC and AHA statements elevating quantitative plaque analysis as a defined clinical consideration in suspected CAD. The company previously showed economic and clinical benefits in large datasets and registry work. However, shares trading 36.23% below the 52‑week high and below the 200-day MA highlight prior pressure. Investors would have to weigh enthusiasm for guideline support against past volatility around data and conference news.

Key Terms

coronary artery disease medical

"the leader in AI technology for coronary artery disease (CAD)"

Coronary artery disease is a condition in which the blood vessels that supply the heart become narrowed or blocked by fatty buildup, reducing oxygen-rich blood flow and making the heart work harder. For investors, it matters because the condition drives demand for medications, medical devices, diagnostics and procedures, can affect healthcare spending and payer policies, and influences the financial prospects of companies involved in cardiovascular care—similar to how a clogged pipe changes maintenance and replacement needs.

coronary computed tomography angiography medical

"critical role of the coronary computed tomography angiography (CTA) + Heartflow pathway"

A coronary computed tomography angiography (CCTA) is a noninvasive medical scan that uses X-rays and computer processing to create detailed images of the heart’s blood vessels, like a high-resolution road map showing where arteries are narrowed or blocked. Investors care because how widely the test is used, reimbursed, and trusted by doctors affects demand for imaging equipment, hospital and clinic revenue, and makers of related software and contrast agents, all of which can influence healthcare company earnings and growth.

quantitative plaque assessment medical

"highlight the importance of quantitative plaque assessment and underscore the benefits"

A quantitative plaque assessment is a medical imaging measurement that counts and sizes fatty deposits (plaque) inside arteries and often grades their composition and growth over time. Investors care because these objective measurements drive demand for imaging equipment, drugs and devices, clinical trial outcomes, and reimbursement decisions; like measuring debris in a pipe, clearer numbers help predict treatment needs, market size and regulatory success.

nonobstructive CAD medical

"plaque burden and composition as central in managing nonobstructive CAD"

Nonobstructive CAD is coronary artery disease in which the heart’s blood vessels show plaque or damage but no major narrowings that block blood flow (typically less than about half blocked). It can still cause chest pain, reduced oxygen delivery, and risk of heart events because of small-vessel problems or unstable plaque, so it matters to investors as it shapes demand for diagnostics, drugs, monitoring technologies and services, influences clinical trial outcomes and regulatory decisions, and affects long‑term healthcare costs.

myocardial infarction medical

"predictor of future heart attacks or cardiovascular death"

Myocardial infarction, commonly called a heart attack, happens when blood flow to part of the heart is suddenly blocked and heart muscle is damaged—like a garden hose being pinched so a patch of lawn starts to die. For investors, heart attacks matter because they drive demand for drugs, devices, hospitals and rehabilitation, affect health-care costs and workforce productivity, and can lead to regulatory actions, litigation or shifts in insurance and pricing that impact company earnings.

retrospective analysis medical

"A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study"

A retrospective analysis examines existing records, data or outcomes from past events to determine what happened and why, and to measure how effective earlier decisions or treatments were. For investors, it is useful because it reveals real-world performance, risks or side effects that weren’t apparent at the time—like rereading past customer reviews before buying—helping refine forecasts, adjust valuations and manage future risk.

prospective registry medical

"the DECIDE registry, the largest prospective registry evaluating the clinical impact"

A prospective registry is an organized, ongoing database that enrolls patients or users before future outcomes occur and then collects information about their experiences over time. Like a public diary that records events as they happen, it gives investors clearer, forward-looking evidence about a product’s real-world performance, safety and adoption trends, which can reduce uncertainty about regulatory approval, future revenue and long-term risk.

plaque burden medical

"reinforces plaque burden and composition as central in managing nonobstructive CAD"

Plaque burden is the total amount of fatty deposits and hardened material built up inside blood vessels, usually measured as how much of an artery’s space is blocked or coated. Like grime narrowing a household pipe, higher plaque burden reduces blood flow and raises the risk of heart attacks or strokes; for investors it signals potential demand for medical treatments, devices and diagnostics and often drives clinical and regulatory decisions tied to market value.

AI-generated analysis. Not financial advice.

Reinforces Role of AI-Powered Quantitative Coronary Plaque Assessment

MOUNTAIN VIEW, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), announced the American College of Cardiology (ACC) and the American Heart Association (AHA) published new scientific statements supporting the prognostic value of quantifying coronary plaque and reinforcing the critical role of the coronary computed tomography angiography (CTA) + Heartflow pathway in CAD patient management. The ACC’s consensus recommendations, published this week in JACC: Cardiovascular Imaging, highlight the importance of quantitative plaque assessment and underscore the benefits of adopting AI-powered Heartflow Plaque Analysis for personalized, precision cardiac care.¹ The ACC statement elevates plaque analysis from an emerging technology to a defined clinical consideration in CAD management, outlining appropriate patient selection and best practices for interpreting and reporting.

In direct alignment with the ACC’s call for rigorous quality assurance, reproducible results, and “human in the loop” analysis, Heartflow delivers a differentiated standard for clinical plaque quantification by combining AI-driven analysis with expert quality review. Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with 95% agreement to the gold standard, IVUS, using blinded core lab adjudication.² This rigor, together with Heartflow’s commitment to standardized reporting and advanced algorithmic approaches such as adaptive thresholds, reflects a level of validation and quality oversight consistent with ACC guidance.

The AHA statement, published recently in Circulation, reinforces plaque burden and composition as central in managing nonobstructive CAD.³ The expert authors emphasize that patients with nonobstructive CAD should not be considered low-risk, recognizing that coronary plaque burden, extent, and composition are major determinants of outcomes. Earlier this year, a commission perspective published in The Lancet called for a fundamental shift in managing CAD, urging clinicians to focus on identifying and managing plaque early, before the opportunity for prevention has been lost.⁴ Together, the scientific statements from ACC and AHA reinforce that broader paradigm shift toward understanding plaque burden, not just artery obstruction, in modern CAD management.

“The ACC and AHA scientific statements address an important need by providing evidence-based consensus recommendations for clinicians and imagers, solidifying coronary CTA-based quantitative plaque analysis as a powerful tool for enhanced risk stratification in patients with suspected CAD,” said Ron Blankstein, M.D., writing committee member for both the ACC and AHA statements, Director of Cardiac Computed Tomography at Brigham and Women's Hospital, and Professor of Medicine and Radiology at Harvard Medical School. “These statements highlight the limitations of current methods to assess risk based on risk factors or stenosis severity alone. Integrating AI-powered technology into clinical practice using ACC and AHA’s guidance can help clinicians move beyond diagnosing blockages, toward predicting and preventing major cardiovascular events.”

Both the ACC and AHA scientific statements support the use of quantitative coronary plaque analysis to identify high-risk patients, enabling the immediate and appropriate initiation of preventive treatment. Heartflow Plaque Analysis addresses the need to quantify disease following visual detection of plaque, and is delivered instantly upon order to maintain seamless clinical integration and enable timely clinical decision-making.

“The ACC and AHA scientific statements signal growing consensus that plaque assessment is essential for risk stratification, prevention, and long-term CAD management. Heartflow Plaque Analysis enables more precise risk stratification for personalized, preventive treatment plans,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “The expert guidance articulates the need for rigorous validation and standardization, which Heartflow is uniquely positioned to address, given our technology and quality systems already align with these stringent recommendations. We are energized by the opportunity to continue collaborating with clinicians as a catalyst to redefine and improve precision cardiovascular care.”

The ACC and AHA’s scientific statements reflect a growing body of clinical evidence further substantiating the prognostic significance of Heartflow Plaque Analysis. A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study presented at the AHA Scientific Sessions 2025 provided the largest validation to date of the Heartflow Plaque Staging framework based on total plaque volume measurement as a predictor of future heart attacks or cardiovascular death.⁵ The company is generating additional real-world evidence through the DECIDE registry, the largest prospective registry evaluating the clinical impact of Heartflow Plaque Analysis on medical management decisions. The DECIDE registry showed that more than 50% of patients had their medical management changed when Plaque Analysis with Plaque Staging* was added compared to their management based on CCTA alone.⁶

About Heartflow’s Technology and Research
Heartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide. Key benefits include:

• Proprietary data pipeline: Built from more than 110 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.
• Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.
• Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.
• Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001.

About Heartflow, Inc.
Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com.

Media Contact
Elliot Levy
elevy@heartflow.com

Investor Contact
Nick Laudico
nlaudico@heartflow.com

¹ Chandrashekhar Y, Blankstein R, Shaw L. et al. Quantitative Coronary Plaque Analysis in Clinical Practice: 2025 ACC Scientific Statement: A Report of the American College of Cardiology. J Am Coll Cardiol Img. doi: 10.1016/j.jcmg.2025.11.008
² Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.
³ Slipczuk L, Blankstein R, Bucciarelli-Ducci C. et al. State of the art: evaluation and medical management of nonobstructive coronary artery disease in patients with chest pain: a scientific statement from the American Heart Association. Circulation. 2025;152:e443–e466. doi: 10.1161/CIR.0000000000001394
⁴ Zaman, Sarah et al. The Lancet Commission on rethinking coronary artery disease: moving from ischaemia to atheroma. The Lancet. 2025;405,10486:1264-1312. Doi: 10.1016/S0140-6736(25)00055-8
⁵ Fairbairn et al. AHA 2025.
⁶ DECIDE Registry. Rinehart, et al., presented at SCCT 2025.
*Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA.

FAQ

What did ACC and AHA publish about plaque assessment and Heartflow on Dec 18, 2025?

They published scientific statements endorsing quantitative coronary plaque assessment and supporting the coronary CTA + Heartflow pathway for CAD management.

Is Heartflow Plaque Analysis FDA-cleared and how accurate is it versus IVUS?

Heartflow Plaque Analysis is FDA-cleared and reported 95% agreement with IVUS using blinded core-lab adjudication.

How did Heartflow Plaque Analysis affect clinical management in the DECIDE registry?

The DECIDE registry showed Plaque Analysis changed medical management in more than 50% of patients compared with CCTA alone.

What evidence supports Heartflow Plaque Staging as a predictor of heart attacks?

A retrospective FISH&CHIPS cohort analysis presented at AHA Scientific Sessions 2025 validated Heartflow Plaque Staging based on total plaque volume as a predictor of future heart attacks or cardiovascular death.

What clinical role does Heartflow claim for its plaque analysis in CAD care?

Heartflow positions Plaque Analysis as an AI-powered, quality-reviewed tool to quantify plaque burden for more precise risk stratification and earlier preventive treatment decisions.

Will the ACC/AHA guidance change how clinicians use coronary CTA and Heartflow (HTFL)?

The ACC and AHA statements emphasize quantitative plaque assessment and may increase adoption of coronary CTA combined with Heartflow Plaque Analysis for personalized CAD management.