iCAD’s ProFound AI Suite Uncovers Hidden Heart Disease Risk According to New Data Presented at American College of Cardiology Meeting

Rhea-AI Summary

iCAD's AI Algorithm Successfully Detects Breast Arterial Calcification, Signaling Cardiovascular Disease

Positive

• iCAD's AI-powered solution effectively uncovers calcium deposits in breast vessels, indicating possible cardiovascular disease in women.
• Study involved 117,189 women, showing a BAC prevalence of 14.8% and increasing with age.
• ProFound Heart Health AI algorithm standardizes BAC detection, potentially improving efficiency and reducing variability.
• Women with BAC are 51% more likely to develop heart disease, emphasizing the importance of early detection.
• AI software aids in accurate BAC identification, leading to more consistent detection and reporting.

Negative

• None.

Study confirms iCAD’s Breast Arterial Calcification AI Algorithm successfully detects calcification of breast vessels, an indicator of cardiovascular disease, from mammograms

NASHUA, N.H., April 08, 2024 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global leader in clinically proven AI-powered cancer detection solutions, announced today that new data indicates its AI-powered solution effectively uncovers calcium deposits in the breast vessels, a sign of possible cardiovascular disease in women. iCAD research collaborator Chirag Parghi, M.D., Chief Medical Officer of Solis Mammography, presented the findings at the American College of Cardiology (ACC) annual meeting taking place April 6 - 8, 2024, in Atlanta, GA.

For the study, Dr. Parghi and his team included mammograms from a multiracial cohort of 117,189 women, using iCAD’s ProFound AI Heart Healthⁱ solution, specifically designed for Breast Arterial Calcification (BAC) detection. The 15-site prospective study included 2D screening mammograms from women ages 20 to 100, with a median age of 56.

“The ProFound BAC AI algorithm may provide a critical surrogate biomarker for women at risk of heart disease or stroke,” said Dana Brown, president and CEO of iCAD. “We are thrilled to be able to collaborate with Solis Mammography on this state-of-the-art software that gives women the power of knowing—earlier—if they are at potential risk of heart disease during a routine screening mammogram. This provides women valuable information that may lead to obtaining additional cardiovascular screening. We anticipate that ProFound Heart Health will positively impact cardiovascular disease prevention for women as iCAD’s ProFound Detection and Risk solutions do for breast cancer.”

Analyzing the data of the prospective study involving 117,189 women, Dr. Parghi and his team found the overall prevalence of BAC (score >1) was 14.8%. Prevalence increased with age, with a 4.2% prevalence in women under 50 years old, 9.0% in women aged 50-59, 19.9% in women in the 60-69 year-old age group, and 40.7% in women 70 years and above. Future work includes tracking patients longitudinally to identify associated cardiovascular risk factors and guiding primary care physicians in managing patients with detected BAC. The study also suggests the ProFound Heart Health AI algorithm can standardize BAC detection, potentially improving efficiency and reducing variability among observers. These findings also align with previous literature emphasizing the association between BAC and cardiovascular risk, underscoring potential opportunity of BAC detection on screening mammography for women’s health.

“Artificial Intelligence software can be used to detect breast arterial calcifications with high accuracy,” said Dr. Parghi. “With this tool, we will be able to identify patients that can benefit from additional cardiovascular screening, potentially intervening before adverse outcomes manifest. To be able to have one screening mammogram unveil meaningful insights for two of the leading causes of death for women – breast cancer and heart disease – is remarkable.”

“At present, radiologists must rely on visual detection of breast arterial calcifications, which is time-consuming and leads to consistent underreporting of BAC results,” continued Dr. Parghi. “With an AI algorithm accurately identifying BAC, we will see more consistent BAC detection and reporting, which will ultimately benefit patients the most.”

Recent research shows that calcium deposits inside the blood vessels of the breast correlate to hardening of the cardiovascular arteries, and women with BAC are 51% more likely to develop heart disease. Early cardiovascular disease detection is key, as among asymptomatic women, the first manifestation of underlying coronary heart disease is often acute myocardial infarction (MI) or sudden death. Although women tend to have a lower burden of obstructive coronary artery disease on angiography, they typically have a worse prognosis after MI compared with men.

About iCAD, Inc.
iCAD, Inc. (NASDAQ: ICAD) is a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered solutions that enable medical providers to accurately and reliably detect cancer earlier and improve patient outcomes. Headquartered in Nashua, N.H., iCAD’s industry-leading ProFound Breast Health Suite provides AI-powered mammography analysis for breast cancer detection, density assessment and risk evaluation. Used by thousands of providers serving millions of patients, ProFound is available in over 50 countries. In the last five years alone, iCAD estimates reading more than 40 million mammograms worldwide, with nearly 30% being tomosynthesis. For more information, including the latest in regulatory clearances, please visit www.icadmed.com.

Forward-Looking Statements
Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the expansion of access to the Company’s products, improvement of performance, acceleration of adoption, expected benefits of ProFound AI®, the benefits of the Company’s products, and future prospects for the Company’s technology platforms and products. Such forward-looking statements involve a number of known and unknown risks, uncertainties, and other factors that may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited, to the Company’s ability to achieve business and strategic objectives, the willingness of patients to undergo mammography screening in light of risks of potential exposure to Covid-19, whether mammography screening will be treated as an essential procedure, whether ProFound AI will improve reading efficiency, improve specificity and sensitivity, reduce false positives and otherwise prove to be more beneficial for patients and clinicians, the impact of supply and manufacturing constraints or difficulties on our ability to fulfill our orders, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights, product market acceptance, possible technological obsolescence of products, increased competition, government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,” “continue,” “anticipate,” “likely,” “seek,” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

CONTACTS

Media inquiries: pr@icadmed.com
Investor Inquiries: ir@icadmed.com

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ⁱ Breast Arterial Calcification Assessment is pending regulatory licensing and is available for investigational use only.

FAQ

How many women were involved in the study confirming iCAD's Breast Arterial Calcification AI Algorithm?

The study involved 117,189 women.

What is the prevalence of BAC in women according to the study?

The overall prevalence of BAC was 14.8%, increasing with age.

What does the ProFound Heart Health AI algorithm aim to achieve?

The algorithm aims to standardize BAC detection, improving efficiency and reducing variability.

Why is early cardiovascular disease detection crucial for women?

Women with BAC are 51% more likely to develop heart disease, highlighting the importance of early detection.

How does AI software benefit the detection of breast arterial calcifications?

AI software aids in accurate BAC identification, leading to more consistent detection and reporting.