iCAD’s ProFound Detection Version 4.0 Gains FDA Clearance

Provides 22% Overall Improvement in Detecting Challenging and Aggressive Cancer Subtypes and Enables Clinicians to Incorporate a Prior Exam into Current Screening Analysis

NASHUA, N.H., Nov. 12, 2024 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ: ICAD) (“iCAD” or the “Company”) a global leader in clinically proven AI-powered cancer detection solutions, announced today that its ProFound Detection Version 4.0 for Digital Breast Tomosynthesis (DBT) has received clearance from the U.S. Food and Drug Administration (FDA). This next-generation AI solution, trained using advanced deep learning convolutional neural networks (CNN), offers advancements in cancer detection and specificity, achieving a 6.3% improved area under the receiver operating characteristic curve (AUC) over prior version, significantly improving the identification of hard-to-find and aggressive cancers while reducing false positives. Additionally, this version introduces an option for clinicians to incorporate a prior exam into a current exam’s ProFound Detection analysis.

With over 20 years of innovation and experience, iCAD was the first to introduce an FDA-cleared AI solution for DBT in 2016. ProFound Detection Version 4.0 now extends that pioneering legacy by offering enhancements in detection and precision. With today’s FDA clearance, ProFound Detection Version 4.0 is now available for implementation in the U.S. Additional global and vendor-specific regulatory expansions are anticipated through 2025.

Beyond its enhanced clinical performance, ProFound Detection Version 4.0 presents substantial growth potential for iCAD. As existing and new customers upgrade to this latest version and adopt cloud-based deployment and subscription programs, iCAD anticipates steady growth in Annual Recurring Revenue (ARR). This strategic shift to the cloud enables facilities to remain at the forefront of AI advancements while benefiting from enhanced scalability, continuous updates, and streamlined operational efficiency.

Compared to previous version 3, ProFound Detection Version 4.0 provides a 22% overall improvement in detecting some of the most challenging and aggressive cancer subtypes, including:

• 50% improvement in identifying cancers within dense breast tissue,
• 60% improvement in identifying invasive lobular cancers,
• 21% improvement in detecting invasive cancers, and
• 38% improvement in identifying cancers smaller than 1 cm

“With FDA clearance of ProFound Detection Version 4.0, iCAD continues to set new benchmarks in cancer detection, especially in the most challenging cases where accurate and early detection is critical,” said Dana Brown, President and CEO, iCAD. “This groundbreaking fourth generation of our AI solution not only enhances detection for cancers feared most by even the expert fellowship-trained breast radiologists, but also reduces the burden of potential false positives, thereby providing clinicians with a highly precise and efficient AI concurrent-reader solution. We believe this advancement strengthens our competitive position and represents a powerful driver for long-term growth.”

“ProFound Detection Version 4.0 will dramatically improve breast cancer detection,” said Dr. Chirag Parghi, MD, MBA, Chief Medical Officer at Solis Mammography. “The newest version’s ability to detect subtle invasive cancers, especially within dense breast tissue, addresses one of the biggest challenges in breast imaging today. The improved precision in ProFound Detection’s lesion marking combined with the option to incorporate prior exams allows for improved clinical accuracy and more efficient reading workflows. Collectively, these upgrades will enhance the AI-enriched interpretation experience leading to meaningful adoption of AI.”

Along with improved cancer detection capabilities, ProFound Detection Version 4.0 delivers more precise lesion marking, with an 18% improvement in cases with no marks, reducing potential false positives by enhanced specificity performance. This includes:

• 20% fewer marks related to vascular calcifications, and
• 51% fewer marks related to non-vascular calcifications.

In a significant leap forward, ProFound Detection Version 4.0 enables clinicians to incorporate a prior exam into its AI analysis and case-score/lesion assessment on the current case, emulating the approach radiologists take when interpreting current screening exams with historical context. By integrating prior imaging data, the software provides greater precision and insight, further enhancing clinical decision-making.

iCAD will showcase this next-generation AI, along with its end-to-end breast health AI suite and the recently launched ProFound Cloud deployment solutions, at the upcoming 2024 Radiological Society of North America (RSNA) annual meeting, held in Chicago, IL, from December 1^st to December 4^th. Visit iCAD’s RSNA event page to learn more and book a live demonstration: https://www.icadmed.com/about/news-events/upcoming-tradeshows-and-meetings/rsna-2024.

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, 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 https://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

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