iCAD’s ProFound Detection Version 4.0 Receives FDA Clearance

NASHUA, NH, Nov. 12, 2024 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ: ICAD) (“iCAD” or the “Company”), a global leader in clinically proven AI-powered cancer detection solutions, today announced that its ProFound Detection version 4.0 for digital breast tomosynthesis (DBT) has received US Food and Drug Administration (FDA) clearance. This next-generation AI solution, trained with advanced deep learning convolutional neural networks (CNN), delivers advances in cancer detection and specificity, achieving a 6.3% improvement in area under the previous version Receiver Operating Characteristic Curve (AUC), which significantly improves the identification of hard-to-find and aggressive cancers while reducing false positives. Additionally, this version offers physicians the ability to include a previous exam in the ProFound Detection analysis of a current exam.

With over 20 years of innovation and experience, iCAD became the first company to bring an FDA-cleared AI solution for DBT to market in 2016. ProFound Detection Version 4.0 now extends this groundbreaking legacy with improvements in detection and precision. With today’s FDA approval, ProFound Detection version 4.0 is now available for implementation in the United States. Further global and manufacturer-specific regulatory expansions are expected by 2025.

Beyond improved clinical performance, ProFound Detection version 4.0 offers significant growth potential for iCAD. As existing and new customers upgrade to this latest version and adopt cloud-based deployment and subscription programs, iCAD expects to see continued annual recurring revenue (ARR) growth. This strategic shift to the cloud enables facilities to remain at the forefront of AI advancements while benefiting from improved scalability, continuous updates, and optimized operational efficiency.

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

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

“With the FDA approval of ProFound Detection Version 4.0, iCAD continues to set new standards in cancer detection, particularly in the most challenging cases where accurate and early detection is critical,” said Dana Brown, President and CEO of iCAD. “This groundbreaking fourth generation of our AI solution not only improves the detection of cancers most feared by even experienced breast radiologists, but also reduces the burden of potential false positives, providing physicians with a highly accurate and efficient AI reader.” Solution. We believe this advancement strengthens our competitive position and represents a strong driver for long-term growth.”

“ProFound Detection Version 4.0 will significantly improve breast cancer detection,” said Dr. Chirag Parghi, MD, MBA, Chief Medical Officer at Solis Mammography. “The latest version’s ability to detect subtle invasive cancers, particularly in dense breast tissue, addresses one of the biggest challenges in breast imaging today. ProFound Detection’s improved lesion marking precision, combined with the option to incorporate previous examinations, enables improved clinical accuracy and more efficient reporting workflows. Taken together, these upgrades will improve the AI-powered interpretation experience and lead to meaningful AI adoption.”

In addition to improved cancer detection capabilities, ProFound Detection version 4.0 provides more precise lesion marking with an 18% improvement in unmarked cases, reducing potential false positives through improved specificity performance. This includes:

20% fewer stains associated with vascular calcification and
51% fewer spots associated with non-vascular calcifications.

In a significant advancement, ProFound Detection version 4.0 enables physicians to incorporate a previous exam into their AI analysis and case score/lesion assessment of the current case, mimicking the approach radiologists take when interpreting current screening exams with historical context. By integrating previous imaging data, the software provides greater precision and insight, further improving clinical decision making.

iCAD will showcase this next-generation AI, along with its end-to-end breast health AI suite and recently launched ProFound Cloud delivery solutions, at the upcoming 2024 Radiological Society of North America (RSNA) Annual Meeting in Chicago, Illinois , from December 1st^st until December 4th^Th. Visit iCAD’s RSNA events 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 cannot hide by providing clinically proven AI-powered solutions that enable healthcare providers to accurately identify cancer earlier and reliably detect and improve treatment outcomes for patients. Headquartered in Nashua, NH, iCAD’s industry-leading ProFound Breast Health Suite provides AI-powered mammography analysis for breast cancer detection, density assessment and risk assessment. ProFound is used by thousands of providers caring for millions of patients and is available in over 50 countries. In the last five years alone, iCAD estimates that more than 40 million mammograms have been performed worldwide, almost 30% of which were tomosynthesis. For more information, including the latest regulatory approvals, visit www.icadmed.com.

Forward-Looking Statements

Certain statements contained in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding expanding access to the Company’s products, improving performance, accelerating adoption and the expected benefits of ProFound AI^®the benefits of the Company’s products and the 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 Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements . These factors include, but are not limited to, the Company’s ability to achieve business and strategic objectives, patients’ willingness to undergo mammography screening, whether mammography screening is treated as an essential procedure, whether ProFound AI reads efficiency and specificity and sensitivity, the reduction of false positives and other benefits to patients and clinicians, the impact of supply and manufacturing limitations or difficulties on our ability to fulfill our orders, the uncertainty of future sales levels, defense in litigation, 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 associated with our existing and future debt obligations, competitive factors, the impact of a decline in the economy or markets that the Company serves ; 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 these forward-looking statements, which speak only as of the date the statement is made. The Company has no obligation to provide any updates to the information contained in this press release. For further disclosures regarding these and other risks facing iCAD, please see the disclosures in our public filings with the Securities and Exchange Commission, which are available in the Investors section of our website at https://www.icadmed.com and at the SEC website at https://www.sec.gov.

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