New Real-World Evidence Shows ProFound AI Improves Cancer Detection and Accuracy with Digital Breast Tomosynthesis, or 3D Mammography

NASHUA, N.H., May 18, 2022 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that new research supporting ProFound AI^® for Digital Breast Tomosynthesis (DBT) will be presented at the Society of Breast Imaging (SBI/ACR) Breast Imaging Symposium, taking place May 16-19 in Savannah, GA. The Company is also showcasing its complete suite of deep-learning breast cancer detection, density assessment and risk evaluation solutions in the iCAD booth (#504) during the meeting.

In an oral presentation today at 1:30 pm EDT, Colleen Madden, MD, FACR, Assistant Clinical Professor of Radiology at IUH Ball Memorial Hospital at Indiana University School of Medicine, will present promising findings from a retrospective study titled, “Real-World Breast Cancer Detection Before and After the Implementation of an Artificial Intelligence Detection System in a Digital Breast Tomosynthesis Screening Program.” According to study findings, using ProFound AI in clinical practice with DBT, or 3D mammography, significantly enhanced radiologists’ screening performance, improved cancer detection rates and reduced the rate of false positives.

“This recent investigator initiated study confirms ProFound AI offers invaluable insight that helps radiologists to identify cancers more efficiently and accurately, which could dramatically improve outcomes for patients,” said Stacey Stevens, President and CEO of iCAD, Inc. “iCAD is the only company to provide a complete portfolio of unrivaled¹ AI solutions designed to help radiologists find cancers earlier, while reducing false positives and unnecessary patient recalls,^1,2 which can cause unnecessary stress for a woman and her family.”

The first AI cancer detection software for DBT to be cleared by the FDA, ProFound AI is clinically proven to offer superior performance, reduce radiologists' reading time by 52.7 percent, improve radiologists' sensitivity by eight percent and reduce unnecessary patient recall rates by 7.2 percent.² The latest generation of ProFound AI offers up to a 10% improvement in specificity performance, compared to previous versions of the technology, while maintaining an industry-leading high sensitivity level, and approximately 40% faster processing on the new PowerLook platform.³

“Overall, this real-world study suggests ProFound AI can help radiologists find more cancers, and with greater accuracy, indicating that this innovative tool can not only enhance clinical performance but also potentially improve outcomes for patients,” said Dr. Madden. “While AI does not eliminate the need for radiologists, it does extend their capabilities considerably, as it greatly assists clinicians in reviewing large DBT datasets and ultimately providing quality care for our patients. We are pleased that this study contributes to the growing body of research that demonstrates the value AI offers in breast cancer screening.”

“We are committed to helping radiologists transform breast cancer screening and detection by decreasing reading time and improving their reading accuracy, with up to two times the improvement in clinical performance compared to leading competitors,”¹ added Stevens. “These latest data indicate ProFound AI significantly improves radiologists’ performance and helps to reduce their workload, allowing for more time with patients and for additional, potentially complex cases.”

iCAD's Breast AI Suite also includes PowerLook® Breast Density Assessment, which aids in accurate and consistent density-based stratification and reporting, and ProFound AI® Risk, the world's first and only clinical decision support tool that provides an accurate short-term, breast cancer risk estimation that is truly personalized for each woman, based on age, breast density, and mammographic features.

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD® is a global medical technology leader providing innovative cancer detection and therapy solutions. For more information, visit www.icadmed.com and www.xoftinc.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 expected benefits of ProFound AI®, the benefits of the Company’s products, external factors affecting the market for our products, behavior of clients and prospective clients, 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 which 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.

Media Inquiries:
Jessica Burns, iCAD
+1-201-423-4492
jburns@icadmed.com

Investor Inquiries:
iCAD Investor Relations
ir@icadmed.com

References :

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Accessed 1-19-22. FDA 510K submissions K182373, K201019, K193229.
2. Conant, E et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4). Accessed via https://pubs.rsna.org/doi/10.1148/ryai.2019180096.
3. iCAD data on file. Standalone performance varies by vendor. FDA Cleared.