iCAD’s Breast AI Suite Empowers Customers to Lead the Way in Support of FDA’s National Breast Density Reporting Standard

NASHUA, N.H., March 23, 2023 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced its technologies are empowering customers to lead the way in breast care, while supporting the national breast density reporting standard recently established by the U.S. Food and Drug Administration (FDA). The Company will be showcasing its Breast AI Suite at the National Consortium of Breast Centers (NCoBC) Annual Conference in Las Vegas, NV from March 25-27 in the iCAD booth (#106).

“We applaud the FDA for its recent decision to implement a national breast density reporting standard. This is a significant advancement, as nearly 50% of all women aged 40 and over have dense breasts, one of the strongest and most prevalent breast cancer risk factors,”^i,ii said Dana Brown, President and CEO of iCAD, Inc. “However, dense breast notifications are only as effective as the assessments themselves, as studies show wide variation in visual assessment agreement, and radiologists may even disagree with their own assessment year to year.ⁱⁱⁱ This can be confusing for patients, lead to unnecessary additional imaging, and increase patient and facility costs.”

“With thousands of installations in more than 20 countries, iCAD’s breast health solutions are trusted by the country’s largest and most prestigious imaging centers and hospitals. Our technologies not only meet the needs recently outlined by the FDA, but they have long been used worldwide to enhance patient care and personalize results. With our Breast AI Suite, our customers are well-equipped to provide accurate breast density assessments, and we expect more facilities to demand this technology as they work to bring care standards in line with new federal regulations,” Ms. Brown added.

The Company’s Breast AI Suite offers a 360-degree solution of clinically proven cancer detection, density assessment, and risk evaluation technologies, including PowerLook^® Density Assessment, the world’s first multi-vendor deep-learning algorithm for standardizing breast density assessments using synthesized 2D images. PowerLook Density Assessment removes the challenges of subjectivity in breast density reporting, offering accurate and reproducible breast density assessments. This innovative solution analyzes the woman’s breast anatomy and categorizes her breast density within the appropriate BI-RADS^® 5th edition density category, automating the process of breast density reporting and empowering clinicians to further personalize breast cancer screening recommendations for patients. In a large study, PowerLook Density Assessment correctly classified density and demonstrated substantial agreement with radiologists for 99.8% of cases.^iv

“Last year we adopted iCAD’s Breast AI Suite, which includes PowerLook Density Assessment, across the majority of our enterprise as we see tremendous value in offering the highest level of sophistication to our mammography interpretation,” said Chirag Parghi, M.D., Chief Medical Officer, Solis Mammography, the largest independent provider of breast screening and diagnostic services in the United States. “At the heart of the FDA guidelines is a campaign to inform our patients about their anatomic composition of their breasts and we are partnering with iCAD to offer a complete understanding of this composition. Women need to be informed of their breast density as it is directly associated with their individual risk of breast cancer.”

Dense breasts can make it challenging to detect breast cancer during annual screenings as overlapping tissue can camouflage breast cancer, even with digital breast tomosynthesis (DBT) exams. Women with dense breasts have a 20% higher risk of developing breast cancer compared to women with non-dense breasts.^v

“As an early adopter of iCAD’s technology, I have been using PowerLook Density Assessment for nearly five years now and I cannot imagine reading mammography without it,” said Randy Hicks, M.D., MBA, owner and CEO of Regional Medical Imaging (RMI). “PowerLook Density assessment not only offers incredibly accurate and reliable results, but it has streamlined our process for reporting breast density results, both to techs and to patients. With this technology, we are more than prepared to offer patients critical information about their breast health that easily meets or exceeds what is now required by the FDA. We are proud to offer iCAD’s technology on every mammogram across all nine RMI locations, and we have found that it considerably improves operational efficiency, clinician confidence, and patient care.”

“For more than 10 years, Radiology Partners has been committed to providing the highest quality breast screening across our enterprise of more than 3,000 facilities. The recent FDA decision to implement a national reporting standard further validates what we have known for some time: understanding a patient’s breast density is a key component to preserving her breast health. We believe AI is essential to our ability to deliver the most informed results to our patients, which is why we decided to adopt iCAD’s comprehensive solution. We look forward to offering these leading technologies to further strengthen clinical performance and patient care nationwide,” said Nina Kottler, M.D., Associate CMO for Clinical Artificial Intelligence at Radiology Partners, the largest radiology practice in the U.S.

In addition to establishing partnerships with the nation’s leading imaging facilities, iCAD has also joined forces with several patient advocacy organizations focused on raising awareness of the importance of knowing one’s breast density.

“For 13 years, my mammograms came back ‘normal,’ but I had a walnut-sized tumor growing in my breast that was not visible on mammograms due to my breast density,” said Cynthia Jordan, founder and CEO, Learn Look Locate. “As a breast cancer survivor and patient advocate, I have worked tirelessly to raise awareness of this important issue, and this long-awaited FDA decision comes as a relief. Women across the country will now be equally offered information that could save their lives. With technology like iCAD’s, we can ensure more women avoid situations like mine and are empowered to take control of their breast health.”

“With the FDA’s implementation of a national breast density reporting standard, now more than ever, hospitals and imaging centers nationwide need technology that can not only automate results, but also improve accuracy,” said Ms. Brown. “When it comes to breast health, knowledge is power and our world-leading AI solutions put that power back in the hands of providers, ensuring patients receive the right screening at the right time to detect disease as early as possible. This is critical, because when breast cancer is detected early, clinicians have more options to fight it, treatment can be shorter and less invasive, the impact can be minimized, and ultimately, lives can be saved. We look forward to sharing our world-class portfolio with the NCoBC community again this year.”

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.

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 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.

Contact:

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

Investor Inquiries:
iCAD Investor Relations
ir@icadmed.com

ⁱ National Cancer Institute. Dense Breasts: Answers to Commonly Asked Questions. Accessed via https://www.cancer.gov/types/breast/breast-changes/dense-breasts.
ⁱⁱ Engmann NJ, Golmakani MK, Miglioretti DL, Sprague BL, Kerlikowske K, Breast Cancer Surveillance C. Population-Attributable Risk Proportion of Clinical Risk Factors for Breast Cancer. JAMA Oncology 2017; 3:1228-1236.
ⁱⁱⁱ Sprague B, Conant E, Onega T et al. Variation in Mammographic Breast Density Assessments Among Radiologists in Clinical Practice: A Multicenter Observational Study. Ann Intern Med. 2016; 165(7):457-464. doi:10.7326/M15-2934.
^iv iCAD data on file.
^v Beidler LB, Kressin NR, Wormwood JB, Battaglia TA, Slanetz PJ, Gunn CM. Perceptions of Breast Cancer Risks Among Women Receiving Mammograph Screening. JAMA Netw Open. 2023;6(1):e2252209. doi:10.1001/jamanetworkopen.2022.52209.