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New Research Finds iCAD’s ProFound AI Risk for Digital Breast Tomosynthesis is 2.4x More Accurate than Traditional Lifetime Risk Models

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iCAD inc.

iCAD inc.

Using US guidelines, ProFound AI Risk found that 14% of women studied who screened negative had an almost 20 times greater risk of developing breast cancer within the next year than the general at-risk population.

NASHUA, NH, May 16, 2022 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ:ICAD), a global medical technology leader providing innovative cancer detection and treatment solutions, today announced that clinical research promising supporting ProFound AI® Digital Breast Tomosynthesis (DBT) Risk – the world’s first clinical decision support tool that provides an accurate estimate of short-term breast cancer risk based on age, breast density and characteristics mammograms – was recently published in the peer-reviewed journal, Science Translational Medicine.I

In the study, which involved 154,200 women screened at four participating U.S. screening sitesii using DBT from 2014 to 2019, researchers at Karolinska Institutet in Stockholm, Sweden found that ProFound AI Risk accurately determined which women were at higher risk of developing breast cancer, with an area under the curve receiver operating characteristics (AUC) of 0.82I, (95% CI 0.79-0.85). AUC is a standard performance measure for examination procedures that integrates sensitivity and specificity into a single measure of overall performance. These data support iCAD’s internal research, which previously found that ProFound AI Risk for DBT offers an AUC of 0.80 (95% CI 0.76, 0.83).iii

“iCAD’s Breast AI Suite offers a comprehensive portfolio of unparalleled AI solutions for breast cancer detection, density assessment, and short-term risk assessment, and we’re excited to see this data further validate the clinical value of ProFound AI Risk, the latest addition to our breast AI portfolio,” said Stacey Stevens, President and CEO of iCAD, Inc. “Physicians have traditionally estimated the risk of breast cancer by looking at the patient’s known risk factors, such as family history, but about 85% of breast cancers occur in women who do not have a family history of breast cancer.iv Additionally, traditional long-term risk models may not be as accurate in estimating a woman’s risk of developing breast cancer, as their average AUC is around 0.60.v ProFound AI Risk offers a more individualized approach, as it includes a woman’s mammogram images and focuses one to two years into the future, providing critical information that can help clinicians customize screening treatment regimens breast cancer screening for patients based on their individual risk of developing cancer before or at their next screening.

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Established lifestyle and family risk models, such as Tyrer-Cuzick and Gail, are currently used in the United States to identify women with a greater than 20% lifetime risk of developing breast cancer at who could be offered magnetic resonance imaging (MRI) of the breast as a complementary screening modality for the detection of breast cancer.I However, these long-term risk patterns may result in a high number of false positives due to low to moderate discrimination performance.vi ProFound AI Risk complements traditional risk models and is easy for clinicians and medical institutions to adopt, as it only requires images from a 2D or 3D mammogram, with no questionnaires, portals, or staff required for implementation.

Using US guidelines, the researchers determined that 14% of the women studied were at high risk after a negative or benign screening, with an almost 20 times higher risk of developing breast cancer, compared to the general at-risk population. . In this high-risk group, 76% of stage II cancers or higher, 59% of stage 0 cancers and 58% of stage 1 cancers were observed.

The researchers estimated that if the 12% of women most at risk had been offered additional screening based on the ProFound AI Risk for DBT model, up to 59% of cancers could have been detected, compared to 24% of cancers. using Tyrer–Cuzick. This corresponds to a sensitivity 2.4 times higher than Tyrer-Cuzick.

“Our research showed that women who ProFound AI Risk determined to be at high risk were more likely to have advanced-stage tumors than early-stage cancers,” according to the study’s lead author, Mikael Eriksson, PhD, Karolinska Institutet. “Breast cancer survival is known to be 4 to 12 times worse for stage II and III cancers compared to stage 0 and I cancers in the first four years after diagnosis. Additionally, the cost of treating stage II and III cancers is more than double that of stage 0 and I cancers within the first 24 months of diagnosis. ProFound AI Risk offers the opportunity to help radiologists refine personalized screening recommendations and discuss risks with women, which in turn could influence their compliance with the screening regimen and potentially lead to earlier detection, lower treatment costs and better results.

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The researchers also found that ProFound AI Risk provided high accuracy in estimating future risk for invasive and in situ cancers, screen-detected and interval cancers, and in women with dense and non-dense breasts.

“Early detection of cancer can have a huge impact on women, from treatment to outcome. And because women are often gatekeepers, improving women’s health outcomes can also have cascading benefits for children, families and communities,” Stevens added. “Only iCAD’s Breast AI Suite offers clinicians unprecedented insight into the present and future of every patient, which holds the potential to transform the trajectory of a woman’s outcome and life. “

About iCAD, Inc.

Based in Nashua, NH, iCAD® is a world leader in medical technologies providing innovative solutions for the detection and treatment of cancer. For more information, visit www.icadmed.com.

Forward-looking statements
Certain statements in this press 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® Risk, the implications of clinical studies, the benefits of the Company’s products, external factors affecting the market for our products, the behavior of customers and potential customers, and the future prospects of the Company’s technology platforms and products. These 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. -understood by these statements. forward-looking statements. These factors include, but are not limited to, the Company’s ability to achieve its business and strategic objectives, the willingness of patients to undergo mammography screening in light of the risks of potential exposure to Covid-19, if the Mammography screening will be treated as an essential procedure, if ProFound AI will improve read efficiency, improve specificity and sensitivity, reduce false positives, and otherwise prove more beneficial to patients and clinicians, the impact of supply and manufacturing constraints or difficulties over our ability to fulfill our orders, uncertainty of future sales levels, to defend against litigation, protection of patents and other proprietary rights, market acceptance of products, obsolescence possible product technology, increased competition, government regulation, changes in Medicare or other reimbursement policies, ri risks relating to our existing and future debt, competitive factors, the effects of a decline in the economy or the 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 these forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide updates to the information contained in this release. For additional information regarding these and other risks that iCAD faces, please see the information contained in our public filings with the Securities and Exchange Commission, available in the Investors section of our website at http:/ /www.icadmed.com and on the SEC website. website at http://www.sec.gov.

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Media inquiries:
Jessica Burns, iCAD
+1-201-423-4492
[email protected]

Investor requests:
iCAD Investor Relations
[email protected]

I Eriksson, M et al. A risk model for digital breast tomosynthesis to predict breast cancer and guide clinical care. Science translational medicine. 14 (644). May 11, 2022. Accessed via https://www.science.org/doi/10.1126/scitranslmed.abn3971.
ii Participating US testing sites: Boca Raton Regional Hospital, Boca Raton, FL; Elizabeth Wende Breast Care, Rochester, NY; Larchmont, NJ; Zwanger-Pesiri Radiology, Lindenhurst, NY.
iii iCAD data on file. Variations by provider and population may occur. ProFound AI Risk is a clinical decision support tool. The information is reviewed by the doctor. All care decisions belong to physicians.
iv Breastcancer.org. US breast cancer statistics. Accessed via https://www.breastcancer.org/symptoms/understand_bc/statistics.
v Eriksson M, Czene K, Strand F et al. Identification of women at high risk for breast cancer who need additional screening. Radiology. September 8, 2020. Accessed via https://doi.org/10.1148/radiol.2020201620.
vi MH Gail, RM Pfeiffer, Breast cancer risk model requirements for counselling, prevention and screening. J. Natl. Cancer Institute 110, 994-1002 (2018).

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