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This partnership builds on an existing research agreement whereby researchers at the Karolinska Institutet developed a breast cancer risk prediction model using information identified in mammography images provided by iCAD's AI cancer detection and density assessment solutions. Promising early results based on mammography images from over 70,000 Swedish women enrolled in The Karolinska Mammography Project for Risk Prediction of Breast Cancer (Karma) study were published in Breast Cancer Research in 2017. These data indicated that the model developed enabled early identification of women who were at a high-risk for breast cancer and it was determined that additional examinations were warranted. Since this publication, these results have been improved upon through the use of iCAD's latest ProFound™ AI algorithm. Among other things, the model now takes asymmetry of mammographic features and masking of tumors into consideration.
iCAD and the Karolinska Institutet researchers now intend to collaborate to develop an innovative solution for commercial use to assess an individual's risk of developing breast cancer. iCAD and the researchers have agreed to negotiate in good faith with the expectation of entering into an exclusive license agreement for the breast cancer risk assessment model.
According to the World Health Organization, breast cancer is the most prevalent cancer among women worldwide, impacting over 2 million women each year. Breast cancer screening and early detection are key to improving outcomes and survival rates. However, today, most mammography screening programs are not individualized, so a significant need exists to be able to identify individual risk of the disease in order to most effectively screen for breast cancer.
"Models that accurately predict an individual woman's risk of developing breast cancer are paramount to transitioning from age-based screening to risk-based screening," said Per Hall, Professor, Senior Physician, Karolinska Institutet. "Most current risk models are population-based and focus on lifetime or long-term risk. Our research using the iCAD AI technology has shown that by simply using the information available in the mammogram images, we can more accurately stratify women based on short-term risk. Understanding short-term risk will open the door to new paradigms in both the prevention and treatment of breast cancer."
iCAD announced the commercial availability of its ProFound AI for breast cancer detection in digital breast tomosynthesis in 2018, which delivers critical benefits, including improvements of cancer detection rates, a decrease in unnecessary patient recalls, and shorter reading times for radiologists.
"We envision the field of mammography moving from age-based screening protocols to 'risk adaptive screening'. Concurrently, we foresee the emergence of individualized breast screening protocols based on risk characteristics," said Mike Klein, Executive Chairman and CEO of iCAD. "This new frontier of predictive risk assessment for cancer is indicative of the continued expansion of our newly released ProFound AI offering for breast cancer detection. Correlating iCAD's high cancer detection rates, low false positive levels and a 50% reduction in reading time with the burgeoning volume of patent risk data, may provide a quantum leap in clinical efficacy and patient care.
We are extremely pleased to have the opportunity to partner with researchers from one of the most prestigious medical institutes in the world. The fusion of research from Karolinska Institute with iCAD's advanced AI capability has the potential to transform breast disease management. We envision that novel AI technology will further evolve the clinician and patient interface to a proactive disease management approach where prediction, and possibly even prevention, become a part of the clinical dialogue."
On Friday, March 1st at the European Congress of Radiology in Vienna, Austria, iCAD will host AI After Dark, an evening reception titled "New Frontier: Predicting Breast Cancer through AI." The event will feature industry leaders in breast health who will discuss their perspectives on how the industry is transforming breast cancer detection, and share their personal experiences with ProFound AI in research and clinical practice. In addition, Dr. Hall will discuss Karolinska's collaborative approach to a "risk stratified approach to breast cancer screening."
For more information about iCAD and its solutions or to register for a meeting or demonstration at ECR, please visit www.icadmed.com/ecr2019.html.
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.
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Certain statements contained in this News Release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. 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 possibility that the parties cannot agree on a definitive license agreement, Company's ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or 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", "would", "could", "consider", "project", "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, including the 10-K for the year ended December 31, 2017, available on the Investors section of our website at http://www.icadmed.com and on the SEC's website at http://www.sec.gov.
ARPR, on behalf of iCAD, Inc.
Paul Barren, (855) 300-8209
LifeSci Advisors, on behalf of iCAD, Inc.
Jeremy Feffer, (212) 915-2568
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