ProFound AI™ Risk Receives CE Mark in Europe

7/15, 2:00 PM (Source: GlobeNewswire)

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First and only commercially available clinical decision support tool provides accurate two-year breast cancer risk estimation personalized for each woman

iCAD unveils new technology and clinical research at major medical conference

NASHUA, N.H., July 15, 2020 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced ProFound AI™ Risk received a CE Mark in Europe. ProFound AI Risk is the first and only clinical decision support tool that provides an accurate two-year, breast cancer risk estimation that is truly personalized for each woman, based only on a screening mammogram. The Company unveiled the technology at the European Congress of Radiology (ECR) virtual meeting from July 15-19, 2020. New data supporting ProFound AI™ will also be presented at the meeting. Information about these products will be available in the virtual iCAD booth (https://ecr2020.expo-ip.com/icad) throughout the meeting.

ProFound AI Risk uniquely combines a range of risk factors, including age, breast density and subtle mammographic features, offering superior performance in assessing short-term risk compared to traditional breast cancer risk models.i It offers an easy-to-implement solution that provides superior insightsii that empower clinicians to tailor a woman’s breast screening regimen and potentially identify cancers earlier.

“At last year’s Radiological Society of North America (RSNA) Annual Meeting, we introduced Panorama Powered by ProFound AI, which will enable clinicians to provide more tailored and personalized patient care. With ProFound AI Risk, this concept is coming to life. The CE Marking of this technology is a significant milestone that represents the Company’s continued efforts to globally commercialize leading-edge solutions that are positioned to enhance patient care and improve outcomes,” said Stacey Stevens, President of iCAD. “ProFound AI Risk has the potential to address a significant unmet need in breast cancer screening, with an eligible screening population of approximately 250 million women worldwide.iii ProFound AI Risk offers a more holistic clinical approach that can provide clinicians with a broader view of each individual patient’s case and two year breast cancer risk. This technology offers more valuable insights for clinicians, compared to other risk models, which offer five or 10 year-risk estimates. ProFound AI Risk will be available for 2D mammography, which is particularly applicable for the European market, where 2D mammography is still primarily used for breast cancer screening.”

ProFound AI Risk is the latest addition to iCAD’s suite of breast health solutions, which includes ProFound AI™ for Digital Breast Tomosynthesis (DBT), ProFound AI™ for 2D Mammography, and software solutions for automated breast density assessment. ProFound AI is a deep-learning, artificial intelligence (AI) cancer detection software solution, available for 2D and 3D mammography, or digital breast tomosynthesis (DBT).

“We have had outstanding feedback from our European customers on the clinical value that ProFound AI has brought to their practices. Our AI solution is currently being used daily in a growing number of leading hospitals and imaging centers across Europe, and its adoption continues to grow as more doctors and facilities learn of the benefits it offers to both physicians and patients. This powerful software empowers doctors to find breast cancers earlier, when they may be more easily treated, while reducing the rate of false positives, which could lead to fewer unnecessary biopsies or treatments.iv Additionally, it is particularly effective in challenging cases, such as those with dense breast tissue,v” said Michele Debain, Vice President, Europe, Middle East, Africa, iCAD.

Positive new data supporting ProFound AI will be presented in several abstracts at the virtual ECR meeting. Of note, the efficacy of ProFound AI for 2D Mammography was validated in a study led by Sylvia H. Heywang-Köbrunner, MD, titled “The value of 2D-AI-based CAD for second or third reading tested on 17,910 screening mammograms” (abstract RPS 702-4). This study examined 18,002 consecutive screening mammograms acquired between January and November 2018, which were anonymized and processed using ProFound AI for 2D Mammography. The AI technology’s ability to detect cancers was superior to that of two radiologists, who read the same cases. ProFound AI for 2D Mammography achieved a sensitivity of 91.5 percent and a specificity of 80.2 percent for 32 ductal carcinoma in situ (DCIS) and 85 invasive cancers. The findings of this study suggest that while AI may not be a replacement for radiologists, it is a valuable tool that can enhance performance and offer better sensitivity than a second reading by radiologists.

“ProFound AI improves my diagnostic confidence. It helps me move faster on negative cases and assists me in discovering positive findings, so that I can focus more time on difficult cases,” according to Dr. Michael Gruber, Radiologist, Radiologische Gruppenpraxis Baden, Austria.

Other relevant abstracts featured during the meeting include:

  • RPS 605b-6: “Breast cancer detection by mammographic view with artificial intelligence in digital breast tomosynthesis,” by Emily F. Conant, MD, professor and chief of breast imaging from the Department of Radiology at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia
  • RPS 602b-1: “Identification of women at high risk of breast cancer and in need of supplementary screening,” by Mikael Eriksson, MD, PhD, Karolinska Institutet

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions.

ProFound AI™ is a high-performing workflow solution for 2D and 3D mammography, or digital breast tomosynthesis (DBT), featuring the latest in deep-learning artificial intelligence. In 2018, ProFound AI for Digital Breast Tomosynthesis (DBT) became the first artificial intelligence (AI) software for DBT to be FDA-cleared; it was also CE marked and Health Canada licensed that same year. It offers clinically proven time-savings benefits to radiologists, including a reduction of reading time by 52.7 percent, thereby halving the amount of time it takes radiologists to read 3D mammography datasets. Additionally, ProFound AI for DBT improved radiologist sensitivity by 8 percent and reduced unnecessary patient recall rates by 7.2 percent.8

The Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is FDA-cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. It uses a proprietary miniaturized x-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, while minimizing risk of damage to healthy tissue in nearby areas of the body.

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 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 ability of ProFound AI Risk to enable clinicians to provide more tailored and personalized patient care, to address a significant unmet need, to provide clinical value, lead to fewer unnecessary biopsies, to be more beneficial for patients, to be accepted by clinicians, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, 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,” “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.

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

Europe:
Emmanuelle Vella, iCAD
+33 6 20 49 48 57
evella@icadmed.com

FP2COM
Florence Portejoie
+ 33 6 07 76 82 83
fportejoie@fp2com.fr

Investor Relations:
Jeremy Feffer, LifeSci Advisors
+1-212-915-2568
jeremy@lifesciadvisors.com

i Brentall A, Harkness E, Astley S et al. Mammographic density adds accuracy to both the Tyrer-Cuzick and Gail breast cancer risk models in a prospective UK screening
cohort. Breast Cancer Res. 2015; 17,147.

ii iCAD data on file

iii Renub Research (2014) Breast Cancer Screening (Mammography, MRI & Ultrasound) Market & Forecast – Worldwide. http://www.renub.com/breast-cancer-screening-mammography-mri-and-ultrasound-market-and-forecast-worldwide-63-p.php

iv 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

v Hoffmeister, J. (2018). Artificial Intelligence for Digital Breast Tomosynthesis – Reader Study Results. [White paper]. Accessed via https://www.icadmed.com/assets/dmm253-reader-studies-results-rev-a.pdf

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