iCAD Announces Exceptional Study Results Demonstrating Significant Advantages of Revolutionary Artificial Intelligence Technology for Digital Breast Tomosynthesis

Results demonstrate unprecedented improvements in clinical performance and reading times, validating the substantial benefits of artificial intelligence when used with 3D mammography

Company to showcase latest innovations in cancer detection at The European Society of Breast Imaging annual meeting in booth 14

NASHUA, N.H. and ATHENS, Greece, Oct. 11, 2018 — iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced outstanding clinical results of its new, leading-edge digital breast tomosynthesis (DBT) cancer detection software. The study demonstrated significant positive results for clinical performance and workflow efficiency.

The findings confirmed that the latest artificial intelligence (AI) software solution to support DBT increased improvements in both reader sensitivity (8.0 percent on average) and specificity (6.9 percent on average). In addition, when reading tomosynthesis cases with the solution, radiologists’ reading times were reduced by more than half (52.7 percent on average). 

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“As incidence rates of breast cancer continue to rise, we are proud to provide valuable technology that is proven to significantly improve detection rates while reducing unnecessary recalls resulting from false positives. We also understand that radiologists are concerned about the extra workload and long reading times of tomosynthesis cases in everyday practice and we are pleased to have created a meaningful solution to address this problem,” said Jeff Hoffmeister, MD, Vice President and Medical Director at iCAD. “As tomosynthesis moves into the screening arena, our AI software provides important benefits to radiologists, their practices, and their patients.”

“iCAD’s unique technology assists me in detecting more cancers, reassures me of my findings, and helps me concentrate on the essential work of a radiologist. The product reduced my reading time by approximately 50 percent, allowing me to read these cases in nearly the same amount of time as 2D mammograms. I consider it to be one of the greatest tools in modern radiology,” said Dr. Axel Gräwingholt, Radiologie am Theater, Paderborn, Germany.

iCAD’s high-performance, concurrent read, cancer detection and workflow solution for breast tomosynthesis delivers critical benefits to both radiologists and their patients. The new technology is trained to detect malignancies and determine the probability of malignant findings, providing radiologists with a “certainty of finding” score for each case and each detected lesion. These scores represent the algorithm’s confidence that the detected soft tissue densities (masses, architectural distortions and asymmetries) and calcifications are malignant.

“Upon receiving CE mark approval and showcasing our solution at the European Congress of Radiology earlier this year, we’ve seen tremendous interest in our product among European radiologists,” said Ken Ferry, CEO of iCAD. “We are proud to be able to offer providers and patients alike greater access to an advanced breast cancer detection solution that is proven to substantially increase cancer detection performance and help to dramatically streamline workflows.”

iCAD’s revolutionary AI technology is available for use with leading digital breast tomosynthesis systems in Europe. The solution is pending clearance by the United States Food and Drug Administration (FDA). The company will showcase its latest innovations in cancer detection at The European Society of Breast Imaging annual meeting in booth 14 from October 11-13 at the Megaron Athens International Conference Center, Megaro Mousikis Athinon in Athens, Greece.

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.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995

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 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.

Contact:

Media Inquiries:

ARPR, on behalf of iCAD, Inc. Paul Barren, +1 (855) 300-8209 [email protected]

Investor Relations: LifeSci Advisors Jeremy Feffer, +1 (212) 915-2568 [email protected]

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