iCAD Reports Over 1,000 Licenses Sold as Part of ProFound AI Sales

Significant Percentage of Licenses Sold to Facilities with GE, Siemens, and Sites with Multiple Vendors Including Hologic and Fuji

ProFound AI for DBT Offers Superior Clinical Performance When Compared to Other Commercially Available Breast AI Systems

NASHUA, N.H., Nov. 24, 2020 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today reported that over 1,000 licenses have been sold as part of ProFound AI® sales since the products were launched, signaling the rapid and wide-spread adoption of the pioneering cancer detection software solution built on artificial intelligence (AI). The sales have been distributed across all major mammography system vendors and enterprise-wide viewing applications with a significant percentage to date sold to hospitals and imaging centers with GE and Siemens, as well as facilities with more than one imaging system vendor, including Hologic and Fuji.

The solid momentum is led by the Company’s growing customer base and demand for its expanded suite of leading breast health AI solutions, including ProFound AI for both Digital Breast Tomosynthesis (DBT) and 2D mammography, and interest in the recently introduced ProFound AI Risk, which is helping to transform breast cancer screening from age-based screening to risk-adapted precision screening, individualized for each woman.

“iCAD offers the full continuum of breast health AI products—both for the detection of current breast cancers and for future risk assessment,” said Michael Klein, Chairman and CEO of iCAD. “We do so on a non-exclusive, open architecture basis, therefore allowing all global customers access to the best of breed AI software available. Of significant note is that no other breast AI solution has been shown to improve radiologists’ clinical performance when reading DBT more so than ProFound AI. Specifically, our high-performing cancer detection and workflow solution offers the highest cancer detection rate, the lowest false positive rate and a dramatic 52.7% reduction in radiologists’ reading time, representing a high level of clinical significance and advantage.”

According to Kathy Schilling, MD, Medical Director of the Christine E. Lynn Women’s Health & Wellness Institute at the Boca Raton Regional Hospital, “ProFound AI for DBT rapidly and accurately analyze patients’ DBT mammography images, identifying suspicious lesions and producing quantifiable AI scores, which enables us to identify cancers earlier. The software also improves workflow issues, as we’re able to more quickly navigate through DBT datasets.”

ProFound AI Risk is the first and only commercially available clinical decision support tool to provide an accurate two-year breast cancer risk estimation based solely on a screening mammogram. Compelling research published in the peer-reviewed journal, Radiology concluded that the ProFound AI Risk model is effective at identifying women at high likelihood of being diagnosed with breast cancer within two years of a negative screening mammogram and in possible need of supplemental screening.

“I was very enthusiastic about the launch of ProFound AI Risk, which I believe is more accurate than the other risk tools I’ve used, and it is very easy to integrate into my daily workflow,” said Carine Van De Merckt, MD, Radiologist at Institut Jules Bordet in Brussels, Belgium. “Furthermore, it has proven to help me in my clinical decision making, allowing me to continue to provide the best care to my patients with even more confidence.”

As part of the Company’s growth, iCAD has recently achieved significant milestones, including:

• Sequential Revenue Growth of 44% in Third Quarter: The Company realized significant revenue growth over the second quarter in 2020, particularly with its innovative ProFound AI product offerings, which grew 44%.
• Strong International Growth: The Company, with products now distributed in 22 countries outside the U.S., recently signed distribution agreements in Switzerland and Portugal. The first ProFound AI for DBT sold in the United Kingdom and the first ProFound AI Risk sold in Belgium both occurred in October 2020.
• Distribution Agreement with Change Healthcare: A new agreement with the leading independent healthcare technology company, Change Healthcare, enhances commercial access to enterprise imaging and integrated delivery system networks throughout the U.S.

According to Change Healthcare’s Tracy Byers, Senior Vice President and General Manager of Imaging, as Change Healthcare looks to accelerate and transform enterprise imaging with the use of AI and cloud-native solutions, the partnership with iCAD enables them to offer their customers the ProFound AI platform as part of their Mammography Plus offering. “We are focused on radiologist productivity and aiding them with decision support tools that are elegantly integrated into their workflow,” said Byers. “The integration of iCAD’s AI solutions into our digital mammography platform will help improve patient outcomes by improving early cancer detection and enhancing clinical workflow. We could not be more excited about empowering our customers and our new partnership with iCAD.”

“iCAD’s momentum underscores the increasing demand for our comprehensive breast health AI solutions for DBT, breast density, and 2D mammography, offering clinicians a broad range of powerful tools for early disease detection and optimized reading workflow that results in improved patient outcomes,” said Stacey Stevens, president at iCAD. “This, coupled with ProFound AI’s seamless integration with major PACS for decision support capabilities across large networks, and ProFound AI’s compatibility with all leading mammography systems, allows hospitals and imaging centers with one or multi-vendor imaging systems to have a proven, standardized AI solution.

“Moreover, our principal approach to transforming breast cancer detection and care is best illustrated by our panoramic vision—to provide a more holistic view of each patient’s current imaging exam, history, and short-term risk,” continued Stevens. “With the addition of ProFound AI Risk, we intend to move mammography from primarily an age-based screening paradigm to a risk-adjusted precision screening paradigm that is truly personalized for every woman.”

About iCAD, Inc.

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

ProFound AI for DBT is proven to curtail workflow challenges substantially by reducing radiologists’ reading time by 52.7%, thereby reducing by half the amount of time it takes radiologists to read 3D mammography datasets. Additionally, the platform improved radiologists’ performance measured by Area Under the Curve (AUC) by nearly 6% and reduced unnecessary patient recall rates by more than 7%.ⁱ

ProFound AI Risk is currently available on an introductory basis for 2D mammography and will subsequently be available for the rapidly growing 3D mammography market.

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 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.

Media Inquiries:
Amy Cook, iCAD
+1 (925) 200-2125
acook@icadmed.com

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

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ⁱ 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