iCAD Signs Global Distribution Agreement with Sectra

Agreement will expand access to ProFound AI and ProFound AI Risk to more facilities and imaging centers worldwide

NASHUA, N.H., June 08, 2021 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced it has signed a worldwide distribution agreement with Sectra, an international medical imaging IT and cybersecurity company. Through this agreement, ProFound AI^® and ProFound AI^® Risk will be offered through the Sectra Amplifier Marketplace, which will expand their access to more facilities and imaging centers worldwide.

“iCAD’s technology offers unparalleled benefits to clinicians and patients alike. ProFound AI is clinically proven to enhance breast cancer screening by improving radiologists’ accuracy and efficiency. ProFound AI Risk is the first and only commercially available clinical decision support tool that provides an accurate two-year breast cancer risk estimation that is personalized for each woman, based solely on a screening mammogram,” according to Michael Klein, Chairman and CEO of iCAD. “These technologies empower clinicians to provide more accurate and personalized breast cancer screening.”

Sectra develops and sells imaging IT solutions. It provides healthcare providers worldwide with enterprise imaging solutions comprising picture archiving and communications systems (PACS) for imaging-intense departments (radiology, pathology, cardiology, orthopedics), vendor neutral archives (VNA) to store all types of medical images and information, as well as solutions for sharing and collaborating around medical imaging.

“To help healthcare providers get on the AI adoption journey, we have created the Sectra Amplifier Marketplace. We aim to facilitate easier access and usage of AI applications in medical imaging. This distribution agreement is an example of that. With iCAD’s tools deeply embedded in the Sectra diagnostic workspace, we provide our radiologists with enhanced diagnostic confidence for breast imaging reading,” said Nynke Breimer, Global Product Manager AI Radiology, Sectra.

In December 2019, ProFound AI for Digital Breast Tomosynthesis (DBT) became the first 3D tomosynthesis software using artificial intelligence (AI) to be FDA cleared; it is also CE marked and Health Canada licensed. It is a high-performance, deep-learning, workflow solution trained to detect malignant soft tissue densities and calcifications. It is also available for 2D mammography. In a reader study published in Radiology: Artificial Intelligence, ProFound AI for DBT was shown to offer clinically proven time-savings benefits to radiologists, reducing reading time by 52.7 percent, improving radiologists’ sensitivity by 8 percent, and reducing false positives and unnecessary patient recall rates by 7.2 percent.ⁱ

ProFound AI Version 3.0 for Digital Breast Tomosynthesis (DBT) was recently cleared by the U.S. Food and Drug Administration (FDA) in March 2021. Compared to previous versions of the software, the ProFound AI 3.0 algorithm offers up to a 10% improvement in specificity performance and up to 1% improvement in sensitivity.ⁱⁱ ProFound AI Version 3.0 also offers up to 40% faster processing on the new PowerLook platform.ⁱⁱ ProFound AI Version 3.0 was developed using over five million images from 30,000 cases, including almost 8,000 biopsy-proven cancers, and validated on approximately one million images from 3,500 cases that included 1,200 biopsy-proven cancers.ⁱⁱ

ProFound AI Risk uniquely combines aspects within mammographic images, as well as age and breast density, to provide a highly accurate short-term risk estimation that is specific to each woman. The technology provides clinicians with a two-year breast cancer risk category [low, general, moderate and high] and absolute breast cancer risk score for each patient, based on information garnered from a standard bilateral two-view full field digital mammogram. ProFound AI Risk is supported by a recent study, which showed ProFound AI Risk significantly outperforms existing breast cancer risk models, with an area under the curve (AUC) of 0.73 (95% CI 0.71, 0.74).ⁱⁱⁱ AUC is a standard performance measurement for AI technology that incorporates sensitivity and specificity into a single metric of overall performance. ProFound AI Risk’s AUC of 0.73 indicates high accuracy for risk assessment.

“Although ProFound AI and ProFound AI Risk are already available throughout a growing number of leading institutions in the U.S. and the rest of the world, we are energized by this agreement with Sectra, as it will enable more clinicians and women around the world to benefit from iCAD’s transformative, first-in-kind innovations,” Klein added. “Sectra offers unique access to recurring revenue segments of the global market. Particularly noteworthy is Sectra’s strong presence in the European market, which we see as integral to enhanced growth of our ProFound AI product offering.”

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.

About Sectra
Sectra assists hospitals throughout the world to enhance the efficiency of care, and authorities and defense forces in Europe to protect society’s most sensitive information. Thereby, Sectra contributes to a healthier and safer society. The company was founded in 1978, has its head office in Linköping, Sweden, with direct sales in 19 countries, and operates through partners worldwide. Sales in the 2020/2021 fiscal year totaled SEK 1,632 million. The Sectra share is quoted on the Nasdaq Stockholm exchange. For more information, visit Sectra’s website.

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 benefits of the Company’s agreement with Sectra and 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.

Contacts:

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

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

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
ⁱⁱ iCAD data on file. Standalone performance varies by vendor. FDA Cleared.
ⁱⁱⁱ Eriksson M., Czene K., Strand F., et al. Identification of Women at High Risk of Breast Cancer Who Need Supplemental Screening. [published online ahead of print September 8, 2020]. Radiology. Accessed via https://doi.org/10.1148/radiol.2020201620