iCAD and Densitas Partner to Enhance Precision Breast Health with Leading AI Solutions for Mammography Quality, Cancer Detection, and Risk Evaluation

• Provides a holistic breast health solution, including breast cancer screening focused on quality, safety and efficiency, breast cancer detection, breast density assessment, and risk evaluation
• Expands access to iCAD’s AI-powered ProFound Breast Health Suite and Densitas’ AI solutions to patients and medical professionals worldwide

NASHUA, N.H. and HALIFAX, Nova Scotia, April 09, 2024 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ: ICAD), a global leader in clinically proven AI-powered cancer detection solutions, announced a strategic partnership with Densitas, Inc., a global leader in operational AI solutions for breast cancer screening. The partnership enables breast imaging centers and radiologists to provide end-to-end breast health care that ensures every aspect of a woman’s breast health journey is addressed, starting from the first step of quality screening mammograms and extending through breast cancer detection, breast density assessment, and a comprehensive evaluation of breast cancer risk.

“We are thrilled to announce this strategic collaboration with Densitas to offer physicians and patients a more comprehensive, holistic approach to precision breast health care,” said Dana Brown, President and CEO of iCAD. “By combining Densitas’ AI-powered intelliMammo^® platform with iCAD’s AI-powered ProFound Breast Health Suite, we are transforming early breast cancer detection and intervention.”

Densitas offers a robust and comprehensive mammography quality assurance platform, comprised of intelliMammo^® and intelliMaven™. IntelliMammo^® is built on deep learning and machine learning algorithms that assess clinical image quality and breast density that are the foundation for advanced analytics, continuous quality control, efficient workflows and remote quality oversight. In an industry-first move, intelliMaven™ is a GPT AI application engineered to streamline workflows, deliver on-demand expert feedback, and foster a culture of confidence and autonomy among technologists. The integrated platform delivers a scalable, sustainable quality assurance system tailored for mammography facilities to maximize operational efficiency, optimize compliance with the FDA Mammography Quality Standards Act (MQSA) EQUIP, and meet ACR accreditation standards. The platform empowers facilities to maximize resource allocation and focus on activities that drive the most value.

With iCAD’s AI-enabled ProFound Breast Health Suite, offering clinically proven solutions for cancer detection, density assessment, and personalized risk evaluation, medical professionals will have a more well-rounded set of data on each patient’s breast health. Clinical studies have demonstrated that the use of iCAD’s ProFound AI solutions can significantly improve reading sensitivity and specificity and reduce reading times, thus enhancing clinical decision support and workflow efficiency for radiologists.

“Our partnership with iCAD is a commitment to women’s health that spans the spectrum of breast health care,” said Mo Abdolell, founder and CEO of Densitas. “At the heart of this collaboration is the understanding that mammography is the first line of defense in breast cancer detection. It sets the stage for every decision that follows in the diagnostic, prevention, and treatment pathways. Our operational AI solutions, intelliMammo^® and intelliMaven™ GPT AI assistant, together with iCAD’s AI-powered Breast Health Suite elevate the standard for image quality, screening and diagnostic accuracy, and comprehensive care with state-of-the-art AI innovations. This synergy ensures that every woman receives the most precise and personalized care journey possible.”

ProFound Breast Health Suite
ProFound AI offers clinically proven time-saving benefits to radiologists, including reducing reading time by 52.7%, thereby halving the time it takes radiologists to read 3D mammography datasets. ProFound AI for DBT improved radiologist sensitivity by 8% and reduced unnecessary patient recall rates by 7.2%.ⁱ The ProFound Riskⁱⁱ platform has a proven track record of predicting the risk of breast cancer 2.4x more accurately in the next year than traditional lifetime risk models.^iii,iv iCAD’s ProFound Density Assessment uses mammography images to categorize breast density, leading to personalized patient care plans with supplemental screenings and a custom schedule.

IntelliMammo^® AI Mammography Quality Platform
IntelliMammo^® reduces clinical image quality error rates by as much as 44%,^v and streamlines compliance with key MQSA EQUIP and adherence to ACR accreditation requirements, quality assurance and oversight tasks in mere seconds and minutes, as opposed to days and weeks. IntelliMaven™ is designed to increase radiological technologists’ clinical confidence and autonomy, and to limit interruptions to radiologists when reading exams. IntelliMammo^® densityAI™ breast density has been clinically validated to have a strong association with breast cancer risk, providing a practical automated method for risk stratification.^vi

About Densitas, Inc.
Densitas, Inc. is a global leader in AI-driven solutions for breast cancer screening focused on improving mammography quality, workflows, and operational efficiencies that enable care providers to realize higher returns from high-value activities while ensuring sustainable service delivery and better patient outcomes. Headquartered in Halifax, NS, Densitas’ intelliMammo^® AI-powered platform redefines mammography quality compliance with operational AI solutions that provide mammography positioning and breast density assessments, streamline compliance with MQSA EQUIP/ACR standards, and supply care providers with actionable information through digitized workflows and evidence-based decision tools. For more information, visit www.densitashealth.com.

About iCAD, Inc.
iCAD, Inc. (NASDAQ: ICAD) is a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered solutions that enable medical providers to accurately and reliably detect cancer earlier and improve patient outcomes. Headquartered in Nashua, N.H., iCAD’s industry-leading ProFound Breast Health Suite provides AI-powered mammography analysis for breast cancer detection, density assessment and risk evaluation. Used by thousands of providers serving millions of patients, ProFound is available in over 50 countries. In the last five years alone, iCAD estimates reading more than 40 million mammograms worldwide, with nearly 30% being tomosynthesis. For more information, including the latest in regulatory clearances, please visit www.icadmed.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 expansion of access to the Company’s products, improvement of performance, acceleration of adoption, expected benefits of ProFound AI^®, the benefits of the Company’s products, 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 that 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: pr@icadmed.com
Investor Inquiries: ir@icadmed.com

Media inquiries: marketing@densitashealth.com

ⁱ Conant, E. et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial Intelligence.

ⁱⁱ ProFound Risk is CE Marked, Health Canada Licensed, and available for investigational use only in U.S.

ⁱⁱⁱ Mikael Eriksson et al. A risk model for digital breast tomosynthesis to predict breast cancer and guide clinical care. Sci. Transl. Med. 14, eabn3971 (2022). DOI: 10.1126/scitranslmed.abn3971

^iv Eriksson M, Czene K, Strand F, Zackrisson S, Lindholm P, Lång K, Förnvik D, Sartor H, Mavaddat N, Easton D, Hall P. Identification of Women at High Risk of Breast Cancer Who Need Supplemental Screening. Radiology. 2020 Nov;297(2):327-333. doi: 10.1148/radiol.2020201620. Epub 2020 Sep 8. PMID: 32897160.

^v Abdolell, M. et al. (2023) Driving mammography image quality improvement using A.I. in Guyana during the Covid-19 pandemic. European Congress of Radiology. Vienna Austria. Poster #C-23808

^vi Astley, SM. et al. (2018) A comparison of five methods of measuring mammographic density: a case- control study. Breast Cancer Research