iCAD’s Breast AI Platform Earns U.S. Department of Defense Authorization to Operate

NASHUA, N.H., Jan. 24, 2022 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that the Company’s breast artificial intelligence (AI) platform was granted an Authorization to Operate (ATO) from the U.S. Department of Defense (DoD). iCAD’s breast AI platform includes ProFound AI^®, which became the first AI software for digital breast tomosynthesis (DBT) to be FDA cleared in 2018.

“It is a significant accomplishment for our technology to achieve this authorization,” said Stacey Stevens, President and incoming Chief Executive Officer of iCAD, Inc. “This distinction is a testament to the security of our technology and reinforces our steadfast commitment to providing safe and reliable health solutions to our customers and their patients. We look forward to capitalizing on this new market opportunity and continuing to expand access to ProFound AI and enhancing patient care for those in the military and their families.”

The DoD’s Risk Management Framework (RMF) requires technologies be granted an ATO in order to be approved for use at a DoD healthcare facility. Earning an ATO distinction requires the technology to meet the DoD’s stringent cybersecurity prevention thresholds, which are designed to minimize the risk of a potential cyber-attack. There are currently more than 500 DoD hospitals, inpatient facilities, ambulatory care and occupational health facilities worldwide.ⁱ The Military Health System (MHS) offers healthcare benefits and services through its TRICARE program to approximately 9.62 million beneficiaries, including servicemembers, military retirees, and family members.ⁱⁱ

ProFound AI is a high-performing cancer detection solution that rapidly and accurately analyzes each tomosynthesis image, detecting both malignant soft tissue densities and calcifications. Built with the latest in deep-learning AI technology, the software is clinically proven to assist radiologists by improving cancer detection and reducing reading times, while lowering false positive rates and unnecessary recalls. Used concurrently when reading mammography exams, Profound AI’s algorithm produces Certainty of Finding lesion and Case Scores, which represent the algorithm’s confidence that a detection or case is malignant. According to a large reader study, Profound AI for DBT achieved an 8 percent improvement in average reader sensitivity and a 7 percent improvement in average reader specificity. ⁱⁱⁱ Furthermore, the technology reduced reading time for radiologists by 52.7 percent.ⁱⁱⁱ

“ProFound AI is unrivaled in its accuracy, performance, and speed, and is truly transforming breast cancer screening and detection by enhancing both the patient and radiologist experience,” added Stevens. “With one in eight women at risk of being diagnosed with breast cancer in their lifetime^iv, the need for accurate and secure technology like ProFound AI could not be more important to help doctors catch the disease earlier and, ultimately, improve health outcomes for patients.”

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.

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 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 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.

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

  
Investor Relations:
Brian Ritchie, LifeSci Advisors
+1-212-915-2578
britchie@lifesciadvisors.com

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ⁱ MHS Health Facilities. Accessed via https://www.health.mil/I-Am-A/Media/Media-Center/MHS-Health-Facilities
ⁱⁱ Congressional Research Service (CRS). Defense Primer: Military Health System. Accessed via https://sgp.fas.org/crs/natsec/IF10530.pdf
ⁱⁱⁱ 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
^iv American Cancer Society. Key Statistics for Breast Cancer. Accessed via https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html