iCAD’s Breast AI Platform Earns U.S. Department of Defense Authorization to Operate
Leading-edge breast cancer
detection platform meets stringent U.S. government security thresholds required
for use across military healthcare facilities
NASHUA, N.H. – January 24, 2022 – 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
Investor
Relations:
Brian
Ritchie, LifeSci Advisors
+1-212-915-2578
[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