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"The publication of our reader study results in such a renowned peer-reviewed journal is a significant milestone that further validates ProFound AI as a world-class, deep-learning workflow solution that offers real-world benefits to radiologists and patients alike," said Michael Klein, Chairman and CEO of iCAD. "This endorsement of our research substantiates ProFound AI as the leading artificial intelligence breast cancer detection technology that empowers clinicians to read DBT images in less time and find cancers earlier, when they may be more easily treated."
ProFound AI is a high-performing workflow solution that assists radiologists by detecting malignant soft-tissue densities and calcifications. The software rapidly and accurately analyzes each image, or slice, and provides radiologists with crucial information, such as Certainty of Finding lesion and Case Scores, which can assist in clinical decision-making and prioritizing caseloads. Featuring the latest in deep-learning intelligence, the technology allows for continuously improved performance via ongoing software updates.
"While screening with DBT has been shown to increase cancer detection while also decreasing false positive recalls, the exponentially larger number of images in a DBT study compared to 2D screening studies almost doubles the reading time for radiologists," said principal investigator and lead author, Emily F. Conant, M.D., professor and chief of breast imaging from the Department of Radiology at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. "This reader study shows that the concurrent use of AI when reading DBT screening studies optimizes efficiency while also improving accuracy."
The reader study examined the performance of 24 radiologists, including 13 breast subspecialists, reading an enriched set of 260 DBT cases, both with and without ProFound AI. The study found ProFound AI increased radiologist performance, measured by mean area under the receiver operating characteristic curve (AUC), from 0.795 to 0.852. ProFound AI also increased sensitivity from 77.0 percent to 85.0 percent, increased specificity from 62.7 percent to 69.6 percent, and decreased the recall rate for noncancers from 38.0 percent to 30.9 percent. Reading time for radiologists decreased from 64.1 seconds to 30.4 seconds with ProFound AI.
ProFound AI for DBT was FDA cleared, CE marked, and Health Canada licensed in 2018. For more information, visit https://www.icadmed.com/profoundai.html.
About this study
Case data were retrospectively collected in compliance with the Health Insurance Portability and Accountability Act, with institutional review board approval and waiver of informed consent. The study was financially supported by iCAD and performed by Intrinsic Imaging.
About iCAD, Inc.
Headquartered in Nashua, N.H., iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions. For more information, visit www.icadmed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
Certain statements contained in this News Release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. 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 defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or 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.
Jessica Burns, iCAD
Jeremy Feffer, LifeSci Advisors, Inc.
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