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ProFound AI is a high-performance, deep learning, workflow solution that assists radiologists reading digital breast tomosynthesis (DBT), or 3D mammography; it became the first artificial intelligence (AI) software for DBT to be FDA-cleared in 2018.
"With an average rate of 6 cancers detected per 1,000 screening mammograms,i breast cancer remains a major health concern for women, even in the face of this pandemic. The breast cancer mortality rateii is greater than current COVID mortality percentages in many countries,iii which puts breast cancer screening in a unique risk/benefit category. This risk increases with the duration of time screening is deferred," according to Michael Klein, Chairman and CEO of iCAD.
Trained with the latest in artificial intelligence and pattern recognition technology, ProFound AI rapidly and accurately analyzes each individual DBT image to identify potentially malignant lesions. The technology provides radiologists with crucial information, such as Certainty of Finding lesion and Case Scores, which assists in clinical decision-making and improving reading efficiency. ProFound AI for DBT was clinically proven in a large reader study to increase radiologist sensitivity by 8 percent and specificity by 6.9 percent, as well as reduce the rate of false positives and unnecessary callbacks by 7.2 percent and slash reading time for radiologists by 52.7 percent.iv Additionally, ProFound AI for DBT cut reading time by up to 57.4 percent for radiologists reading cases with dense breasts.v It is available for use with a number of mammography vendors, including GE, Hologic and Siemens 3D mammography equipment.
"As with many medical procedures, mammography screening was impacted in areas of our global served market.vi However, as mammography resumes, many radiologists are now being presented with new challenges introduced by the pandemic. Not only is there a significant backlog of women who need to be screened, many sites are offering expanded hours and adjusting patient spacing to accommodate proper safety precautions, which puts an added strain on radiologists reading DBT images," added Klein. "ProFound AI offers a practical solution that can help clinicians continue screening at an appropriate pace, particularly for patients with higher risk profiles, while helping to address some of these emerging issues. This leading-edge technology offers a trifecta of clinically proven benefits to patients and clinicians alike: not only may it offer improved specificity and sensitivity, it may decrease reading time for radiologists by more than half, which can help them more effectively manage the backlog of patients who urgently need to be screened. It also offers critical data for clinicians, such as unique Certainty of Finding Case Scores, which can assist them in making proper care decisions. We are pleased to partner with SimonMed in this effort to expand access to this state-of-the-art technology across its vast network of facilities."
"SimonMed has always been a leader in advancing early breast cancer detection, from the early nationwide adoption of 3D mammography and 3D ultrasound, to the use of the newest technology, such as automated breast density measurement and now ProFound AI. This technology empowers our radiologists to read cases with improved accuracy, reducing the rate of false positives and unnecessary callbacks, which can be stressful for patients," according to John Simon, M.D., Founder and CEO of SimonMed. "Additionally, with ProFound AI, every patient has the benefit of a second reader, whose input has been clinically proven to support the early detection of breast cancer, making 3D mammography at SimonMed even more beneficial for our patients."
SimonMed Imaging is the largest physician owned outpatient radiology practice in the United States and specializes in all major medical fields of medical imaging. Our vision is to change the medical imaging experience with advanced technology, and our mission is to provide high quality, affordable medical imaging to all. The expertise of our physicians, technologists, scientists and advanced technology leads to more accurate and early reporting. We offer multiple convenient locations, broad health plan access, and low out-of-pocket costs.
About iCAD, Inc.
Headquartered in Nashua, NH, iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions.
ProFound AI™ is a high-performing workflow solution for 2D and 3D mammography, or digital breast tomosynthesis (DBT), featuring the latest in deep-learning artificial intelligence. In 2018, ProFound AI for Digital Breast Tomosynthesis (DBT) became the first artificial intelligence (AI) software for DBT to be FDA-cleared; it was also CE marked and Health Canada licensed that same year. It offers clinically proven time-savings benefits to radiologists, including a reduction of reading time by 52.7 percent, thereby halving the amount of time it takes radiologists to read 3D mammography datasets. Additionally, ProFound AI for DBT improved radiologist sensitivity by 8 percent and reduced unnecessary patient recall rates by 7.2 percent.
The Xoft System is FDA-cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. It uses a proprietary miniaturized x-ray source to deliver a precise, concentrated dose of radiation directly to the tumor site, while minimizing risk of damage to healthy tissue in nearby areas of the body.
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 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.
Jessica Burns, iCAD
Lauren Strait, SimonMed Imaging
Jonathan Wexler, Scope Investor Relations, LLC
i Conant, E. et al. (2020). Five Consecutive Years of Screening with Digital Breast Tomosynthesis: Outcomes by Screening Year and Round. Radiology. Accessed via https://doi.org/10.1148/radiol.2020191751.
ii GLOBOCAN 2018: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2018. https://www.uicc.org/news/new-global-cancer-data-globocan-2018.
iii Johns Hopkins University. Mortality Analysis. Accessed via https://coronavirus.jhu.edu/data/mortality
iv 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
v Hoffmeister, J. (2018). Artificial Intelligence for Digital Breast Tomosynthesis - Reader Study Results. [White paper]. Accessed via https://www.icadmed.com/assets/dmm253-reader-studies-results-rev-a.pdf
vi Duszak, R. et al. (2020) Characteristics of COVID-19 Community Practice Declines in Non-Invasive Diagnostic Imaging Professional Work. Journal of the American College of Radiology. ISSN 1546-1440. Accessed via https://doi.org/10.1016/j.jacr.2020.06.031.
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