SimonMed Imaging Accelerates Nationwide Deployment of iCAD’s ProFound AI™
Leading-edge artificial intelligence (AI) software
allows patients to receive “real time” essential breast screening amidst pandemic
NASHUA, N.H. and PHOENIX– July 13, 2020 – iCAD,
Inc. (NASDAQ: ICAD), a global medical
technology leader providing innovative cancer detection and therapy solutions, and SimonMed Imaging, one of the largest outpatient
medical imaging providers and largest physician radiology practices in the
United States, today announced that ProFound AI™ will be deployed throughout SimonMed
Imaging’s network.
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 rate[ii]
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.”
About SimonMed
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.
For more
information, visit www.icadmed.com and www.xoftinc.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 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.
Contacts:
Media
inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Lauren
Strait, SimonMed Imaging
+480-998-2600
Investor
inquiries:
Jonathan Wexler,
Scope Investor Relations, LLC
+1-203-247-8767
[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.