iCAD Announces Compelling Data Supporting Launch of First and Only Commercially Available Technology to Provide Short-Term Breast Cancer Risk Assessment
Research published in Radiology shows technology significantly
outperforms existing breast cancer risk models, accelerating movement towards
risk-adaptive screening
NASHUA, N.H. –
September 15, 2020 – iCAD, Inc. (NASDAQ: ICAD), a
global medical technology leader providing innovative cancer detection and
therapy solutions, today announced compelling data supporting ProFound AI™ Risk was published in the peer-reviewed journal, Radiology.[i]ProFound
AI Risk is the first and only commercially available clinical decision support
tool that provides an accurate two-year breast cancer risk estimation that is
personalized for each woman, based solely on a screening mammogram. The
technology was clinically proven to significantly outperform existing
breast cancer risk models.
ProFound
AI Risk was created from an exclusive relationship between iCAD and leading
researchers at the Karolinska Institutet in Stockholm, Sweden, one
of the world’s foremost medical research universities and the home of the Nobel
Assembly, which selects the Nobel laureates in Physiology or Medicine. This
partnership built upon a previous research agreement whereby researchers at the
Karolinska Institutet developed a breast cancer risk prediction model using
information identified in mammography images provided by iCAD’s AI solutions.
“ProFound AI
Risk and the publication of this supporting study represent a giant leap
forward in the realm of breast cancer screening. This first-in-kind solution
provides crucial data about patients’ individual risk of developing breast
cancer between screenings and empowers clinicians to truly personalize patient
care,” according
to Michael Klein, Chairman and CEO of iCAD. “This
technology may help clinicians tailor unique screening regimens for patients, within country guidelines,
and may help reduce unnecessary
supplemental screenings for women with low risk.”
ProFound AI
Risk software uniquely combines aspects within mammographic images, as well as
age and breast density, to provide a highly accurate short-term risk estimation
that is specific to each woman. The technology provides clinicians with a
two-year breast cancer risk category [low, general, moderate and high] and
absolute breast cancer risk score for each patient, based on information
garnered from a standard bilateral two-view full field digital mammogram.
“ProFound AI
empowers women to participate and advocate for the management of their breast
care. There is a growing demand among patients to know more information about
their individual risk. According to a recent survey, 87% of women expressed
interest in learning about their estimated lifetime risk of breast cancer,[ii]”
according to Stacey Stevens, President of iCAD. “ProFound AI Risk has the
potential to revolutionize the way breast cancer risk is assessed and
could contribute to the acceleration of breast cancer screening from what has historically been an aged-based
screening paradigm to a risk-adapted screening paradigm, unique to each woman.”
ProFound AI Risk is supported by a recent study led by researchers at
the Karolinska Institutet based on the prospective screening cohort, Karolinska
Mammography Project for Risk Prediction of Breast Cancer (KARMA), which
recruited women from 2011-2017. Of 70,877 participants in the KARMA cohort, 974
women with incident cancers and 9,376 healthy women were sampled. ProFound AI
Risk reached an area under the curve (AUC) of 0.73 (95% CI 0.71, 0.74). AUC is
a standard performance measurement for AI technology that incorporates
sensitivity and specificity into a single metric of overall performance.
ProFound AI Risk’s AUC of 0.73 indicates high accuracy for risk assessment.
“The Profound AI Risk
model performs better than any other current model,” according to the study’s
principal investigator, Per Hall, MD, Professor/Senior Physician at the
Karolinska Institutet. “The model is a short term risk model which is an
advantage in the screening setting, builds heavily on analyses of mammograms,
has a flexibility that allows users to choose variables included in the model,
is easy and cheap to implement and has little requirement of staff and systems
to manage the data.”
Researchers also found a statistically significant superior
performance when comparing the ProFound AI Risk model to existing risk models
at two years, such as the Tyrer-Cusick v8 model (+11 points) or GAIL model (+12
points), all including breast density within their calculations. Researchers
concluded ProFound AI Risk identified women at high likelihood of being
diagnosed with breast cancer within two years of a negative screen and in
possible need of supplemental screening.i
“ProFound
AI Risk is a powerful tool that may aid in the detection of interval cancers,
or lesions that are detected between routine mammography screenings,” according
to Dr. Axel Gräwingholt, Radiologie am Theater, Paderborn, Germany. “In my
experience using the technology following its CE Mark approval and launch in
Europe earlier this year, I have found it offers valuable insights for
clinicians who may be looking to provide a stratified risk assessment for
patients, and is easy to use compared to other breast cancer risk models.”
ProFound
AI Risk is currently available on an introductory basis for 2D mammography and
will subsequently be available for the rapidly growing 3D mammography market.
It is the latest addition to iCAD’s Breast Health Solutions suite, which
includes ProFound AI™ for Digital Breast Tomosynthesis (DBT), ProFound AI™ for
2D Mammography, and software solutions for breast density. ProFound AI Risk was
CE marked and launched in Europe at the European Congress of Radiology (ECR)
virtual meeting in July 2020.
“Last
year we introduced our initiative, Panorama Powered by ProFound AI, and with
ProFound AI Risk, this concept is beginning to come to life,” added Mr. Klein.
“iCAD continues to bring innovative solutions like this to market, and we look
forward to advancing the field of mammography as we are working to further
expand the ProFound AI portfolio to include next-generation technology that
will also incorporate patient’s prior images.* The ability to correlate
patients’ past and present images along with future risk will provide
clinicians with a broader panoramic vision for each patient that will enable
them to evaluate findings across time and ultimately lead to more tailored and
personalized patient care.”
For
more information about ProFound AI Risk, visit https://www.icadmed.com/profoundai-risk.html.
*Not
yet commercially available
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.[iii]
The Xoft® Axxent® Electronic
Brachytherapy (eBx®) 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 ability of
ProFound AI Risk to enable clinicians to provide more tailored and personalized
patient care, to address a significant unmet need, to provide clinical value,
lead to fewer unnecessary biopsies, to be more beneficial for patients, to be accepted by clinicians, the
impact of supply and manufacturing constraints or difficulties, uncertainty of
future sales levels, to defend itself in litigation matters, 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.
Contacts:
Media inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Investor Relations:
Jeremy Feffer,
LifeSci Advisors
+1-212-915-2568
[i] Eriksson, M., et al.
Identification of Women at High Risk of Breast Cancer Who Need Supplemental
Screening. [published online ahead of print September 8, 2020]. Radiology.
Accessed via https://doi.org/10.1148/radiol.2020201620
[ii] Amornsiripanitch N,
Ameri SM, Goldberg RJ. Impact of Age, Race, and Socioeconomic Status on Women’s
Perceptions and Preferences Regarding Communication of Estimated Breast Cancer
Risk. Academic Radiology. May 2020. Accessed via
https://doi.org/10.1016/j.acra.2020.03.041
[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