Agreement will expand access to ProFound AI
and ProFound AI Risk to more facilities and imaging centers worldwide
NASHUA, N.H. – June 8th, 2021 – iCAD, Inc. (NASDAQ: ICAD),
a global medical technology leader providing innovative cancer detection and
therapy solutions, today announced it has signed a worldwide distribution
agreement with Sectra, an international medical imaging IT and cybersecurity
company. Through this agreement, ProFound AI® and ProFound AI® Risk will be
offered through the Sectra Amplifier Marketplace, which will expand their
access to more facilities and imaging centers worldwide.
“iCAD’s technology offers
unparalleled benefits to clinicians and patients alike. ProFound AI is
clinically proven to enhance breast cancer screening by improving radiologists’
accuracy and efficiency. 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,” according to Michael Klein, Chairman and CEO of
iCAD. “These technologies empower clinicians to provide more accurate and
personalized breast cancer screening.”
Sectra develops and sells imaging IT solutions. It provides
healthcare providers worldwide with enterprise imaging solutions comprising
picture archiving and communications systems (PACS) for imaging-intense
departments (radiology, pathology, cardiology, orthopedics), vendor neutral
archives (VNA) to store all types of medical images and information, as well as
solutions for sharing and collaborating around medical imaging.
“To help healthcare providers get on the AI adoption
journey, we have created the Sectra Amplifier Marketplace. We aim to facilitate
easier access and usage of AI applications in medical imaging. This
distribution agreement is an example of that. With iCAD’s tools deeply embedded
in the Sectra diagnostic workspace, we provide our radiologists with enhanced
diagnostic confidence for breast imaging reading,” said Nynke Breimer, Global Product
Manager AI Radiology, Sectra.
In December 2019, ProFound AI for Digital Breast Tomosynthesis
(DBT) became the first 3D tomosynthesis software using artificial intelligence
(AI) to be FDA cleared; it is also CE marked and Health Canada licensed.
is a high-performance, deep-learning, workflow solution trained to detect malignant
soft tissue densities and calcifications. It is also available for 2D
mammography. In a reader study published in Radiology: Artificial
Intelligence, ProFound AI for DBT was shown to offer clinically proven
time-savings benefits to radiologists, reducing reading time by 52.7 percent,
improving radiologists’ sensitivity by 8 percent, and reducing false positives
and unnecessary patient recall rates by 7.2 percent.[i]
ProFound AI Version 3.0 for Digital Breast Tomosynthesis (DBT) was
recently cleared by the U.S. Food and Drug Administration (FDA) in March 2021.
Compared to previous versions of the software, the ProFound AI 3.0 algorithm
offers up to a 10% improvement in specificity performance and up to 1%
improvement in sensitivity.[ii] ProFound AI Version 3.0 also offers
up to 40% faster processing on the new PowerLook platform.ii ProFound
AI Version 3.0 was developed using over five million images from 30,000 cases,
including almost 8,000 biopsy-proven cancers, and validated on approximately
one million images from 3,500 cases that included 1,200 biopsy-proven cancers.ii
ProFound AI Risk 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 Risk is supported by a recent study, which showed
ProFound AI Risk significantly outperforms existing breast cancer risk models,
with an area under the curve (AUC) of 0.73 (95% CI 0.71, 0.74).[iii]
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.
“Although ProFound AI and
ProFound AI Risk are already available throughout a growing number of leading
institutions in the U.S. and the rest of the world, we are energized by this
agreement with Sectra, as it will enable more clinicians and women around the
world to benefit from iCAD’s transformative, first-in-kind innovations,” Klein
added. “Sectra offers unique access to recurring revenue segments of the global
market. Particularly noteworthy is Sectra’s strong presence in the European
market, which we see as integral to enhanced growth of our ProFound AI product
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.
assists hospitals throughout the world to enhance the efficiency of care, and
authorities and defense forces in Europe to protect society’s most sensitive
information. Thereby, Sectra contributes to a healthier and safer society. The
company was founded in 1978, has its head office in LinkÃ¶ping, Sweden, with
direct sales in 19 countries, and operates through partners
worldwide. Sales in the 2020/2021 fiscal year totaled SEK 1,632
million. The Sectra share is quoted on the Nasdaq Stockholm exchange. For more
information, visit Sectra’s website.
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
benefits of the Company’s agreement with Sectra 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.
Jessica Burns, iCAD
Jeremy Feffer, LifeSci Advisors
[i] 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
[ii] iCAD data on file. Standalone performance
varies by vendor. FDA Cleared.
[iii] Eriksson M., Czene K., Strand F., 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