iCAD’s ProFound AI for Digital Breast Tomosynthesis Version 3.0 Receives CE Mark Approval
iCAD’s
third generation artificial intelligence solution for 3D mammography offers considerable
improvement in algorithm specificity performance and faster processing compared
to previous generations
NASHUA, N.H. –
June 14, 2021 – iCAD, Inc. (NASDAQ: ICAD), a
global medical technology leader providing innovative cancer detection and
therapy solutions, today announced that ProFound AI® Version 3.0 for
Digital Breast Tomosynthesis (DBT) received CE Mark approval.
Compared to previous software versions, the latest
generation of ProFound AI offers up to a 10% improvement in specificity
performance while maintaining an industry-leading high sensitivity level, and approximately
40% faster
processing on
the new PowerLook platform.[1]
“This CE Mark certification is another momentous
achievement that positions iCAD in the vanguard of cancer detection and illustrates
the Company’s commitment to offering leading-edge solutions that continue to be
unmatched by other technologies,” said Michael Klein, Chairman and CEO of iCAD.
“This regulatory milestone will provide the opportunity for our recently
installed customers to upgrade to the latest version of the technology, while
also expanding the potential to bring this solution to more markets – and thus
more women – worldwide. This is not only consistent with our goal of establishing
recurring revenue streams and predictable high margin revenues, it also stands
to have a truly positive impact on patient care.”
The third generation of ProFound
AI for DBT offers clinicians the ability to interpret the vast amount of data
in DBT cases with greater precision and efficiency. A recent study involving
ProFound AI Version 2.0 presented at two major breast imaging conferences
earlier this year found that when radiologists factored in breast density and
age, ProFound AI helped radiologists identify up to 58.6 percent of normal
cases, with no false negatives.[2] ProFound AI Version 3.0 offers additional
specificity and performance improvements over previous versions of the
software, which stands to further improve these study results, and may also contribute
to a reduction in the rate of false positives, without compromising cancer
detection.
Built with the latest in deep-learning technology,
ProFound AI for DBT Version 3.0 rapidly analyzes each tomosynthesis image,
detecting malignant soft tissue densities and calcifications with unrivaled accuracy. Certainty of Finding and
Case Scores are assigned to each detection and each case respectively. These
are relative scores computed by the ProFound AI algorithm that represent the
algorithm’s confidence that a detection or case is malignant; this crucial
information may help radiologists in clinical decision making.
“The European launch of our third generation of ProFound
AI for DBT demonstrates iCAD’s unwavering dedication to improving breast cancer
detection,” said Michele Debain, Vice President, Europe, Middle East, Africa and
APAC at iCAD. “Since obtaining CE Mark certification with our first generation of
this technology in July 2019, ProFound AI has been installed in a growing
number of medical imaging centers across Europe. ProFound AI offers benefits
not only to physicians, but also to women. It helps improve workflow for radiologists
and enhances their ability to accurately detect suspicious lesions and
ultimately find cancers at earlier stages, which can lead to better patient
management, with less burdensome treatments and increased chances of survival. This
CE Mark certification will help us to bring the latest generation of our
advanced technology to more physicians and women across Europe.”
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.
The technology was also recently cleared by the U.S. Food and Drug
Administration (FDA) in March 2021.
“Breast cancer is the most
common cancer among women; however, the chances of survival are constantly
increasing, especially thanks to technological advances in medical imaging that
are improving screening performances. ProFound AI is fully in line with this
desire to constantly improve radiologists’ abilities to detect breast cancer as
early as possible. This is why I chose to install the new generation of the
ProFound AI solution in my medical imaging center dedicated to breast imaging,
in order to offer my patients the best possible care,” said Elena Cauzza, MD, a
radiologist at Radiomedica and xDonna, a mammography and breast diagnosis center
in Bellinzona, Switzerland.
In a reader
study published in Radiology: Artificial Intelligence,
ProFound AI for DBT Version 2.0 was clinically proven to reduce radiologists’ reading
time by 52.7 percent, improve radiologists’ sensitivity by 8 percent, and reduce
false positives and unnecessary patient recall rates by 7.2 percent.[3]
iCAD’s Breast
Health Solutions suite also includes ProFound AI for 2D Mammography, ProFound
AI Risk, the world’s first and only clinical decision support tool that
provides an accurate two-year, breast cancer risk estimation that is truly
personalized for each woman based only on a screening mammogram,[4]
and software to evaluate breast density.
About iCAD, Inc.
Headquartered
in Nashua, NH, USA, iCAD is a global medical technology
leader providing innovative cancer detection and therapy solutions. For
more information, visit www.icadmed.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 benefits of ProFound AI 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.
Contacts:
Media inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Media inquiries, Europe:
Emmanuelle Vella, iCAD
+33 6-20-49-48-57
Investor Relations:
Jeremy Feffer,
LifeSci Advisors
+1-212-915-2568
[1] iCAD data on file. Standalone
performance varies by vendor. FDA Cleared.
[2] Conant, E et al. Use of an artificial
intelligence software to identify low-likelihood of cancer exams collected
across four commercial digital tomosynthesis screening systems. Abstract presented
at European Congress of Radiology (ECR) Virtual Meeting and the Society of
Breast Imaging (SBI) Symposium, 2021.
[3] 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
[4] 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