ProFound AI™ Risk Receives CE Mark in Europe
First and only commercially
available clinical decision support tool provides accurate two-year breast cancer risk
estimation personalized for each woman
iCAD unveils new technology and clinical research at
major medical conference
NASHUA, N.H. – July 15, 2020 – iCAD, Inc. (NASDAQ: ICAD), a global
medical technology leader providing innovative cancer detection and therapy
solutions, today announced ProFound AI™ Risk received a CE Mark in Europe.
ProFound AI Risk is the 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. The Company
unveiled the technology at the European Congress of Radiology (ECR) virtual
meeting from July 15-19, 2020. New data supporting ProFound AI™ will also be
presented at the meeting. Information about these products will be available in
the virtual iCAD booth (https://ecr2020.expo-ip.com/stand/1115)
throughout the meeting.
ProFound AI Risk uniquely
combines a range of risk factors, including age, breast density and subtle
mammographic features, offering superior performance in assessing short-term
risk compared to traditional breast cancer risk models.[i] It
offers an easy-to-implement solution that provides superior insights[ii]
that empower clinicians to tailor a woman’s breast screening regimen and
potentially identify cancers earlier.
“At last year’s Radiological Society of North America (RSNA)
Annual Meeting, we introduced Panorama Powered by ProFound AI, which will
enable clinicians to provide more tailored and personalized patient care. With
ProFound AI Risk, this concept is coming to life. The CE Marking of this
technology is a significant milestone that represents the Company’s continued
efforts to globally commercialize leading-edge solutions that are positioned to
enhance patient care and improve outcomes,” said Stacey Stevens, President of
iCAD. “ProFound AI Risk has the potential to address a significant unmet
need in breast cancer screening, with an eligible screening population of
approximately 250 million women worldwide.[iii]
ProFound AI Risk offers a more holistic clinical approach that can provide
clinicians with a broader view of each individual patient’s case and two year
breast cancer risk. This technology offers more valuable insights for
clinicians, compared to other risk models, which offer five or 10 year-risk
estimates. ProFound AI Risk will be available for 2D mammography, which is
particularly applicable for the European market, where 2D mammography is still
primarily used for breast cancer screening.”
ProFound AI
Risk is the latest addition to iCAD’s suite of breast health solutions, which
includes ProFound AI™ for Digital Breast Tomosynthesis (DBT), ProFound AI™
for 2D Mammography, and software solutions for automated breast density
assessment. ProFound AI is a deep-learning, artificial intelligence (AI) cancer
detection software solution, available for 2D and 3D mammography, or digital
breast tomosynthesis (DBT).
“We have had outstanding feedback from our European customers on
the clinical value that ProFound AI has brought to their practices. Our AI
solution is currently being used daily in a growing number of leading hospitals
and imaging centers across Europe, and its adoption continues to grow as more
doctors and facilities learn of the benefits it offers to both physicians and
patients. This powerful software empowers doctors to find breast cancers
earlier, when they may be more easily treated, while reducing the rate of false
positives, which could lead to fewer unnecessary biopsies or treatments.[iv]
Additionally, it is particularly effective in challenging cases, such as those
with dense breast tissue,[v]”
said Michele Debain, Vice President, Europe, Middle East, Africa,
iCAD.
Positive new data
supporting ProFound AI will be presented in several abstracts at the virtual
ECR meeting. Of note, the efficacy of ProFound AI for 2D Mammography was validated
in a study led by Sylvia H. Heywang-Köbrunner, MD, titled “The value of
2D-AI-based CAD for second or third reading tested on 17,910 screening
mammograms” (abstract RPS 702-4). This study
examined 18,002
consecutive screening mammograms acquired between January and November 2018,
which were anonymized and processed using ProFound AI for 2D Mammography. The
AI technology’s ability to detect cancers was superior to that of two
radiologists, who read the same cases. ProFound AI for 2D Mammography achieved
a sensitivity of 91.5 percent and a specificity of 80.2 percent for 32 ductal
carcinoma in situ (DCIS) and 85 invasive cancers. The findings of this study
suggest that while AI may not be a replacement for radiologists, it is a
valuable tool that can enhance performance and offer better sensitivity than a
second reading by radiologists.
“ProFound AI improves my diagnostic confidence. It helps me move
faster on negative cases and assists me in discovering positive findings, so
that I can focus more time on difficult cases,” according to Dr. Michael
Gruber, Radiologist, Radiologische Gruppenpraxis Baden, Austria.
Other relevant abstracts featured during the meeting include:
- RPS 605b-6: “Breast cancer detection by mammographic view with artificial
intelligence in digital breast tomosynthesis,” by Emily F. Conant, MD,
professor and chief of breast imaging from the Department of Radiology at the
Perelman School of Medicine at the University of Pennsylvania in Philadelphia - RPS 602b-1:
“Identification of women at high risk of breast cancer and in need of
supplementary screening,” by Mikael Eriksson, MD, PhD, Karolinska Institutet
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.8
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
https://www.icadmed.com and on the SEC’s website at http://www.sec.gov.
Contacts:
Media inquiries:
Jessica Burns, iCAD
+1-201-423-4492
Europe:
Emmanuelle
Vella, iCAD
+33 6 20
49 48 57
FP2COM
Florence Portejoie
+ 33 6 07 76 82 83
Investor Relations:
Jeremy Feffer,
LifeSci Advisors
+1-212-915-2568
[i] Brentnall A, Harkness E, Astley S et al.
Mammographic density adds accuracy to both the Tyrer-Cuzick and Gail breast
cancer risk models in a prospective UK screening cohort. Breast
Cancer Res. 2015; 17,147.
[ii] iCAD data on file
[iii] Renub Research (2014) Breast Cancer Screening
(Mammography, MRI & Ultrasound) Market & Forecast – Worldwide.
http://www.renub.com/breast-cancer-screening-mammography-mri-and-ultrasound-market-and-forecast-worldwide-63-p.php
[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