Compelling
clinical evidence shows ProFound AI Risk accurately identified a high-risk
group of women with 32 times higher risk of breast cancer than the general population

NASHUA,
N.H. – July 13, 2022 – iCAD, Inc. (NASDAQ: ICAD), a global medical
technology leader providing innovative cancer detection and therapy solutions,
today announced that the Company will showcase and demonstrate the complete
portfolio of its Breast AI solutions, including ProFound AI®, PowerLook®
Density Assessment
, and ProFound AI® Risk, in booth
#AI-20 at the European Congress of Radiology (ECR), July
13-17 in Vienna.

 

“iCAD is the only company to offer a comprehensive, high-performing
suite of AI solutions for breast cancer detection for both 2D and 3D
mammography, breast density assessment and personalized risk evaluation,” said Michele
Debain, Vice President Europe, Middle East, Africa and Asia-Pacific. “These
solutions are clinically proven to assist clinicians in daily practice and are
helping to address some of the most common challenges radiologists face today,
including reducing unnecessary patient recalls and false positives,
standardizing breast density assessments, identifying women at high risk of
developing breast cancer in the short-term, and reducing radiologists’ reading
time.”

At the
virtual ECR meeting earlier this year, distinguished researchers from the
Karolinska Institutet presented compelling research from a study supporting ProFound
AI Risk
, titled
“A Risk Model for Digital Breast Tomosynthesis to Predict Breast Cancer and
Guide Clinical Care.” ProFound AI Risk is the latest addition to iCAD’s Breast AI
Suite and the world’s first clinical decision support tool that provides an
accurate[i],ii
short-term breast cancer risk estimation based on age, breast density and
mammographic features. According to study findings, ProFound AI Risk
accurately identified a group of high-risk women with 32 times higher risk of
developing breast cancer than the general population, using National Institute
for Health and Care Excellence (NICE) guidelines. Researchers concluded ProFound
AI Risk is 2.4 times more accurate than traditionally used risk models.ii This
research was also recently published in the peer-reviewed journal ScienceTranslational Medicine.[ii]

 

“Our research shows that an image-based risk assessment has the advantage
over commonly used risk models for identifying the women who could benefit for
additional follow-up due to their high risk of breast cancer,” said
lead author of the study, Mikael Erikson, PhD, Medical Epidemiology and
Biostatistics, Karolinska Institutet, Stockholm, Sweden. “ProFound AI Risk,
available for 2D and 3D mammography, offers a unique clinical value, as it provides
radiologists with critical information about a woman’s short-term individual
risk of developing breast cancer. This could potentially allow clinicians to
tailor screening regimens for patients based on their individual short-term
risk, which could ultimately lead to earlier detection and hopefully, improved
prognosis. Additionally, ProFound AI Risk is easy-to-implement in the clinical
setting, with no additional testing, surveys, or other procedures required, as
may be the case with other, long-term risk models.”

 

Traditionally, physicians have
estimated risk by examining known risk factors such as family history, but
about 85% of breast cancers occur in women with no family history of breast
cancer.[iii] ProFound
AI Risk utilizes information garnered from a screening mammography exam,
including age, breast density and other image-related information proprietary
to iCAD’s algorithm, in order to calculate a woman’s short-term risk of breast
cancer. The latest version of ProFound AI Risk, launched in September 2021,
offers expanded features, including the
ability to produce 1, 2, and 3-year risk estimations – geared specifically
towards annual, bi-annual and tri-annual screening regimens and other
clinically relevant global screening guidelines – as well as more than 15
country incidence and mortality reference tables, further personalizing results.

“Currently a number of sites in Europe are using ProFound AI Risk
in their daily workflow to assist them with their patient management. For
example, when a woman presents with no cancer detection findings but with a high-risk
score, a physician may decide to use supplemental imaging such as ultrasound or
MRI, and/or perhaps reduce the interval screening time for the woman in
question” adds Ms. Debain.

iCAD will also host a “Cocktails and Conversation” event during
ECR, titled “The AI Revolution in Breast Cancer Screening for Today and
Tomorrow” on July 14 at 6 pm CEST. The event will feature leading experts in
breast imaging, including Alexandra Athanasiou, MD, a radiologist at Mitera
Hospital in Greece and Dr. Emily Conant, MD, professor and chief, Division of
Breast Imaging at the Hospital of the University of Pennsylvania Medical Center.
For more information, visit this link.


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.

 

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 expected benefits
of ProFound AI®, the benefits of the Company’s products, 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 https://www.icadmed.com and on the SEC’s
website at http://www.sec.gov.

 

Contact:

Media Inquiries:

Jessica
Burns, iCAD 

+1-201-423-4492

jburns@icadmed.com

  

Investor
Inquiries:

iCAD
Investor Relations

ir@icadmed.com

 

 


[i]
Eriksson M et al. Identification of Women at High Risk of Breast Cancer Who
Need Supplemental Screening. Radiology. 2020 Sept 8. Accessed via
https://doi.org/10.1148/radiol.2020201620.

[ii]
Eriksson, M et al. A risk model for digital breast tomosynthesis to predict
breast cancer and guide clinical care. Science Translational Medicine. 14
(644). 2022 May 11. Accessed via DOI: 10.1126/scitranslmed.abn3971.

[iii]
Breastcancer.org. U.S. Breast Cancer Statistics. Accessed via
https://www.breastcancer.org/symptoms/understand_bc/statistics.