Groundbreaking
ProFound AI Risk Helps Transform Breast Cancer Screening from an Age-Based Paradigm
to Risk-Adapted Precision Screening, Individualized for Each Woman

 

NASHUA, N.H. – November 30, 2020 – iCAD, Inc. (NASDAQ: ICAD), a global
medical technology leader providing innovative cancer detection and therapy
solutions, today announced that the Company is showcasing its leading Breast Health Solutions,
including the expanded ProFound AI® platform powered by Panorama, at the 106th
Scientific Assembly and virtual Annual Meeting of the Radiological Society of
North America (RSNA), November 29 – December 5.

 

The Company’s full suite of solutions includes the latest
generation of ProFound
AI for Digital Breast Tomosynthesis
(DBT), the first artificial
intelligence (AI) cancer detection software for DBT to be cleared by the US
Food & Drug Administration, as well as ProFound AI for 2D Mammography,* and ProFound AI Risk for 2D
mammography, the first and only commercially available clinical decision support
tool that provides an accurate two-year breast cancer risk estimation based
solely on a screening mammogram.

 

“Our efforts to commercialize pioneering solutions
positioned to enhance patient care and improve outcomes is underscored by the
superior performance and unrivaled specificity of our breast imaging AI that is
transforming breast cancer detection and risk-based, personalized screening,”
said Michael Klein, Chairman and CEO of iCAD. “We’re thrilled to highlight our
expanded ProFound AI platform powered by Panorama at RSNA 2020, which is poised
to further boost radiologists’ performance, improve detection and care, and is uniquely
positioned to address the ongoing challenges presented by COVID-19.

 

“Our new ProFound AI Risk is helping to change the way
breast cancer risk is assessed and contribute to the acceleration of breast
cancer screening from an aged-based screening paradigm to a risk-adapted
screening paradigm,” continued Klein. “It is extremely gratifying to fulfill
our panoramic vision of providing a complete clinical approach with a broader
view of each patient’s case, history, and short-term risk, for truly
personalized and enhanced patient care.”

 

ProFound AI Risk was created from a relationship between
iCAD and leading researchers at the Karolinska Institutet in Stockholm,
Sweden. This partnership is 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.

The clinical decision support tool 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 Profound AI Risk model performs better than any
other current model,” according to 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,
is easy and inexpensive to implement and has little requirement of staff and
systems to manage the data. Further, the risk model was also tested using other
variables, such as lifestyle factors and genetic determinants, which may be added
to the iCAD product in the future.”

Compelling research published in the peer-reviewed
journal, Radiology,
reveals that ProFound AI Risk significantly outperforms existing breast cancer
risk models.

 

Trained with one of the largest available DBT datasets,
ProFound AI rapidly and accurately analyzes each DBT image, or slice, and
provides radiologists with key information, such as Certainty of Finding
lesion and Case Scores, which assists in clinical decision-making and improving
reading efficiency. Featuring the latest in deep-learning artificial
intelligence, the algorithm allows for continuously improved performance in
detection via ongoing updates. ProFound AI for DBT and 2D mammography* is
compatible with a majority of leading DBT and digital 2D mammography systems.

 

About iCAD, Inc.

 

Headquartered in Nashua, NH, iCAD is a
global medical technology leader providing innovative cancer detection and
therapy solutions.

 

ProFound AI for DBT is proven to curtail workflow
challenges substantially by reducing radiologists’ reading time by 52.7
percent, thereby
reducing by half the amount of time it takes radiologists to read 3D
mammography datasets. Additionally, the platform improved radiologists’
sensitivity by 8 percent and reduced unnecessary patient recall rates by 7
percent.[i]

 

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.

 

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 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.

 

 

*CE Mark countries only.

 

Media Inquiries:

Amy Cook, iCAD

+1 (925) 200-2125

acook@icadmed.com

 

Investor
Relations:

Jeremy Feffer, LifeSci
Advisors

+1 (212) 915-2568

jeremy@lifesciadvisors.com

 

###


[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
https://pubs.rsna.org/doi/10.1148/ryai.2019180096