Health Canada Grants Device License for iCAD's ProFound Risk 2.0, Revolutionizing Breast Cancer Risk Via a 1-2 Year Assessment
16 Agosto 2023 - 9:00AM
iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader
providing innovative cancer detection and therapy solutions, today
announced Health Canada has issued a device license for ProFound
Risk version 2.0, the latest version of iCAD's personalized 1-2
year breast cancer risk assessment solution.
"We are delighted to receive the device license from Health
Canada for the latest version of ProFound Risk, marking a major
milestone in our mission to help women worldwide know where and
when breast cancer may be hiding," said Dana Brown, President and
CEO of iCAD, Inc. "This regulatory approval further validates the
clinical efficacy of our technology, paving the way for its use in
healthcare facilities across Canada, where breast cancer accounts
for approximately 25% of new cases of cancer and 13% of all cancer
deaths in Canadian women.i Our technology offers the potential to
address this significant unmet burden by empowering clinicians to
personalize care for patients at higher risk of developing breast
cancer in the next 1-2 years, and ultimately improve outcomes for
women."
Available for both 2D and 3D mammography, ProFound Risk
harnesses the power of artificial intelligence (AI) to provide
personalized, accurate, and efficient risk estimations for each
woman within the upcoming 1-2 years, despite having a current
mammogram with no current evidence of breast cancer. By uniquely
combining a range of risk factors, including age, breast density,
and subtle mammographic features, this first-in-kind technology
empowers clinicians to tailor screening and intervention strategies
based on individual patient risk profiles, offering a more
personalized and holistic approach to breast cancer detection and
risk assessment.
A growing body of clinical evidence has demonstrated ProFound
Risk's unique ability to more accurately predict short-term cancer
risk compared to commonly used risk models, including Gail and
Tyrer-Cuzick. According to a recent study published in Science
Translational Medicine, ProFound Risk for 3D mammography is up to
2.4 times more accurate than traditional risk models for short-term
risk assessments.ii,iii Another study published in the Journal of
Clinical Oncology demonstrated ProFound Risk for 2D Mammography is
more accurate than Tyrer-Cuzick v8, a commonly used lifestyle risk
model, for both short-term and long-term risk assessments.iv
"We are committed to advancing women's health through
cutting-edge technology and are dedicated to delivering innovative
solutions that have a meaningful impact on patient care," added Ms.
Brown. "The device license for ProFound Risk from Health Canada
represents another giant leap forward in our journey to transform
breast cancer risk assessment, and we remain focused on our mission
to improve the lives of women and healthcare professionals
worldwide."
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 expansion of access to the Company’s products,
improvement of performance, acceleration of adoption, 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 http://www.icadmed.com and on the SEC’s website at
http://www.sec.gov.
Contact:
Media Inquiries:Jessica Burns, iCAD
+1-201-423-4492jburns@icadmed.com
Investor Inquiries:iCAD Investor Relationsir@icadmed.com
i Government of Canada. Breast Cancer Fact Sheet. Accessed via
https://www.canada.ca/en/public-health/services/chronic-diseases/cancer/breast-cancer.html.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
https://www.science.org/doi/10.1126/scitranslmed.abn3971iii
Eriksson M, Czene K, Strand F et al. Identification of Women at
High Risk of Breast Cancer Who Need Supplemental Screening.
Radiology. 2020 Sept 8.iv Eriksson M, CzeneK , Vachon C, Conant E,
Hall P. Long-Term Performance of an Image-Based Short-Term Risk
Model for Breast Cancer. Journal of Clinical Oncology. DOI:
10.1200/JCO.22.01564.
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