Health Canada Grants Device License for iCAD’s ProFound Risk 2.0, Revolutionizing Breast Cancer Risk Via a 1-2 Year Assessment
NASHUA, N.H., August 16, 2023 – 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
+1-201-423-4492
Investor Inquiries:
iCAD Investor
Relations
[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.abn3971
[iii] 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.