Health Canada Grants Device License for iCAD's ProFound Risk 2.0, Revolutionizing Breast Cancer Risk Via a 1-2 Year Assessment

Rhea-AI Summary

iCAD, Inc. (NASDAQ: ICAD) - Health Canada issued a device license for ProFound Risk version 2.0, iCAD's personalized 1-2 year breast cancer risk assessment solution. The technology uses AI to provide personalized, accurate, and efficient risk estimations for each woman, offering a more personalized and holistic approach to breast cancer detection and risk assessment. Clinical evidence demonstrates its unique ability to more accurately predict short-term cancer risk compared to traditional risk models. The device license represents a significant milestone in iCAD's mission to improve breast cancer risk assessment and patient care.

Positive

• ProFound Risk version 2.0 has received a device license from Health Canada, validating its clinical efficacy and paving the way for its use in healthcare facilities across Canada. The technology offers a more personalized and holistic approach to breast cancer detection and risk assessment, empowering clinicians to tailor screening and intervention strategies based on individual patient risk profiles. Clinical evidence has demonstrated its unique ability to more accurately predict short-term cancer risk compared to traditional risk models.

Negative

• None.

NASHUA, N.H., Aug. 16, 2023 (GLOBE NEWSWIRE) -- 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
jburns@icadmed.com

Investor Inquiries:
iCAD Investor Relations
ir@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.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.

FAQ

What is ProFound Risk version 2.0?

ProFound Risk version 2.0 is iCAD's personalized 1-2 year breast cancer risk assessment solution that uses artificial intelligence (AI) to provide personalized, accurate, and efficient risk estimations for each woman.

What does the device license from Health Canada mean for iCAD?

The device license from Health Canada validates the clinical efficacy of ProFound Risk version 2.0 and paves the way for its use in healthcare facilities across Canada.

How accurate is ProFound Risk in predicting short-term cancer risk?

Clinical evidence has demonstrated that ProFound Risk is up to 2.4 times more accurate than traditional risk models for short-term risk assessments.

What are the key features of ProFound Risk?

ProFound Risk combines a range of risk factors, including age, breast density, and subtle mammographic features to empower clinicians to tailor screening and intervention strategies based on individual patient risk profiles.