CORRECTION – iCAD Advances Fight Against Breast Cancer with FDA-cleared, Next-Generation AI Solutions and ProFound Health Partnership with Cascaid Health at RSNA 2024

Rhea-AI Summary

iCAD announces significant developments at RSNA 2024, including its FDA-cleared ProFound Detection Version 4.0 and a new partnership with Cascaid Health. The collaboration will launch ProFound Health in Q1 2025, offering virtual second reads of mammograms using AI technology to enhance breast cancer detection.

The new ProFound Detection Version 4.0 improves aggressive cancer detection by 22% and reduces cases with no marks by 18%. Clinical results show a 23% increase in overall cancer detection rates, 32% enhanced detection in dense breast tissue, and a 12% reduction in invasive cancer size.

The company is showcasing these innovations at RSNA 2024 in Chicago (December 1-5), featuring presentations on real-world AI implementation results and advances in calcification detection. The initiative aims to democratize access to AI-powered mammography and improve breast cancer detection outcomes.

ProFound Health, a Virtual Care Partnership with Cascaid Health, to Democratize Access to AI-Powered Mammography for All Patients – Launching Q1 2025

NASHUA, N.H., Dec. 04, 2024 (GLOBE NEWSWIRE) -- Further to a release issued under the same headline on November 26, 2024 13:00 ET by iCAD, Inc., the headline and fourth paragraph have been updated to acknowledge a pending trademark application for the mark “SecondReadAI” by Lunit, Inc. The corrected release follows:

iCAD, Inc. (NASDAQ: ICAD) (“iCAD” or the “Company”), a global leader in clinically proven AI-powered cancer detection solutions, will showcase its groundbreaking breast health AI technologies at the Radiological Society of North America (RSNA) 2024 Annual Meeting in Chicago, December 1-5.

Key highlights include the recent FDA-cleared ProFound Detection Version 4, clinical research presentations, and a new partnership with Cascaid Health to expand access to AI-driven breast health solutions.

iCAD and Cascaid Health Partner to Expand Access to AI-Driven Breast Health

In alignment with their vision to enable all women to access to AI-powered breast health services, iCAD and Cascaid Health will unveil their collaboration to integrate the ProFound AI Breast Health Suite into Cascaid’s leading edge digital health marketplace and access to care platform. Scheduled for beta launch in Q1 2025, this partnership between iCAD and Cascaid Health will launch ProFound Health, a virtual care model powered by Cascaid. ProFound Health will enable women who have not otherwise received an AI-read on their screening mammogram to access iCAD’s advanced breast health technology. The initiative reflects both companies’ dedication to democratizing access to life-saving technology and creating a world where cancer can’t hide.

ProFound Health partnership will offer virtual second reads of mammograms leveraging ProFound AI Breast Health Suite, an AI service providing patients without access to AI an opportunity to receive enhanced breast health insights. The initial service will include a second read detection, breast density assessment, and cancer risk evaluation from a Cascaid-affiliated specialist network of clinical experts in women’s health through Cascaid’s seamlessly integrated digital platform. By combining AI insights with expert clinical reviews, ProFound Health ensures that patients everywhere, regardless of location, can receive precision screening and personalized care.

“ProFound Health empowers patients with access to critical information about their mammograms and overall breast health, allowing them to make informed decisions and take control of their care journey,” said Dana Brown, CEO and President of iCAD. “Our collaboration with Cascaid Health’s network of clinicians and AI-powered solutions is part of our ongoing commitment to bridging gaps in breast cancer care, ensuring all patients everywhere can access the accuracy and timeliness of AI solutions, and ultimately transforming patient outcomes.”

“We believe that every woman should have access to the best possible information about her breast health and a high quality, personalized care plan to catch cancer early or prevent it altogether. Through our partnership with iCAD, we’re addressing a critical need to improve access to advanced breast health services,” said Dr. Candace Westgate, Director of Women’s Health for Cascaid Health. “ProFound Health is more than just a technological innovation, it’s a lifeline that empowers patients and healthcare providers with actionable insights, bridging care gaps and ensuring equitable access to precision screening and personalized breast cancer care.”

Advancing Next Generation AI Breast Health Solutions at RSNA 2024

In addition to ProFound Health, iCAD will feature its flagship ProFound Detection Version 4.0, which recently received FDA clearance. This next-generation AI solution enhances breast cancer detection by incorporating prior exams into current analysis, improving the detection of aggressive cancers by 22%, reducing cases with no marks by 18%, and providing clinicians with more reliable insights for better decision-making.

“Every two minutes, someone loses their life to breast cancer—a disease affecting over 2.3 million women annually. Early detection is critical, as five-year survival rates exceed 99% for stage 1 disease. Yet traditional mammography misses over 20% of breast cancers, particularly in dense tissue, resulting in potentially avoidable late-stage diagnoses,” said Dana Brown, President and CEO of iCAD, Inc. “ProFound Detection Version 4 revolutionizes breast cancer detection by uniquely integrating prior exams into its analysis. This advanced capability enhances sensitivity, sharpens precision, and provides radiologists with a deeper, longitudinal view of a patient’s breast health. By enabling earlier and more accurate detection, especially in dense tissue, ProFound Detection Version 4 sets a new standard in breast health AI, empowering providers to improve outcomes and save lives. Together with our strategic partnerships, we are advancing the fight against cancer and making a meaningful difference for patients worldwide.”

ICAD’S RSNA 2024 Program Highlights

AI-Powered Insights: Advancing Cancer Detection

• Oral Abstract Presentation: “Real World Effect of Artificial Intelligence on Histopathology and Stage in Breast Cancer Screening”
  
  
  • Presenter: Kathy Schilling, M.D., Boca Raton Regional Hospital
  • When: Sunday, December 1 | 10:30–11:30 AM
  • Where: S406A: S2-SSBR01-6
  • Details: Dr. Kathy Schilling discusses the experience with tenured radiologists on how the current use of ProFound AI improves cancer detection, even in women with dense breast tissue, compared to their performance prior to the implementation of AI. In addition, she will describe the decrease in the mean size and stage of cancers after the implementation, along with an increase in the diagnosis of lobular cancers.
    

“The integration of ProFound AI alongside our nine dedicated breast radiologists has demonstrated remarkable improvements in cancer detection and patient outcomes across our imaging network,” said Dr. Kathy Schilling, Medical Director of the Christine E. Lynn Women’s Health & Wellness Institute at Boca Raton Regional Hospital. “We’ve seen a 23% overall increase in cancer detection rates, a 4% rise in invasive cancer detection, and doubled rates of lobular cancer detection. ProFound AI also enhanced detection in dense breast tissue by 32%, reduced invasive cancer size by 12%, and lowered histopathologic stage with a 40% reduction in T2 tumors—all without increasing DCIS diagnoses or recall rates. These advancements underscore the transformative potential of AI in improving early breast cancer detection, elevating patient care, and ultimately saving lives.”

• AI Theater Presentation: “The Thin White Line: Which Calcifications Matter? Advances in AI Breast Cancer Detection”
  
  
  • Presenter: Chirag R. Parghi, M.D., M.B.A., Solis Mammography
  • When: Tuesday, December 3 | 1:00–1:20 PM
  • Where: AI Showcase Theater (South Hall A), Booth 5536
  • Details: A look at how ProFound Detection’s next-generation capabilities reduce uncertainty in interpreting calcifications on a mammogram by displaying 20% fewer marks related to vascular calcifications and 51% fewer marks related to non-vascular calcifications, leading to enhanced precision and accuracy.
    

Collaborative Panels and Partner Showcases

• GE HealthCare Expert Corner: Seamless integration of ProFound AI with GE mammography systems to enhance workflow and detection capabilities. Daily at Booth 7330 (North Hall).
• Densitas Panel: “Elevating Patient Care through Quality Images & Precise Detection.” Daily at Booth 4747 (South Hall).
• CancerIQ: Daily at Booth 4747(South Hall).
• Blackford Panel: “Enhancing Breast Cancer Care with AI.” Tuesday, December 3, 2:30-2:50 PM at Booth 4729 (South Hall).
• CARPL.ai Breast AI Panel: Wednesday, December 4, 11:00 AM at Booth 5733 (South Hall).
  

Customer Appreciation Event

iCAD will be hosting a customer appreciation event, "AI in the Sky: Discover ProFound Insights & Breast Health Innovations," on Sunday, December 1, at 6:00 PM at VU Rooftop in Chicago. Network with industry experts, hear insights from key opinion leaders including iCAD’s CEO and Board of Directors, and explore how iCAD’s solutions are transforming breast health. Visit the iCAD RSNA 2024 event page for the latest updates, event details, and partnership announcements.

About Cascaid Health

Cascaid Health Inc. delivers a personalized, expert-driven proactive and preventative approach, supported by an integrated platform designed to promote longevity, detect issues early, reverse risks, and optimize healthspan for all. The company’s platform offers a curated marketplace featuring innovative products, services, and access to world-class multidisciplinary experts in women’s health, precision health, lifestyle medicine, wellness, and performance. Cascaid Health Inc. is committed to advancing health equity, ensuring that cutting-edge healthcare solutions are accessible to everyone.

About iCAD, Inc.

iCAD, Inc. (NASDAQ: ICAD) is a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered solutions that enable medical providers to accurately and reliably detect cancer earlier and improve patient outcomes. Headquartered in Nashua, N.H., iCAD’s industry-leading ProFound Breast Health Suite provides AI-powered mammography analysis for breast cancer detection, density assessment and risk evaluation. Used by thousands of providers serving millions of patients, ProFound is available in over 50 countries. In the last five years alone, iCAD estimates reading more than 40 million mammograms worldwide, with nearly 30% being tomosynthesis. For more information, including the latest in regulatory clearances, please 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 that 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, 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.

CONTACTS

Media Inquiries:
pr@icadmed.com

Investor Inquiries:
John Nesbett/Rosalyn Christian
IMS Investor Relations
icad@imsinvestorrelations.com

FAQ

What improvements does iCAD's ProFound Detection Version 4.0 offer for breast cancer detection?

ProFound Detection Version 4.0 improves aggressive cancer detection by 22%, reduces cases with no marks by 18%, and enhances detection in dense breast tissue by 32%. It incorporates prior exams into current analysis for better decision-making.

When will iCAD and Cascaid Health launch ProFound Health?

ProFound Health is scheduled for beta launch in Q1 2025, offering virtual second reads of mammograms using AI technology.

What clinical results were presented at RSNA 2024 for iCAD's AI technology?

Clinical results showed a 23% increase in overall cancer detection rates, 32% improved detection in dense breast tissue, 12% reduction in invasive cancer size, and a 40% reduction in T2 tumors.

What services will ProFound Health offer through the iCAD-Cascaid partnership?

ProFound Health will offer virtual second reads of mammograms, breast density assessment, and cancer risk evaluation through Cascaid's network of clinical experts using iCAD's AI technology.