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iCAD Advances Fight Against Breast Cancer with FDA-cleared, Next-Generation AI Solutions and a Second-Read AI Partnership with Cascaid Health at RSNA 2024

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iCAD announces major developments at RSNA 2024, including its FDA-cleared ProFound Detection Version 4.0 and a partnership with Cascaid Health. The collaboration will launch ProFound Health in Q1 2025, offering AI-powered second-read mammography services to expand access to breast health technology. The new Version 4.0 improves aggressive cancer detection by 22% and reduces no-mark cases by 18%. Clinical data shows significant improvements, including a 23% increase in cancer detection rates and 32% enhanced detection in dense breast tissue. The company will showcase these innovations at RSNA 2024 in Chicago, December 1-5, featuring presentations on real-world AI implementation results and technical advances.

iCAD annuncia importanti sviluppi durante l'RSNA 2024, tra cui la sua versione ProFound Detection Version 4.0 approvata dalla FDA e una partnership con Cascaid Health. Questa collaborazione porterà al lancio di ProFound Health nel primo trimestre del 2025, offrendo servizi di mammografia a lettura secondaria potenziati dall'IA, per ampliare l'accesso alla tecnologia per la salute del seno. La nuova Version 4.0 migliora la rilevazione dei tumori aggressivi del 22% e riduce i casi senza marcatura del 18%. I dati clinici mostrano miglioramenti significativi, compreso un aumento del 23% nei tassi di rilevazione dei tumori e un 32% di rilevazione migliorata nei tessuti mammari densi. L'azienda presenterà queste innovazioni all'RSNA 2024 a Chicago, dal 1 al 5 dicembre, con presentazioni sui risultati dell'implementazione dell'IA nel mondo reale e sui progressi tecnici.

iCAD anuncia importantes desarrollos en RSNA 2024, incluida su ProFound Detection Version 4.0 aprobada por la FDA y una asociación con Cascaid Health. La colaboración lanzará ProFound Health en el primer trimestre de 2025, ofreciendo servicios de mamografía de segunda lectura impulsados por IA para ampliar el acceso a la tecnología de salud mamaria. La nueva versión 4.0 mejora la detección de cáncer agresivo en un 22% y reduce los casos sin marca en un 18%. Los datos clínicos muestran mejoras significativas, incluyendo un aumento del 23% en las tasas de detección de cáncer y un 32% de mejora en la detección en tejido mamario denso. La empresa presentará estas innovaciones en RSNA 2024 en Chicago, del 1 al 5 de diciembre, con presentaciones sobre resultados de la implementación de IA en el mundo real y avances técnicos.

iCAD는 RSNA 2024에서 FDA 승인된 ProFound Detection Version 4.0Cascaid Health와의 파트너십을 포함한 주요 개발 사항을 발표했습니다. 이 협력은 2025년 1분기에 ProFound Health를 출시하여 유방 건강 기술에 대한 접근을 확대하기 위해 AI 기반의 2차 유방 촬영 서비스를 제공합니다. 새로운 버전 4.0은 공격적인 암 탐지를 22% 개선하고 마크가 없는 사례를 18% 줄입니다. 임상 데이터는 암 탐지율이 23% 증가하고 밀집 유방 조직에서 32% 향상된 탐지를 포함하여 상당한 개선 사항을 보여줍니다. 회사는 12월 1일부터 5일까지 시카고에서 열리는 RSNA 2024에서 실제 세계 AI 구현 결과 및 기술 발전에 대한 발표를 통해 이러한 혁신을 선보일 예정입니다.

iCAD annonce des développements majeurs lors de l'RSNA 2024, y compris sa ProFound Detection Version 4.0 approuvée par la FDA et un partenariat avec Cascaid Health. Cette collaboration lancera ProFound Health au premier trimestre 2025, offrant des services de mammographie de deuxième lecture alimentés par l'IA pour élargir l'accès à la technologie de santé mammaire. La nouvelle Version 4.0 améliore la détection du cancer agressif de 22 % et réduit les cas sans marquage de 18 %. Les données cliniques montrent des améliorations significatives, notamment une augmentation de 23 % des taux de détection du cancer et une détection améliorée de 32 % dans les tissus mammaires denses. L'entreprise présentera ces innovations à l'RSNA 2024 à Chicago, du 1er au 5 décembre, avec des présentations sur les résultats de l'implémentation de l'IA dans le monde réel et les avancées techniques.

iCAD kündigt bedeutende Entwicklungen auf der RSNA 2024 an, darunter die von der FDA genehmigte ProFound Detection Version 4.0 und eine Partnerschaft mit Cascaid Health. Die Zusammenarbeit wird ProFound Health im ersten Quartal 2025 einführen und KI-gestützte Zweitlesedienste für die Mammographie anbieten, um den Zugang zur Technologie für die Brustgesundheit zu erweitern. Die neue Version 4.0 verbessert die Erkennung aggressiver Krebserkrankungen um 22% und reduziert die Anzahl der unmarkierten Fälle um 18%. Klinische Daten zeigen signifikante Verbesserungen, darunter einen Anstieg der Krebserkennungsraten um 23% und eine 32% verbesserte Erkennung in dichtem Brustgewebe. Das Unternehmen wird diese Innovationen auf der RSNA 2024 in Chicago vom 1. bis 5. Dezember präsentieren, einschließlich Präsentationen zu den Ergebnissen der Implementierung von KI in der realen Welt und technischen Fortschritten.

Positive
  • FDA clearance obtained for ProFound Detection Version 4.0
  • 22% improvement in aggressive cancer detection
  • 23% increase in overall cancer detection rates
  • 32% enhancement in dense breast tissue detection
  • 12% reduction in invasive cancer size
  • 40% reduction in T2 tumors
Negative
  • None.

Insights

The partnership with Cascaid Health and FDA clearance of ProFound Detection Version 4.0 represent significant advancements in breast cancer screening technology. The new version shows 22% improved detection of aggressive cancers and 18% reduction in false marks, addressing critical gaps in traditional mammography which misses over 20% of breast cancers.

Clinical data from Boca Raton Regional Hospital demonstrates impressive real-world results: 23% increase in overall cancer detection, 32% improvement in dense tissue detection and 12% reduction in invasive cancer size. The Q1 2025 launch of ProFound Health's second-read service could significantly expand market reach and revenue potential while improving care accessibility.

This development positions iCAD strategically in the growing AI healthcare market. The Cascaid Health partnership creates a new revenue stream through a virtual care model, potentially expanding beyond traditional hospital-based sales. The FDA clearance strengthens market position, while clinical validation from major healthcare providers enhances credibility.

For a company with a $41.6M market cap, these developments could drive significant growth through increased adoption and market expansion. The Q1 2025 launch timeline provides a clear catalyst for potential value creation.

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., Nov. 26, 2024 (GLOBE NEWSWIRE) -- 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 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 will offer a “Second Read” virtual AI service, providing patients without access to AI an opportunity to receive enhanced breast health insights. The initial service will include 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 are the key features of iCAD's ProFound Detection Version 4.0?

ProFound Detection Version 4.0 incorporates prior exams into current analysis, improves aggressive cancer detection by 22%, reduces cases with no marks by 18%, and enhances detection particularly in dense breast tissue.

When will iCAD and Cascaid Health launch ProFound Health?

ProFound Health is scheduled for beta launch in Q1 2025.

What clinical improvements has iCAD's ProFound AI demonstrated?

ProFound AI showed a 23% increase in cancer detection rates, 32% enhanced detection in dense breast tissue, 12% reduction in invasive cancer size, and 40% reduction in T2 tumors.

Where will iCAD showcase its new technologies in December 2024?

iCAD will showcase its technologies at the Radiological Society of North America (RSNA) 2024 Annual Meeting in Chicago, December 1-5.

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