iCAD Announces Compelling New and Real-World Data Demonstrating the Value of ProFound AI to be Presented at RSNA 2021

Rhea-AI Summary

iCAD (NASDAQ: ICAD) announced that its advanced breast cancer detection software, ProFound AI, will be highlighted in three scientific presentations at the RSNA 2021 meeting. Key studies focus on ProFound AI's effectiveness in improving cancer detection outcomes in digital breast tomosynthesis (DBT) screenings. Presentations will discuss AI's role in identifying aggressive lesions and its real-world impact on detection rates. Notably, ProFound AI reduces reading time by 52.7% and enhances radiologist sensitivity by 8%. The company continues to advance its technology for better patient care in breast health.

Positive

• ProFound AI reduces reading time by 52.7%, significantly improving workflow efficiency for radiologists.
• Demonstrated an 8% increase in radiologists' sensitivity, enhancing breast cancer detection accuracy.
• ProFound AI has over 2,000 licenses sold worldwide, indicating strong market acceptance.
• Compatibility with Hologic Clarity HD showcases adaptability and integration with major mammography systems.

Negative

• None.

World’s first FDA cleared AI breast cancer detection software to be highlighted in three scientific presentations at largest radiological meeting in the world

iCAD’s innovative breast health solutions, including ProFound AI Risk and PowerLook Density Assessment, to be showcased during the meeting

NASHUA, N.H., Nov. 29, 2021 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced new and real-world research demonstrating the value of ProFound AI^® for Digital Breast Tomosynthesis (DBT) will be highlighted at the 107^th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), November 28 – December 2. The Company is also showcasing its portfolio of world-class breast health solutions, including the latest versions of ProFound AI^® Risk and PowerLook^® Density Assessment, at McCormick Place in Chicago in the South Hall meeting suites 214-216.

“We are thrilled to have three important scientific presentations at RSNA this year, as these abstracts provide compelling new and real-world data regarding ProFound AI and the potential it offers to improve outcomes by supporting the earlier detection of breast cancer,” said Stacey Stevens, President of iCAD, Inc. “Our efforts to empower clinicians with deep-learning technologies to optimize efficiency, confidence, and patient outcomes are demonstrated by the unrivaled specificity of our breast imaging AI solutions that are transforming breast cancer detection and risk-based personalized screening.”

In a poster presentation titled “Use Of Artificial Intelligence Software To Identify Clinically Aggressive Lesions On Prior Digital Breast Tomosynthesis Exams Based On Molecular Subtypes,” lead author Mary F. Ice, MD, radiologist at Rose Imaging Specialist and Solis Mammography, will discuss her research evaluating the use of ProFound AI in identifying and scoring lesions in prior DBT screening exams of cancer cases (session ID: SPR-BR-4).

Additionally, the following poster discussions will take place on Tuesday, November 30:

• 12:15 to 12:45 pm (session ID: BR03-A2):
  “Effect Of Artificial Intelligence Software On Digital Breast Tomosynthesis Screening Cancer Detection And Abnormal Interpretation Rates Among Subspecialized Breast Radiologists: A Real-World Experience.” Principal investigator Haley P. Letter, MD, Assistant Professor, Program Director of Breast Imaging and Intervention Fellowship and Associate Clerkship Director at University of Florida Health – Jacksonville, will present research from a real-world study assessing the impact of ProFound AI in DBT screening exams.

• 12:45 to 1:15 pm (session ID: BR03-B3):
  “Tomosynthesis-driven AI-derived Breast Cancer Scoring Among A Racially Diverse Cohort Of Women Undergoing Screening: Potential For Triage And Precision Cancer Screening.” Principal investigator Emily F. Conant, MD, professor and chief, Division of Breast Imaging at the Hospital of the University of Pennsylvania Medical Center, will discuss findings from an observational study evaluating ProFound AI and the impact of race on the software’s performance and Case Scores.

“Our research presented at RSNA this year adds to the growing body of evidence supporting the importance of AI in breast screening and women’s health,” said Dr. Conant. “The findings from our study suggest that AI can be a valuable tool to help clinicians further personalize and tailor breast cancer screening regimens for women, which may help to detect cancers earlier, when they may be more easily treated.”

“ProFound AI delivers a level of precision, speed and efficacy that is unrivaled in the industry. With more than 2,000 licenses sold worldwide, ProFound AI offers multi-vendor compatibility and seamlessly integrates into the diagnostic process,” continued Stevens. “Moreover, ProFound AI is now compatible with Hologic Clarity HD, further demonstrating our commitment to integrate with all major mammography system vendors and enterprise-wide viewing applications.”

The Company’s full suite of breast health solutions includes the latest generation of ProFound AI for DBT, the first AI cancer detection software for DBT to be cleared by the FDA, as well as ProFound AI^® for 2D Mammography, the latest generation of ProFound AI Risk for 2D and 3D mammography, and PowerLook Density Assessment.

ProFound AI for DBT is proven to curtail workflow challenges substantially by reducing radiologists’ reading time by 52.7 percent, thereby reducing by half the amount of time it takes radiologists to read 3D mammography datasets. Additionally, the platform is clinically proven to improve radiologists’ sensitivity by 8 percent and reduce unnecessary patient recall rates by 7.2 percent.ⁱ

The latest generation of ProFound AI Risk offers the ability to calculate a short-term risk estimation for 3D mammography, with greater accuracy compared to both the previous version of the risk software based on 2D mammography and traditionally used risk models. Expanded features include the ability to calculate short-term (one-, two- or three-year) absolute risk based on either 2D or 3D mammography images. Specifically designed to factor in racial and ethnic backgrounds, ProFound AI Risk also factors in clinically relevant global screening guidelines and more than 15 country incidence and mortality reference tables, for alignment with that country’s general population.

The latest version of PowerLook Density Assessment software on the new PowerLook 10 platform enables clinicians to automate breast density assessment accurately and reliably,ⁱⁱ removing the challenges of subjectivity. It identifies the patient’s anatomy, segments the breast, then measures adipose and fibroglandular tissue and its dispersion to determine the density category in alignment with BI-RADS^® 5th Edition lexicon. Its consistent scores bring confident density assessment and standardized stratification in density-based breast cancer screening and reporting.

During the RSNA meeting this year, iCAD will also host “Cocktails and Conversations” events on November 29 and November 30, featuring leading AI experts in breast imaging who will share their experience with ProFound AI. The events will take place at Fatpour Tap Works McCormick at 5:30 pm CT on both days. To register for a meeting with iCAD at RSNA or RSVP for an event, please visit: https://www.icadmed.com/rsna2021.html.

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 expected benefits of ProFound AI^® Risk for digital breast tomosynthesis (DBT) and the updated version of PowerLook^® Density Assessment, 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. 

Contacts:
Media inquiries:
Jessica Burns, iCAD  
+1-201-423-4492
jburns@icadmed.com

Investor Relations:
Brian Ritchie, LifeSci Advisors
+1-212-915-2578
britchie@lifesciadvisors.com

ⁱ Conant, E et al. (2019). Improving Accuracy and Efficiency with Concurrent Use of Artificial Intelligence for Digital Breast Tomosynthesis. Radiology: Artificial Intelligence. 1 (4). Accessed via https://pubs.rsna.org/doi/10.1148/ryai.2019180096
ⁱⁱ iCAD data on file

 

FAQ

What key presentations will iCAD showcase at the RSNA 2021 meeting?

iCAD will present three key studies focusing on the effectiveness of ProFound AI in breast cancer detection, including real-world data on its impact in DBT screenings.

How does ProFound AI improve breast cancer detection?

ProFound AI enhances detection by reducing reading time by 52.7% and increasing radiologists' sensitivity by 8%, leading to earlier cancer detection.

What is the significance of FDA clearance for ProFound AI?

The FDA clearance positions ProFound AI as a leading technology for digital breast tomosynthesis, validating its safety and effectiveness in clinical settings.

How many licenses has ProFound AI sold worldwide?

ProFound AI has sold over 2,000 licenses globally, demonstrating strong demand and acceptance in the medical community.

What are the highlights of iCAD's breast health solutions?

iCAD's breast health solutions, including ProFound AI Risk and PowerLook Density Assessment, focus on personalized screening and accurate density assessments, enhancing patient care.