iCAD Announces Significant Commercial Momentum for ProFound AI Among Customers Equipped with the Leading Provider of 3D Mammography Systems

Customers report continued workflow advantages and clinical superiority with iCAD’s suite of AI‐powered breast health solutions, compared to other available breast AI solutions

NASHUA, N.H., April 26, 2022 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, announced significant commercial momentum for ProFound AI^®, driving attachment to the leading provider of 3D mammography, or digital breast tomosynthesis (DBT), systems.

“Our customers who have adopted the leading 3D mammography systems have recognized that they cannot fully access the power of that technology without ProFound AI,” said Stacey Stevens, President and CEO of iCAD, Inc. “With about two times the improvement in clinical performance compared to leading competitors,ⁱ ProFound AI offers unrivaled accuracy, as well as multi‐vendor compatibility and unique workflow advantages. Our high‐performance breast AI solutions empower clinicians, administrators and IT specialists to provide excellent, cost-effective patient care, and the powerful testimonials from our growing installed base of customers speak to the advantages this leading‐edge technology offers when paired with DBT.”

ProFound AI Prevailed as the Premier AI Solution in a Competitive Trial at Wake Radiology
With 14 imaging locations in the Raleigh‐Durham metropolitan area and a full fleet of Hologic^® gantries, Wake Radiology offers a wide array of imaging exams in the outpatient setting, including screening and diagnostic mammography. But when Wake Radiology upgraded to 3D mammography, the organization soon realized that the substantial increase in the volume of images compared to 2D mammography resulted in workload challenges for its radiologists. The organization sought an AI solution that would offer the flexibility and scalability to work with different picture archiving and communication systems (PACS) across 21 gantries and a variety of viewing environments, and decided to explore all available AI solutions for mammography, ultimately choosing to adopt ProFound AI for DBT.

“After comparing all available options, we felt that iCAD’s technology was simply the best,” said Matt Dewey, Chief Information Officer at Wake Radiology. “We needed an AI solution that would allow us to read mammograms from either the Hologic workstation or from the Intelerad^® PACS and ProFound AI, which supports multiple output formats, was able to provide that flexibility.”

The team first began using ProFound AI for screening mammograms, but in June 2021 they also began using it for diagnostic mammograms.

“As a diagnostic radiologist, I’m not reading nearly as many mammograms as someone reading screening mammograms, but I have still grown to rely on the technology,” said William G. Way Jr., MD, Diagnostic Radiologist at Wake Radiology. “I see a fair number of screening callbacks, and when I review the diagnostic images, I rely heavily on the areas of concern detected by ProFound AI on the original screening mammogram. When my findings at the time of the diagnostic workup are concordant with ProFound AI from the original screening examination, I feel much better about signing off on the case as a BIRADS 2 or 3. I have come to appreciate that when ProFound AI indicates the risk of malignancy is low, you can almost always trust it. And for my colleagues who do large volume screening mammography, ProFound AI serves as a reliable ‘second reader’ that helps them avoid making errors in interpretation.”

After a year of implementing the technology, the team at Wake Radiology reports continued satisfaction with ProFound AI, particularly as it improves over time with ongoing updates and new versions.

“iCAD is definitely continuing to put resources into improving their technology. Over the last year of using ProFound AI in our clinical practice, we’ve seen the technology advance over time, with noticeable improvements for the latest versions compared to its predecessor,” added Dewey. “Not only has the algorithm itself improved since we adopted it, the formatting has also improved, making it even better for our radiologists.”

RCI Became the First in the State to Adopt ProFound AI as its Breast AI Solution for Mammography
Iowa’s largest radiology group, Radiology Consultants of Iowa (RCI), upgraded to Hologic’s Selenia^® Dimensions^® 3D mammography system in 2014 and Hologic Clarity HD™ with 3DQuorum™ in 2021. However, the organization then found their previous computer‐aided detection (CAD) solution was not providing adequate support to help radiologists manage the increase in workload. The organization sought a breast AI solution that would seamlessly integrate into their workflow, without overloading the facility with additional hardware, and after a thorough evaluation of all available technologies, in 2021 the organization ultimately decided to become the first facility in Iowa to adopt ProFound AI for DBT.

“When it comes to AI, iCAD was the first in the game. Although AI itself is still in its infancy, iCAD is ahead of other companies that are just now entering the market of breast AI. Additionally, the data supporting ProFound AI speaks for itself. After looking at reader studies for other AI solutions, we were not as confident that what they were offering was as robust as iCAD’s technology,” said Arnold B. Honick, MD, a Diagnostic Radiology Specialist at RCI. “Other AI solutions are essentially a black box attached to each gantry, and there is a significant cost per gantry. ProFound AI operates on just one centralized server, which streamlined and accelerated the integration process.”

“We decided to adopt ProFound AI because we felt it was the best product available to provide valid CAD markers on DBT. We also found iCAD’s other breast AI solutions enticing, such as PowerLook^® Density Assessment and ProFound AI^® Risk, as technologies we would like to assess,” added Dr. Honick.

Upon adoption, Dr. Honick and the RCI team noticed ProFound AI boosted their confidence and helped them to read cases more efficiently and accurately.

“ProFound AI has provided noticeable efficiency improvements for us already. It gives me the confidence that I’m looking at the appropriate slices, or images. And using the Case Scores, we are now able to help decipher mammograms with very low likelihood of containing an abnormality from one that might require further evaluation,” said Dr. Honick. “I’ve learned to trust ProFound AI. We found a couple cases where ProFound AI helped the radiologist find a subtle area of distortion that might have been easily overlooked. And these are clearly abnormalities on the synthetic view that you would never see, so it has certainly helped improve our performance and accuracy as well.”

Kettering Health Traded out Previous AI Software for ProFound AI Enterprise‐Wide
The team at Kettering Health, a leading faith based, not‐for‐profit hospital system in southwest Ohio, recently set upon a journey to upgrade its 14 breast centers with new 3D mammography equipment. However, the team soon found that the AI solution on some of their mammography units was not supporting radiologists adequately. After extensive research, the organization chose ProFound AI as its AI solution for DBT, ultimately deciding to implement this technology across all of their locations.

“ProFound AI is a game changer. Other AI technologies for DBT seem like smoke and mirrors when compared with ProFound AI. It is clearly the most advanced technology of its kind on the market,” said Sally Grady, Director of Kettering Health Breast Centers. “Improving accuracy and efficiency is key. Every time a patient is called back, that woman assumes she has cancer. Reducing false positives and callbacks is a huge benefit, not only to our patients but to our technologists and radiologists. We only want to call back the women who really need it, and ProFound AI can help our team differentiate that and read mammograms more accurately.”

Meghan Musser, DO, Medical Director for Breast Imaging at Kettering Health, agreed that ProFound AI has helped to improve both accuracy and efficiency for radiologists at the facility, helping them to detect small, subtle lesions that might not stand out to the naked eye, which has ultimately enhanced patient care.

“ProFound AI helps to improve clinical confidence while reading mammograms, which then translates into the discussion I have with the patient,” said Dr. Musser. “ProFound AI is particularly helpful in finding subtle lesions, such as invasive lobular cancers, which tend to be the type of cancers radiologists fear the most, simply because they can be so difficult to detect. In fact, we were hoping to determine whether ProFound AI detected some of the cancers that we had later deemed as interval breast cancers, or cancers that develop between screenings, and in a good portion of those cases, we confirmed ProFound AI did detect something, even if it was subtle, which only further increased our confidence in the technology.”

Kettering Health initially offered breast cancer screening with ProFound AI at four locations, but Grady soon made the decision to expand access to this technology across its entire enterprise of facilities.

“We felt it was critical to offer this potentially lifesaving technology to all of our patients,” added Grady. “We felt offering it to only some of our patients was almost creating a disparity of sorts, and we felt that the value this technology offers was something we wanted to offer to every woman who is screened for breast cancer at one of our centers. Having ProFound AI really helps to set us apart from other facilities in the area; while we upgraded all of our breast screening technology, ProFound AI is truly the icing on the cake.”

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^®, 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 Relations:
iCAD Investor Relations
ir@icadmed.com

ⁱ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Accessed 1-19-22. FDA 510K submissions K182373, K201019, K193229.