iCAD Reports Over 1,000 Licenses Sold as Part of ProFound AI Sales
Significant
Percentage of Licenses Sold to Facilities with GE, Siemens, and Sites with
Multiple Vendors Including Hologic and Fuji
ProFound
AI for DBT Offers Superior Clinical Performance When Compared to Other
Commercially Available Breast AI Systems
NASHUA, N.H. – November 24, 2020 – iCAD, Inc. (NASDAQ: ICAD), a global
medical technology leader providing innovative cancer detection and therapy
solutions, today reported that over 1,000 licenses have been sold as part of
ProFound AI® sales since the products were launched, signaling the rapid and
wide-spread adoption of the pioneering cancer detection software solution built
on artificial intelligence (AI). The sales have been distributed across all
major mammography system vendors and enterprise-wide viewing applications with
a significant percentage to date sold to hospitals and imaging centers with GE
and Siemens, as well as facilities with more than one imaging system vendor,
including Hologic and Fuji.
The solid momentum is led by the Company’s growing customer base
and demand for its expanded suite of leading breast
health AI solutions, including ProFound AI for both Digital
Breast Tomosynthesis (DBT) and 2D mammography, and interest in the recently
introduced ProFound AI Risk, which is helping to transform breast cancer
screening from age-based screening to risk-adapted precision screening,
individualized for each woman.
“iCAD offers the full continuum of breast health AI products—both
for the detection of current breast cancers and for future risk assessment,”
said Michael
Klein, Chairman and CEO of iCAD. “We do so on a non-exclusive, open
architecture basis, therefore allowing all global customers access to the best
of breed AI software available. Of significant note is that no other breast AI
solution has been shown to improve radiologists’ clinical performance when
reading DBT more so than ProFound AI. Specifically, our high-performing cancer
detection and workflow solution offers the highest cancer detection rate, the
lowest false positive rate and a dramatic 52.7% reduction in radiologists’ reading
time, representing a high level of clinical significance and advantage.”
According to Kathy Schilling, MD, Medical Director of the Christine
E. Lynn Women’s Health & Wellness Institute at the Boca Raton Regional
Hospital, “ProFound AI for DBT rapidly and accurately analyze patients’ DBT
mammography images, identifying suspicious lesions and producing quantifiable
AI scores, which enables us to identify cancers earlier. The software also
improves workflow issues, as we’re able to more quickly navigate through DBT
datasets.”
ProFound AI Risk is the first and only commercially available
clinical decision support tool to provide an accurate two-year breast cancer
risk estimation based solely on a screening mammogram. Compelling research
published in the peer-reviewed journal, Radiology concluded
that the ProFound AI Risk model is effective at identifying women at high
likelihood of being diagnosed with breast cancer within two years of a negative
screening mammogram and in possible need of supplemental screening.
“I was very enthusiastic about the launch of
ProFound AI Risk, which I believe is more accurate than the other risk tools
I’ve used, and it is very easy to integrate into my daily workflow,” said
Carine Van De Merckt, MD, Radiologist at Centre d’Imagerie Medicale in
Brussels, Belgium. “Furthermore, it has proven to help me in my clinical
decision making, allowing me to continue to provide the best care to my
patients with even more confidence.”
As part of the Company’s growth, iCAD has recently achieved
significant milestones, including:
- Sequential Revenue Growth of 44% in Third
Quarter: The Company realized significant revenue growth over the second
quarter in 2020, particularly with its innovative ProFound AI product
offerings, which grew 44%. - Strong International Growth: The
Company, with products now distributed in 22 countries outside the U.S.,
recently signed distribution agreements in Switzerland and Portugal. The first
ProFound AI for DBT sold in the United Kingdom and the first ProFound AI Risk
sold in Belgium both occurred in October 2020. - Distribution Agreement with Change Healthcare: A new agreement with the
leading independent healthcare technology company, Change Healthcare, enhances
commercial access to enterprise imaging and integrated delivery system networks
throughout the U.S.
According
to Change Healthcare’s Tracy Byers, Senior Vice President and General Manager
of Imaging, as Change Healthcare looks to accelerate and transform enterprise
imaging with the use of AI and cloud-native solutions, the partnership with
iCAD enables them to offer their customers the ProFound AI platform as part of
their Mammography Plus offering. “We are focused on radiologist productivity
and aiding them with decision support tools that are elegantly integrated into
their workflow,” said Byers. “The integration of iCAD’s AI solutions into our
digital mammography platform will help improve patient outcomes by improving
early cancer detection and enhancing clinical workflow. We could not be more
excited about empowering our customers and our new partnership with iCAD.”
“iCAD’s momentum underscores the increasing demand for our
comprehensive breast health AI solutions for DBT, breast density, and 2D
mammography, offering clinicians a broad range of powerful tools for early
disease detection and optimized reading workflow that results in improved
patient outcomes,” said Stacey
Stevens, president at iCAD. “This, coupled with ProFound AI’s seamless
integration with major PACS for decision support capabilities across large
networks, and ProFound AI’s compatibility with all leading mammography systems,
allows hospitals and imaging centers with one or multi-vendor imaging systems
to have a proven, standardized AI solution.
“Moreover, our principal approach to transforming breast cancer
detection and care is best illustrated by our panoramic vision—to provide a
more holistic view of each patient’s current imaging exam, history, and
short-term risk,” continued Stevens. “With the addition of ProFound AI Risk, we
intend to move mammography from primarily an age-based screening paradigm to a
risk-adjusted precision screening paradigm that is truly personalized for every
woman.”
Headquartered in Nashua, NH, iCAD is a global medical technology leader
providing innovative cancer detection and therapy solutions.
ProFound AI for DBT is proven to curtail workflow
challenges substantially by reducing radiologists’ reading time by 52.7%, thereby
reducing by half the amount of time it takes radiologists to read 3D
mammography datasets. Additionally, the platform improved radiologists’ performance
measured by Area Under the Curve (AUC) by nearly 6% and reduced unnecessary
patient recall rates by more than 7%.[i]
ProFound AI Risk is currently available on an introductory basis
for 2D mammography and will subsequently be available for the rapidly growing
3D mammography market.
For more information, visit www.icadmed.com and www.xoftinc.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 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.
Media Inquiries:
Amy Cook, iCAD
+1 (925) 200-2125
Investor
Relations:
Jeremy Feffer,
LifeSci Advisors
+1 (212) 915-2568
[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