iCAD Showcases Technology for Cancer “Discovery to Recovery” including ProFound AI Platform and Xoft System at Arab Health 2020 in Dubai
iCAD’s cancer
detection and therapy technologies to be exhibited together for the first time
in the Middle East, including the world’s first commercial deep-learning
digital breast tomosynthesis solution and a single-fraction therapy option for
early-stage breast cancer
NASHUA, N.H. – January 27, 2019 – iCAD, Inc. (NASDAQ: ICAD), a global
medical technology leader providing innovative cancer detection and therapy
solutions, today announced it will showcase its latest advancements in cancer
detection and therapy, including ProFound AI™ and the Xoft® Axxent® Electronic
Brachytherapy (eBx®) System®, in the iCAD exhibition booth (# S1.C71) at Arab Health 2020 in Dubai from January
27-30. Arab Health is the largest gathering of healthcare companies, technologies,
products and services in the Middle East and North African (MENA) region.
“This
medical meeting represents a significant milestone for the Company, as it is
the first time iCAD’s technologies for both the detection and treatment of
cancer will be exhibited together in the Middle East, where breast cancer rates
are expected to double between 2012 and 2030 – the highest relative increase of
any region globally,”1 according to Michael Klein, Chairman and CEO
of iCAD. “A growing body of evidence suggests early cancer diagnosis leads to
better outcomes,2,3,4 and demand continues to grow for increasingly
targeted, more personalized treatment options. iCAD’s technology is congruent
with both of these trending forces in healthcare today.”
iCAD’s Breast Health Solutions suite includes ProFound AI for
Digital Breast Tomosynthesis (DBT), as well as software solutions for 2D
mammography and breast density. ProFound AI is a high-performing workflow
solution featuring the latest in deep-learning artificial intelligence
capabilities. In December 2018, ProFound AI for DBT became the first artificial
intelligence software for DBT to be cleared by the U.S. Food and Drug
Administration; it was also CE marked and Health Canada licensed that same
year. ProFound AI for 2D Mammography was CE marked in July 2019.
Intended to be used by radiologists reviewing mammography or DBT
images, ProFound AI rapidly and accurately analyzes each individual image, or
slice, and identifies potentially malignant lesions. Trained with one of the
largest available image datasets, it provides radiologists with crucial
information, such as Certainty of Finding lesion and Case Scores, which
assists in clinical decision-making and prioritizing caseloads. The technology
also allows for continuously improved performance via ongoing product
updates.
Positive clinical data from a large reader study involving
ProFound AI for DBT were recently published in Radiology: Artificial Intelligence.5 According to study findings, ProFound AI for DBT
improved radiologist sensitivity by 8 percent, reduced unnecessary
patient recall rates by 7.2 percent, and slashed reading time for radiologists by 52.7 percent.5
Additionally, ProFound AI for DBT cut reading time by up to 57.4
percent for radiologists reading cases with dense breasts.6
“ProFound AI increases my confidence reading 3D mammograms,”
according to Lisa Sheppard, MD, PINK Breast Center. “We find this technology
not only benefits our patients, reducing unnecessary callbacks and giving us
more confidence when we recommend biopsies, ProFound AI fits with our workflow
and protocols. Ultimately, this helps us continue to improve patient care.”
iCAD’s flagship product for cancer therapy is the Xoft System,
which is FDA-cleared, CE marked and licensed in a growing number of countries
for the treatment of cancer anywhere in the body, including early-stage breast
cancer, non-melanoma skin cancers (NMSC), and gynecological cancers.
“The Xoft System is an innovative radiation oncology treatment
solution that offers significant cost, mobility, and treatment time advantages
over competitors or the standard of care,” according to Stacey Stevens, President
of iCAD. “It offers a clinically-proven, single-fraction therapy for
early-stage breast cancer, while also offering added flexibility to treat other
types of cancers, including nonmelanoma skin cancers and gynecological
cancers.”
The Xoft System uses a miniaturized x-ray source to
deliver a precise, concentrated dose of radiation directly to the tumor site,
while minimizing risk of damage to healthy tissue in nearby areas of the body. For
the treatment of early-stage breast cancer, intraoperative radiation therapy
(IORT) with the Xoft System allows appropriately selected patients to
potentially replace four to six weeks of post-operative external beam radiation
therapy (EBRT) with a single-fraction of radiation that can last as little as
eight minutes.
The Company recently unveiled new and updated x-ray sources and the
full suite of applicators for existing and emerging applications at the American
Society for Radiation Oncology (ASTRO) Annual Meeting last year. These included
applicators in development for minimally-invasive robotic surgery, such as prostate,
an advanced prototype for early-stage rectal cancers, and extended-length
balloon applicators, now available in 25 cm and 50 cm lengths, which offer
added versatility and the potential for additional applications for Xoft eBx in
different areas of the body. The Company also showcased its latest
extended-life x-ray sources, which feature a ten-fold increase in treatment
times, offering time-saving benefits for clinicians and enhancing efficiency.
Additionally,
the Company offers world-class treatment planning programs, developed for both
the Xoft controller and general IORT with the Xoft System.
The full suite of currently available eBx applicators, including
those with established data for early-stage breast cancer, gynecological
cancers, nonmelanoma skin cancers, and most recently, brain cancers, will be
available for demonstration in the iCAD booth throughout Arab Health 2020.
“ProFound AI
and the Xoft System are currently available in a growing number of countries
worldwide, and demand continues to grow as more clinicians and patients learn
about the benefits our cancer detection and therapy solutions offer,” added
Klein. “These leading-edge solutions empower physicians to offer more
personalized care for patients and are paving the way towards a ‘discovery to
recovery’ disease management plan and pathway that may improve patient outcomes
in the years ahead as the cancer diagnosis and treatment paradigm continues to
evolve.”
References:
1.)Ginsburg O, Bray F, Coleman MP, Vanderpuye V, Eniu A,
Kotha SR, et al. The global burden of women’s cancers: a grand challenge in
global health. Lancet. (2017) 389:847–60. doi: 10.1016/S0140-6736(16)31392-7
2.)Tabár, L. et al. Swedish two-county trial: impact of
mammographic screening on breast cancer mortality during 3 decades. Radiology
260, 658–663 (2011).
3.)The Canadian Task
Force on Preventive Health Care. Recommendations on screening for breast cancer
in average-risk women aged 40–74 years. CMAJ 183, 1991–2001 (2011).
4.)Marmot, M. G. et al. The benefits and harms of breast cancer screening: an
independent review. Br. J. Cancer 108, 2205–2240 (2013).
5.)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
6.)Hoffmeister, J.
(2018). Artificial Intelligence for Digital Breast Tomosynthesis – Reader Study
Results. [White paper]. Accessed via https://www.icadmed.com/assets/dmm253-reader-studies-results-rev-a.pdf
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
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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
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impact of supply and manufacturing constraints or difficulties, product market
acceptance, possible technological obsolescence of products, increased competition,
litigation and/or government regulation, changes in Medicare or other
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“anticipate,” “likely,” “seek,” and similar expressions identify forward-looking
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these and other risks faced by iCAD, please see the disclosure contained in our
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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
Europe:
Emmanuelle
Vella, iCAD
+33 6 20
49 48 57
Investor Relations:
Jeremy Feffer, LifeSci Advisors, on behalf of iCAD,
Inc.
+1-212-915-2568