NASHUA, N.H., Jan. 27, 2020 (GLOBE NEWSWIRE) -- 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
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 defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the 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 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
Europe:
Emmanuelle Vella, iCAD
+33 6 20 49 48 57
evella@icadmed.com
Investor Relations:
Jeremy Feffer, LifeSci Advisors, on behalf of iCAD, Inc.
+1-212-915-2568
jeremy@lifesciadvisors.com
