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iCAD Announces AERB Approval of Xoft System in India
First installation of versatile, multi-platform Xoft System in India demonstrates strong, continued momentum in global commercialization of electronic brachytherapy (eBx)
NASHUA, N.H. and HYDERABAD, India, Aug. 29, 2018 (GLOBE NEWSWIRE) -- iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, announced today that its Xoft® Axxent® Electronic Brachytherapy (eBx®) System® has received an Atomic Energy Regulatory Board (AERB) Type Approval for use in India. The approval affirms that the system conforms to established safety standards and makes the full suite of the Company’s electronic brachytherapy products available to clinicians and patients across the country. The Omega Hospitals – Hyderabad, part of the Hyderabad Institute of Oncology, is the first site to adopt the Xoft System in India. Omega Hospitals is a world-class, integrated healthcare delivery system providing more than 89,500 patient care visits annually.
“AERB approval of the Xoft System represents an important milestone in our continued efforts to provide healthcare facilities worldwide with leading-edge technology offering clinically-proven treatment options for a range of cancers,” said Ken Ferry, CEO of iCAD. “We are pleased to join with the Omega Hospitals to provide unprecedented access to this advanced therapy to patients in India, where cancer cases are significantly increasing. We look forward to partnering with additional providers to deliver electronic brachytherapy on a broader scale throughout the country.”
Omega Hospitals – Hyderabad will be utilizing the Xoft System for the treatment of early-stage breast cancer and gynecological cancers. The Xoft System is FDA cleared, CE marked and licensed in a growing number of countries for the treatment of cancer anywhere in the body. The system utilizes a proprietary, miniaturized x-ray source to deliver precise radiation treatment directly to a cancerous area while sparing surrounding healthy tissue. The system requires only minimal shielding and therefore does not require construction investment.
“At Omega Hospitals, we strive to provide patients with state-of-the-art treatment options and unparalleled medical expertise, resulting in outstanding patient care,” said Dr. Ch. Mohana Vamsy, Chief Surgical Oncologist at Omega Hospitals. “The Xoft System offers a uniquely valuable solution to eradicate an array of cancers, equipping us with cutting-edge technology that strongly aligns with our mission to deliver positive patient outcomes. We are pleased to partner with iCAD to offer electronic brachytherapy with the Xoft System to patients in India.”
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.
Omega Hospitals – Hyderabad is a world-class, multi-specialty hospital where a renowned team of specialists and sophisticated technology come together to deliver high-quality medical care. The hospital is proud to be the most sought-after cancer hospital in southern India. From the day it was launched in July 2010, Omega Hospitals began developing its prestigious reputation as a leading center focused on pioneering medical work, research and academics in south India with a global reach.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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, 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”, “would”, “could”, “consider”, “project”, “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, including the 10-K for the year ended December 31, 2017, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.
ARPR, on behalf of iCAD, Inc.
Paul Barren, (855) 300-8209
LifeSci Advisors, on behalf of iCAD, Inc.
Jeremy Feffer, (212) 915-2568