iCAD Announces Approval of Xoft® Axxent® Balloon Applicators by China Food & Drug Administration for Treatment of Early-Stage Breast Cancer
Availability of full suite of Xoft System products in China represents significant milestone in expanding global access to advanced technology to treat range of cancers
NASHUA, NH – August 30, 2017 - iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that the company’s Xoft Axxent balloon applicators have received approval from the China Food & Drug Administration (CFDA) for the treatment of early-stage breast cancer. The Xoft Axxent balloon applicators are a key component of the Xoft® Axxent® Electronic Brachytherapy (eBx®) System®, which is used to perform intraoperative radiation therapy (IORT) in early-stage breast cancer patients who meet specific selection criteria. With this CFDA approval, the complete suite of Xoft System products is now available to clinicians and patients in China.
“A growing number of countries recognize the unique benefits the Xoft System offers to both patients and clinicians in treating a range of cancers,” said Ken Ferry, CEO of iCAD. “In 2015, more than 268,000 women in China were diagnosed with breast cancer, more than 69,000 women died of the disease, and the incidence has been rising rapidly in recent years. Regulatory approval of Xoft Axxent balloon applicators in China represents a significant milestone in our continued efforts to bring this innovative, safe and clinically-proven treatment option to women worldwide with early-stage breast cancer.”
IORT with the Xoft System allows radiation oncologists and breast surgeons to work together to deliver a full course of radiation to the tumor site at the time of lumpectomy. The balloon applicator is used to deliver a single, precise dose of radiation to the lumpectomy cavity, directly targeting cancer cells while minimizing exposure to healthy surrounding tissue. In the procedure, the Xoft System’s miniaturized x-ray source is inserted into the balloon applicator, providing a channel to deliver high-dose rate, low energy radiation treatment. The balloon applicator is available in multiple sizes and shapes, can be filled with different volumes of saline to best fit the contour of the surgical cavity, and allows delivery of a more conformal radiation dose.
“The Xoft Axxent balloon applicators offer an attractive option for physicians and patients who desire improved flexibility, precision and personalization in the targeted treatment of early-stage breast cancer,” said Liu Yu, COO of Chindex Medical Limited, the distributor of iCAD’s Xoft System in China. “We are pleased to continue working with iCAD in offering our customers access to the most advanced cancer treatments, including the complete portfolio of Xoft System products, in the years ahead.”
The Xoft System is FDA-cleared for the treatment of cancer anywhere in the body, including early-stage breast cancer, non-melanoma skin cancer and gynecological cancers.
About Xoft Axxent Electronic Brachytherapy System
The Xoft System is an isotope-free radiation treatment that is FDA cleared, CE marked, and licensed in a growing number of countries for the treatment of cancer anywhere in the body, including treatment of early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. It utilizes a proprietary miniaturized x-ray as the radiation source that delivers precise treatment directly to cancerous areas while sparing healthy tissue and organs. The Xoft System requires only minimal shielding and therefore does not require room redesign or construction investment. Minimal shielding also allows medical personnel to remain in the room with the patient during treatment. The mobility of the Xoft System makes it easy to treat patients at multiple locations and to easily store the system when not in use. The Axxent Hub is a cloud-based oncology collaboration software solution that enables centers to monitor treatment workflow and enhance communication between clinical specialists. Xoft is a wholly owned subsidiary of iCAD, Inc. For more information about Xoft visit www.xoftinc.com, like us on Facebook or follow us on Twitter at @xofticad.
About Chindex Medical Limited
Chindex Medical Limited (CML) is a prominent supplier of leading edge healthcare technologies to Greater China. With over 1,500 employees worldwide, headquarters located in China, and operations in North America, Europe, and Asia, CML offers a unique full-service distribution platform to manufacturers of medical devices, including product registration, marketing and sales (both direct and through a closely-managed network of carefully-selected sub dealers), warehousing and sales in local currency, clinical support, and installation and after-sales service provided by factory-trained engineers. Additionally, CML owns and manufactures several patented technologies, including proprietary blood banking and transfusion equipment, wound closure products, and general surgery theater instruments. The R&D and manufacturing processes utilized in the Chinese factories are at international levels, and the products are sold in more than 70 countries in Europe and the Americas. For more information, visit www.chindex.com.
About iCAD, Inc.
iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast and colorectal cancers. iCAD’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is a painless, non-invasive technology that delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA cleared and CE marked for use anywhere in the body, including treatment of non-melanoma skin cancer, early-stage breast cancer and gynecological cancers. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit www.icadmed.com or www.xoftinc.com.
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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, 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”, “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, 2016, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.
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