iCAD Announces First Early-Stage Breast Cancer Patient Treated with Intraoperative Radiation Therapy Using the Xoft System at Monash Cancer Centre, a partnership between Peter MacCallum Cancer Centre and Monash Health in Australia

First installation of advanced, multi-platform Xoft System in Australia increases global access to versatile, clinically proven technology

NASHUA, NH and Melbourne, Australia – May 1, 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 the first early-stage breast cancer patient was treated in Australia with intraoperative radiation therapy (IORT) using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System®. The patient was treated at Monash Cancer Centre, a partnership between Peter MacCallum Cancer Centre and Monash Health, in Melbourne, Australia.

“In recent years, healthcare facilities around the world have increasingly adopted the Xoft System, recognizing the unique benefits this revolutionary technology offers to both patients and clinicians in treating a range of different cancers,” said Ken Ferry, CEO of iCAD. “We are pleased to join with Monash Cancer Centre to provide unprecedented access to this advanced treatment option to patients in Australia.”

In March 2017, Monash Cancer Centre became the first medical center in Australia to adopt the Xoft System through iCAD’s local distribution partner, Regional Health Care Group Pty Ltd. The system is FDA cleared, CE marked, entered in the Australian Register of Therapeutic Goods (ARTG), 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 cancer, and gynecological cancer.

For the treatment of early-stage breast cancer, IORT with the Xoft System allows radiation oncologists and breast surgeons to work together to administer one precise, concentrated dose of radiation to a tumor site at the time of lumpectomy. IORT with the Xoft System can be completed in as little as eight minutes, making it possible to replace six to eight weeks of traditional radiation therapy with a single treatment.

The Xoft System’s miniaturized x-ray source can be inserted into a variety of applicators that are specifically designed for certain clinical indications. Monash Cancer Centre will offer the complete suite of Xoft System applicators used to deliver IORT, skin eBx, endometrial and cervical cancer radiation treatment.

“Our adoption of the Xoft System underscores our commitment to providing optimal quality of care to our patients and we are proud to be the first to offer this technology to patients in Australia in the context of an international clinical trial,” said Dr. Steven David, MBBS, FRANZCR, Radiation Oncologist, Moorabbin Campus Director, Peter MacCallum Cancer Centre. “In our detailed review of the range of available radiation therapy solutions, the Xoft System’s distinguished versatility across a variety of clinical applications, mobility, and unique patient benefits made it the preeminent solution for our practice.”

Monash Cancer Centre is the second international site to participate in iCAD’s clinical trial evaluating the Xoft System for the treatment of early-stage breast cancer, called the ExBRT trial (“A Safety and Efficacy Study of Intra-Operative Radiation Therapy [IORT] Using the Xoft® Axxent® Electronic Brachytherapy [eBx®] System at the Time of Breast Conservation Surgery for Early-Stage Breast Cancer”).

“Intraoperative radiotherapy will offer women with early-stage breast cancer another therapeutic option, and, we believe, a better patient experience with less treatment morbidity, and a more rapid return to normal activity. As well as our current commitment to the study, we hope the breast service and other Monash Cancer Centre tumor services, will be able to contribute to understanding the use of this technology in other disease types and stages,” said Dr. Jane Fox, Director, Breast Services, Monash Health. “We are encouraged by the research to date as the global community of treatment centers continues to provide appropriate patients with the unique option to complete a full dose of radiation therapy in a single treatment.”

“Monash Cancer Centre’s participation in the ExBRT trial offers important growth of the body of international clinical data demonstrating the safety and efficacy of the Xoft System for appropriate patients,” added Mr. Ferry. “We remain committed to continuing to expand research to identify additional treatment areas like IORT that have the potential to transform the treatment of cancer for patients worldwide.”

About Monash Cancer Centre

Monash Cancer Centre at Moorabbin Hospital is a key service of Monash Health – Victoria’s largest health service. The Monash Cancer Centre provides the more than 1.5 million residents of southern Melbourne with access to world leading cancer treatment integrated in one convenient location through this key collaboration between Monash Health and the Peter MacCallum Cancer Centre. Cancer patients receive all care, from diagnosis to treatment and follow-up support, at the one place.

About Peter MacCallum Cancer Centre

Peter MacCallum Cancer Centre is one of the world’s leading cancer research, education and treatment centres and is Australia’s only public hospital solely dedicated to caring for people affected by cancer. Peter MacCallum Cancer Centre has over 2,500 staff, including more than 580 laboratory and clinical researchers, all focused on providing better treatments, better care and potential cures for cancer. For more information on Peter MacCallum Cancer Centre, please visit the website at www.petermac.org.

About Regional Health Care Group

Regional Health Care Group (RHCG) is 100% Australian-owned and one of Australia’s most successful privately-owned groups of companies in the Healthcare / Research & Development sector.  RHCG is highly regarded in all clinical settings as a provider of premium quality capital equipment & medical consumables, with business extending across the Australian continent & New Zealand.  RHCG are specialists in successfully introducing innovative technology & devices to the Australian & NZ healthcare market. For more information on RHCG, please visit the company’s website at www.rhcg.com.au.

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 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, prostate and colorectal cancers. iCAD’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® 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 or www.icadmed.com or www.xoftinc.com.

"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, 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.

iCAD Contact:

For iCAD investor relations:

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Bob@lifesciadvisors.com

or

For iCAD media inquiries:

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lgranito@berrypr.com

 

Regional Health Care Group Contact:

Neil Spence
ANZ Marketing Manager
Regional Health Care Group
3-11 Primrose Avenue
ROSEBERY, NSW 2018
+61 418 274 034
neils@regionalhealth.com.au

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