iCAD Announces Presentation of Positive Clinical Data on Xoft System for Treatment of Early-Stage Breast Cancer and Gynecological Cancers at ESTRO 37


Company to showcase advanced, multi-platform electronic brachytherapy (eBx) technology in booth 6800

NASHUA, N.H. and BARCELONA, Spain, April 19, 2018 (GLOBE NEWSWIRE) -- ESTRO Booth 6800 -- iCAD, Inc. (NASDAQ:ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced that researchers from Hospital Universitario Miguel Servet in Zaragoza, Spain will present new results from three clinical studies supporting the efficacy of the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® for the treatment of early-stage breast cancer and gynecological cancers during the European Society for Radiotherapy & Oncology (ESTRO 37) meeting at the Barcelona International Convention Centre in Barcelona, Spain. The Xoft System is a proprietary eBx platform designed to deliver isotope-free (non-radioactive) radiation therapy.

“We are pleased that clinical results from multiple studies continue to demonstrate the therapeutic value of this innovative treatment option,” said Ken Ferry, CEO of iCAD. “This important new research adds to a growing body of data confirming the significant benefits that the Xoft System offers to patients and clinicians worldwide.”

At ESTRO 37, clinicians from Hospital Universitario Miguel Servet will present new preliminary findings from three studies that further demonstrate the efficacy of the Xoft System in the treatment of early-stage breast cancer and gynecological cancers. Since their adoption of the technology in 2015, clinicians at Hospital Universitario Miguel Servet have treated more than 350 early-stage breast cancer and gynecological cancer patients with the Xoft System.

“By precisely targeting cancer cells and sparing surrounding healthy tissue, the Xoft System has empowered our clinicians to significantly improve patient outcomes and reduce toxicity in treating a range of cancers,” said Martin Tejedor, M.D., Chief of Radiation Oncology, Hospital Universitario Miguel Servet. “We are very encouraged by our results to date with this transformative technology, and we are committed to offering this valuable treatment option to appropriately selected patients in Spain.”

Summarized findings and links to the electronic data are available below.

  • PO-1089: IORT for Breast Cancer Treated with Axxent Xoft. Our Experience: Toxicity Analysis 

    Preliminary results in 136 patients treated from May 2015 to August 2016 show feasible acute and late toxicity and good cosmetic outcomes.
  • EP-1314: Breast Treatments with Axxent Equipment. Comparison with Mammosite for Skin, Lung and Heart Dose 

    Preliminary results in 250 patients treated from May 2015 to September 2017 show no recurrences in patients treated to date and low skin toxicity.
  • EP-2226: Toxicity Results After Treatment with Electronic Brachytherapy in Patients with Endometrial Cancer 

    Preliminary results in 94 patients treated from September 2015 to September 2017 show targeted approach reduces toxicity to organs at risk.

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, including early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. It uses a proprietary, miniaturized x-ray source to deliver targeted radiation directly to the cancerous site, sparing healthy tissues and surrounding organs. The Xoft System is highly mobile and requires minimal shielding, allowing it to be used in a variety of clinical settings and eliminating the need for room redesign or construction investment. For more information, please visit booth 6800 during the ESTRO 37 meeting, or www.xoftinc.com.

About iCAD, Inc.
Headquartered in Nashua, N.H., iCAD is a global medical technology leader providing innovative cancer detection and therapy solutions. For more information, visit www.icadmed.com.

About Hospital Universitario Miguel Servet
The Hospital was founded in 1955 with the name “Residencia Jose Antonio”. In 1971, it was extended with the Rehabilitation, Traumatology and Burns Hospital and the Maternity Hospital. In 1976, it undertook a multi-phase modernization program, converting over the years to form what since 1984 has been known as the “Hospital Miguel Servet”. In 1999, the Hospital reached the category of University Hospital, under the name of the “Hospital Universitario Miguel Servet”. In addition to undergraduate teaching, the hospital offers training for residents in around forty specializations. The Hospital today is the largest in Aragon and among the first in Spain in terms of both volume as well as complexity. It has 1,288 installed beds, 33 operating rooms and a long list of Units, with a reference population of over 800,000 inhabitants in the Autonomous Community of Aragon. Every year the hospital receives 46,000 admissions, offers 800,000 consultations and performs 37,000 surgeries. The hospital has an average occupation of over 76%, and 5,500 employees. The hospital also has two national reference units (Burns and Multiple Sclerosis) as well as special reference units for all of Aragon and neighboring provinces.

"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,” “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.

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