NASHUA, N.H. and ZARAGOZA, Spain, June 28, 2016 /PRNewswire/ -- 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 cervical cancer patient in Europe was treated with the Xoft® Axxent® Electronic Brachytherapy (eBx®) System® at the Hospital Universitario Miguel Servet in Zaragoza, Spain in May 2016.
"International adoption of the Xoft System has increased significantly in recent years, further demonstrating our commitment to providing global access to electronic brachytherapy for patients who may benefit from iCAD's revolutionary technology," said Ken Ferry, CEO of iCAD. "Cervical cancer continues to be an international health risk for many women, with an estimated 530,000 new cases diagnosed each year.i We are pleased to partner with the Hospital Universitario Miguel Servet to offer this lifesaving treatment option to women in Spain and throughout the E.U."
In April 2015, Hospital Universitario Miguel Servet became the first hospital in Spain to adopt 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 nonmelanoma skin cancer, early-stage breast cancer, and gynecological cancer.
The cervical applicator is Xoft's first multi-channel applicator; it is used to deliver a precise dose of radiation to target areas of the cervix, uterus, endometrium, and vagina while minimizing exposure to healthy tissue. Cervical cancer treatments with the Xoft System are usually administered in an outpatient setting under anesthesia.
Hospital Universitario Miguel Servet was named a Xoft Center of Excellence in November 2015. Within the first year of adoption, clinicians at the hospital have consistently utilized the Xoft System on a weekly basis to treat more than 100 breast cancer patients and more than 30 endometrial cancer patients.
"The Xoft System was seamlessly integrated into our clinical practice due to its mobility advantages and overall versatility," said Martin Tejedor, M.D., chief of radiation oncology at Hospital Universitario Miguel Servet. "The technology's minimal shielding requirements and small footprint allow it to be easily transported between multiple departments, enabling us to treat patients five days a week across a variety of clinical indications."
The Xoft System delivers a therapeutic dose of isotope-free radiation to target sites from inside the body or directly on the skin's surface through procedure-specific applicators. Its proprietary miniaturized 50 kV x-ray source is uniquely designed to target cancer and spare healthy tissues.
"A growing body of research continues to support electronic brachytherapy as a viable treatment option across a range of clinical applications," added Ferry. "The Xoft System's multidisciplinary approach offers a cost-effective treatment option with many important advantages for both clinicians and patients."
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 1288 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 5500 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.
About Xoft Axxent Electronic Brachytherapy (eBx) 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® 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, 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. 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.
"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", "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.
Contact:
For iCAD investor relations: The Ruth Group Zack Kubow, 646-536-7030 www.theruthgroup.com [email protected]
or
For iCAD media inquiries: Berry & Company Public Relations, LLC Jessica Burns, 212-253-8881 [email protected]
i World Health Organization, HPV and Cervical Cancer Fact Sheet. Accessed Sept. 21, 2015. Available at: http://www.who.int/mediacentre/factsheets/fs380/en/
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"International adoption of the Xoft System has increased significantly in recent years, further demonstrating our commitment to providing global access to electronic brachytherapy for patients who may benefit from iCAD's revolutionary technology," said Ken Ferry, CEO of iCAD. "Cervical cancer continues to be an international health risk for many women, with an estimated 530,000 new cases diagnosed each year.i We are pleased to partner with the Hospital Universitario Miguel Servet to offer this lifesaving treatment option to women in Spain and throughout the E.U."
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In April 2015, Hospital Universitario Miguel Servet became the first hospital in Spain to adopt 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 nonmelanoma skin cancer, early-stage breast cancer, and gynecological cancer.
The cervical applicator is Xoft's first multi-channel applicator; it is used to deliver a precise dose of radiation to target areas of the cervix, uterus, endometrium, and vagina while minimizing exposure to healthy tissue. Cervical cancer treatments with the Xoft System are usually administered in an outpatient setting under anesthesia.
Hospital Universitario Miguel Servet was named a Xoft Center of Excellence in November 2015. Within the first year of adoption, clinicians at the hospital have consistently utilized the Xoft System on a weekly basis to treat more than 100 breast cancer patients and more than 30 endometrial cancer patients.
"The Xoft System was seamlessly integrated into our clinical practice due to its mobility advantages and overall versatility," said Martin Tejedor, M.D., chief of radiation oncology at Hospital Universitario Miguel Servet. "The technology's minimal shielding requirements and small footprint allow it to be easily transported between multiple departments, enabling us to treat patients five days a week across a variety of clinical indications."
The Xoft System delivers a therapeutic dose of isotope-free radiation to target sites from inside the body or directly on the skin's surface through procedure-specific applicators. Its proprietary miniaturized 50 kV x-ray source is uniquely designed to target cancer and spare healthy tissues.
"A growing body of research continues to support electronic brachytherapy as a viable treatment option across a range of clinical applications," added Ferry. "The Xoft System's multidisciplinary approach offers a cost-effective treatment option with many important advantages for both clinicians and patients."
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 1288 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 5500 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.
About Xoft Axxent Electronic Brachytherapy (eBx) 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® 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, 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. 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.
"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", "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.
Contact:
For iCAD investor relations: The Ruth Group Zack Kubow, 646-536-7030 www.theruthgroup.com [email protected]
or
For iCAD media inquiries: Berry & Company Public Relations, LLC Jessica Burns, 212-253-8881 [email protected]
i World Health Organization, HPV and Cervical Cancer Fact Sheet. Accessed Sept. 21, 2015. Available at: http://www.who.int/mediacentre/factsheets/fs380/en/
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SOURCE iCAD, Inc.
