iCAD Launches Post-Market Study of Intra-Operative Radiation Therapy to Treat Early Stage Breast Cancer
March 15 2012 - 10:00AM
Business Wire
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, announced
today the launch of a post-market study to assess the safety and
efficacy of the company’s FDA-cleared Xoft Axxent® eBx™ System when
used for single-fraction, intra-operative radiation therapy (IORT)
at the time of lumpectomy for early stage breast cancer. A
historical comparison will be made to the current standard of care,
external beam radiation therapy (EBRT). The announcement was made
during the 29th Annual Miami Breast Cancer Conference where iCAD is
showcasing the Xoft System.
“While many breast surgeons and radiation oncologists have
already experienced the benefits of treating early stage breast
cancer patients with a single dose of radiation during lumpectomy,
external beam after lumpectomy remains the current standard of
care, subjecting many patients to weeks of daily radiation
treatments,” said Helena Chang, MD, PhD, University of California
Los Angeles and co-principal investigator for the study. “This
study will enable users of the Xoft System to treat patients with
suitable early stage breast cancer under a standardized IORT
protocol and follow long-term patient outcomes in a controlled
manner.”
The study, “A Safety and Efficacy Study of Intra-Operative
Radiation Therapy (IORT) Using the Xoft Axxent eBx System at the
Time of Breast Conservation Surgery for Early-Stage Breast Cancer,”
is a prospective, multi-center, historical control trial.
Researchers plan to enroll up to 1,000 patients at as many as 50
study sites across the U.S. and Europe. Study subjects will be
followed for 10 years after treatment to determine the safety and
efficacy of IORT with the Xoft System, and interim data will be
collected on an annual basis. The studies will also assess cosmetic
outcomes and quality of life for subjects treated with Xoft
IORT.
“We believe the results from this study will further validate
existing data showing IORT to be as safe and effective as external
beam radiation, positioning the Xoft System as a treatment
alternative that may be delivered more conveniently while improving
a patient’s quality of life,” said Ken Ferry, President and CEO of
iCAD. “Compliance rates with EBRT vary widely between different
populations based on proximity to care, length of treatment, and
other factors. The use of Xoft’s technology significantly expands
patient access to this potentially life-saving treatment. This
study underscores iCAD’s continued commitment to advancing the
field of cancer detection and treatment.”
iCAD is currently seeking investigative sites to participate in
this study. For more information contact Michael Patz, Director of
Clinical Affairs at iCAD at mpatz@icadmed.com or visit
www.clinicaltrials.gov.
About Xoft
The Xoft eBx™ Electronic Brachytherapy System from iCAD is an
isotope-free (non-radioactive) radiation treatment cleared by the
FDA for use anywhere in the body, including for the treatment of
early stage breast cancer, endometrial cancer and skin cancer. The
Xoft System utilizes a proprietary miniaturized x-ray as the
radiation source that delivers precise treatment directly to
cancerous areas while sparing healthy tissue and organs. Xoft eBx™
can be administered as a single course of radiation therapy during
surgery in the form of intraoperative radiation therapy (IORT) or
in the form of partial breast irradiation (APBI). The Xoft System
does not require a shielded environment and the system’s relatively
small size and mobility allow for it to be used in virtually any
clinical setting. For more information about Xoft visit
www.xoftinc.com
About iCAD, Inc.
iCAD, Inc. is an industry-leading provider of advanced image
analysis, workflow solutions and radiation therapies for the early
identification and treatment of cancer. iCAD offers a comprehensive
range of high-performance, upgradeable Computer-Aided Detection
(CAD) systems and workflow solutions for mammography, Magnetic
Resonance Imaging (MRI) and Computed Tomography (CT). iCAD recently
acquired Xoft, Inc., developer of the Axxent® eBx™ electronic
brachytherapy system (eBx). Axxent uses isotope-free, miniaturized
X-ray tube technology and is FDA-cleared for treatment of early
stage breast cancer, skin cancer and endometrial cancer. The Axxent
System is also cleared for use in the treatment of other cancers or
conditions where radiation therapy is indicated including
Intraoperative Radiation Therapy (IORT). For more information, call
(877) iCADnow or visit www.icadmed.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, the risks relating to the
Company’s acquisition of Xoft including, the expected benefits of
the acquisition may not be achieved in a timely manner, or at all;
the Xoft business operations may not be successfully integrated
with iCAD’s and iCAD may be unable to achieve the expected
synergies, business and strategic objectives following the
transaction, the risks of uncertainty of patent protection; the
impact of supply and manufacturing constraints or difficulties;
product market acceptance; possible technological obsolescence;
increased competition; customer concentration; 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”, 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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