GIVEN IMAGING LTD - News Release - 2002-05-06 22:26
Given Imaging Launches M2A Plus Capsule Following FDA Clearance Of New
Localization Feature Advanced 'camera pill' enables physicians to pinpoint
location of disease in small intestine
Given Imaging Launches M2A Plus Capsule Following FDA Clearance Of New
Localization Feature
Advanced 'camera pill' enables physicians to pinpoint location of
disease in small intestine
YOQNEAM, Israel, May 6, 2002 /PRNewswire-FirstCall via COMTEX/ -- Given Imaging,
Ltd. (Nasdaq: GIVN) announced today the launch of its M2A Plus, a new "camera
pill" that allows physicians to locate small intestine disease with increased
precision. The announcement follows the company's receipt of U.S. Food and Drug
Administration clearance for its new version of RAPID(R) software, which
supports the M2A Plus. The product will be available for the first time during
the Digestive Disease Week (DDW) medical conference, May 19-22 in San Francisco.
Extending the original M2A platform technology for small intestine imaging, the
M2A Plus and RAPID software create a graphic representation of a patient's GI
tract to pinpoint the exact location of a detected pathology. Armed with this
knowledge, gastroenterologists can then treat patients more accurately and
efficiently, through either additional scope procedures or surgery.
The 92-case validation study prepared for the FDA successfully compared the
graphic capsule location, determined by the RAPID system, to the actual location
found by fluoroscopy.
"This localization system allows for total precision in surgery," said Brian
Catz, M.D., assistant clinical professor, Department of Surgery, Mount Sinai
Medical Center.
The M2A Plus, together with the supporting RAPID Software, will be launched
during Digestive Disease Week (DDW) 2002 at the Given Imaging Booth (213). This
newest version of the Given Diagnostic System software also includes improved
data-saving capabilities that allow users to specify and splice footage segments
that can be saved as stand-alone files. The new RAPID software also has the
capability to trim footage into files small enough to fit on portable data
storage units, such as floppy disks and standard compact discs.
"Given Imaging is committed to our customers and to building upon the M2A
platform technology as it is integrated into mainstream medicine," said Dr.
Gavriel D. Meron, CEO and president of Given Imaging, Ltd. "The M2A Plus capsule
was developed in direct response to gastroenterologists who expressed their need
for a localization capability. The localization feature is the first of several
developments that will enhance physicians' diagnostic capabilities."
About Given Imaging
Given Imaging produces and markets the Given Diagnostic System, which features
the M2A(R) Capsule Endoscope, a fundamentally new approach to examining the
gastrointestinal tract. The system uses a disposable miniature video camera
contained in a capsule that is ingested by a patient and delivers high quality
color images in a painless and noninvasive manner. The test can be conducted
while a patient continues normal daily activities. The system received clearance
from the FDA in August 2001 and received permission to affix the CE mark in May
2001. It is currently available in 33 countries worldwide, including the USA,
Canada, Europe, Central and South America and Asia. Many thousands of patients
suffering from diseases in the small intestine such as Crohn's, celiac disease,
unexplained abdominal pain with diarrhea, polyposis, intestinal tumors, iron
deficiency, anemia and obscure bleeding have already benefited from this
innovative technology. For more information, visit givenimaging.com .
This press release contains forward-looking statements, including projections
about our business, within the meaning of Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934. For example,
statements in the future tense, words such as "anticipates," "estimates,"
"expects," "intends," "plans," "believes," "intends" and words and terms of
similar substance used in connection with any discussion of future operating or
financial performance identify such forward-looking statements. Those
forward-looking statements are not guarantees of future performance and actual
results could differ materially from our current expectations as a result of
numerous factors, including but not limited to the following: changes in
regulatory environment, our success in implementing our sales, marketing and
manufacturing plan, protection and validity of patents and other intellectual
property rights, the impact of currency exchange rates, the effect of
competition by other companies, the outcome of future litigation, the
reimbursement policies for our product from healthcare payors, and other risks
disclosed in our filings with the U.S. Securities Exchange Commission.
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SOURCE Given Imaging, Ltd.
CONTACT: Media, Scott Fraser of Given Imaging, +1-404-810-0926,
sfraser@givenimaging.com; or David Carey or Fern Lazar, both of Lazar Partners
for Given Imaging, +1-866-GIVEN-IR, dcarey@lazarpartners.com
URL: givenimaging.com
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