Given Imaging Ltd. (NASDAQ: GIVN) a world leader in specialty GI
products and pioneer of capsule endoscopy, today announced that the
German Ministry of Health has announced its intent to create an
outpatient reimbursement code for PillCam® SB capsule endoscopy for
obscure gastrointestinal bleeding. The declaration begins a 12 to
15-month process for establishing a medical code, after which the
73 million Germans covered by the public health system, or about 90
percent of the entire German population, will have access to the
PillCam SB procedure, with full reimbursement under the German
statutory health insurance system.
Approximately eight million Germans or ten percent of the
population currently have coverage for PillCam SB capsule endoscopy
through private health insurers. PillCam SB capsule endoscopy has
been covered for inpatient use since 2004.
"A comprehensive body of clinical evidence has established video
capsule endoscopy as the gold standard in small bowel evaluation
and is an easy procedure for patients, requiring no sedation,
intubation or insufflation," said Prof. Friedrich Hagenmüller,
Department of Internal Medicine, Asklepios Klinik Altona, Hamburg,
Germany. "Access to small bowel capsule endoscopy will enable
German physicians to improve our quality of patient care and result
in better patient outcomes."
The indication for obscure gastrointestinal bleeding includes
cases of persistent iron deficiency anemia if other causes of
enteral blood loss can be ruled out and cases of bleeding
associated with low Hb levels and inconclusive prior upper and
lower endoscopy.
"The establishment of an outpatient reimbursement code for
PillCam SB capsule endoscopy represents an important milestone for
Given Imaging, potentially enabling us to significantly increase
our annual sales in Germany from the current level of several
million dollars within the next few years," said Homi Shamir,
president and CEO of Given Imaging. "More importantly, German
patients will soon have reimbursed access to the standard of care
for diagnosing small bowel disorders, which may result in improved
outcomes and quality of life."
Given Imaging's European headquarters is based in Hamburg
Germany.
About PillCam SB The PillCam SB video
capsule measures 11 mm x 26 mm and weighs less than four grams. Now
in its second generation, PillCam SB 2 contains an imaging device
and light source and transmits images at a rate of two images per
second generating more than 50,000 pictures during the course of
the procedure. Initially cleared by the U.S. Food and Drug
Administration in 2001, PillCam SB is clinically validated by more
than 1,200 peer-reviewed studies. It is the most accurate,
patient-friendly tool for visualization of the small bowel in
patients two years and older and is used by physicians to evaluate
patients with obscure GI bleeding, including iron deficiency
anemia, suspected Crohn's disease, suspected small intestinal
tumors, monitoring patients with polyposis syndromes and in
suspected or refractory malabsorptive syndromes, such as celiac
disease. PillCam® SB is the gold standard in small bowel
evaluation.
The risks of PillCam® capsule endoscopy include capsule
retention, aspiration, or skin irritation. The risks of the Agile™
GI patency test include capsule retention and aspiration.
Endoscopic placement may present additional risks. Medical,
endoscopic, or surgical intervention may be necessary to address
any of these complications, should they occur. Please refer to the
User Manual or www.GivenImaging.com for detailed information.
About Given Imaging Ltd. Since 2001, Given
Imaging has advanced gastrointestinal visualization by developing
state-of-the art, patient-friendly tools based on its PillCam®
Platform. PillCam® capsule endoscopy uses miniature video cameras
in a capsule, wireless technology, and advanced software to provide
physicians with clear images of the small intestine via PillCam® SB
and the esophagus through PillCam® ESO. The PillCam® COLON video
capsule, which is an investigational device in the U.S., is
designed to visualize the colon. Given Imaging's other capsule
products include the Agile™ patency capsule, to verify intestinal
patency, and Bravo®, the only wireless, catheter-free, 48-hour pH
test commercially available for pH testing to assess
gastroesophageal reflux disease (GERD). In April 2010, Given
Imaging acquired Sierra Scientific Instruments, the leading
provider of specialty GI diagnostic solutions and pioneer of
high-resolution manometry for assessing gastrointestinal motility.
Sierra Scientific is now a wholly-owned subsidiary of Given
Imaging. Given Imaging's headquarters, manufacturing and R&D
facilities are located in Yoqneam, Israel, with operating
subsidiaries in the United States, Germany, France, Japan,
Australia, and Hong Kong. For more information, please visit
www.givenimaging.com.
Forward-Looking Statements This press
release contains forward-looking statements within the meaning of
the "safe harbor" provisions of the U.S. Private Securities
Litigation Reform Act of 1995. These forward-looking statements
include, but are not limited to, projections about our business and
our future revenues, expenses and profitability. Forward-looking
statements may be, but are not necessarily, identified by the use
of forward-looking terminology such as "may," "anticipates,"
"estimates," "expects," "intends," "plans," "believes," and words
and terms of similar substance. Forward-looking statements involve
known and unknown risks, uncertainties and other factors which may
cause the actual events, results, performance, circumstances or
achievements of the Company to be materially different from any
future events, results, performance, circumstances or achievements
expressed or implied by such forward-looking statements. Factors
that could cause actual events, results, performance, circumstances
or achievements to differ from such forward-looking statements
include, but are not limited to, the following: (1) our ability to
develop and bring to market new products, (2) our ability to
successfully complete any necessary or required clinical studies
with our products, (3) our ability to receive regulatory clearance
or approval to market our products or changes in regulatory
environment, (4) our success in implementing our sales, marketing
and manufacturing plans, (5) the level of adoption of our products
by medical practitioners, (6) the emergence of other products that
may make our products obsolete, (7) lack of an appropriate bowel
preparation materials to be used with our PillCam COLON capsule,
(8) protection and validity of patents and other intellectual
property rights, (9) the impact of currency exchange rates, (10)
the effect of competition by other companies, (11) the outcome of
significant litigation, (12) our ability to obtain reimbursement
for our product from government and commercial payors, (13)
quarterly variations in operating results, (14) the possibility of
armed conflict or civil or military unrest in Israel, (15) the
impact of global economic conditions, (16) our ability to
successfully integrate acquired businesses, (17) changes and
reforms in applicable healthcare laws and regulations, and (18)
other risks and factors disclosed in our filings with the U.S.
Securities and Exchange Commission, including, but not limited to,
risks and factors identified under such headings as "Risk Factors,"
"Cautionary Language Regarding Forward-Looking Statements" and
"Operating Results and Financial Review and Prospects" in the
Company's Annual Report on Form 20-F for the year ended December
31, 2009. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
press release. Except for the Company's ongoing obligations to
disclose material information under the applicable securities laws,
it undertakes no obligation to release publicly any revisions to
any forward-looking statements, to report events or to report the
occurrence of unanticipated events.
For further information contact: Fern Lazar/David Carey Lazar
Partners Ltd. 1-212-867-1768 Email Contact Email Contact
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