Given Imaging Ltd. (NASDAQ: GIVN), the world leader in specialty GI
products and pioneer of capsule endoscopy, today announced that the
Brazilian Medical Association (Associação Médica Brasileira) issued
a reimbursement code for PillCam® SB capsule endoscopy.
Published in the revised Classificação Brasileira Hierarquizada
de Procedimentos Mẽdicos, the national publication of reimbursable
procedures, code 4.02.01.34-1 provides for the reimbursement of
capsule endoscopy and does not require any other prior endoscopic
procedures.
This is the first step in a process that is expected to
eventually enable all of Brazil's 190 million citizens to have
access to PillCam SB capsule endoscopy for visualization of the
small bowel. Approximately 9.1 million of Brazil's 44.3 million
privately insured citizens are covered immediately for the PillCam
SB procedure with the issuance of this code. The company believes
coverage for the additional 35.2 million privately insured
individuals will be fully implemented by the latter part of 2011.
Upon implementation of private reimbursement, the public healthcare
system is expected to begin the process of bringing coverage to the
remaining 145 million Brazilians in the months that follow.
"There is clear clinical proof supporting the value of PillCam
SB for detecting small bowel disorders, and we welcome the
Brazilian Medical Association's decision to establish a
reimbursement framework for this valuable device," said Carlos
Saul, MD, from the Brazilian Society of Endoscopy, South
Sector.
"Physicians eventually will be able to use capsule endoscopy to
help Brazilians who may benefit from capsule endoscopy," said Dr.
Ricardo Ganc from Albert Einstein Hospital, Sao Paulo.
"All Brazilians will gradually have access to gold standard care
in visualizing small bowel disorders. The reimbursement of PillCam
SB will impact patient care and marks a milestone in Brazilian GI
care," said Dr. Carlos Alberto Cappelannes, President of SOBED
(Brazilian Society of Endoscopy).
"PillCam SB is an easy procedure for patients, requiring no
sedation, intubation or insufflation," said Dr. Gregório Feldman
from Rio de Janeiro.
"We are pleased about the Brazilian Medical Association's
decision to support the use of capsule endoscopy as a first-line
tool to image the small bowel," said Homi Shamir, President and
Chief Executive Officer, Given Imaging Ltd. "Given Imaging is
committed to providing physicians with innovative solutions for the
detection of abnormalities of the small intestine so they may
improve the lives of Brazilians and others around the world who
suffer from digestive disorders."
Under Brazil's healthcare system, once reimbursement is
available, capsule endoscopy procedures prescribed by a physician
for the approved indication will be reimbursed and are not subject
to institutionally-determined funding allocations. The Brazilian
Medical Association has already begun notifying Brazil's 6,000
gastroenterologists to make them aware of the procedure
availability.
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 an accurate,
patient-friendly tool used in patients two years and older by
physicians to visualize the small bowel. 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 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, which is an investigational device in the
U.S., is designed to visualize the colon. The PillCam® capsules are
miniature video cameras that patients ingest. Given Imaging's other
capsule products include 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 "will," "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) the
availability of reimbursement or other forms of funding for our
products 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. 212-867-1768 Email Contact Email Contact
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