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Given Imaging Receives Clearance to Sell and Market PillCam(TM) SB in Japan
Company to Host Conference Call Today at 12 pm ET
| Source: Given Imaging
YOQNEAM, ISRAEL -- (MARKET WIRE) -- April 24, 2007 -- Given Imaging Ltd. (NASDAQ : GIVN ), the
global leader in capsule endoscopy, today announced that Japan's Ministry
of Health, Labor and Welfare (MHLW) has granted a regulatory approval
number for the company's PillCam™ SB capsule endoscope. With this
decision, Given Imaging will begin selling and marketing PillCam SB in
Japan.
"This is a major milestone for our company as it means that we will now be
able to sell our flagship PillCam SB in the second largest healthcare
market in the world," said Homi Shamir, president and CEO of Given Imaging.
"Working closely with our partners, we plan to increase awareness of
PillCam SB among Japanese gastroenterologists and build a strong installed
base of Given workstations. Concurrently, we will work towards obtaining
national reimbursement for capsule endoscopy. We expect this process to
take between nine to twelve months."
"Over the past thirty years we made significant progress in the detection
and treatment of gastrointestinal disorders as a result of the endoscope.
However the endoscope's inability to visualize the entire length of the
small intestine has continued to pose challenges for physicians in
detecting diseases that directly impact the small intestine. The approval
of capsule endoscopy is a win-win for both physicians and patients as we
will now be able to fully visualize and better detect small bowel
disorders," said Professor Terano, President of Dokkyo Medical University.
In 2002, Given Imaging established a Japanese subsidiary with its partners,
Suzuken Co. Ltd., Japan's largest medical device and pharmaceutical
distributor, and Marubeni Corporation, one of Japan's largest trading
companies. Suzuken will serve as the exclusive distributor of PillCam SB
in Japan. Given Imaging maintains a 51% controlling interest in the unit,
responsible for commercializing the PillCam line of products in Japan.
The company will host a conference call today at 12:00 pm ET, 7:00 pm
Israel time, to discuss Japan approval. To participate in the
teleconference, please dial (866) 288-0542 fifteen minutes before the
conference begins. International callers should dial (913) 312-6669. The
call will also be webcast live at www.givenimaging.com. A replay of the
call will be available for thirty days on the company's website, or until
May 8, 2007 by dialing (888) 203-1112. International callers should dial
(719) 457-0820. The replay participant code is 8574882.
The company will also host a conference call in Hebrew on Wednesday, April
25 at 2:30pm Israel time. For additional information, please contact
Shirlee Lev of Given Imaging at +972 4 909 7791.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing,
producing and marketing innovative, patient-friendly products for detecting
gastrointestinal disorders. The company's technology platform is the
PillCam™ Platform, featuring the PillCam video capsule, a disposable,
miniature video camera contained in a capsule, which is ingested by the
patient, a sensor array, data recorder and RAPID® software. Given
Imaging has three commercially available capsules: the PillCam SB video
capsule to visualize the entire small intestine which is currently marketed
in the United States and in more than 60 other countries; the PillCam ESO
video capsule to visualize the esophagus; and the Agile™ patency capsule
to determine the free passage of the PillCam capsule in the GI tract. The
PillCam COLON video capsule to visualize the colon has been cleared for
marketing in the European Union, and multi-center clinical trials are
underway in Europe and the U.S. A capsule to visualize the stomach is under
development. More than 500,000 patients worldwide have benefited from the
PillCam capsule endoscopy procedure. Given Imaging's headquarters,
manufacturing and R&D facilities are located in Yoqneam, Israel; it has
direct sales and marketing operations in the United States, Germany and
France, and local offices in Japan, Spain and Australia. For more
information, visit http://www.givenimaging.com.
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) satisfactory results of clinical trials with PillCam
Colon, (2) our ability to receive regulatory clearance or approval to
market our products or changes in regulatory environment, (3) our success
in implementing our sales, marketing and manufacturing plans, (4)
protection and validity of patents and other intellectual property rights,
(5) the impact of currency exchange rates, (6) the effect of competition by
other companies, (7) the outcome of future litigation, including patent
litigation with Olympus Corporation, (8) the reimbursement policies for our
product from healthcare payors, (9) quarterly variations in operating
results, (10) the impact of the newly adopted SFAS 123R for expensing
option-based payments, (11) the possibility of armed conflict or civil or
military unrest in Israel, and (12) 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, 2005. 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.