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Agile(TM) Patency Capsule Clears Stricture Patients for Small Bowel Diagnostic Procedure
Study Concludes More Than Half of Patients With Strictures May Undergo Small Bowel Capsule Endoscopy; Subsequent PillCam(R) SB Procedure Found Significant Findings in Many Patients
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - April 30, 2008) - Given Imaging Ltd. (NASDAQ : GIVN ) today
announced a study entitled, "Agile Patency System Eliminates Risk of
Capsule Retention in Patients with Known Intestinal Strictures who Undergo
Capsule Endoscopy," appeared in the May edition of Gastrointestinal
Endoscopy. The study utilizing the AgileTM patency capsule aided physicians
in identifying patients with known strictures (areas where the GI tract has
narrowed) whose small bowel patency was sufficient for the PillCam® SB
video capsule to pass. Capsule endoscopy helped physicians diagnose
numerous small bowel diseases in these patients. The study was led by Juan
M. Herrerias, MD, of Virgen Macarena University Hospital, Seville, Spain.
"Physicians have limited options to identify small bowel disorders in
patients with strictures due to the high risk of the patient retaining the
capsule endoscope. The Agile patency capsule safely identifies those
patients who are able to undergo further evaluation using PillCam® SB, so
the physician can effectively diagnose their small bowel disorder and
identify a proper treatment," said Prof. Herrerias.
The Agile patency capsule study assessed the ability of the device to
identify which patients with known strictures may safely undergo small
bowel capsule endoscopy. Of 106 patients with known strictures, the Agile
patency capsule examination demonstrated that 56% of patients had a patent
small bowel. These patients all proceeded to have a safe PillCam SB
evaluation. Forty-one percent were found to have significant findings,
including ulcers, tumors and vascular lesions.
The Agile patency capsule allows physicians to determine whether small
bowel patency is sufficient for safe passage of the PillCam SB video
capsule. Small bowel follow through (SBFT) provides radiographic images
only and has been shown to be unreliable when verifying functional patency
of the small bowel. Without the Agile patency capsule, some patients with
known strictures included in the study would likely have been determined to
be ineligible for small bowel capsule endoscopy and, therefore, would not
have benefited from PillCam SB.
The Agile patency capsule is the same size and shape as the PillCam SB
video capsule. It includes two timer plugs that seal the dissolvable
capsule's body. If the Agile patency capsule is retained in the small
bowel, the timer plugs begin to erode after 30 hours, allowing penetration
of intestinal fluids and subsequent dissolution of the capsule.
The Agile patency capsule is a unique product from Given Imaging. No other
product exists solely to determine eligibility for small bowel capsule
endoscopy.
About Agile™ Patency System
Cleared by the U.S. Food and Drug Administration in May 2006, the Agile
Patency System is an accessory to the PillCam video capsule and is intended
to verify adequate patency of the gastrointestinal tract prior to
administration of the PillCam video capsule in patients with known or
suspected strictures.
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 a number of 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; the Agile™ patency capsule to
determine the free passage of the PillCam capsule in the GI tract and the
PillCam COLON video capsule to visualize the colon that has been cleared
for marketing in the European Union. PillCam COLON has received a CE Mark,
but is not cleared for marketing or available for commercial distribution
in the USA. More than 650,000 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
operating subsidiary companies in the United States, Germany, France,
Japan, Australia and Singapore. Given Imaging's largest shareholders
include Elron Electronic Industries (NASDAQ & TASE: ELRN). 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) our ability to obtain
reimbursement for our product from government and commercial payors, (9)
quarterly variations in operating results, (10) the possibility of armed
conflict or civil or military unrest in Israel, and (11) other risks and
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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
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forward-looking statements, which speak only as of the date of this press
release. Except for the Company's ongoing obligations to disclose material
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statements, to report events or to report the occurrence of unanticipated
events.