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Endoscopy Study Concludes PillCam(R) COLON May Be a Cost-Effective Strategy for Preventing Colo-Rectal Cancer
Potential for Improved Patient Compliance May Help Reduce CRC Screening Costs
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - April 10, 2008) - Given Imaging Ltd. (NASDAQ : GIVN ) today
announced a study in the May issue of Endoscopy found PillCam® COLON to
be a cost-effective approach to preventing colo-rectal cancer (CRC) when
used in the average-risk, general population that fails to comply with
current CRC screening guidelines. The aim of the analysis was to provide a
model to assess the cost and effectiveness of population-based screening
for CRC using capsule endoscopy compared with that of a standard
colonoscopy screening program. The study was conducted by Professor Cesare
Hassan, M.D. of the Gastroenterology and Digestive Endoscopy Unit of the
Nuovo Regina Margherita Hospital in Rome.
"PillCam COLON holds great promise in improving compliance to CRC screening
standards in the general population," Dr. Hassan said. "CRC screening rates
remain disappointingly low when compared to the success of other cancer
screening programs. Colo-rectal cancers are preventable through early
detection, and this non-invasive option may aid in significantly reducing
the more than 212,000 annual deaths in Europe due to colo-rectal cancer."
The researchers showed that the cost effectiveness of CRC screening using
the PillCam® COLON will mainly depend on its ability to improve
compliance in the general population. Given past uptake evidence seen with
capsule endoscopy in other areas of the GI tract (small bowel, esophagus),
Dr. Hassan and his colleagues state that there is a "ubiquitous
expectation" that capsule examinations will achieve better acceptance and
thus will increase compliance to screening. If such uptake mirrors that
for other cancer screenings, the authors conclude, capsule endoscopy will
be an efficient strategy for CRC prevention, with cost-effectiveness
potentially superior to colonoscopy.
The study employed a mathematical Markov model(1) and simulated a
comparison of CRC screening scenarios comparing PillCam® COLON with
standard colonoscopy. Model parameters were varied to simulate alterations
in cost, thresholds for treatments, sensitivities and specificities, and
screening adherence rates. Through pooled analyses, it was determined that
a greater than or equal to 6 mm threshold for polypectomy referral
substantially reduced costs while only minimally impacting efficacy.
PillCam® COLON received the CE Mark in Europe in October 2006 and is
available in select clinics across Europe. Given Imaging now markets three
video capsules: PillCam® COLON, PillCam® SB for the small bowel and
PillCam® ESO for the esophagus, as well as the Agile™ patency capsule.
About PillCam COLON
Capsule endoscopy with PillCam COLON enables the physician to directly see
the colon mucosa in its natural state while not requiring sedation,
intubation, insufflation or radiation. The PillCam COLON video capsule is a
smooth plastic capsule that measures 11mm by 31mm and can be naturally
ingested with a sip of water. It has tiny video cameras at each end which
together capture 4 images per second for up to 10 hours. PillCam COLON
utilizes advanced optics technology, which have been specially adapted for
the wider lumen and high degree of compartmentalization that characterizes
colon physiology.
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
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, 2007. 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.
(1) Markov models are useful when a decision problem involves risk that is
continuous over time, when the timing of events is important, and when
important events may happen more than once -
http://www.ncbi.nlm.nih.gov/pubmed/8246705