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New Clinical Study Shows Over Half of Eligible OGIB Patients May Benefit From Small Bowel Capsule Endoscopy as Recommended by GI Society Guidelines
(Market Wire Via Acquire Media NewsEdge) CHICAGO, IL -- (MARKET WIRE) -- 06/03/09 --
Given Imaging Ltd. (NASDAQ: GIVN) today
announced a new study that shows over half of the eligible patients with
occult or obscure gastrointestinal bleeding (OGIB) may benefit from the
additional diagnostic information provided by small bowel capsule endoscopy
in accordance with existing gastrointestinal (GI) society guidelines, which
call for the patient-friendly, non-invasive procedure following a negative
upper endoscopy and colonoscopy. Additional studies advocate broader
utility of capsule endoscopy in iron deficiency anemia (IDA) and suspected
small bowel Crohn's disease. The studies were presented at the Digestive
Disease Week® (DDW) 2009 conference taking place in Chicago from May 30 -
June 4, where Given Imaging also demonstrated a new, simplified procedure
for performing PillCam® capsule endoscopy of the small bowel and the
latest version of its RAPID® Software Suite at booth #2235 at the
conference.
In presentation #299, Professor Ian M. Gralnek, of the Technion-Israel
Institute of Technology and Rambam Medical Center, Haifa, Israel, concluded
that based on an analysis of a US-based, multi-payer medical claims
database that analyzed the records of 2.7 million adults suspected of GI
bleeding, less than half of patients with OGIB and a negative endoscopic
workup had received a diagnostic capsule endoscopy procedure in accordance
with guidelines set by GI societies, including the American Society for
Gastrointestinal Endoscopy and the American Gastroenterological
Association, and the British Society of Gastroenterology. This study also
found extensive use of contrast radiography, an x-ray or gamma-ray based
test.
"Capsule endoscopy is recognized as the diagnostic standard of care for
OGIB, but many patients are undergoing multiple tests, such as contrast
radiography, that are less conclusive and expose them to additional
radiation," said Professor Gralnek. "Several studies also show that PillCam
SB is a clinically and economically effective tool among patients with IDA
and those with suspected small bowel Crohn's disease."
Additional studies presented at DDW provide evidence for broader use of
PillCam SB in IDA and suspected small bowel Crohn's disease:
-- A poster presentation (#W1082) led by Professor Gralnek that analyzed
a US-based, multi-payer medical claims database and found a high use of
contrast radiography studies in the evaluation of patients with unexplained
iron deficiency anemia (IDA) despite current published data demonstrating
the diagnostic value of capsule endoscopy. Of 37,338 patients with a
potential need for small bowel capsule endoscopy, only 7,894 capsule
endoscopy studies were performed (21 percent of expected) while 30,088
received contrast radiography. Small bowel capsule endoscopy is recommended
in males and selected females with IDA and negative upper endoscopy and
colonoscopy.
-- A poster presentation (#W1084) led by Jonathan A. Leighton, of the
Mayo College of Medicine in Scottsdale, Arizona concluded that capsule
endoscopy is less costly than small bowel follow through (SBFT) for
evaluating patients with suspected small bowel Crohn's disease. Using a
decision analytic model, researchers compared estimated total costs for
diagnosis and disease management for one year.
-- A poster presentation (#T1515) led by Professor Gralnek reports an
extensive literature review utilizing the six most accepted evidence
grading systems(1) and concluded that clinicians and policymakers have
evidence to use capsule endoscopy for patients with suspected Crohn's
disease. The grading systems used in the study were developed to assist
clinicians and policymakers in determining when sufficient evidence has
accumulated to incorporate new technologies into clinical practice.
New, Simplified Procedure for PillCam® of the Small Bowel
In separate news, the company also demonstrated a simplified procedure for
performing PillCam capsule endoscopy of the small bowel. First unveiled to
nurses at the Society of Gastroenterology Nurses and Associates (SGNA)
meeting which took place in St. Louis, from May 15 - 20, the simplified
procedure that uses the new SensorBelt with the RecorderPouch and obviates
the need to use the sensor array and recorder belt previously required.
The new procedure has been very well received, with nurses surveyed
indicating that this new procedure would save them time and be welcomed by
their patients. Specifically, the nurses also indicated that, on average,
they would save 15 to 30 minutes of preparation and maintenance time per
procedure. Both products can be washed or disinfected using common liquid
disinfectants and are priced to enable cost-effective reorder. The
RecorderPouch is available now while the SensorBelt is pending 510(k)
clearance.
"This new procedure makes a patient-friendly diagnostic test even easier
while improving workflow productivity at the same time," said Pat Moushey,
RN, CGRN, St. Luke's Hospital, St. Louis. "The SensorBelt reduces the time
required to prepare the patient for a capsule endoscopy and time spent on
equipment preparation and maintenance. The RecorderPouch is less visible
and allows greater freedom of movement for patients."
Next-Generation Software
The latest version of RAPID® Software Suite, which includes RAPID 6,
RAPID® 6 Access and RAPID® 6 Reader, incorporates the following new
features:
-- Image Adjustment with FICE (Flexible spectral Imaging Color
Enhancement), developed by FUJIFILM, a partner of Given Imaging. FICE is an
image-enhancing technology that aids the physician in viewing surface
tissue characteristics and blood vessels by visually enhancing potential
areas of disease;
-- PillCam Progress Indicator, which may aid in planning therapeutic
intervention by providing an estimation of linear distance within the small
bowel along with information concerning rate of capsule progress through
the small bowel;
-- Mosaic View, which allows the reader to view an array of consecutive
images showing how the tissue changes as the PillCam video capsule
progressed;
-- An updated Study Manager and patient management screens including user-
customizable fields, pull-down menus for easy, error-free data entry and an
exportable database.
About Occult GI Bleeding
Occult gastrointestinal bleeding (OGIB) occurs when blood is lost from the
digestive tract without visible, or overt, signs of bleeding.(2) The
condition is usually discovered only with positive results for a fecal
occult blood test or through detection of iron deficiency anemia, and there
are many potential causes. In approximately half of patients with OGIB, the
source of bleeding is unexplained.(3)
About IDA
Iron deficiency anemia (IDA) is a common type of anemia in which the
patient lacks adequate healthy red blood cells.(4) Lack of iron in the
blood affects the body's ability to carry oxygen and results in patients
feeling tired, weak, irritable and lightheaded. The causes of IDA vary but
can include loss of blood, pregnancy, inadequate diet, the inability to
absorb iron from food and internal bleeding due to a bleeding ulcer, a
colon polyp or colon cancer.(5)
About Crohn's Disease
Crohn's disease is a chronic condition that causes inflammation in the
lining of the small intestine wall. It usually occurs in the lower part of
the small intestine called the ileum, but can affect any part of the
digestive tract. Symptoms can include diarrhea, abdominal pain, weight loss
and rectal bleeding. Roughly 50 percent of all cases of Crohn's disease are
diagnosed in the last part of the small intestine (the terminal ileum) and
cecum. This area is also known as the ileocecal region. Other cases of
Crohn's may affect one or more of the following: the colon only, the small
bowel only (duodenum, jejunum and/or ileum), the stomach or esophagus.(6)
Roughly 500,000 Americans suffer from Crohn's disease, and about 20 percent
have a direct relative with some form of inflammatory bowel disease
(IBD).(7) It affects men and women equally. The cause is unknown, but the
most popular theory is that the immune system is reacting to a virus or
bacterium that causes inflammation.(8) An upper GI endoscopy, upper GI
radiography series and colonoscopy are often used to test for inflammation
and intestinal abnormalities. Depending on the severity, treatment options
include nutritional supplements, drugs and surgery. There is currently no
cure for the disease.
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 close to 1,000 peer-reviewed
studies. It is the most accurate, patient-friendly diagnostic and
monitoring tool for visualization of the small bowel and is used by
physicians to evaluate patients with obscure GI bleeding, including iron
deficiency anemia, suspected Crohn's disease, suspected small intestinal
tumors and monitoring patients with polyposis syndromes and in suspected or
refractory malabsorptive syndromes, such as celiac disease. The PillCam®
family of products are the gold standard in capsule endoscopy.
Research for studies #299 and W1082 were assisted by Given Imaging.
Professor Ian Gralnek and Jonathan Leighton, M.D., are consultants to Given
Imaging. Denise Malvehy is an employee of Given Imaging.
About Digestive Disease Week
DDW is the largest international gathering of physicians, researchers and
academics in the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American Association for
the Study of Liver Diseases, the American Gastroenterological Association
(AGA) Institute, the American Society for Gastrointestinal Endoscopy and
the Society for Surgery of the Alimentary Tract, DDW takes place May 30 -
June 4, 2009, at the McCormick Place, Chicago, IL. The meeting showcases
approximately 5,000 abstracts and hundreds of lectures on the latest
advances in GI research, medicine and technology. For more information,
visit www.ddw.org.
About Given Imaging Ltd.
Since 2001 Given Imaging has advanced gastrointestinal diagnosis by
developing innovative, patient-friendly tools based on its PillCam®
Platform. PillCam capsule endoscopy provides physicians with natural images
of the small intestine via PillCam SB, the esophagus through PillCam ESO
and the colon with PillCam COLON [not cleared for use in the USA]. The
PillCam capsules are miniature video cameras that patients ingest. Given
Imaging's other capsule products include Agile(TM) 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). Given Imaging's products use
cutting-edge, wireless technology and advanced software to enable
gastroenterologists to better diagnose diseases of the esophagus, small
bowel and colon [PillCam COLON is not cleared for use in the USA.] and more
accurately treat patients. All Given Imaging products allow patients to
maintain normal activities. 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 Singapore. For
more information, please visit http://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 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 significant litigation, (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, (11) the impact of
global economic conditions, 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, 2008. 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) Evidence grading systems used in the study were: the American College
of Chest Physicians (ACCP), Australian National Health and Medical Research
Council (ANHMRC), Oxford Centre for Evidence-Based Medicine (OCEBM),
Scottish Intercollegiate Guidelines Network (SIGN), US Task Force on
Community Preventive Services (USTFCPS) and US Preventive Services Task
Force (USPSTF)
(2) http://www3.utsouthwestern.edu/endocrine/Rockey.htm
(3) http://www.aafp.org/afp/20040215/875.html
(4) http://www.mayoclinic.com/health/iron-deficiency-anemia/DS00323
(5) http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html
(6) http://qurlyjoe.bu.edu/cduchome.html Inflammatory Bowel Disease
Frequently Asked Questions
(7) Crohn's and Colitis Foundation of America (www.ccfa.org)
(8) National Institute of Diabetes and Digestive and Kidney Diseases
(www.niddk.nih.gov)
For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
1-866-GIVEN-IR
Email Contact/
Email Contact
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