Given Imaging Announces Significant New Data on PillCam(R) SB at DDW
May 22 2012 - 11:00AM
Marketwired
Given Imaging (NASDAQ: GIVN), a world leader in specialty GI
products and pioneer of capsule endoscopy, today announced new data
on recommendations for early use of PillCam SB, as well as new
technological advances. Given Imaging also announced new studies
confirming PillCam
® SB
's benefits in several specialized patient populations,
including octogenarians and those with neutropenic cancer, for whom
the minimally-invasive procedure might be a safer alternative to
other diagnostic methods. The studies are being presented at the
American Society for Gastrointestinal Endoscopy (ASGE) Research
Forum at Digestive Disease Week® (DDW), taking place May 19 - 22 in
San Diego.
Data on Earlier Use of PillCam SB
- "Improved Diagnostic Yield With Early Video
Capsule Endoscopy After Diagnosis of Obscure Gastrointestinal
Bleeding" (216) Investigators led by
Dhavan A. Parikh, Department of Internal Medicine, UC Davis,
Sacramento, CA conducted a retrospective analysis of 410
consecutive VCE studies from a single reader to determine the
optimal timing of capsule endoscopy for the evaluation of OGIB.
Based on their findings, they concluded that VCE should ideally be
performed within one week of OGIB diagnosis to maximize diagnostic
yield. Video capsule endoscopy within 48 hours is preferable to
prevent a delay in diagnosis.
- "Immediate Capsule Endoscopy or Angiogram in
Patients With Acute Obscure Gastrointestinal Bleeding: a
Prospective Randomized Study With Long Term Follow
up" (150) Wai Keung Leung, M.D., of the
Department of Medicine, University of Hong Kong, Hong Kong, Hong
Kong led a prospective randomized study that compared capsule
endoscopy with angiogram in patients with acute overt OGIB to
compare the diagnostic yield and long term outcome of patients of
each method. Investigators concluded that capsule endoscopy has a
higher diagnostic yield than angiogram in patients with acute overt
OGIB, supporting the early use of CE as the first line
investigation for patients with active OGIB.
Data on Specialized Patient
Populations
- "Capsule Endoscopy in Octogenarians: Analysis
of a Large Prospectively Collected Database" (Sa1742) Investigators led by Victoria Gomez, M.D.,
Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL
studied PillCam SB in 188 patients over 80 years old to evaluate
its safety and efficacy in this distinct patient group who often
present with iron deficiency anemia (IDA), overt and occult obscure
gastrointestinal bleeding (OGIB). There is limited published data
on the outcomes and findings of CE in patients, particularly over
the age of 80. The authors concluded that capsule endoscopy is safe
to use in the older patient population, with very low capsule
retention rate and a very good diagnostic yield.
- "Safety and Efficacy of Wireless Capsule
Endoscopy in Cancer Patients With Low Neutrophil Counts and Obscure
Gastrointestinal Bleeding: a Case Controlled Study" (Sa1745) Nirav Thosani, M.D., of the Department of
Gastroenterology, Hepatology and Nutrition, The University of
Texas, Houston Medical School, Houston, studied the safety and
diagnostic yield of wireless capsule endoscopy (WCE) in neutropenic
cancer patients with obscure gastrointestinal bleeding (OGIB)
through a retrospective review of 426 cancer patients who underwent
WCE at the M.D. Anderson Cancer Center from July 2005 to September
2011. Their results showed that WCE is a safe and effective tool in
cancer patients with low neutrophil counts and OGIB, with an
overall diagnostic yield of 72%.
New Technological Advances
- "Evaluation of the QuickView and Suspected
Blood Indicator Modes for Primary Capsule Endoscopy Reading in
Active Small Bowel Bleeding" (217) Led
by Anoop Appannagar, M.D., Department of Medicine, University of
Chicago Medical Center, Chicago, IL, investigators studied the
performance of PillCam SB's QuickView (QV) plus Suspected Blood
Indicator (SBI) features compared to the standard view software to
determine sensitivity of the new features. The group reviewed all
WCE studies performed for suspected small bowel bleeding from
4/2007 to 3/2011 and concluded that in patients with active small
bowel bleeding, the QV+SBI reading format of WCE is highly
sensitive with a 100% NPV and can be performed in a short amount of
time. QV+SBI also provided excellent inter-observer agreement in
novice readers with minimal training. These findings may justify a
clinical algorithm for evaluating suspected small bowel bleeding
that utilizes WCE and immediate QV+SBI. A positive finding directs
immediate therapy, while a negative study may require re-review
with SV or additional testing.
- "The Twelve-Hour Battery Given Wireless
PillCam SB2ex Improves Overall Cecal Intubation Rate and Increases
the Positive Yield" (153) Neel K. Mann
presented a single center study evaluated the 12-hour Given WCE
PillCam SB2EX in cecal intubation rates in both inpatients and
outpatients to see if the longer battery time could improve cecal
intubation rates (currently averaging 80% with the 8-hour Given
wireless PillcamSB2). Investigators completed a retrospective
review of a total of 108 patients who received a 12-hour capsule
and 147 patients who received an 8-hour capsule between November
2010 - November 2011 and determined that a 12-hour battery capsule
may improve cecal intubation rate and cecal transit time,
especially in the inpatient setting. Investigators also reported a
higher yield of clinically relevant findings.
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 1,500 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 PillCam
patency capsule 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.
About Digestive Disease Week Digestive
Disease Week (DDW) is the largest international gathering of
physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. DDW is 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. 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 pioneering
the field of capsule endoscopy in 2001, Given Imaging has become a
world leader in GI medical devices, offering health care providers
a range of innovative options for visualizing, diagnosing and
monitoring the digestive system. The company offers a broad product
portfolio including PillCam® video capsules for the small bowel,
esophagus and colon [PillCam® COLON not approved for use in the
United States.], industry-leading ManoScan™ high-resolution
manometry and Bravo® pH and Digitrapper® pH and impedance
monitoring. Given Imaging is committed to delivering breakthrough
innovations to the GI community and supporting its ongoing clinical
needs. Given Imaging's headquarters are located in Yoqneam, Israel,
with operating subsidiaries in the United States, Germany, France,
Japan, Australia, Vietnam 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 "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) our ability to obtain reimbursement
for our product 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, (18) quality
issues and adverse events related to our products, such as capsule
retention, aspiration and failure to attach or detach, bleeding or
perforation that could require us to recall products and impact our
sales and net income, and (19) 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, 2011. 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 flazar@lazarpartners.com
dcarey@lazarpartners.com Israel Investor Contact: Nava Ladin
Gelbart Kahana Investor Relations +972-3-6074717
nava@gk-biz.com
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