Given Imaging (Nasdaq:GIVN), a world leader in specialty GI
products and pioneer of capsule endoscopy, today announced numerous
studies confirming the value of its reflux and manometry products
in diagnosing, monitoring and managing a range of gastrointestinal
diseases. The studies were presented at United European
Gastroenterology Week (UEG Week), taking place from October 12-16,
2013 at the Internationales Congress Centrum Berlin where Given
Imaging is exhibiting at Hall 15.1, Booth #7 throughout the
conference. Results of more than 110 clinical studies of Given
Imaging's products were presented at UEG Week this year
demonstrating the breadth and utility of its portfolio.
"New tools like high-resolution manometry and prolonged pH
monitoring deliver more detailed and more relevant information that
allow us to explain the causes of patient symptoms and to better
manage patients with esophageal disorders," said Mark Fox, M.D.,
Division of Gastroenterology of University Hospital Zurich. "It is
important that we continue to use these tools to select the most
appropriate pharmacologic as well as surgical therapies."
Key Given Imaging highlights include the following
studies at UEG Week:
pH and pH-Impedance Monitoring
- "Understanding the Cause of Persistent GERD Symptoms
Despite Proton Pump Inhibitor Therapy: Impedance-pH Monitoring
Revisited"(poster 460): Daphne Ang M.D.,
Changi General Hospital, Department of Gastroenterology, Singapore,
presented data on use of impedance-pH testing showing that both
acid reflux and non-acid reflux events account for persistent
symptoms in PPI (proton pump inhibitors) non-responders, especially
patients with typical reflux symptoms. Authors noted that therapies
beyond PPI may be necessary.
- "The Real Prevalence of Functional Heartburn: The
Lesson of Prolonged Wireless pH Monitoring" (poster 1598):
Roberto Penagini M.D. of the Cattedra di Gastroenterologia,
Università degli Studi and Fondazione IRCCS, Ospedale Maggiore,
Mangiagalli e Regina Elena, Milan, Italy, presented a study showing
how use of either a 48-hr catheter or 48 to 96-hr wireless study
can provide a more accurate diagnosis of functional heartburn than
standard of care. Functional heartburn is diagnosed in patients
with heartburn refractory to PPIs when endoscopy, esophageal acid
exposure time (AET), and symptom index (SI) are negative.
Diagnosing functional heartburn is important as it often leads to a
change in the way patients are managed.
- "Assessment of Patients Referred for GERD Evaluation:
To Continue or Stop Acid Suppressants Before Functional
Tests?" (oral presentation 379): Presenter Daphne Ang
M.D., of Changi General Hospital, Department of Gastroenterology,
Singapore, showed data from a study involving 2925 patients that
aimed to determine the diagnostic yield of functional studies
performed on and off proton pump inhibitor (PPI)
therapy. Investigators concluded that among those GERD
patients with insufficient treatment response, improved diagnostic
yield was achieved with multichannel intraluminal
impedance-wireless pH monitoring performed on PPI therapy for
evaluation of non-acid reflux and off therapy for acid reflux
evaluation.
- "Esophageal Work-Up Prior to Bariatric Surgery: Who and
How to Investigate?" (poster 1599): Benjamin Heimgartner,
M.D., Inselspital, Bern University Hospital, Gastroenterology and
Hepatology, Bern, Switzerland, presented data from this study that
examined the optimal diagnostic work-up in an obese patient
population. Results showed that reflux monitoring is superior
to endoscopy in detecting GERD, yet a substantial number of
patients with erosive esophagitis had "normal" esophageal acid
exposure. Since typical reflux symptoms do not predict the
presence of esophagitis and abnormal acid exposure, the study
investigators recommend including endoscopy and reflux monitoring
as part of the pre-operative work-up prior to bariatric
surgery.
High Resolution Manometry
- "Long Term Outcome of Patients with Reflux Symptoms and
Symptomatic Esophageal Dysfunction During and After a Standardized
Test Meal: A High-Resolution Manometry
Study" (poster 1587): Mark Fox M.D.,
Nottingham University Hospital NIHR Digestive Disease BRU, United
Kingdom, presented results from a study to assess esophageal
function and symptoms using high resolution manometry (HRM) with
5ml water and a test meal followed by 10min post-meal observation
of symptoms and events. HRM studies which include a test meal and
post-meal observation provide an objective explanation for symptoms
in the majority of patients investigated for reflux symptoms.
Long-term follow-up suggests this information can guide management.
- "Prevalence of Relaxation Disorders of the Lower
Esophageal Sphincter in Patients Undergoing High Resolution
Manometry" (poster 1585): Presented byJutta Keller M.D.,
Israelitisches Krankenhaus Internal Medicine, Hamburg, Germany,
this study used esophageal manometry to determine the integrated
relaxation pressure (IRP) according to the Chicago Classification
in 787 patients. Results showed that LES (lower esophageal
sphincter)-relaxation occurred in more than 10% of patients
undergoing high resolution manometry.
- "Factors that Affect the Disruption of Esophagogastric
Junction and its Relation with High Resolution Manometry
Alterations and Acidic Reflux" (poster 1007): Constanza
Ciriza de Los Rios M.D. of the Hospital 12 de Octubre, Dept. de
Gastroenterologia, Madrid, Spain, presented data from a study of
115 patients evaluating the risk factors associated with
esophagogastric junction disruption (EGJ) and the relationship
between esophagogastric junction type, manometric alterations and
acid reflux. The study results indicated that high resolution
manometry (HRM) facilitates the investigation of the OGJ and its
progressive disruption showing that age, weight and central obesity
pose a greater risk for hiatus hernia. Greater EGJ disruption
is associated with lower pressure, esophageal shortening,
and higher acid exposure in pH-metry.
About UEG Week
UEG Week is the largest and most prestigious gastroenterology
meeting in Europe and has developed into a global congress. It
attracts over 14,000 participants each year, from more than 120
countries, and numbers are steadily rising. UEG Week provides a
forum for basic and clinical scientists from across the globe to
present their latest research in digestive and liver diseases, and
also features a two-day postgraduate course that brings together
top lecturers in their fields for a weekend of interactive
learning.
About ManoScan high resolution manometry
Given Imaging pioneered ManoScan high resolution manometry, the
first high resolution manometry system. ManoScan system
continues to remain the market leader in comprehensive solutions
for assessing gastrointestinal motility. ManoScan is the only
system with automatic findings incorporated into the Chicago
Classification algorithms, a standardized categorization system for
identifying and classifying motility disorders. Through the
combination of proprietary tactile-sensing catheter technology and
easy-to-use ManoView® software, ManoScan reveals complex functional
anatomy, enabling physicians to more accurately diagnose
abnormalities of the gastrointestinal tract.
Manometry products have certain risks associated with catheter
insertion. Medical, endoscopic or surgical intervention may be
necessary to address complications, should they occur. These
systems are not compatible for use in an MRI magnetic field.
About Bravo pH monitoring
Bravo pH monitoring is the only catheter-free pH test. The
procedure uses a pH capsule that is temporarily attached to the
wall of the esophagus to wirelessly transmit pH data continuously
for up to 96 hours. Like catheter-based pH tests, the Bravo pH
monitoring system is an ambulatory method of pH monitoring,
considered the gold standard for pH measurement and monitoring of
gastric reflux. The Bravo pH monitoring system collects data that
are more reflective of the patient's normal daily routine to assess
if the patient has GERD.
The risks of Bravo pH monitoring include: premature detachment,
discomfort, failure to detach, failure to attach, capsule
aspiration, capsule retention, tears in the mucosa, bleeding, and
perforation. Endoscopic placement may present additional risks.
Medical, endoscopic, or surgical intervention may be necessary to
address any of these complications, should they occur. Because the
capsule contains a small magnet, patients should not have an MRI
study within 30 days of undergoing the Bravo pH test.
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® capsule
endoscope for the small bowel, esophagus and colon. The company
also offers industry-leading GI functional diagnostic solutions
including ManoScan® high resolution manometry, Bravo® capsule-based
pH monitoring, Digitrapper® pH-Z monitoring, and SmartPill®
motility monitoring systems. 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, Hong
Kong and Brazil. For more information, please visit
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. Such forward-looking statements
include statements relating to the Company exploring strategic
alternatives and considering possible strategic transactions
involving the Company. 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, 2012. 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 to the extent expressly required under
applicable law, the Company undertakes no obligation to release
publicly any revisions to any forward-looking statements, to report
events or to report the occurrence of unanticipated events.
CONTACT: For further information contact:
Chantal Beaudry/Martyna Gawrych
Lazar Partners Ltd.
cbeaudry@lazarpartners.com
mgawrych@lazarpartners.com
212-867-1762
Investor Contact:
David Carey
Lazar Partners Ltd.
dcarey@lazarpartners.com
212-867-1762
Israel Investor Contact:
Nava Ladin
Gelbart Kahana Investor Relations
+972-3-6074717
nava@gk-biz.com
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