Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced new data
that was presented at the American College of Gastroenterology 2012
annual meeting that highlighted the economic value of using its
newly acquired SmartPill GI monitoring system in evaluating
patients with both upper and lower functional gastrointestinal
symptoms.
Traditionally, patients with symptoms of upper or lower
gastromotility disorders undergo gastric emptying scintigraphy and
colonic sitzmarker testing. Due to the expense of conducting these
types of evaluations, SmartPill is being studied as a
cost-effective, radiation-free alternative for measuring gastric
emptying and total GI transit times along with pH, pressure and
temperature of the GI tract.
In the podium presentation, Cost-Effectiveness
Analysis of Wireless Capsule Motility (WCM) Compared to Traditional
Testing for Patients with Functional Gastrointestinal
Disorders (#62), Lauren Gerson, MD, MSc, FACG, Stanford
University, presented findings from a five year Markov analysis
comparing the SmartPill GI monitoring system with traditional
testing, including gastric emptying scintigraphy and colonic
sitzmarker testing, of upper or lower GI motility disorders. Using
costs based on 2011 Medicare rates, the study used a 45-year-old
female patient with both upper and lower GI functional symptoms as
the base case to analyze cost and quality-adjusted life years. The
study found that the incremental cost-effectiveness ratio for
wireless capsule motility testing was $18.437 and concluded that
SmartPill was the more cost-effective approach in patients with
both upper and lower GI symptoms compared with traditional testing.
The study also concluded that for patients with isolated upper GI
or lower GI symptoms, traditional testing is preferred.
"The economic indicators presented in this study, along with the
proven benefits of SmartPill as a patient-friendly tool for
evaluating motility disorders like gastroparesis and constipation,
make SmartPill an exciting addition to our portfolio of innovative
GI solutions," said Homi Shamir, President and CEO, Given Imaging.
"We look forward to leveraging Given Imaging's substantial
technological, clinical, marketing and sales resources to help
realize SmartPill's full potential."
About ACG The American College of
Gastroenterology is a recognized leader in educating GI
professionals and the general public about digestive disorders.
Their mission is to serve the evolving needs of physicians in the
delivery of high quality scientific, humanistic and cost-effective
health care to gastroenterology patients. For more information,
visit http://gi.org.
About SmartPill® GI Monitoring System
SmartPill is an ingestible medical capsule device that provides
data that can assist physicians in the evaluation of gastroparesis
and chronic constipation. The SmartPill GI Monitoring System was
granted initial 510(k) release from the U.S. Food and Drug
Administration (FDA) in July 2006.
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
impedance, and the SmartPill® GI 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 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. 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 ability of the Company to
reach agreement on any strategic alternative and/or to complete any
such alternative, as well as 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 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.
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 1-212-867-1762 flazar@lazarpartners.com
dcarey@lazarpartners.com Israel Investor Contact: Nava Ladin
Gelbart Kahana Investor Relations +972-3-6074717
nava@gk-biz.com
Given Imaging (NASDAQ:GIVN)
Historical Stock Chart
From Jun 2024 to Jul 2024
Given Imaging (NASDAQ:GIVN)
Historical Stock Chart
From Jul 2023 to Jul 2024