New Studies Show Given Imaging's SmartPill(R) Provides Standardized and Comprehensive Evaluation in Patients With Gastrointes...
14 Octubre 2013 - 7:01AM
Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced results
from two new studies that provide new information about
gastroparesis, constipation and small intestinal bacterial
overgrowth when using its SmartPill product. The studies were
presented by researchers from the Cleveland Clinic and Texas Tech
University Health Sciences Center at the American College of
Gastroenterology's 2013 Annual Scientific Meeting (ACG) taking
place October 11-16, 2013 in San Diego, California.
The SmartPill motility monitoring system offers a unique way to
assess motility by collecting and analyzing data from within the
entire GI tract via a test that can be performed in the clinic or
physician's office. As the SmartPill capsule passes through the GI
tract, it transmits data to a recorder worn by the patient. Once
the single-use capsule has passed from the body, study data are
downloaded from the recorder to a computer for evaluation by a
physician.
"SmartPill provides clinicians with a powerful tool that helps
us measure GI tract transit in patients who we cannot otherwise
evaluate," said Zubin Arora M.D., Cleveland Clinic. "In our study,
SmartPill revealed that many patients with symptoms suggestive of
gastroparesis or constipation actually have more generalized gut
dysmotility which definitely has implications for how we manage
these patients therapeutically."
- "Clinical Utility and Diagnostic Yield of 165 Wireless
Capsule Studies at a Tertiary Referral Center,"
poster 1684: presented by Zubin Arora, M.D., and
colleagues from the Cleveland Clinic, is a retrospective study of
165 patients with suspected motility disorders who underwent
SmartPill studies. SmartPill provided the researchers with new
information about bowel transit time that could aid patient
management. In the study, SmartPill revealed abnormal findings in
78% of patients, including delayed large bowel transit time (39%),
delayed gastric emptying time (35%) and delayed small bowel transit
time (29%). In patients who received SmartPill for evaluation of
gastroparesis, small bowel transit time was delayed in 39% of
patients, and large bowel transit time was delayed in 28% of
patients. Similarly, in patients who received a SmartPill test for
evaluation of constipation, gastric emptying time was delayed in
27% of patients, and small bowel transit time was delayed in 25% of
patients. 25% of patients suspected to have both gastroparesis and
constipation had abnormal small bowel transit time. A large number
of patients with abnormal gastric emptying scintigraphy also had
abnormal small bowel transit time (36%) and large bowel transit
time (41%). Similarly, many patients with abnormal Sitzmarks
studies also had delayed gastric emptying time (50%) and delayed
small bowel transit time (15%).
- "Does Small Intestinal Bacterial Overgrowth Delay Small
Bowel Transit Time?," poster 767:
presented by Irene Sarosiek, M.D., and colleagues from Texas Tech
University, the investigators used SmartPill to explore the theory
that symptoms of chronic idiopathic constipation may be related to
alterations and abnormal colonization within the gut microbiata
resulting in small intestinal bacterial overgrowth. The study
found that small bowel transit time was 20% slower in patients with
small intestinal bacterial overgrowth. After two weeks of
treating the patients' constipation with lubiprostone, 37% no
longer had small intestinal bacterial overgrowth and their small
bowel transit time was reduced by 21%.
About SmartPill® motility monitoring
systems
The SmartPill motility monitoring system offers a unique way to
assess motility by collecting and analyzing data from within the
entire GI tract via a test that can be performed in the clinic or
physician's office. The test is ambulatory, allowing the patient to
go about their normal routine throughout the test. As the SmartPill
capsule passes through the GI tract, it transmits data to a
recorder worn by the patient. Once the single-use capsule has
passed from the body, study data are downloaded from the recorder
to a computer. The physician then uses MotiliGI® software to
display and analyze the data, providing test results in both
graphical and report formats. Results are used for the evaluation
of gastroparesis and chronic constipation. The SmartPill motility
monitoring system was granted initial 510(k) release from the U.S.
Food and Drug Administration (FDA) in July 2006.
SmartPill may not be a solution for every type of patient and is
not indicated for children under the age of 18. The risks of
SmartPill motility monitoring include capsule retention and
aspiration. Patients should not have an MRI while SmartPill is in
their body.
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: 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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