Given Imaging Ltd, (Nasdaq:GIVN), a world leader in
gastrointestinal medical devices and pioneer of capsule endoscopy,
today announced results from four studies confirming PillCam SB as
the gold standard for detecting diseases of the small bowel. The
studies were presented at United European Gastroenterology Week
(UEG Week) taking place October 12-16, 2013 in Berlin, Germany
where Given Imaging will be exhibiting throughout the conference at
Booth #7, located in Hall 15.1.
Key findings from PillCam SB studies presented at UEG Week
included:
- PillCam SB led to a new diagnosis in over 40% of IBD cases
- PillCam SB provides relevant findings in over 50% of patients
who underwent capsule endoscopy for unexplained Iron Deficiency
Anemia after negative upper and lower GI endoscopy
- Emergency use of PillCam SB in patients with signs of acute
upper/mid gastrointestinal bleeding whose gastroscopy exams were
negative detected the bleeding source and helped guide further
therapy
- PillCam SB is a useful and safe diagnostic modality in children
with suspected small-bowel diseases in the largest cohort of
pediatric patients
"In the area of small bowel evaluation, PillCam SB is widely
used by the GI community and is considered a highly accurate
diagnostic modality," said Fevronia Kiparissi M.D., Department of
Gastroenterology, Great Ormond Street Hospital NHS Foundation
Trust, London, United Kingdom. "The studies being presented at UEG
Week demonstrate PillCam's potential to improve diagnostic yield
and change the course of treatment in cases where other modalities
failed to identify conditions of the small bowel leading to better
outcomes for patients suffering from inflammatory bowel disease,
gastrointestinal bleeding, or iron deficiency anemia. This is
especially valuable for pediatric patients which we have
been following-up for many years."
"The Diagnostic Value in Pediatric Small Bowel
Assessment by Wireless Capsule Endoscopy: A Tertiary Center
Experience," poster P1333: presented by Efstratios
Saliakellis M.D., and colleagues, Great Ormond Street Hospital, NHS
Foundation Trust, London, United Kingdom, assessed the diagnostic
value, tolerance and safety of PillCam in pediatric patients. The
retrospective review of PillCam capsule endoscopy (CE) in 291
children showed over 60% had positive findings and 34% were
diagnostic in terms of establishing a diagnosis or altering the
therapeutic approach in the patient. The results, which represent
the largest cohort of pediatric patients and include the youngest
child ever to undergo capsule endoscopy, demonstrated that with
careful selection, CE is a useful and safe diagnostic modality in
children with suspected small bowel diseases.
"Why Should We Still Use Capsule Endoscopy in
Inflammatory Bowel Disease," oral presentation OP430:
presented by Lucia Marquez M.D., and colleagues, Hospital del Mar,
Digestive Diseases, Barcelona, Spain, analyzed the impact of
PillCam capsule endoscopy (CE) on the diagnosis and management of
suspected or established Inflammatory Bowel Disease (IBD). Results
confirmed that CE findings led to a new diagnosis in over 40% of
cases and that CE is a useful tool for diagnosis of new IBD as well
as for guiding treatment.
"Findings and Long Term Outcomes for Patients Following
Video Capsule Endoscopy to Investigate Iron Deficiency
Anemia," poster P1336: presented by Janisha Patel M.D.,
and colleagues, Kings College Hospital, Dept. of Hepatology,
London, United Kingdom, observed long term outcomes in patients who
have undergone capsule endoscopy to investigate iron deficiency
anemia (IDA). The results of this retrospective study analyzing
long term outcomes of 115 patients who had a negative upper and
lower GI endoscopy, showed capsule endoscopy (CE) presented
relevant findings in over 50% of patients who underwent CE to
investigate unexplained IDA and a significant number of these
patients were then actively treated.
"Emergency Video Capsule Endoscopy in Patients with
Acute Gastrointestinal Bleeding, poster," poster
P1332:presented by Christoph Schlag M.D., and colleagues, Technical
University Munich, Munich, Germany, analyzed the use of PillCam
capsule endoscopy (CE) for acute gastrointestinal bleeding in the
emergency setting. Of the patients who failed to have their source
of bleeding identified with gastroscopy, 93% showed complete
examination using emergency CE and 73% had the bleeding source
identified with CE. Results confirm that for patients with
signs of acute upper/mid gastrointestinal bleeding who have had a
negative gastroscopy, emergency CE can be used to immediately
detect the bleeding source and to guide therapy.
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 PillCam® SB
The PillCam SB capsule is a minimally invasive procedure to
visualize and monitor small bowel abnormalities associated with
Crohn's disease, iron deficiency anemia (IDA) and obscure GI
bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less
than four grams. Now in its third generation, PillCam SB 3 contains
an imaging device and light source and transmits images at a rate
between two and six images per second. Initially cleared by
the U.S. Food and Drug Administration in 2001, PillCam SB is an
accurate, patient-friendly tool used in patients two years and
older by physicians to visualize the small bowel. PillCam SB 3
builds on Given Imaging's unique expertise and collaborative
efforts as an industry leader that includes more than 2 million
uses of PillCam capsules in patients worldwide and more than 1,900
clinical studies.
The risks of PillCam capsule endoscopy include capsule
retention, aspiration and skin irritation. Endoscopic placement may
present additional risks. Medical, endoscopic, or surgical
intervention may be necessary to address any of these
complications, should they occur.
About Given Imaging
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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