Given Imaging (Nasdaq:GIVN), a world leader in specialty GI
products and pioneer of capsule endoscopy, today announced new
studies validating PillCam SB's role in improving care, management
and outcomes for patients with known or suspected Crohn's disease.
The studies were presented at the American College of
Gastroenterology's Annual Scientific Meeting and Postgraduate
Course (ACG), taking place October 11-16, 2013, at the San Diego
Convention Center, San Diego, CA, where Given Imaging is exhibiting
at booth #1200 throughout the conference.
"PillCam SB is one of the most important tools we have for
detecting and monitoring small bowel diseases, such as Crohn's
disease. Due to the evolving nature of Crohn's disease, it's
crucial that we monitor mucosal healing, as well as disease
progression, so that we are able to continually improve the
targeting of our treatment regimens," said Neel K. Mann, M.D.,
Associate Director, Small Bowel Enteroscopy, Cedars-Sinai Medical
Center. "The compelling new data being presented at this year's ACG
meeting shows that PillCam SB can help us reclassify disease
phenotype to create a more tailored and effective management plan
for each patient."
Several ACG poster presentations highlighted the clinical
benefit of PillCam SB in Crohn's patients as a safe and valuable
tool in disease evaluation and management, including:
- "Capsule Endoscopy (CE) Can Improve Outcomes in Crohn's
Disease: An Evaluation of Pre- and Post-treatment CE,"
poster 426, presented by Neel K. Mann, M.D. and Simon K. Lo, M.D.,
Division of Gastroenterology, Cedars-Sinai Medical Center, Los
Angeles, Calif. The aim of this retrospective study was to assess
small bowel mucosal healing based on the Capsule Endoscopy Crohn's
Disease Activity Index (CECDAI, Dig Dis Sci (2008) 53:1933-27)
after initiation or escalation of therapy. CE results led to an
escalation of therapy or switching of biologic agents in 53.6% of
patients. There was a statistically significant difference in the
CECDAI between the pre- and post-treatment CE (p=0.0250.) The
study's authors concluded that PillCam SB helped to re-classify
disease phenotype in more than 60% of patients with suspected
Crohn's disease or unclassified Inflammatory Bowel Disease, thereby
potentially changing the management as well as the natural outcomes
of small bowel Crohn's disease. More importantly, capsule endoscopy
demonstrated mucosal healing in 70% patients, after assessment of
therapy, positively changing disease outcome and achieving
therapeutic goals in patients with non-stricturing phenotype
Crohn's disease.
- "Clinical Impact of Capsule Endoscopy in Patients with
Established Crohn's Disease," poster
1720, presented by researchers at McGill
University Health Center, Montreal, QC, Canada, examined the impact
of PillCam SB on the management of patients with established
Crohn's disease. The results of this retrospective cross-sectional
study of patients with established Crohn's disease showed that as a
result of PillCam SB findings, 67% of patients had a change in
management, including escalation in therapy, referral for surgery,
de-escalation of anti-inflammatory therapy or initiation of therapy
for concomitant IBS. Investigators concluded that PillCam SB,
a safe and valuable tool in disease evaluation and management, had
a significant impact on managing treatment options for patients
with established Crohn's disease.
- To help assess the value of monitoring in therapeutic
management for Crohn's disease, Given Imaging supported researchers
from the University of Chicago, Chicago Ill. and Cedars Sinai
Medical Center, Los Angeles, Calf. in a national survey of
gastroenterologists. An analysis of this survey was presented
by Adam C. Stein, M.D. in poster 420, "Mucosal Healing in
Inflammatory Bowel Disease: A Nationwide Survey of
Gastroenterologists' Current Practice Patterns". The
survey was conducted among community and academic
gastroenterologists to determine current practice patterns for both
achieving and maintaining mucosal healing in Crohn's and Ulcerative
Colitis. Results showed that the majority of surveyed
gastroenterologists agreed that mucosal healing is the primary
management goal in patients with both Crohn's and Ulcerative
Colitis, and 57.1% indicated they would perform periodic endoscopy
for disease monitoring even after mucosal healing was achieved and
the patient was asymptomatic, or to assess for post-operative
recurrence in Crohn's disease after ileocectomy with primary
anastomosis.
About Crohn's Disease
Crohn's disease is a chronic condition that causes inflammation
in the lining of the small intestine wall and can affect any part
of the digestive tract. Symptoms can include diarrhea, abdominal
pain, weight loss and rectal bleeding. Other cases of Crohn's may
affect one or more of the following: the colon only, the small
bowel only (duodenum, jejunum and/or ileum), the stomach or
esophagus.1 Roughly 500,000 Americans suffer from Crohn's disease,
and about 20% have a direct relative with some form of inflammatory
bowel disease (IBD).2 Crohn's disease affects men and women
equally. The cause is unknown; but, the most popular theory is that
the immune system is reacting to a virus or bacterium that causes
inflammation.3 Depending on the severity, treatment options include
nutritional supplements, drugs and surgery. There is currently no
cure for the disease.4
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 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.
(1) http://www.ccfa.org/info/about/crohns Inflammatory
Bowel Disease Frequently Asked Questions.
(2) Crohn's and Colitis Foundation of America (ccfa.org)
(3) National Institute of Diabetes and Digestive and Kidney
Diseases (niddk.nih.gov)
(4)
http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html
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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