- Ten abstracts including more than 1,200
patients to be presented on PillCam COLON - - Topics range from
confirming the diagnostic yield of PillCam COLON and validating
feasibility of PillCam COLON in a general practice setting -
Given Imaging Ltd, (Nasdaq:GIVN), a world leader in
gastrointestinal medical devices and pioneer of capsule endoscopy,
today announced that ten abstracts highlighting the clinical
utility of PillCam COLON were presented during United European
Gastroenterology Week (UEG Week) taking place October 12-16, 2013
at the Internationales Congress Centrum Berlin where Given Imaging
is exhibiting at Hall 15.1, Booth #7.
"The growing body of data supporting both the clinical accuracy
for PillCam COLON and patient preference for a non-invasive,
radiation-free colorectal exam strengthen our efforts to expand
access to PillCam COLON in Europe and markets across the globe,"
said Homi Shamir, president and CEO, Given Imaging.
Highlights of the ten studies presented at UEG Week include:
- Patients prefer PillCam COLON because of concern about pain and
embarrassment related to colonoscopy.
- PillCam COLON shows significantly higher diagnostic yield
compared to CTC in polyps 6 mm or larger.
- Use of PillCam COLON following incomplete colonoscopy reveals
new lesions in 60% of patients resulting in therapy modifications
for 45% of these patients.
- Head-to-head, retrospective comparison of PillCam COLON versus
colonoscopy finds PillCam COLON generated 90% sensitivity and 96%
specificity on a per-lesion basis for detecting flat lesions shown
to have a higher risk of being cancerous.
"As utilization of PillCam COLON increases, we are generating
useful information about its use in a range of settings and for
different indications including polyp detection rates," said
Jean-Christophe Saurin, M.D., Ph.D., French Society of Digestive
Endoscopy. "These quantifiable outcomes underscore that
PillCam COLON is an interesting colonic screening option for
patients who cannot or prefer not to have a traditional
colonoscopy, but studies on acceptance in these patients are
warranted."
- "French Multicenter Experience of Colon Capsule
Endoscopy in Real Practice: Primary Results of the Colon Capsule
Endoscopy Observatory 'ONECC'" (poster #1337) was
conducted by Dr. Saurin and colleagues to analyze survey results
from a 161-user, 116-center French database of PillCam COLON
procedures. Researchers evaluated the feasibility of using
PillCam COLON in a general practice setting and the indications for
which PillCam COLON was being used. Survey results from 585
PillCam procedures showed that PillCam COLON detected polyps in 253
patients, of which, significant polyps were discovered in 125
patients, or 28% of all the PillCam COLON procedures. Researchers
also discovered that PillCam was used equally among three
indications: patients with previous incomplete colonoscopy,
patients contraindicated for colonoscopy and patients who refused
colonoscopy. Of these indications, PillCam COLON detected
significant polyps in 20.4% of patients with previous incomplete
colonoscopy, 23.1% of patient contraindicated for colonoscopy and
14.5% of patients who refused colonoscopy. Based on the broad
indications used for PillCam COLON and the significant polyp
detection rate, researchers confirmed the practical application of
PillCam COLON in a general practice setting.
- "Patients Perception of Colonoscopy: Astonishing
Reasons for Colon Capsule Endoscopy Preference" (poster
#791) validated patient preference for a non-invasive colorectal
exam. Researchers from the Department of Gastroenterology and
Hepatology at the Institute for Clinical and Experimental Medicine
in Prague, Czech Republic led by Marek Benes, M.D. conducted a 100
patient survey analysis to find that 42% of patients reported they
will never undergo a screening colonoscopy even though 45% of this
subgroup had a positive family history of colorectal
cancer. The top reason for preference for PillCam COLON over
colonoscopy was due to concerns about privacy and embarrassment
experienced with colonoscopy, with 38% of patients reporting this
as their top concern. Concern of pain was the second most
common reason to prefer PillCam COLON over colonoscopy, with 35% of
patients reporting this as a concern.
- "Flat Colorectal Lesions At Pillcam Colon Capsule
Endoscopy" (oral presentation #432) was a head-to-head,
retrospective comparison of PillCam COLON versus colonoscopy to
evaluate the ability of PillCam COLON to diagnose flat colonic
lesions. Led by Cristiano Spada, M.D., Catholic University,
Rome, Italy, researchers collected data from patients who underwent
PillCam COLON followed by a traditional
colonoscopy. Physicians were able to identify 27 conventional
polyps with colonoscopy and 25 conventional polyps with PillCam
COLON. In one patient, PillCam COLON visualized an 11 mm flat
lesion that was not confirmed by colonoscopy. PillCam COLON
generated 90% sensitivity and 96% specificity on a per-lesion
basis. Based on these findings, researchers concluded that
PillCam COLON has high accuracy for detecting flat
lesions.
The utilization of PillCam COLON following incomplete
colonoscopy was highlighted in UEG Week abstracts including:
- "Colon Capsule Endoscopy Versus CT-Colonography in the
Evaluation of Patients with Incomplete Traditional Colonoscopy: A
Prospective Comparative Trial" (oral presentation #431)
presented by Cristiano Spada, M.D., and colleagues from the
Catholic University in Rome, Italy. Patients in the study
underwent both CT-colonography (CTC) and PillCam COLON with the
goal of identifying polyps and masses that were at least six
millimeters and located in segments of the colon that could not be
examined in the previous incomplete colonoscopy. Both PillCam
COLON and CTC successfully completed the colonic exam in 98% of
patients due to 2% of patients refusing CTC due to air
insufflation. Of the 98 patients included in the analysis, PillCam
COLON identified polyps at least six millimeters in size in 19
patients, while CTC identified only seven patients. Resulting
sensitivity and specificity for PillCam COLON was 100% and 91%
respectively and 35% and 92% respectively for CTC. Researchers
concluded that both exam modalities were effective in completing a
colonic exam, however PillCam COLON had a significantly higher
diagnostic yield compared to CTC in identifying polyps six
millimeters or larger.
- "Utility of Colon Capsule Endoscopy After an Incomplete
Colonoscopy - Multicenter Spanish Study" (poster #793) led
by Oscar Nogales, M.D., Hospital General Universitario Gregorio
Marañón, Department of Gastroenterology, Madrid, Spain analyzed the
use of PillCam COLON 98 patients with previous incomplete
colonoscopies. Overall, PillCam COLON was able to identify new
lesions in in 60% of patients. Within this group, therapy
modifications resulted for 45% of the patients. Polyps were
the most frequent finding with 41% of patients having a polyp
identified by PillCam COLON. Additional findings by PillCam
COLON included diverticulae, neoplasia and solitary colonic
ulcers. Based on these results, researchers concluded that
Pillam COLON is a useful diagnostic tool to identify a significant
number of lesions in unexplored regions of the colon following
incomplete colonoscopy and, as a result, may produce favorable
therapeutic changes for these patients.
About PillCam COLON
The PillCam COLON video capsule is equipped with two miniature
color video cameras (one on each end), a battery and an LED light
source; it measures 11 mm X 31 mm. PillCam COLON is designed to be
ingested by the patient and transmit up to 35 frames per second for
approximately 10 hours to a recording device worn by the patient.
Data are transferred from the device to a computer that uses RAPID
software to compile the video data and enable the physician to
review and report the results of the PillCam study.
The risks of PillCam capsule endoscopy include capsule
retention, aspiration and skin irritation. The risks associated
with colon preparation are allergies or other known
contraindication to any preparation agents or medications used for
the PillCam COLON regimen, according to laxative medication
labeling and per physician discretion. After ingesting the PillCam
capsule and until it is excreted, patients should not be near any
source of powerful electromagnetic fields, such as one created by
an MRI device. Medical, endoscopic or surgical intervention may be
necessary to address these complications, should they occur. A
normal or negative capsule endoscopy examination does not exclude
the possibility of colon polyps or colon cancer.
PillCam COLON has received a CE Mark, but is pending FDA
clearance and is not cleared for marketing or available for
commercial distribution in the U.S. and certain other
countries.
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 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: 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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