PillCam COLON is the Only Non-Invasive and
Radiation-Free Solution for the Approximately 750,000 Patients in
the U.S. Who Experience an Incomplete Colonoscopy Each Year
The Company's PillCam COLON Has a Global Market
Opportunity of 3 Million Procedures Annually
Fourth Major Product Clearance for Given Imaging
in the Past Year
Given Imaging Ltd, (Nasdaq:GIVN), a world leader in GI medical
devices and pioneer of capsule endoscopy, today announced that the
U.S. Food and Drug Administration (FDA) has cleared PillCam COLON
as a new modality to provide visualization of the colon. It may be
used for detection of colon polyps in patients after an incomplete
optical colonoscopy with adequate preparation and a complete
evaluation of the colon was not technically possible. PillCam COLON
received clearance under the direct de novo classification for
devices with low to moderate risk that have no predicate on the
market.
A photo accompanying this release is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=23359
Videos accompanying this release are available at
http://www.globenewswire.com/newsroom/prs/?pkgid=23357
http://www.globenewswire.com/newsroom/prs/?pkgid=23358
As previously announced at Digestive Disease Week in May 2013,
Given Imaging conducted an 884-patient, 16-site clinical trial
studying the accuracy and safety of PillCam COLON 2 compared to
optical colonoscopy in detecting adenomas 6 millimeters or larger.
Results from this clinical trial demonstrated that the sensitivity
for PillCam COLON was 88% and specificity was 82% in detecting
adenomas at least 6 millimeters in size.1 The FDA based its
clearance decision on an analysis of this clinical trial data that
used a more restrictive methodology for matching polyps. In this
analysis, which was conducted on hyperplastic polyps and adenomas,
the positive percent agreement for PillCam COLON and optical
colonoscopy was 69% and negative percent agreement was 81% for
polyps at least 6 millimeters in size.2
"PillCam COLON will improve patient care by offering a new and
effective colon imaging option for patients who have experienced an
incomplete colonoscopy. Among the limited alternatives available
after incomplete colonoscopy, PillCam COLON gives us a minimally
invasive, radiation-free option that provides endoscopic images of
the same basic type that have made colonoscopy so useful," said
Douglas Rex, M.D., Distinguished Professor of Medicine and
Chancellor's Professor, Indiana University School of Medicine and
Director of Endoscopy, Indiana University Hospital.
Incomplete colonoscopies occur in approximately 750,000 patients
in the United States per year.3,4 Patients with incomplete
colonoscopies often incur additional costs along with the
inconvenience and risk of other procedures to complete the
colorectal examination. The incidence of incomplete colonoscopies
is higher in women due to the increase in past pelvic surgeries and
the differing anatomy of women that includes particularly acute
rectosigmoid angles in thin women. Patients with a redundant or
long colon, history of abdominal surgery or advanced diverticular
disease are also at a higher risk for experiencing an incomplete
colonoscopy.
"We have made tremendous strides in increasing the number of
people who are getting screened for colon cancer, starting at age
50 for the average risk individual. Colonoscopy is the most
comprehensive option, but for up to 10% of individuals, achieving a
complete colonoscopy may not be possible. For those individuals,
PillCam COLON capsule endoscopy could be an effective option to
allow their gastroenterologist to complete a colon examination. And
who wouldn't want that kind of peace of mind for this unique cancer
-- that we can largely prevent with the aid of diagnostic exams
that detect the presence of polyps," said Eric Hargis, CEO, Colon
Cancer Alliance.
"The clearance of PillCam COLON by the FDA represents a pivotal
moment in the evolution of Given Imaging as a GI medical device
leader. This important event caps a string of significant
regulatory milestones for our company including clearance of
PillCam COLON in Japan and PillCam SB 3 in both the U.S as well as
Japan. We look forward to working closely with the U.S.
gastroenterology community to bring this clinically-proven,
diagnostic tool to patients who need to have a thorough colorectal
exam following an incomplete colonoscopy," said Homi Shamir,
President and CEO, Given Imaging. "While we believe that
PillCam COLON will ultimately play an important role in both the
global colorectal cancer diagnostic and screening market, this
initial indication is an important first step. To this end, we
are making good progress in advancing additional clinical studies
that should support the expanded indications."
To date, PillCam COLON clinical data have been validated in 34
publications. PillCam COLON is commercially available in more than
eighty markets including Japan, Europe, Latin America, Canada,
Australia and parts of Asia and Africa.
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 12 mm X 33 mm. PillCam COLON is designed to be
ingested by the patient and transmits 4 or 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.
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 ability of the Company to market
and sell the PillCam COLON capsule in the United States and Japan
and financial results and projections in connection with the
foregoing. 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 Rex DK et al. Accuracy of PillCam Colon 2 for detecting
subjects with adenomas ≥ 6 mm. Abstract presented at Digestive
Disease Week; 2013 May 18-21; Orlando, FL.
2 Data on file with Given Imaging
3 Rex DK, Petrinin JL, Baron TH, et al. Quality Indicators for
Colonoscopy. Am J Gastroenterol 2006;101:873-85.
4 Seeff LC, Richards TB, Shapiro JA, et al. How many
endoscopies are performed for colorectal cancer screening? Results
from CDC's survey of endoscopic capacity. Gastroenterology
2004;127:1670–1677.
The photo is also available via AP PhotoExpress.
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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