Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI
products and pioneer of capsule endoscopy, today announced that it
has acquired from The SmartPill Corporation, a U.S. based-company,
the assets related to the SmartPill® GI Monitoring System for $6
million. The SmartPill® is an ingestible capsule that uses sensor
technology to measure pH, pressure and temperature in the GI tract.
The SmartPill System measures gastric emptying and total GI
(stomach, small bowel and colon) transit times and is used to
evaluate motility disorders like gastroparesis and constipation.
"SmartPill is an excellent strategic fit with Given Imaging's
proprietary technology and extensive portfolio of GI diagnostic
tools," said Homi Shamir president and CEO of Given Imaging.
"Incorporating SmartPill into our business strengthens our value
proposition to gastroenterologists as we will now provide an
industry-leading platform of patient-friendly GI diagnostic
solutions. We anticipate that this acquisition will have an
immediate contribution to our top-line results and will be
accretive to our bottom-line by the end of 2014."
The SmartPill is cleared by the FDA and CE marked for the
evaluation of gastroparesis and constipation, and has an existing
CPT code. A category 1 CPT code specifically and exclusively for
the SmartPill procedure goes into effect in January, 2013. Given
Imaging plans to invest in market development activities designed
to expand the body of clinical evidence for and awareness of
SmartPill.
Administered in the physician's office, the SmartPill is
completely ambulatory and allows the patient to go about their
normal routine during the course of the test. As the SmartPill
capsule passes through the GI tract, it transmits data to a
recorder worn by the patient. The SmartPill capsule moves through
the intestines by peristalsis, or the normal rhythmic contraction
of the intestinal muscles, and is capable of transmitting data
continuously for at least five days. The single-use, non-imaging
capsule is excreted naturally from the body, usually within a day
or two. Once the capsule has passed from the body, the patient
returns the data recorder to the physician, who then can download
the collected data to a computer. The physician then uses
SmartPill's MotiliGI™ software to display and analyze the data,
providing the physician with test results in both graphical and
report formats.
"For millions of patients who suffer from the challenging and
painful symptoms of gastroparesis or chronic constipation,
SmartPill provides an ambulatory, patient-friendly and
radiation-free alternative for assessing GI motility, providing the
information we need to more accurately treat their conditions,"
said Braden Kuo M.D., Instructor of Medicine, Harvard Medical
School, Assistant Physician, Gastroenterology Unit and Director of
the Gastrointestinal Motility Laboratory at Massachusetts General
Hospital. "While SmartPill does not replace procedures like
endoscopy and colonoscopy, it can replace multiple procedures used
to assess gut transit requiring radiation exposure such as a timed
Small Bowel Follow Through (SBFT), gastric emptying scintigraphy
(GES) or sitzmarkers (ROM) which would be required to deliver the
same clinical information."
Given Imaging does not expect that this acquisition will have a
meaningful contribution to its fourth quarter 2012 revenues. The
Company will record the acquisition expenses in its fiscal year
2012 financial statements.
The Company expects that its 2013 revenues will include low
single-digit revenue in millions of US dollars from SmartPill, and
plans to make additional investments in clinical trials, market
development and manufacturing efficiency to support future
growth.
The acquisition also includes an earn-out component, based on
sales of the SmartPill product between 2013 and 2016. The Company
expects that earn-out payments, if any, will not be material.
About Gastroparesis
Gastroparesis, also called delayed gastric emptying, is a
disorder in which the stomach takes too long to empty its contents.
The most common symptoms of gastroparesis are nausea, a feeling of
fullness after eating only a small amount of food, and vomiting.
Other symptoms include acid reflux, abdominal pain or bloating and
lack of appetite. Diabetes is the primary cause of gastroparesis in
roughly 30% of cases and often occurs in people with type 1 or type
2 diabetes. Growth in the diabetic population is the primary reason
for the increased incidence of gastroparesis.
About Chronic Constipation
Chronic constipation is a condition of infrequent bowel
movements -- typically fewer than three stools a week -- and
difficult passage of stools which does not go away. In some cases,
chronic constipation may be caused by an underlying medical
condition.
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 and Digitrapper® pH-Z impedance 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 www.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. 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, 2011. 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 for the Company's ongoing obligations to
disclose material information under the applicable securities laws,
it undertakes no obligation to release publicly any revisions to
any forward-looking statements, to report events or to report the
occurrence of unanticipated events.
For further information contact: Fern Lazar/David Carey
Lazar Partners Ltd. 1-212-867-1768 flazar@lazarpartners.com
dcarey@lazarpartners.com Israel Investor Contact: Nava Ladin
Gelbart Kahana Investor Relations +972-3-6074717
nava@gk-biz.com
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