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Oct 5th, 2012
Given Imaging acquires assets of SmartPill Corporation
Given Imaging Ltd. a world leader in specialty GI products and pioneer of capsule endoscopy announces 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.
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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.

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