SOURCE: Given Imaging

November 20, 2008 08:30 ET

Study Shows Endoluminal Image Analysis With Capsule Endoscopy Is an Effective Test for Assessing Intestinal Motility

New Approach Is Less Invasive and May Be as Effective as Current Standard of Care

YOQNEAM, ISRAEL--(Marketwire - November 20, 2008) - Given Imaging Ltd. (NASDAQ: GIVN) (TELAVIV: GIVN) today announced that a study published in the October issue of Gastroenterology confirms the potential of a new approach to measuring small bowel intestinal motility based on video images obtained through small bowel capsule endoscopy. Patients with intestinal dysmotility may suffer from pain, bloating, nausea or vomiting. This condition is generally related to weak or disorganized muscle contractions in the intestine. Small bowel manometry, the current standard of care, is a relatively complex, invasive and unpleasant procedure that requires specialized clinical expertise in order to interpret its findings. As a result, it is not widely available. A new, minimally invasive technique to evaluate intestinal motility utilizes a sophisticated, automated analysis of the images obtained during capsule endoscopy and could prove to be an easier and more convenient tool than manometry for both the patient and the physician. It could also reduce the number of diagnostic tests required to evaluate patients by providing one procedure to analyze both intestinal structure and function at the same time.

The study was conducted by Fernando Azpiroz, M.D. and Juan-R Malagelada, M.D. of the Digestive System Research Unit at the Hospital General Vall d'Hebron in Barcelona, Spain.

"Since only a few centers around the world are capable of performing traditional motility tests, only a small fraction of intestinal motor dysfunctions are diagnosed," said Dr. Azpiroz. "Evaluation of small bowel intestinal motility by capsule endoscopy is relatively non-invasive and simple to perform. Hence, virtually any GI setting, both hospital and ambulatory, could offer our diagnostic method of motility dysfunction based on computer analysis of capsule studies."

The aim of this study was to use capsule endoscopy to evaluate small bowel motor function based on a computerized image analysis program in 36 patients with severe intestinal motility disorders and 50 healthy subjects.

Image analysis was performed with a proprietary computer program specifically developed to detect contractile and non-contractile patterns, intestinal content and motion within the small bowel. As compared to healthy subjects, patients exhibited fewer contractions (25% less phasic luminal closures; p-value less than 0.05) and more non-contractile patterns (151% more tunnel pattern; p-value less than 0.05), static sequences (56% more static images; p-value less than 0.01) and cloudy intestinal content (94% more static cloudy images; p-value less than 0.01).

The study suggested the software may be improved in the future by expanding the subsets, refining algorithms and introducing new features into the analysis program. With the use of this new tool, PillCam capsule endoscopy may allow the diagnosis of a broad range of specific motor abnormalities that are not generally achieved in many patients.

"We believe that the results of this study could support the use of PillCam SB in an additional indication: assessing intestinal motility. Through our collaboration with our partners in Spain, we have completed the initial testing of PillCam SB with this new, proprietary, minimally invasive technique with the goal of accelerating diagnosis and treatment of those patients suffering from motility disorders," said Homi Shamir, president and CEO of Given Imaging.

"We are pleased with the results to date and look forward to working with gastroenterologists from around the world to continue to study and develop this product."

The PillCam SB 2 video capsule, when used with the PillCam Platform, is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up. The PillCam SB 2 capsule and the PillCam Platform are not cleared for assessing intestinal motility dysfunction and should not be used outside of the context of approved clinical trials with such patients.

The Endoluminal Image Analysis research program is sponsored by Given Imaging.

About Given Imaging Ltd.

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging markets a number of available capsules: the second-generation PillCam SB 2 video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the second-generation PillCam ESO 2 video capsule to visualize the esophagus; the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark and various country approvals, but is not cleared for marketing or available for commercial distribution in the USA. More than 820,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries (NASDAQ:ELRN) (TELAVIV:ELRN). For more information, visit www.givenimaging.com.

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