Study Recommends Given Imaging Ltd.'s PillCam SB As First-Line Diagnostic Tool For Patients With Suspected Crohn’s Disease

YOQNEAM, Israel, Oct. 24 /PRNewswire-FirstCall/ -- Given Imaging Ltd. today announced that 16 independent studies of its PillCam SB were presented at the 13th United European Gastroenterology Week (UEGW), including one that confirmed data from past studies recommending use of PillCam(TM) SB as a first line diagnostic tool in patients with suspected small bowel Crohn’s Disease (CD). Additional studies announced at the meeting, which took place in Copenhagen, Denmark from October 15 to 19, examined PillCam SB’s role in influencing clinical outcomes in patients with unexplained bleeding and suspected Crohn’s disease.

“These studies confirm the positive impact that our PillCam technology has made on improving the diagnosis of small bowel disorders,” said Gavriel D. Meron, president and chief executive officer of Given Imaging. “To date, approximately 250,000 individuals have ingested PillCam and more than 300 peer review papers and abstracts have been published demonstrating PillCam’s diagnostic superiority compared to traditional endoscopic techniques, including intra-operative enteroscopy, the former gold standard.”

Crohn’s Disease Study

Dr. Ervin Toth of Malmo University Hospital, Lund University, Department of Medicine, Malmo, Sweden presented a single center, prospective and partly-blinded study comparing the diagnostic value of PillCam SB to traditional methods of evaluating small bowel Crohn’s disease including conventional barium enterography, push enteroscopy and colonoscopy in 65 patients with clinically-suspected active Crohn’s disease.

“PillCam SB should be the method of choice in patients with suspected, non-stricturing small bowel Crohn’s disease,” Dr. Toth said. “PillCam SB is not only a more accurate imaging modality for visualizing Crohn’s lesions in the small bowel, but it was also preferred by almost all patients in our study.”

Using one or more traditional methods, researchers were able to detect Crohn’s lesions (multiple erosions, ulcerations and/or strictures) in the small intestine in 38 (58%) of the 65 patients. PillCam SB found all the cases of small bowel Crohn’s disease detected by the other diagnostic modalities except for 5 (13%) cases when the capsule did not image the entire small intestine during the examination. Notably, PillCam SB alone identified 8 (21%) additional patients with Crohn’s disease and detected more extensive disease in 12 patients (31%) compared to the other methods. Capsule retention occurred in two (3%) patients who had a normal conventional barium enterography. CE was preferred to barium enterography by 92% of patients. The sensitivity of capsule endoscopy was 89%, specificity was 100% and accuracy was 92%.

Diagnosis with PillCam SB Leads to Improved Clinical Outcomes

Bleeding

A multi-center study in 294 patients with obscure gastrointestinal bleeding led by Jorg Albert, M.D. of Martin-Luther-University Hospital/First Department of Medicine, Halle, Germany sought to determine how well PillCam SB could help physicians diagnose the cause of the patients’ intestinal bleeding and decide how best to treat it. To date, 278 cases (92.9%) were analyzed and follow-up data is available on 101 (33.7%) patients. In 171 of the 278 patients (61.5%), PillCam SB led to a definitive diagnosis of the bleeding source and investigators were able to implement a specific intervention or change of management in 66% of this patient segment. Overall, the use of capsule endoscopy led to a subsequent change in patient management in 50% of all cases.

A second study conducted by Danny De Looze, M.D. of University Hospital Gent, Belgium, evaluated 45 patients with gastrointestinal bleeding of unknown origin to determine the impact of PillCam SB on the clinical outcome of patients with digestive bleeding. The study concluded that in 78% of patients, capsule endoscopy directly influenced the patient’s clinical outcome either by detecting the cause of small bowel bleeding or eliminating the possibility that the bleeding was small bowel in origin.

Crohn’s Disease

A study conducted by Manuela De Bona, M.D., Santa Maria del Prato Hospital Gastroenterology Department, Feltre, Italy sought to determine the clinical outcome of capsule endoscopy in patients with suspected Crohn’s disease undetected by conventional modalities.

The study assessed the role of PillCam SB in the diagnostic work-up of patients with suspected CD and evaluated the impact of PillCam SB on patient outcomes. Thirty-eight patients with suspected Crohn’s disease underwent the PillCam SB procedure. The patients were evaluated in two groups. Group 1 had ongoing symptoms such as weight loss, chronic diarrhea, abdominal pain, and anemia. Group 2 had biochemical changes (increases in CRP and ESR) and ongoing symptoms, which are laboratory markers of inflammation. Previous conventional imaging procedures -- including upper and lower endoscopy as well as small-bowel follow-through -- were negative in all patients.

The study’s findings were classified into four categories -- positive, defined when multiple erosions and ulcerations were present, suspicious when < or = to 3 ulcerations/erosions were seen, non-specific when the findings were other then ulcerations/erosions and normal. PillCam SB endoscopy led to a positive Crohn’s diagnosis in 13 (34.2%) of the patients, suspicious in 2 (5.3%), non-specific in 5 (7.0%) and normal findings in 19 (50%), with an overall detection rate of 39.5%. Patients who had positive findings underwent treatment: 14 received pharmacotherapy and one patient had surgery. After twelve months, this group of treated patients received a follow-up examination and 12 (80%) were deemed to have a positive clinical outcome. Study investigators concluded that PillCam SB is a valuable tool in diagnosing patients with suspected Crohn’s disease that is unconfirmed by standard imaging techniques, with a significantly higher diagnostic yield in patients with both clinical and biochemical changes presumably linked to Crohn’s disease. Capsule endoscopy was seen to improve clinical outcomes among those patients with positive findings.

About UEGW

United European Gastroenterology Week is organized by the United European Gastroenterology Federation and is devoted to all aspects of gastroenterology and its affiliated and related disciplines. The Federation was founded in 1992 by seven Associations and Societies representing Gastroenterology, Endoscopy, Digestive Surgery, Liver Disease, Pancreatic Disease and Paediatric Gastroenterology. UEGF is at present the most comprehensive European Gastroenterological organization. Its federative structure incorporates 15 professional Societies either as Founding or Associate members. The scope of these Societies ranges from general gastroenterological medicine and/or surgery to focused organ oriented and special interests association. More than 8,000 participants (mainly from Europe) were registered at this year’s UEGW in Copenhagen, Denmark,

About Given Imaging

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam(TM) video capsules for detecting disorders of the gastrointestinal tract. The company’s technology platform is the Given(R) Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam(TM) SB capsule is the only naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 50 other countries and has benefited more than 230,000 patients worldwide. The PillCam(TM) ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development. Given Imaging’s headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit http://www.givenimaging.com.

This press release contains forward-looking statements about Given Imaging, including projections about our business and our future revenues, expenses and profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as “anticipates,” “estimates,” “expects,” “intends,” “plans,” “believes,” and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the impact of the newly adopted SFAS 123R for expensing option-based payments, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities and Exchange Commission.

Given Imaging Ltd.

CONTACT: Matthias Steif of Given Imaging Ltd., +49-160-7464-313; or FernLazar, flazar@lazarpartners.com, or David Carey, dcarey@lazarpartners.com,both of Lazar Partners Ltd., 1-866-GIVEN-IR, for Given Imaging Ltd.

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