Given Imaging Ltd. announced new studies that confirm the value of PillCam SB in diagnosing, monitoring and managing patients with known or suspected Crohn's disease and other conditions of the small bowel. The studies were presented at Digestive Disease Week(R) (DDW), taking place May 18-21, 2013. Several DDW poster presentations underscore the clinical utility of using PillCam SB in patients with Crohn's disease and PillCam SB's positive impact in improving disease management including: Wireless Capsule Endoscopy Improves Outcomes in Nonstricturing Crohn's Disease: An Evaluation of Pre- and Post- Treatment Capsule Endoscopy (CE) poster Sa1634, presented by Neel K. Mann, M.D., M.P.H. and Simon K. Lo, M.D. Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, CA. This retrospective review showed that capsule endoscopy was able to re-classify disease phenotype in >60% of patients with suspected Crohn's disease or unclassified Inflammatory Bowel Disease, thereby potentially changing the management outcome of these patients. More importantly, capsule endoscopy demonstrated mucosal healing in >70% patients, after assessment of therapy, positively changing disease outcome and achieving therapeutic goal in patients with non-stricturing phenotype. An additional study, 8-Hour CE Versus 12-Hour CE in a Cohort of Hospitalized Patients Undergoing CE for Suspected Small Bowel Disorders, poster Tu1301, presented by Rafiul S. Islam, M.D., Mayo Clinic, Scottsdale, AZ, and colleagues, compared the diagnostic yield and completion rates of 8-hour capsule endoscopy (CE) and 12-hour CE in a cohort of hospitalized patients. The study sought to determine patient characteristics associated with an incomplete CE and define an association with the type of lesions found. Results show that a previous inability to reach the cecum using the 8-hour capsule was accomplished with the 12-hour capsule. Furthermore, the 12-hour capsule produced significantly higher diagnostic yields compared with the 8-hour capsule, even though there was no difference in the completion rates between the two capsules. Incomplete examinations were more common in non-obese patients, and were not influenced by diabetes, narcotic use, motility disorders, or gender.

Given Imaging Ltd. announced data from several European studies confirming the effectiveness of PillCam COLON in detecting colonic lesions in patients following incomplete colonoscopies and monitoring diverse digestive diseases in both adults and children. All data are being presented during Digestive Disease Week (DDW) taking place May 18 - 21, 2013 at the Orange County Convention Center, Orlando, FL. Given Imaging is exhibiting at booth #1059 throughout the conference. Dr. Spada presented the analysis, "Prospective Trial of PillCam COLON versus CT-Colonography (CTC) in the Evaluation of Patients with Incomplete Conventional Colonoscopy (CC)" (Podium presentation 703). After undergoing traditional colonoscopies that were unable to be completed for various reasons, 100 patients had PillCam COLON and CTC exams to determine how well doctors using each method were able to visualize areas of the colon that couldn't be seen with the incomplete colonoscopy. PillCam COLON and CTC enabled physicians to see additional areas beyond colonoscopy in 98% of the patients. The results of this study suggested that both PillCam COLON and CTC are effective in patients with incomplete colonoscopies, however, PillCam COLON tends to detect more polyps than CTC in segments of the colon that were not visualized by incomplete colonoscopies. Separately, Dr. Spada presented the results of a retrospective study, "Flat Colorectal Lesions At PillCam Colon Capsule Endoscopy (CCE)" (Podium presentation 857), that indicates that PillCam COLON has high accuracy for detecting flat lesions, which have been shown to carry a higher risk for cancer. The retrospective study collected data from patients who underwent PillCam COLON followed by an optical colonoscopy, which is considered the gold standard tool for colorectal cancer detection. Physicians were able to identify 27 conventional polyps with colonoscopy, while they found 25 conventional polyps with PillCam COLON. In one patient, PillCam COLON visualized an 11 mm flat lesion that was not confirmed by colonoscopy. PillCam COLON generated 90% sensitivity and 96% specificity on a per-lesion basis. The value of PillCam COLON was also confirmed in "Evaluation of the Second Generation Colon Capsule Endoscopy (CCE-2) in Pediatric Ulcerative Colitis (UC)" (Podium presentation 689). Thirty pediatric patients with known ulcerative colitis underwent PillCam COLON and colonoscopy exams to determine how well each method helps physicians detect inflammation in the colon. Blinded results from the procedures showed 95% sensitivity for PillCam COLON to detect colonic inflammation and 100% specificity in accurately ruling it out. Based on the comparability of PillCam COLON to standard colonoscopy, investigators led by Salvatore Oliva, M.D. concluded that PillCam COLON is a very useful, safe and well-tolerated procedure to monitor disease activity and progression in children. Dr. Olivia and his team also suggested that given the noninvasive and patient-friendly characteristics of the PillCam COLON, it could have an impact on the diagnostic work-up of children with ulcerative colitis. Dr. Oliva practices at the Pediatric Gastroenterology and Liver Unit at the Sapienza University of Rome in Italy. Investigators from Clinic Hospital in Barcelona, Spain presented "Capsule Endoscopy (CE) Is Superior to Magnetic Resonance Enterography (MRE) for the Assessment of Small Bowel Lesions in Crohn's Disease Patients (CD): a Comparative Trial," (Poster presentation Sa1635). Thirty-four patients with established or suspected Crohn's disease and indeterminate colitis were enrolled in the comparative trial. All patients initially underwent Magnetic Resonance Enterography (MRE), a special type of magnetic resonance imaging (MRI) performed with a contrast material to produce detailed images of the digestive tract. Following MRE, PillCam COLON was used in twenty-three patients while PillCam SB was used in the remaining eleven patients. By using capsule endoscopy, investigators identified small bowel lesions in twenty-eight patients while they found lesions in only twenty-two patients using MRE. Capsule endoscopy detected lesions in the first (distal duodenum) and middle portions of the small bowel in nine patients where physicians found no lesions in these areas with MRE. Based on these data, researchers concluded that capsule endoscopy is superior to MRE for detecting lesions in the first and middle portions of the small bowel in patients with Crohn's disease.

Given Imaging Ltd. reported unaudited consolidated earnings results for the first quarter ended March 31, 2013. For the period, the company reported net loss and net loss attributable to shareholders of $221,000 or $0.01 per basic and diluted share on revenues of $40,620,000 against net loss was $108,000 and net loss attributable to shareholders of $201,000 or $0.01 per basic and diluted share on revenues of $41,839,000 a year ago. On a GAAP basis, operating profit was $100,000 compared to $400,000 a year ago. The decline in GAAP and non-GAAP operating profit is attributable to dominantly, to the decline in revenues. Non-GAAP operating profit was $2 million compared to $2.1 million in the first quarter of 2012. Profit before taxes on income was $91,000 compared to $732,000 a year ago. Net cash used in operating activities was $2,222,000 compared to net cash provided by operating activities was $674,000 a year ago. Purchase of fixed assets and intangible assets was $1,012,000 compared to $1,480,000 a year ago. On a non-GAAP basis, net income for the first quarter of 2013 was $1.5 million or $0.05 per share on a fully diluted basis compared to $1.8 million or $0.06 per share on a fully diluted basis in the first quarter of 2012.