Key Developments For GIVUN IMIZHING BE`AM
GIVUN IMIZHING BE`AM (GIVN.O) (Consolidated Issue listed on NASDAQ Global Market)
Given Imaging Ltd. Announces New Studies That Demonstrate Clinical Utility Of PillCam SB Capsule Endoscopy And Unveils RAPID pH Software for Bravo pH Monitoring System
Given Imaging Ltd. announced three new studies that demonstrate the clinical utility of PillCam SB capsule endoscopy in providing physicians with critical information on how they manage and/or diagnose intestinal disorders. These novel studies were carried out in pediatric patients with gastrointestinal symptoms, including children with known or suspected Crohn's disease. The three studies were presented at the Gastro 2009 conference taking place in London from November 21 to 25. Given Imaging is exhibiting at booth #83 at the conference. In presentation # OP182, Professor Annette Fritscher-Ravens, Department of Interdisciplinary Endoscopy, University Hospital Kiel, Germany, concluded that physicians should consider wireless capsule endoscopy exams for children under eight years of age when other diagnostic methods failed to identify the cause of their GI symptoms. Physicians participating in this study changed the clinical management 100% of the time when capsule endoscopy studies revealed pathology. The study also concluded that negative findings may be as useful as positive findings in influencing the patient management plan. The Company unveiled RAPID pH review and analysis software for the Bravo pH Monitoring System. This all-new software was designed to streamline pH monitoring workflow through simplified, easy-to-use screen layouts and intuitive software navigation.
Given Imaging Ltd. Launches PillCam COLON 2
Given Imaging Ltd. announced that it has launched its PillCam COLON capsule at the Gastro 2009 Conference taking place in London. Like Given Imaging's other capsule endoscopes, PillCam SB and PillCam ESO, PillCam COLON could be tool for imaging the gastrointestinal tract.
Given Imaging Ltd. Announces Multicenter Study Concludes PillCam SB Is Safe And Effective In Young Children
Given Imaging Ltd. announced that a multi-center study published in the November edition of Gut showed PillCam capsule endoscopy of the small bowel to be just as useful and equally as safe in children under eight years old as it is in older children or adults. The study demonstrated that children as young as four years of age were able to swallow PillCam SB without any complications. The study also concluded that for children who were unable to swallow the capsule, a delivery device may be employed to place the capsule endoscopically. In this prospective study, physicians in nine centers studied 83 children under eight years of age who had previously undergone routine endoscopy and radiological tests with inconclusive test results. The children suffered from a variety of small bowel disorders including: occult gastrointestinal bleeding, suspected Crohn's disease, abdominal pain of unknown etiology, protein-losing enteropathy and malabsorptive disorders. The PillCam capsule was either swallowed by the child or introduced endoscopically. Key findings included: - 53% (16/30) of patients with obscure GI bleeding or chronic anemia had small bowel capsule endoscopy (CE) findings which identified the source of the bleeding. - In 55% (11/20) of patients with suspected Crohn's, small bowel capsule endoscopy found evidence of small intestinal Crohn's disease despite prior negative upper and lower intestinal endoscopy.
Given Imaging Ltd. Sees FY 2009 Revenue Guidance At Low End Of Prior Range; Raises FY 2009 EPS Guidance
Given Imaging Ltd. announced that it expects fiscal 2009 revenue to be near the low end of prior guidance of between $141 and $148 million. The Company increased fiscal 2009 earnings per share (EPS) guidance and now expects GAAP EPS to be between $0.42 - $0.46, compared to prior guidance of $0.20 - $0.28 and non-GAAP EPS of $0.64 - $0.68 compared to prior guidance of $0.46 - $0.54. According to Reuters Estimates, analysts on an average were expecting the Company to report GAAP EPS of $0.31 on revenue of $141 million for the same period.
New Studies Suggest PillCam SB Has Positive Impact On Healthcare Outcomes & Costs In Patients With Occult GI Bleeding
Given Imaging Ltd. announced that new data presented show that by visualizing the small bowel with the PillCam SB video capsule, physicians can detect the cause of occult gastrointestinal bleeding (OGIB) and adapt how they manage and treat these patients. A separate study demonstrated that use of capsule endoscopy reduced the need for follow-up procedures, such as endoscopies as well as other procedures, thereby improving patient outcomes and reducing costs to the healthcare system. Data were collected on all patients who underwent capsule endoscopy at Tulane University Hospital and Clinic from April 2003, through August 2005. Multiple diagnoses were discovered and many patients had more than one diagnosis. 47 patients suffering from obscure GI bleeding (OGIB) underwent capsule endoscopy and met the one-year follow-up criteria; 27 patients had other diagnoses. Researchers documented the number of office visits, units of Packed Red Blood Cell (PRBC) transfusions, as well as EGDs and colonoscopies for one year before and after the capsule endoscopy procedure. Findings included: For OGIB patients 69% reduction in the number of colonoscopies, 42% reduction in the number of EGDs performed, 24% reduction in the number of office visits, 20% reduction in the units of PRBC transfused. For patients with other diagnoses 55% reduction in colonoscopies performed, 50% reduction in units of PRBCs transfused, 44% reduction in EGDs, 35% reduction in office visits.
