SOURCE: Given Imaging

Given Imaging

May 10, 2011 09:00 ET

Given Imaging Announces New Presentations Emphasize Value of PillCam® Capsule Endoscopy in Patients With Gastrointestinal Bleeding at Digestive Disease Week 2011

Data Show Benefits of Utilizing PillCam® SB Earlier in the Diagnostic Algorithm and in Managing Patient Outcomes; PillCam® ESO Deemed a Helpful Tool to Triage Patients With Upper GI Bleeding in the Emergency Room

CHICAGO, IL--(Marketwire - May 10, 2011) - Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that new studies confirmed the benefit of using PillCam SB earlier in the diagnostic algorithm to accelerate the diagnosis of patients who present with obscure GI bleeding. Separate data also showed that emergency rooms can effectively use PillCam ESO to triage patients with acute upper GI bleeding when they arrive at the Emergency Room (ER). Studies were presented at the Digestive Disease Week® (DDW) 2011, which concludes today in Chicago.

"GI bleeding is a serious and potentially life-threatening condition if not detected and treated properly," said Laurel Fisher, MD, Director, Capsule Endoscopy and Deep Enteroscopy Program, Division of Gastroenterology, University of Michigan Health System. "These new data underscore the value of using PillCam SB earlier in the diagnostic workup so that we can correctly triage and treat patients as soon as possible."

Use of PillCam SB Earlier in the Diagnostic Algorithm

  • Podium Presentation, abstract #302, "Diagnostic Yield of Capsule Endoscopy vs. Colonoscopy in Patients With Melena and a Negative EGD," presented by Eugene Zolotarevsky, MD of the University of Michigan, Ann Arbor, Michigan, compared PillCam SB to colonoscopy, which has traditionally been the next test following a negative EGD (upper endoscopy) for identifying hemorrhagic lesions in 987 patients with melena, a dark, bloody stool. The authors concluded that in patients with melena and negative EGD, PillCam SB has a higher diagnostic yield than colonoscopy for identifying hemorrhagic lesions (47.4% vs. 20.7%, p < 0.001).

  • Poster presentation Tu1576, "Capsule Endoscopy for Obscure Occult Gastrointestinal Bleeding: Incidence of Pathology Detected Within Reach of a Standard Gastroscope," led by Laura Marelli, MD of the Royal Free Hospital, London, assessed the incidence of upper GI pathologies using PillCam SB, which were previously missed by upper endoscopy in 279 patients referred for iron deficiency anemia (IDA). The researchers concluded that 12.9% of capsule endoscopy procedures performed for obscure GI bleeding showed significant lesions in the upper GI tract, which were missed by a previous upper endoscopy, and probably represented the cause for IDA. The authors suggested that capsule endoscopy might be considered as a first-line investigation for IDA, followed by upper endoscopy if biopsy and/or treatment of a target lesion is necessary.

PillCam SB Impacts Clinical Outcomes

  • Podium Presentation, abstract #303, "Does Timing of Video Capsule Endoscopy Relative to Obscure Overt Gastrointestinal Bleed Alter Diagnostic Yield?" led by Anupam Singh, MD of the University of Massachusetts Medical School, Worcester, Massachusetts, retrospectively investigated 144 PillCam SB procedures to analyze the diagnostic yield of capsule endoscopy in patients who underwent a PillCam procedure within three days of hospital admission for obscure overt GI bleed (OGIB) versus after three days. In addition, the study authors examined if timing of the capsule endoscopy procedure was associated with a decreased length of stay and improved therapeutic success. The mean length of stay for patients who had the PillCam SB procedure less than three days after hospital admission was 6.1 days compared to 10.3 days for patients who had the procedure more than three days after admission. The study authors concluded that the timing of the PillCam SB procedure relative to the onset of OGIB is important for increasing the diagnostic yield, leading to increased therapeutic success and decreased length of hospital stay.

  • Poster presentation Tu1587, "Impact of Capsule Endoscopy on the Clinical Management and Outcome of Patients: A 5-Year Experience," led by Rui Gao, MD, Department of Gastroenterology, Addenbrooke's Hospital, Cambridge, UK, conducted a retrospective study of 340 patients to evaluate the impact of PillCam SB in patient management and outcomes at a tertiary center in the UK. The study authors found that PillCam SB diagnosed small bowel abnormalities in 57.1% of patients, resulting in a change in clinical management in 43.3% of patients. Further, the researchers concluded that PillCam SB remains an important diagnostic tool for a wide variety of SB pathologies, leading to significant change in patient management.

PillCam ESO in the Emergency Room

In addition to data presented on the efficacy of PillCam SB, a podium presentation, abstract #233, highlighted a feasibility study on the utilization of PillCam ESO to visualize upper gastrointestinal bleeding in the ER to more rapidly triage patients.

"This feasibility study demonstrated that PillCam ESO may be a useful tool in diagnosing upper gastrointestinal bleeding," said Professor Ian Gralnek, Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel. "Our data found that early use of PillCam ESO was beneficial in facilitating patient triage and led to earlier endoscopic intervention. We are looking forward to testing this hypothesis in larger comparative studies."

Dr. Gralnek led the podium presentation, abstract #233, on "Capsule Endoscopy (CE) in Persons Presenting With Acute Upper Gastrointestinal Hemorrhage (UGIH) -- A Prospective Cohort Study." Researchers performed a two-center, (Rambam Medical Center, Israel & Prince of Wales Hospital, Hong Kong) prospective, feasibility study to evaluate PillCam ESO in 41 patients presenting to the emergency room with acute UGIH. The study concluded that in an emergency room setting, PillCam ESO appears to be feasible and safe in persons presenting with acute UGIH. In addition, PillCam ESO identifies blood in the upper GI tract significantly more often than nasogastric aspiration and equally identifies peptic disease and inflammatory lesions compared with upper endoscopy. The authors also concluded that PillCam ESO may facilitate patient triage and earlier endoscopic intervention.

About Upper GI Bleeding
Upper GI bleeding can result from a variety of causes, including peptic ulcer disease, hemorrhagic gastritis, gastroesophageal varices and Mallory-Weiss syndrome; and is defined as bleeding above the ligament of Treitz, between the duodenum and jejunum. Regardless of the cause of bleeding, a rapid clinical assessment is critical. Acute upper GI bleeding is one of the most common medical emergencies, responsible for approximately 300,000 hospitalizations each year with a mortality rate close to 10 percent.1

About IDA
Iron deficiency anemia (IDA) is a common type of anemia in which the patient lacks adequate healthy red blood cells.2 Lack of iron in the blood affects the body's ability to carry oxygen and results in patients feeling tired, weak, irritable and lightheaded. The causes of IDA vary, but, can include loss of blood, pregnancy, inadequate diet, the inability to absorb iron from food and internal bleeding due to a bleeding ulcer, a colon polyp or colon cancer.3

About Obscure GI Bleeding
Occult gastrointestinal bleeding (OGIB) occurs when blood is lost from the digestive tract without visible, or overt, signs of bleeding.4 The condition is usually discovered only with positive results for a fecal occult blood test or through detection of iron deficiency anemia; there are many potential causes. In approximately half of patients with OGIB, the source of bleeding is unexplained.5

About Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. DDW is jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

About PillCam SB
The PillCam® SB video capsule measures 11 mm x 26 mm and weighs less than four grams. Now in its second generation, PillCam SB 2 contains an imaging device and light source and transmits images at a rate of two images per second generating more than 50,000 pictures during the course of the procedure. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is clinically validated by more than 1,500 peer-reviewed studies. It is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB is the gold standard in small bowel evaluation.

The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the Agile™ GI patency test include capsule retention and aspiration. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

About PillCam ESO
The PillCam® ESO video capsule was cleared by the U.S. Food and Drug Administration in November 2004 to visualize the esophagus in adult patients in a patient-friendly way. Now in its second generation, PillCam ESO 2 contains imaging devices and light sources at both ends of the capsule that capture up to 18 images per second as it passes down the esophagus in a thirty-minute procedure.

All medical procedures carry some risks. The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the Agile GI patency test include capsule retention and aspiration. After ingesting the PillCam capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created by an MRI device. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

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® video capsules for the small bowel, esophagus and colon [PillCam® COLON not approved for use in the United States], industry-leading ManoScan high-resolution manometry and Bravo® wireless and Digitrapper® pH and impedance products. Given Imaging is committed to delivering breakthrough innovations to the GI community and to 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 and Hong Kong. For more information, please visit www.givenimaging.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) our ability to develop and bring to market new products, (2) our ability to successfully complete any necessary or required clinical studies with our products, (3) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (4) our success in implementing our sales, marketing and manufacturing plans, (5) the level of adoption of our products by medical practitioners, (6) the emergence of other products that may make our products obsolete, (7) lack of an appropriate bowel preparation materials to be used with our PillCam COLON capsule, (8) protection and validity of patents and other intellectual property rights, (9) the impact of currency exchange rates, (10) the effect of competition by other companies, (11) the outcome of significant litigation, (12) our ability to obtain reimbursement for our product from government and commercial payors, (13) quarterly variations in operating results, (14) the possibility of armed conflict or civil or military unrest in Israel, (15) the impact of global economic conditions, (16) our ability to successfully integrate acquired businesses, (17) changes and reforms in applicable healthcare laws and regulations, (18) adverse events related to our products or product quality issues that could require us to recall products and impact our sales, and (19) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2010. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

1 Krumberger, Joanne M. RN, MSN, FAAN. How to manage an acute upper GI bleed. RN/Thomson AHC Home Study Program CE CENTER. March 1, 2005. http://rn.modernmedicine.com/rnweb/article/articleDetail.jsp?id=150046

2http://www.mayoclinic.com/health/iron-deficiency-anemia/DS00323

3http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html

4http://www3.utsouthwestern.edu/endocrine/Rockey.htm

5http://www.aafp.org/afp/20040215/875.html

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