SOURCE: Given Imaging

March 14, 2006 10:27 ET

New Clinical Data on Given Imaging's PillCam Presented at Fifth International Conference on Capsule Endoscopy

YOQNEAM, ISRAEL -- (MARKET WIRE) -- March 14, 2006 -- Given Imaging (NASDAQ: GIVN) today announced highlights from The Fifth Annual International Conference on Capsule Endoscopy (ICCE) which took place in Boca Raton, FL, March 6th to 7th. This year's conference was co-chaired by Dr. Blair Lewis from Mt. Sinai School of Medicine in New York and Dr. Roberto De Franchis, Professor of Medicine at the University of Milan in Italy. ICCE was attended by nearly 400 participants representing 29 countries.

In addition to refining the 2005 ICCE consensus guidelines, leading gastroenterologists added new algorithms using capsule endoscopy as part of the diagnostic work-up in patients with unexplained iron deficiency anemia and for detecting small bowel tumors. As a result of recent data showing the incidence of small bowel tumors to be higher than previously indicated, the leadership of ICCE established a new consensus group to develop a separate diagnostic algorithm for small bowel tumors. The 2006 Consensus will be finalized following the second ICCE meeting in Paris, France, June 9th and 10th.

"Reflecting the growing body of clinical data, the 2006 consensus guidelines offer more specific recommendations on how to utilize capsule endoscopy in the diagnostic work-up of five life-impacting diseases," said Blair Lewis, MD, Clinical Professor of Medicine and Gastroenterology, Mount Sinai School of Medicine, NY and Co-Chairman of ICCE. "This year's conference also enabled us to further refine the clinical use of capsule endoscopy through several proposed new indices that should enhance our ability to categorize and compare data."

The ICCE joint chairmen announced the creation of a new annual award, "The ICCE Young Investigator's Award," honoring the top clinical studies using capsule endoscopy. Four physicians were honored this year:

--  Emanuele Rondonotti, M.D., from the University of Milan's Department
    of Medical Sciences and Gastroenterology and GI Endoscopy Service who led a
    team of Italian researchers in the study, "Video Capsule Endoscopy for the
    Diagnosis of Celiac Disease: Final Results from a Multi-center
    International Study."
    
--  Martha Dirks, M.D. from the Hopital Saint Justine in Montreal Canada,
    for "Video Capsule Endoscopy in Pediatrics: A Four Year Experience."
    
--  Jonathan Erber, M.D., from SUNY Downstate Medical Center for "Wireless
    Capsule Endoscopy (WCE) in the Evaluation of Small Intestinal Inflammatory
    Disease."
    
--  Robbyne Sockolow, M.D., from NY Presbyterian Hospital-Weill Cornell
    Medical College for "Pediatric Wireless Capsule Endoscopy: Safety and
    Benefits in Clarification of Disease."
    
Clinical Highlights from ICCE 2006:

Celiac Disease

Celiac disease is an autoimmune disorder occurring in about 1% of the U.S. population that leads to damage of the mucosal surface of the small intestine caused by a toxic reaction to gluten, a type of protein found in cereal grains. Patients might not show symptoms for years or they may experience diarrhea, abdominal pain, bloating, fatigue and weight loss. Celiac disease can also cause bone pain, anemia, dermatitis, arthritis, alopecia areata (hair loss) and infertility. Typically, physicians diagnose celiac disease by running tests on a biopsy taken when performing an EGD endoscopy procedure.

A multi-center international prospective study conducted by researchers at the University of Milan, several additional facilities in Italy and St. Elizabeth Medical Center in Brighton, MA evaluated capsule endoscopy's ability to detect villous atrophy, the flattening of the villi, in patients with suspected celiac disease compared to an upper GI endoscopy. All 43 patients in the study underwent both upper endoscopy and capsule endoscopy. Gastroenterologists were blinded to each patient's upper GI and pathology results when evaluating the capsule endoscopy findings. Authors concluded that 32 patients had mucosal changes compatible with celiac disease. The results showed that the capsule led physicians to make a correct positive diagnosis in 87.5% of the cases where upper GI had confirmed villous atrophy. Specificity (the ability to avoid a false positive), positive and negative predictive values were 90.9%, 96.5%, 71.4% respectively. Additionally, capsule endoscopy correctly diagnosed celiac disease in one patient where upper endoscopy and biopsy had ruled out disease. What was initially thought to be a "false positive" from CE turned out to be a "false negative" on the part of upper endoscopy and biopsy.

Esophageal Capsule Endoscopy

--  Researchers at the University of California-San Francisco, University
    of Michigan and Oregon Health and Science University compared the cost
    effectiveness of screening with esophageal capsule endoscopy (ECE) versus
    conventional upper endoscopy for esophageal cancer. The authors developed a
    hypothetical model of 50 men with symptoms of GERD and then tracked the
    expected medical costs until they reached 80 years of age or death. Taking
    into account life expectancy and the proportion of cancer deaths averted,
    it was concluded that both tests provided roughly the same outcomes and
    that both models are cost effective. However, the economic analysis did not
    include the macro-economic cost of sedation and loss of days of work in
    conventional upper endoscopy, nor was an economic value applied to patient
    preference.
    
--  A second pilot study led by researchers at Pioneer Valley Hospital in
    West Valley City, Utah evaluated using ECE for acute GI bleeding in the
    emergency room to determine whether it could replace nasogastric sampling,
    a common procedure performed to triage appropriate patients quickly and
    effectively out of the ER. To conduct the study, the ER department was
    trained on administering the exam and a T1 line (high speed internet
    connection) was established between the hospital and the
    gastroenterologist's home or office so he/she could effortlessly view the
    images taken at all hours of the day and night. Out of 10 acute bleeding
    patients, 8 underwent ECE and 2 required an endoscopy. Lesions were
    identified in 62% of these patients compared to the subsequent endoscopy.
    Based on this information the authors concluded that ECE is a useful tool
    in the ER for patients with GI bleeding and could potentially save
    unnecessary medical costs and manpower by replacing nasogastric sampling.
    
--  The PillCam ESO Esophageal Varices Working Group presented initial
    results from its large international trial to determine PillCam ESO's
    ability to detect esophageal varices, a serious side effect of portal
    hypertension. Ninety-seven patients underwent PillCam ESO followed by
    sedated upper endoscopy (EGD). PillCam ESO detected varices in 62 patients,
    63% of the study population, compared to EGD exam, in which the physician
    found varices in 69% (n=67) of the patients. When compared to EGD, PillCam
    ESO had a sensitivity of 86.6%, specificity of 86.7%, a positive predictive
    value of 93.5% and a negative predictive value of 74.3%. The authors
    concluded that PillCam ESO is safe and able to detect esophaegeal varices
    in patients being screened. They also concluded that PillCam ESO is an
    accurate method for determining variceal size.
    
Inflammatory Bowel Disease

--  The AGILE Patency Capsule:
Patients with small bowel problems such as Crohn's disease or damage from using non-steroidal anti-inflammatory (NSAID) drugs may not be able to pass the PillCam because of obstructions or strictures. The dissolvable AGILE Patency Capsule, which is similar in size to the PillCam SB capsule, is designed to be given to patients with suspected strictures or obstructions to determine if the imaging PillCam SB will be able to pass.

A study conducted by researchers at Bikur Holim and Assaf Harofeh Hospitals in Israel assessed the ability of the AGILE Patency Capsule to predict the patency of a patient's small intestine in 26 patients. To be included in the study, x-ray evidence had to show that a patient had a narrow small bowel or the physician had to suspect partial small bowel obstruction. Of the 26 patients, 19 or 73%, were able to pass the capsule. Fourteen of the 19 patients passed the capsule intact and underwent PillCam SB for the small bowel. The authors concluded that a patient's ability to pass a Patency Capsule intact provides physicians enough assurance that a PillCam procedure can be performed safely.

--  The Lewis Score: 
Ian M. Gralnek, M.D., M.S.H.S, Associate Professor of Medicine, David Geffen School of Medicine at the University of California at Los Angeles (UCLA), Rappaport Family Faculty of Medicine, Technion Institute of Technology, Department of Gastroenterology at the Rambam Medical Center in Haifa Israel delivered a presentation on "The Lewis Index," a new index based on findings from capsule endoscopy exams and designed to measure small bowel mucosal disease activity. The proposed Lewis Index would supplement the information gathered through existing indices such as the Crohn's Disease Activity Index, a subjective rating with low reproducibility based on the physician and patient's assessment of the severity of his/her disease; and two endsocopic indices: the Crohn's Disease Endoscopic Index of Severity (CDEIS), which is limited to findings in the colon, and the Rutgeerts Score used to assess post-operative mucosal healing. Existing endoscopic scoring methods are hampered by only viewing certain sections of the small intestine and a lack of data evaluating prognostic significance with enough scientific integrity to be used as a primary study endpoint. Using images obtained from capsule endoscopy exams, The Lewis Index Score is designed to be disease neutral (can be used to assess extent of Crohn's, NSAIDs, Vasculitis and radiation enteritis). Studies are underway to assess extent of disease activity in patients with known Crohn's disease using the Lewis scoring method. The Lewis Index Score is planned to be exclusively incorporated as an integral part of the next version of Given's RAPID (RAPID 5).

Pediatrics:

A prospective study conducted by researchers at McGill University, Sainte Justine Hospital and McMaster University in Canada evaluated 80 patients over the course of a four-year period referred for suspected Crohn's disease, GI bleeding, polyposis or malabsorption. The authors concluded capsule endoscopy alone was able to detect Crohn's disease in 42.2% or 49 patients. A portion of patients, 12.2%, had an alternate diagnosis after undergoing capsule endoscopy. The overall diagnostic yield for specific findings was 55%.

About ICCE:

Started in 2002, The International Conference on Capsule Endoscopy is the main forum for leading gastroenterologists and key opinion leaders to exchange scientific, clinical and practical information about Capsule Endoscopy. The next ICCE will take place in Paris France in June 2006. For more information visit www.2006ICCE.com.


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™ video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the Given® Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam™ 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 60 other countries and has benefited more than 300,000 patients worldwide. The PillCam™ 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, our future revenues and our future 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 possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities Exchange Commission.

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