SOURCE: Given Imaging

Given Imaging

May 11, 2011 07:00 ET

Given Imaging Announces Positive Results From European Multicenter Study of Second-Generation PillCam® COLON

Additional Studies Underscore Clinical Value of Using PillCam COLON for Patients With Incomplete Colonoscopies and to Manage Patients With Suspected or Known Inflammatory Bowel Disease

YOQNEAM, ISRAEL--(Marketwire - May 11, 2011) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, announced today that data from the largest European multicenter study of PillCam® COLON 2 conducted to date confirm that the second-generation PillCam COLON capsule has higher sensitivity for colorectal polyp detection than the first generation technology. Furthermore, the study's authors, led by Cristiano Spada, MD, concluded that PillCam COLON is an appropriate tool for visualizing the colon. The study, abstract #671, was presented Monday at the American Society for Gastrointestinal Endoscopy (ASGE) Topic Forum (9-3185) at Digestive Disease Week® (DDW), which took place earlier this week in Chicago.

"Colon capsule endoscopy is a non-invasive, painless technology that can visualize the colon without sedation or air insufflation, potentially making it an excellent tool for encouraging broader compliance with colorectal cancer screening guidelines. The goal of our study was to determine the feasibility, accuracy and safety of the upgraded PillCam COLON capsule by comparing it directly with colonoscopy," said Dr. Cristiano Spada, of the Digestive Endoscopy Unit, Catholic University, Rome, Italy. "We were pleased to learn that compared to the prior version, PillCam COLON 2 delivered a higher diagnostic yield for detecting colorectal abnormalities. Based on the results, we also believe that PillCam COLON 2 is an appropriate tool for detecting clinically relevant polypoid lesions."

The prospective study conducted at eight European sites compared colon capsule endoscopy with conventional colonoscopy for the detection of colorectal polyps or masses greater than or equal to 6 mm in size in a cohort of patients at average or increased risk of colorectal neoplasia. Colonoscopy was independently performed within 10 hours after capsule ingestion or the next day. Colon capsule endoscopy sensitivity and specificity for detecting patients with polyps greater than or equal to 6 mm and greater than or equal to 10 mm in size were assessed. Capsule-positive but colonoscopy-negative cases were counted as "false-positive." Data from 109 out of 117 patients were analyzed.

Per-patient colon capsule endoscopy sensitivity for polyps 6 mm and over and those 10 mm and over was 84% and 88%, with specificities of 64% and 95%, respectively. In addition, colon capsule endoscopy detected all three invasive carcinomas. The study's authors suggested that colon capsule endoscopy's lower specificity can be attributed to the study methodology used as well as multiple instances of polyp size misclassification after un-blinding. Taking this into account, the specificity of PillCam COLON 2 for polyps greater than or equal to 6 mm would be as high as 92%. In light of these observations, the study's authors concluded that the clinical impact of the lower specificity seen is marginal.

"We are pleased that the results of this study confirm PillCam COLON 2's high sensitivity for detecting polyps of clinically meaningful size," said Homi Shamir, President and CEO of Given Imaging Ltd. "In fact, PillCam COLON detected 5 polyps that colonoscopy did not. We would like to thank the participants of this study and also the early European commercial users for helping us expand our knowledge about PillCam COLON 2's overall clinical value as a diagnostic tool that complements colonoscopy. We believe that we have a strong product and have built the learnings from the European trial into the design of our multicenter US pivotal study which will shortly be underway."

Using PillCam COLON in Patients with Incomplete Colonoscopies

Two additional clinical studies evaluated the impact of colon capsule endoscopy on the management of patients with incomplete colonoscopies:

  • A poster presentation, abstractSa1580, "Impact of Colon Capsule Endoscopy on Medical Decision Making in Patients with Incomplete Optical Colonoscopy" led by Onofre Alarcon-Fernandez, MD of the Servicio de Aparato Digestivo, Hospital Hospiten-Rambla, Santa Cruz de Tenerife, Spain evaluated colon capsule endoscopy's value as an alternative screening method for patients with incomplete colonoscopy exams in a prospective seven-month study of 25 patients. The authors concluded that colon capsule endoscopy is a safe and effective procedure to complete colonic examination and diagnosis in most patients with incomplete colonoscopies. There were no complications and 96% of patients in the study were satisfied with the procedure. Furthermore, they determined that new information revealed by the PillCam COLON procedure led to a change in the medical management of eight (32%) patients.

  • A second poster presentation, abstractTu1535, "Colon Capsule Endoscopy Complements Incomplete Colonoscopy in Clinical Practice" led by Konstantinos Triantafyllou, MD of the Gastroenterology Department, "Tzaneion" General Hospital of Piraeus, Piraeus, Greece evaluated if colon capsule endoscopy could complement incomplete colonoscopy. Investigators measured colon capsule endoscopy completion rate; the additional diagnostic yield of colon capsule endoscopy; the need for further colon examinations; and patients' acceptance rate. The study's authors concluded that in the majority of cases, colon capsule endoscopy successfully complemented incomplete colonoscopy and provided additional significant findings in 44% of the cases. They also noted that colon capsule endoscopy could be performed immediately after an incomplete or difficult colonoscopy and is well tolerated with high patient acceptance rates.

PillCam COLON Capsule as a Tool to Manage Patients with Suspected or Known Inflammatory Bowel Disease

Poster presentation, abstract Tu1201, "PillCam COLON Capsule is an Effective Tool in Management of Patients with Suspected or Known Inflammatory Bowel Disease: Preliminary Results From a UK Tertiary Care Centre" led by Debabrata Majumdar, MD of the Department of Gastroenterology and General Medicine, Nottingham University Hospitals, NHS Trust, UK, concluded that in 29 patients with proven or suspected IBD, colon capsule endoscopy is an effective diagnostic modality since it is minimally invasive and can assess disease activity which often helps to guide treatment strategies.

About Colorectal Polyps
There are two common types of colorectal polyps: adenomatous, which can develop into cancer, and hyperplastic, which are rarely more than 5 mm in size and are infrequently cancerous.1 For adenomas, the potential for malignancy is related to polyp size.2 Larger polyps are more likely to develop into cancer, and polyps that are over 2 cm in size may potentially contain cancer.3

About Colon Cancer
Colon cancer involves the large intestine (colon), the lower part of the digestive tract, while rectal cancer specifically involves the last 6 inches of the colon. Together, they're often referred to as colorectal cancers. Colon and rectal cancers begin in the digestive tract and occur when cells that line the colon or the rectum become abnormal and grow uncontrollably. Despite widespread public education efforts, colorectal cancer screening compliance rates remain low, with just 50% of the eligible US population undergoing a colonoscopy4. About 147,000 people in the U.S. are diagnosed with colorectal cancer annually, according to the National Cancer Institute5. Worldwide, the disease causes 1 million cases and 600,000 deaths every year, with lower CRC screening compliance in Europe and Japan.

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 COLON 2
The PillCam® COLON 2 video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11 mm X 31 mm. PillCam COLON 2 is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.

All medical procedures carry some risk. The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. PillCam COLON capsule endoscopy presents additional risks, including risks associated with the drug products used to prepare the patient for the procedure, which are currently used for colonoscopy, and to move the capsule through the patient's digestive tract faster. It may also present other risks that are unknown, but which the clinical studies are designed to detect. 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 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 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.

1http://www.mayoclinic.com/health/colon-polyps/DS00511/DSECTION=causes
2http://emedicine.medscape.com/article/367452-overview
3http://www.asge.org/PatientInfoIndex.aspx?id=396
4http://www.cdc.gov/cancer/colorectal/statistics/screening_rates.htm
5http://seer.cancer.gov/statfacts/html/colorect.html

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