SAN DIEGO, CA--(Marketwire - May 22, 2012) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced several new studies using PillCam® COLON 2, including data evaluating its viability as an out-of-clinic procedure. The studies are being presented at the American Society for Gastrointestinal Endoscopy (ASGE) Research Forum at Digestive Disease Week® (DDW), taking place May 19-22 in San Diego.
Samuel Adler, MD, of the Gastroenterology Unit, Bikur Holim Hospital, Jerusalem, Israel, presented (abstract 219), "Capsule Colonoscopy with PillCam COLON 2 is Feasible as an Out-of-Clinic Procedure," which showed that PillCam COLON 2 has the potential to increase compliance with colorectal cancer screening guidelines.
"The study showed that PillCam COLON 2, which can be administered without sedation or insufflation, detected some polyps that traditional colonoscopy missed and has proven effective in an outpatient setting," noted Dr. Adler. "These findings may lead to more patients complying with recommended colon cancer screening guidelines, especially those that were previously intolerant or unwilling to undergo traditional colonoscopy."
A second presentation, (Mo 1390), "PillCam Colon (C2) vs. Colonoscopy in the Assessment of Colon Mucosa in Patients With Ulcerative Colitis (Preliminary Data)," led by Mileidis E. San Juan-Acosta MD, of the Department of Gastroenterology, Hospital Universitario Virgen Macarena, Seville, Spain, concludes that PillCam COLON (C2) allows an assessment of the severity and extent of Ulcerative Colitis comparable to that obtained using colonoscopy. Showing no statistically significant differences between PillCam COLON (C2) and colonoscopy, the preliminary data from the study indicates a potential new use for the PillCam COLON (C2) capsule endoscopy for Ulcerative Colitis.
"We thank the clinicians from around the world who continue to evaluate PillCam COLON's utility and clinical value in new settings and disease states," said Homi Shamir, President and CEO of Given Imaging Ltd. "With our new GI resources, such as the PillCam COLON iPad app, and our patient-focused PillCam COLON microsite that provides a comprehensive source for clinical data, patient types and colon exam options in the various markets where PillCam COLON 2 is available today, we are able to help educate patients on all the available colon examination modalities. Outside of the U.S., the microsite can be accessed at pillcamcolon.com starting May 19, 2012."
A third poster presentation, (Tu 1652), "First Guidelines to Implement and Practice Colon Capsule Endoscopy in a Clinical Setting," addresses four key areas of clinical practice and represents a comprehensive framework on how to implement and practice colon capsule endoscopy in a clinical setting and on a daily basis. Led by Cristiano Spada, MD, Digestive Endoscopy Unit, Catholic University, Rome, Italy, the guidelines were formulated on an expert opinion basis, and recently published in the May issue of Endoscopy, the official journal of the European Society of Gastrointestinal Endoscopy. The guidelines will be considered for review in 2014, or sooner if further evidence becomes available.
PillCam COLON 2 is currently not cleared for marketing in the United States.
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.
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, including allergies or other known contraindications to any preparation agents or medications used for the PillCam COLON regimen, according to laxative medication labeling and per physician discretion. 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® pH and Digitrapper® pH and impedance monitoring. 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.
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) quality issues and adverse events related to our products, such as capsule retention, aspiration and failure to attach or detach, bleeding or perforation that could require us to recall products and impact our sales and net income, 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, 2011. 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.