Healthcare Industry News:  endoscopy 

Devices Gastroenterology

 News Release - October 14, 2013

Multiple New Studies Discuss Clinical Benefits of Given Imaging's PillCam(R) COLON at United European Gastroenterology Week

Ten abstracts including more than 1,200 patients to be presented on PillCam COLON

Topics range from confirming the diagnostic yield of PillCam COLON and validating feasibility of PillCam COLON in a general practice setting

BERLIN, Oct. 14, 2013 -- (Healthcare Sales & Marketing Network) -- Given Imaging Ltd, (GIVN), a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced that ten abstracts highlighting the clinical utility of PillCam COLON were presented during United European Gastroenterology Week (UEG Week) taking place October 12-16, 2013 at the Internationales Congress Centrum Berlin where Given Imaging is exhibiting at Hall 15.1, Booth #7.

"The growing body of data supporting both the clinical accuracy for PillCam COLON and patient preference for a non-invasive, radiation-free colorectal exam strengthen our efforts to expand access to PillCam COLON in Europe and markets across the globe," said Homi Shamir, president and CEO, Given Imaging.

Highlights of the ten studies presented at UEG Week include:

Patients prefer PillCam COLON because of concern about pain and embarrassment related to colonoscopy.

PillCam COLON shows significantly higher diagnostic yield compared to CTC in polyps 6 mm or larger.

se of PillCam COLON following incomplete colonoscopy reveals new lesions in 60% of patients resulting in therapy modifications for 45% of these patients.

Head-to-head, retrospective comparison of PillCam COLON versus colonoscopy finds PillCam COLON generated 90% sensitivity and 96% specificity on a per-lesion basis for detecting flat lesions shown to have a higher risk of being cancerous.

"As utilization of PillCam COLON increases, we are generating useful information about its use in a range of settings and for different indications including polyp detection rates," said Jean-Christophe Saurin, M.D., Ph.D., French Society of Digestive endoscopy. "These quantifiable outcomes underscore that PillCam COLON is an interesting colonic screening option for patients who cannot or prefer not to have a traditional colonoscopy, but studies on acceptance in these patients are warranted."

"French Multicenter Experience of Colon Capsule endoscopy in Real Practice: Primary Results of the Colon Capsule endoscopy Observatory 'ONECC'" (poster #1337) was conducted by Dr. Saurin and colleagues to analyze survey results from a 161-user, 116-center French database of PillCam COLON procedures. Researchers evaluated the feasibility of using PillCam COLON in a general practice setting and the indications for which PillCam COLON was being used. Survey results from 585 PillCam procedures showed that PillCam COLON detected polyps in 253 patients, of which, significant polyps were discovered in 125 patients, or 28% of all the PillCam COLON procedures. Researchers also discovered that PillCam was used equally among three indications: patients with previous incomplete colonoscopy, patients contraindicated for colonoscopy and patients who refused colonoscopy. Of these indications, PillCam COLON detected significant polyps in 20.4% of patients with previous incomplete colonoscopy, 23.1% of patient contraindicated for colonoscopy and 14.5% of patients who refused colonoscopy. Based on the broad indications used for PillCam COLON and the significant polyp detection rate, researchers confirmed the practical application of PillCam COLON in a general practice setting.

"Patients Perception of Colonoscopy: Astonishing Reasons for Colon Capsule endoscopy Preference" (poster #791) validated patient preference for a non-invasive colorectal exam. Researchers from the Department of Gastroenterology and Hepatology at the Institute for Clinical and Experimental Medicine in Prague, Czech Republic led by Marek Benes, M.D. conducted a 100 patient survey analysis to find that 42% of patients reported they will never undergo a screening colonoscopy even though 45% of this subgroup had a positive family history of colorectal cancer. The top reason for preference for PillCam COLON over colonoscopy was due to concerns about privacy and embarrassment experienced with colonoscopy, with 38% of patients reporting this as their top concern. Concern of pain was the second most common reason to prefer PillCam COLON over colonoscopy, with 35% of patients reporting this as a concern.

"Flat Colorectal Lesions At Pillcam Colon Capsule endoscopy" (oral presentation #432) was a head-to-head, retrospective comparison of PillCam COLON versus colonoscopy to evaluate the ability of PillCam COLON to diagnose flat colonic lesions. Led by Cristiano Spada, M.D., Catholic University, Rome, Italy, researchers collected data from patients who underwent PillCam COLON followed by a traditional colonoscopy. Physicians were able to identify 27 conventional polyps with colonoscopy and 25 conventional polyps with PillCam COLON. In one patient, PillCam COLON visualized an 11 mm flat lesion that was not confirmed by colonoscopy. PillCam COLON generated 90% sensitivity and 96% specificity on a per-lesion basis. Based on these findings, researchers concluded that PillCam COLON has high accuracy for detecting flat lesions.

The utilization of PillCam COLON following incomplete colonoscopy was highlighted in UEG Week abstracts including:

"Colon Capsule endoscopy Versus CT-Colonography in the Evaluation of Patients with Incomplete Traditional Colonoscopy: A Prospective Comparative Trial" (oral presentation #431) presented by Cristiano Spada, M.D., and colleagues from the Catholic University in Rome, Italy. Patients in the study underwent both CT-colonography (CTC) and PillCam COLON with the goal of identifying polyps and masses that were at least six millimeters and located in segments of the colon that could not be examined in the previous incomplete colonoscopy. Both PillCam COLON and CTC successfully completed the colonic exam in 98% of patients due to 2% of patients refusing CTC due to air insufflation. Of the 98 patients included in the analysis, PillCam COLON identified polyps at least six millimeters in size in 19 patients, while CTC identified only seven patients. Resulting sensitivity and specificity for PillCam COLON was 100% and 91% respectively and 35% and 92% respectively for CTC. Researchers concluded that both exam modalities were effective in completing a colonic exam, however PillCam COLON had a significantly higher diagnostic yield compared to CTC in identifying polyps six millimeters or larger.

"Utility of Colon Capsule endoscopy After an Incomplete Colonoscopy - Multicenter Spanish Study" (poster #793) led by Oscar Nogales, M.D., Hospital General Universitario Gregorio Maranyon, Department of Gastroenterology, Madrid, Spain analyzed the use of PillCam COLON 98 patients with previous incomplete colonoscopies. Overall, PillCam COLON was able to identify new lesions in in 60% of patients. Within this group, therapy modifications resulted for 45% of the patients. Polyps were the most frequent finding with 41% of patients having a polyp identified by PillCam COLON. Additional findings by PillCam COLON included diverticulae, neoplasia and solitary colonic ulcers. Based on these results, researchers concluded that Pillam COLON is a useful diagnostic tool to identify a significant number of lesions in unexplored regions of the colon following incomplete colonoscopy and, as a result, may produce favorable therapeutic changes for these patients.

About PillCam COLON

The PillCam COLON 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 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 and skin irritation. The risks associated with colon preparation are allergies or other known contraindication to any preparation agents or medications used for the PillCam COLON regimen, according to laxative medication labeling and per physician discretion. 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. Medical, endoscopic or surgical intervention may be necessary to address these complications, should they occur. A normal or negative capsule endoscopy examination does not exclude the possibility of colon polyps or colon cancer.

PillCam COLON has received a CE Mark, but is pending FDA clearance and is not cleared for marketing or available for commercial distribution in the U.S. and certain other countries.

About UEG Week

UEG Week is the largest and most prestigious gastroenterology meeting in Europe and has developed into a global congress. It attracts over 14,000 participants each year, from more than 120 countries, and numbers are steadily rising. UEG Week provides a forum for basic and clinical scientists from across the globe to present their latest research in digestive and liver diseases, and also features a two-day postgraduate course that brings together top lecturers in their fields for a weekend of interactive learning.

About Given Imaging

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(R) capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan(R) high resolution manometry, Bravo(R) capsule-based pH monitoring, Digitrapper(R) pH-Z monitoring, and SmartPill(R) motility monitoring systems. 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, Hong Kong and Brazil. For more information, please visit

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. Such forward-looking statements include statements relating to the Company exploring strategic alternatives and considering possible strategic transactions involving the Company. 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, 2012. 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 to the extent expressly required under applicable law, the Company undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

Source: Given Imaging

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