Healthcare Industry News: Given Imaging
News Release - January 5, 2011
Given Imaging Provides PillCam(R) COLON 2 UpdateTrial Underway to Confirm Optimal Procedures and Logistics for Upcoming Larger Trial
YOQNEAM, ISRAEL, Jan 5--(Healthcare Sales & Marketing Network) - Given Imaging (NASDAQ:GIVN ), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced the start of a study in the United States for PillCam® COLON 2 capsule endoscopy. This study will enroll up to 50 patients to confirm the optimal procedures and logistics to be used in a larger trial to help support the Company's planned 510(k) submission to the U.S. Food and Drug Administration (FDA).
"The expense and complexity of the upcoming pivotal study, combined with the large number of patients to be enrolled, are the driving factors in conducting a smaller trial to confirm procedures and logistics, which we believe will enable a more efficient completion of the larger trial," said Homi Shamir, president and chief executive officer, Given Imaging Ltd. "We conducted a controlled European launch of PillCam COLON 2 in 2010. Based on the device's initial success, we plan to expand our sales and marketing efforts in Europe in 2011 and launch this product in Canada and several Latin American countries." To date, approximately 2,000 PillCam COLON 2 capsules have been used in non-U.S. markets both in clinical trials and in clinical practice.
The PillCam COLON 2 video capsule is designed to visualize the colon. Given plans to seek FDA clearance to market PillCam COLON 2 for colorectal cancer screening in patients who are unwilling to undergo standard colonoscopy.
About Colon Cancer
Colorectal cancer remains a potentially fatal disease that generally can be prevented through early detection. Colon cancer occurs in the large intestine (colon), the lower part of the digestive system, while rectal cancer occurs in the last 15-20 centimeters of the colon. Together, they're often referred to as colorectal cancers.
Colon and rectal cancers begin in the digestive system and develop when cells that line the colon or the rectum become abnormal and grow exponentially. Most cases of colon cancer begin as small, non-cancerous (benign) clumps of cells called adenomatous polyps. Only certain kinds of polyps have the potential to become cancerous, and in most people colorectal cancers develop slowly over a period of several years. In the U.S. alone, more than 51,000 people will die from colon cancer in 2010(1).
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 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. PillCam COLON 2 received a CE Mark in 2009.
The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. PillCam COLON 2 capsule endoscopy has additional risks, including those 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. Please consult your physician or refer to www.givenimaging.com for detailed information. Additional information about this clinical trial can be found at www.clinicaltrials.gov.
About Given Imaging Ltd.
Since 2001, Given Imaging has advanced gastrointestinal visualization by developing state-of-the art, patient-friendly tools based on its PillCam® Platform. PillCam® capsule endoscopy uses wireless technology and advanced software to provide physicians with clear images of the small intestine via PillCam® SB and the esophagus through PillCam® ESO. The PillCam® COLON video capsule, which is an investigational device in the U.S., is designed to visualize the colon. PillCam® capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile™ patency capsule, to verify intestinal patency, and Bravo®, the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD). In April, 2010, Given Imaging acquired Sierra Scientific Instruments, the leading provider of specialty GI diagnostic solutions and pioneer of high-resolution manometry for assessing gastrointestinal motility. Sierra Scientific is now a wholly-owned subsidiary of Given Imaging. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, 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, and (18) 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, 2009. 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.
Source: Given Imaging
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