NATIONAL HARBOR, MD--(Marketwire - November 02, 2011) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced two new studies highlighting the utilization of ManoScan AR to better measure muscular response in patients who suffer from anal motility disorders. The abstracts were presented at the American College of Gastroenterology 2011 Annual Scientific Meeting, taking place from October 28th through November 2nd at the Gaylord National Harbor Hotel & Conference Center in National Harbor, Maryland. Given Imaging is exhibiting at booth #1601 throughout the conference.
“High resolution manometry allows more precise interrogation of anorectal sphincter function compared to conventional manometry and has become an important tool in evaluating patients with pelvic floor disorders, particularly chronic constipation and fecal incontinence,” said C. Prakash Gyawali, Professor of Medicine, Washington University in St. Louis. “This technology helps physicians correlate patient symptoms with anorectal sphincter abnormalities, providing for better management of these disorders.”
A poster presentation, abstract P760, entitled, “Correlation of Manometry Findings to Obstetrical Risk Factors in Women with Anal Incontinence,” led by Nina George, DO, Temple University School of Medicine, reviewed ManoScan AR findings in 156 women suffering from fecal incontinence, seeking a correlation among symptoms, medical co-morbidities and obstetrical risk factors. The researchers found that among these women, those who had previously given birth showed an increased risk of abnormal anal function, with vaginal birth mothers at higher risk than those who delivered by c-section. In addition, symptomatic anal incontinence was significantly worse in women who also experienced increased urinary incontinence.
In an additional poster presentation, abstract P1169, entitled, “Anal Sphincter Complex Response after Rectal Balloon Distention at Different Sensation Thresholds,” researchers from the University of Iowa Hospitals and Clinics reported a novel contractile response using ManoScan AR 3D. The study authors used three-dimensional high resolution manometry to compare the anal sphincter complex of ten healthy patients to sixteen patients suffering from either fecal incontinence or constipation. Using ManoScan AR 3D, the researchers observed a unique contractile response and significant differences in the anal function of the healthy patients versus those suffering from an anal disorder, both in response location as well as orientation. The authors recommend further studies to determine the precise role of this response in anorectal motility disorders.
About ManoScan
ManoScan™ pioneered solid state high resolution manometry (HRM) and remains the market leader in comprehensive solutions for assessing gastrointestinal motility. Through the combination of proprietary tactile-sensing catheter technology and easy-to-use ManoView™ software, ManoScan reveals complex functional anatomy, enabling physicians to more accurately diagnose abnormalities of the gastrointestinal tract.
ManoScan AR Risk Information
All medical procedures carry some risks. Procedure complications are rare but may occur. Perforation (tearing) or bleeding of the intestinal wall is possible. Patients with previous rectal surgery, bowel inflammation, or bowel obstruction may have a higher risk for iatrogenic bowel perforation. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur. The system is not compatible for use in an MRI magnetic field. Please consult your physician or refer to www.givenimaging.com for detailed information.
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) 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, 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.
For further information contact:
Fern Lazar/David Carey
Lazar Partners Ltd.
1-212-867-1768
flazar@lazarpartners.com /
dcarey@lazarpartners.com