Healthcare Industry News: Capsule Endoscopy
News Release - August 15, 2006
Given Imaging's PillCam(TM) SB Identifies High Incidence of Small Bowel Tumors In Patients Under 50Study Published in American Cancer Society Journal
YOQNEAM, ISRAEL--(Healthcare Sales & Marketing Network)--Aug 15, 2006 -- Given Imaging Ltd. (NASDAQ:GIVN ) today announced that Cancer, the official journal of the American Cancer Society, published the results of a retrospective study of PillCam SB concluding that PillCam(TM) Capsule Endoscopy offers physicians the best chance of finding tumors in the small bowel compared to other diagnostic tests and may lead to earlier detection and treatment. The study which was published in the July issue also found that 13% of patients diagnosed with small bowel tumors were younger then 50.
PillCam Capsule Endoscopy led physicians to discover the cause of dangerous intestinal problems in 49.3% of the study patients (n=277) who had previously undergone numerous diagnostic tests with inconclusive results, according to the researchers at The Mount Sinai Medical Center in New York. PillCam SB Capsule Endoscopy led physicians to discover small bowel tumors in 8.9% (n=50) of the patients, the study concluded. Of the tumors diagnosed, 48% were malignant.
It was also observed that 9 of 67 patients (13%) under age 50 who underwent Capsule Endoscopy for obscure bleeding had small bowel tumors, making the incidence rate higher in this group than patients over 50. The researchers stressed the importance of searching for tumors in younger patients with obscure bleeding even if the anemia seems mild. While tumors are the second most common cause of small bowel bleeding after angioectasias, it was concluded that their timely diagnosis may be more important for improving a patient's survival rate. These conclusions were supported by previous research conducted by physicians at Mount Sinai Medical Center and Yale University Medical Center.
"This growing incidence of small bowel tumors suggests the need for better diagnostic tools as part of the standard work up of patients," Gena M. Cobrin, M.D., the lead investigator of the study, said. "Currently small bowel tumors are thought to account for 5% of all gastrointestinal tumors and 2% of cancers overall, but the numbers could actually be much larger because other current diagnostic modalities have proved inadequate. Capsule Endoscopy's high yield may lead to earlier detection and treatment of small bowel tumors and an improved prognosis for patients with these neoplasms."
The American Cancer Society estimates that 6,170 people will be diagnosed with small bowel cancer in 2006, a 12% increase over 2005, and that 1,070 people will die from the disease.
Dr. Cobrin and physicians at Mount Sinai conducted a retrospective analysis of the charts of 562 patients who underwent Capsule Endoscopy from August 2001 to November 2003 for a variety of indications. The majority of the patients (n=443) were suffering from intestinal bleeding without a diagnosed cause. Overall, the patients had undergone an average of 4.2 tests each previously without conclusive results. The study was originally presented at the Digestive Disease Week conference in May 2004.
Numerous conditions such as tumors, angiodysplasias (abnormal collections of enlarged blood vessels), ulcers, erosions, and Crohn's disease can cause intestinal bleeding and subsequent anemia.
"We're very pleased that the American Cancer Society and Cancer have published this study demonstrating that Capsule Endoscopy can play a key role in identifying small bowel cancers earlier and thereby potentially improve the care of the small bowel cancer patient," said Skip Ashmore, Corporate Vice President of Small Bowel Products at Given Imaging. "We believe our third generation PillCam SB capsule will further assist physicians in detecting these cancers earlier."
About Given Imaging
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam(TM) video capsules for detecting disorders of the gastrointestinal tract. The company's technology platform is the GivenŽ Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam SB capsule is a naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 50 other countries and has benefited more than 380,000 patients worldwide. The PillCam ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development. Given Imaging's headquarters, manufacturing, and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain, and Australia. For more information, visit http://www.givenimaging.com.
This press release contains forward-looking statements about Given Imaging, including projections about our business and our future revenues, expenses and profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the impact of the newly adopted SFAS 123R for expensing option-based payments, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities and Exchange Commission.
Source: Given Imaging
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