YOQNEAM, ISRAEL--(Marketwire - December 04, 2012) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices, and maker of PillCam® capsule endoscopy, today announced the results of Crohn's Voices, an online survey of Crohn's patients about their understanding of their condition, their approach to managing their condition with their physician, and what matters most to them in a clinical test of disease activity. Key findings from the Crohn's Voices survey show that 75% of patients consider the most important test-related aspect for Crohn's repeat evaluation methods to be for physicians to be able to have a better view of their GI tract. They also shared that they have a significant amount of concern about the use of monitoring methods that include sedation and radiation. The survey also showed that only 19% of patients undergo a regular evaluation of their clinical status, regardless of their Crohn's symptoms.
"The Crohn's Voices survey provides useful insights on Crohn's patients' understanding of their condition, and about the need for meaningful conversations between patients and doctors about the value of regular monitoring of their disease activity," said Joel Rosh, MD, Goryeb Children's Hospital, Morristown, New Jersey. "Physicians and patients also need to discuss what the options for direct visualization of their GI tract are, as the surveyed patients indicate a concern about the risks of sedation and radiation."
Crohn's disease is a chronic and progressive form of inflammatory bowel disease that can affect any area of the GI tract, with lifelong consequences. In 75% of Crohn's cases, patients have lesions in the small bowel(1). However, the small bowel has traditionally been a difficult part of the GI tract for physicians to visualize, but it is an essential part of the anatomy for successfully evaluating and monitoring the progression of Crohn's.
The ongoing assessment, or monitoring, of disease progression in CD patients, even when symptoms are absent, is considered to be key to the management of this lifelong condition. Crohn's disease can progress even without changes in symptoms, and many Crohn's patients can have active disease without exhibiting symptoms for extended periods of time.
Crohn's Voices: Patient Awareness on the Value of Monitoring
While monitoring the condition even in the absence of symptoms is very important, the Crohn's Voices survey also indicates that 45% of respondents only evaluate or monitor their condition, either through observation or testing, when their symptoms change. In fact, only 19% of Crohn's patients surveyed said that they make a point of undergoing routine monitoring tests regardless of symptoms. However, three times more respondents, or 64%, said that they would be more likely to have regular monitoring if they knew that their condition could worsen without symptom changes.
Radiation and Other Concerns in Crohn's Monitoring
Imaging techniques that involve diagnostic radiation are commonly used in assessing Crohn's disease activity, but they have the potential to be harmful to patients' health, with published data showing that individuals have a 1 in 1000 risk of developing cancer from the radiation exposure associated with a CT scan(2).
The Crohn's Voices survey asked patients their thoughts about the various available methods of assessing their condition. The results indicated that 62% of respondents are moderately to strongly concerned about radiation from some Crohn's monitoring methods, and 72% are concerned about long-term effects of radiation in monitoring. Additionally, 50% of those surveyed indicated that they are moderately to strongly concerned about having to be accompanied to their monitoring procedures, and 50% are moderately to strongly concerned about having to be sedated for some of these procedures.
What Patients Want in a Monitoring Method
The Crohn's Voices survey also aimed to determine what patients prefer in a method of evaluating their clinical status. In this regard, 75% of respondents felt strongly that they preferred their doctor to use a tool that provides a better view of the GI tract.
In addition, a large majority, 75%, of those surveyed would strongly prefer a monitoring method that did not require them to undergo sedation or receive radiation, and allowed them the freedom to leave their physician's office during the procedure.
"Traditionally, most of the small bowel could only be visualized with X-rays, which can miss important diagnostic details and expose patients to potentially harmful levels of radiation. Capsule endoscopy (CE) technology, such as PillCam SB, provides a non-invasive way to get a better view of the lining of the GI tract, without radiation, making it a convenient and accurate tool for monitoring disease activity and response to therapy," said Dr. Rosh. "Patients and physicians should have an open dialogue about the importance of regular monitoring and all the available methods."
About the Crohn's Voices Survey
Crohn's Voices is an unblinded Crohn's patient survey, sponsored by Given Imaging, that was conducted by Research Now, an independent survey company. The survey, conducted online in November 2012, asked 102 individuals in the United States living with Crohn's disease about their understanding of their condition, their approach to monitoring, and what matters most to them in a monitoring method. The survey participants received nominal compensation in the form of points towards purchase for their participation.
About PillCam® SB
The PillCam® SB capsule endoscope is a minimally invasive procedure to visualize and monitor lesions associated with inflammatory bowel disease (IBD), Crohn's disease and obscure GI bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less than four grams. Now in its second generation, PillCam SB 2 contains an imaging device and light source and transmits images at a rate of two images per second generating more than 50,000 pictures during the course of the procedure. PillCam SB was cleared by the U.S. Food and Drug Administration in 2001. PillCam capsule endoscopy has been clinically validated by more than 1,800 peer-reviewed studies. It is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the GI tract. PillCam SB is the gold standard in small bowel evaluation.
The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the PillCam patency capsule include capsule retention and aspiration. Endoscopic placement may present additional risks. 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® capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan™ high-resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z impedance, and the SmartPill® GI 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 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. 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 ability of the Company to reach agreement on any strategic alternative and/or to complete any such alternative, as well as 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 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.
(1) Engstrom PF, Goosenberg EB, Diagnosis and Management of Bowel Diseases. Caddo, OK: Professional Communications Publisher; 1999.
(2) ECRI Institute CT Scanning Systems Infographic White Paper 2012 https://www.ecri.org/Forms/Pages/CT-Scanning-Systems-Infographic-White-Paper.aspx