|By Marketwired .||
|December 4, 2012 11:25 AM EST||
YOQNEAM, ISRAEL -- (Marketwire) -- 12/04/12 -- 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
"ciqada is a combined platform of hardware modules and server products that lets people take their existing devices or new devices and lets them be accessible over the Internet for their users," noted Geoff Engelstein of ciqada, a division of Mars International, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 8, 2015 02:15 AM EDT Reads: 535
"We have seen the evolution of WebRTC right from the starting point to what it has become today, that people are using in real applications," noted Dr. Natasha Tamaskar, Vice President and Head of Cloud and Mobile Strategy and Ecosystem at GENBAND, in this SYS-CON.tv interview at WebRTC Summit, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 7, 2015 10:15 PM EDT Reads: 600
The 3rd International WebRTC Summit, to be held Nov. 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 15th International Cloud Expo, 6th International Big Data Expo, 3rd International DevOps Summit and 2nd Internet of @ThingsExpo. WebRTC (Web-based Real-Time Communication) is an open source project supported by Google, Mozilla and Opera that aims to enable bro...
Jul. 7, 2015 08:00 PM EDT Reads: 412
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world and it starts with business models and monetization strategies.
Jul. 7, 2015 07:00 PM EDT Reads: 1,415
Internet of Things (IoT) will be a hybrid ecosystem of diverse devices and sensors collaborating with operational and enterprise systems to create the next big application. In their session at @ThingsExpo, Bramh Gupta, founder and CEO of robomq.io, and Fred Yatzeck, principal architect leading product development at robomq.io, discussed how choosing the right middleware and integration strategy from the get-go will enable IoT solution developers to adapt and grow with the industry, while at the same time reduce Time to Market (TTM) by using plug and play capabilities offered by a robust IoT ...
Jul. 7, 2015 07:00 PM EDT Reads: 1,310
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than
Jul. 7, 2015 05:00 PM EDT Reads: 1,226
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool for visual control over the cloud and the best price/performance value available. ProfitBricks was named one of the coolest Clo...
Jul. 7, 2015 05:00 PM EDT Reads: 1,525
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises are using some form of XaaS – software, platform, and infrastructure as a service.
Jul. 7, 2015 04:00 PM EDT Reads: 800
"In the IoT space we are helping customers, mostly enterprises and industry verticals where time-to-value is critical, and we help them with the ability to do faster insights and actions using our platform so they can transform their business operations," explained Venkat Eswara, VP of Marketing at Vitria, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 7, 2015 03:45 PM EDT Reads: 514
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affect their organization.
Jul. 7, 2015 03:30 PM EDT Reads: 675
WebRTC converts the entire network into a ubiquitous communications cloud thereby connecting anytime, anywhere through any point. In his session at WebRTC Summit,, Mark Castleman, EIR at Bell Labs and Head of Future X Labs, will discuss how the transformational nature of communications is achieved through the democratizing force of WebRTC. WebRTC is doing for voice what HTML did for web content.
Jul. 7, 2015 03:30 PM EDT Reads: 682
To many people, IoT is a buzzword whose value is not understood. Many people think IoT is all about wearables and home automation. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed some incredible game-changing use cases and how they are transforming industries like agriculture, manufacturing, health care, and smart cities. He will discuss cool technologies like smart dust, robotics, smart labels, and much more. Prepare to be blown away with a glimpse of the future.
Jul. 7, 2015 02:15 PM EDT Reads: 908
Connected things, systems and people can provide information to other things, systems and people and initiate actions for each other that result in new service possibilities. By taking a look at the impact of Internet of Things when it transitions to a highly connected services marketplace we can understand how connecting the right “things” and leveraging the right partners can provide enormous impact to your business’ growth and success. In her general session at @ThingsExpo, Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, discussed how this exciting emergence of layers of...
Jul. 7, 2015 12:45 PM EDT Reads: 1,438
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal today!
Jul. 7, 2015 12:30 PM EDT Reads: 846
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Among the proven benefits, DevOps is corr...
Jul. 7, 2015 12:15 PM EDT Reads: 919
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo in Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal an...
Jul. 7, 2015 12:00 PM EDT Reads: 909
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of profound change in the industry.
Jul. 7, 2015 12:00 PM EDT Reads: 759
SYS-CON Events announced today that kintone has been named “Bronze Sponsor” of SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. kintone promotes cloud-based workgroup productivity, transparency and profitability with a seamless collaboration space, build your own business application (BYOA) platform, and workflow automation system.
Jul. 7, 2015 12:00 PM EDT Reads: 1,564
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists peeled away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud environment, and we must architect and code accordingly. At the very least, you'll have no problem fillin...
Jul. 7, 2015 11:45 AM EDT Reads: 1,957
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Architect for the Internet of Things and Intelligent Systems, described how to revolutionize your archit...
Jul. 7, 2015 11:30 AM EDT Reads: 837