|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
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Jun. 26, 2016 05:00 PM EDT Reads: 1,293
SYS-CON Events announced today that Bsquare has been named “Silver Sponsor” of SYS-CON's @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. For more than two decades, Bsquare has helped its customers extract business value from a broad array of physical assets by making them intelligent, connecting them, and using the data they generate to optimize business processes.
Jun. 26, 2016 05:00 PM EDT Reads: 1,203
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, wh...
Jun. 26, 2016 04:30 PM EDT Reads: 936
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th 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 and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Jun. 26, 2016 04:00 PM EDT Reads: 1,239
19th Cloud Expo, taking place November 1-3, 2016, 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 enterpri...
Jun. 26, 2016 04:00 PM EDT Reads: 1,299
Connected devices and the industrial internet are growing exponentially every year with Cisco expecting 50 billion devices to be in operation by 2020. In this period of growth, location-based insights are becoming invaluable to many businesses as they adopt new connected technologies. Knowing when and where these devices connect from is critical for a number of scenarios in supply chain management, disaster management, emergency response, M2M, location marketing and more. In his session at @Th...
Jun. 26, 2016 03:00 PM EDT Reads: 954
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 Day 2 Keynote at @ThingsExpo, Henrik Kenani Dahlgren, Portfolio Marketing Manager at Ericsson, discussed how to plan to cooperate, partner, and form lasting all-star teams to change t...
Jun. 26, 2016 02:00 PM EDT Reads: 1,127
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, explored the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences between wh...
Jun. 26, 2016 01:00 PM EDT Reads: 769
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices 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 opportuni...
Jun. 26, 2016 12:00 PM EDT Reads: 1,282
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Jun. 26, 2016 12:00 PM EDT Reads: 1,106
There is little doubt that Big Data solutions will have an increasing role in the Enterprise IT mainstream over time. Big Data at Cloud Expo - to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA - has announced its Call for Papers is open. Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is...
Jun. 26, 2016 12:00 PM EDT Reads: 1,337
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Jun. 26, 2016 12:00 PM EDT Reads: 1,073
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Jun. 26, 2016 11:00 AM EDT Reads: 1,084
Machine Learning helps make complex systems more efficient. By applying advanced Machine Learning techniques such as Cognitive Fingerprinting, wind project operators can utilize these tools to learn from collected data, detect regular patterns, and optimize their own operations. In his session at 18th Cloud Expo, Stuart Gillen, Director of Business Development at SparkCognition, discussed how research has demonstrated the value of Machine Learning in delivering next generation analytics to imp...
Jun. 26, 2016 09:45 AM EDT Reads: 607
There are several IoTs: the Industrial Internet, Consumer Wearables, Wearables and Healthcare, Supply Chains, and the movement toward Smart Grids, Cities, Regions, and Nations. There are competing communications standards every step of the way, a bewildering array of sensors and devices, and an entire world of competing data analytics platforms. To some this appears to be chaos. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Bradley Holt, Developer Advocate a...
Jun. 26, 2016 08:45 AM EDT Reads: 737
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Jun. 25, 2016 03:00 PM EDT Reads: 1,597
SYS-CON Events announced today that ReadyTalk, a leading provider of online conferencing and webinar services, has been named Vendor Presentation Sponsor at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. ReadyTalk delivers audio and web conferencing services that inspire collaboration and enable the Future of Work for today’s increasingly digital and mobile workforce. By combining intuitive, innovative tec...
Jun. 24, 2016 01:00 PM EDT Reads: 1,355
Amazon has gradually rolled out parts of its IoT offerings, but these are just the tip of the iceberg. In addition to optimizing their backend AWS offerings, Amazon is laying the ground work to be a major force in IoT - especially in the connected home and office. In his session at @ThingsExpo, Chris Kocher, founder and managing director of Grey Heron, explained how Amazon is extending its reach to become a major force in IoT by building on its dominant cloud IoT platform, its Dash Button strat...
Jun. 24, 2016 12:00 PM EDT Reads: 1,638
industrial company for a multi-year contract initially valued at over $4.0 million. In addition to DataV software, Bsquare will also provide comprehensive systems integration, support and maintenance services. DataV leverages advanced data analytics, predictive reasoning, data-driven diagnostics, and automated orchestration of remediation actions in order to improve asset uptime while reducing service and warranty costs.
Jun. 22, 2016 11:00 AM EDT Reads: 1,368
Vidyo, Inc., has joined the Alliance for Open Media. The Alliance for Open Media is a non-profit organization working to define and develop media technologies that address the need for an open standard for video compression and delivery over the web. As a member of the Alliance, Vidyo will collaborate with industry leaders in pursuit of an open and royalty-free AOMedia Video codec, AV1. Vidyo’s contributions to the organization will bring to bear its long history of expertise in codec technolo...
Jun. 19, 2016 12:45 PM EDT Reads: 1,274