|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
SYS-CON Events announced today that IceWarp will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. IceWarp, the leader of cloud and on-premise messaging, delivers secured email, chat, documents, conferencing and collaboration to today's mobile workforce, all in one unified interface
Aug. 28, 2015 03:00 AM EDT Reads: 328
The Internet of Things (IoT) is about the digitization of physical assets including sensors, devices, machines, gateways, and the network. It creates possibilities for significant value creation and new revenue generating business models via data democratization and ubiquitous analytics across IoT networks. The explosion of data in all forms in IoT requires a more robust and broader lens in order to enable smarter timely actions and better outcomes. Business operations become the key driver of IoT applications and projects. Business operations, IT, and data scientists need advanced analytics t...
Aug. 28, 2015 12:30 AM EDT Reads: 328
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and analyzed? As an area of investment, how might a retail company move towards an innovation methodolo...
Aug. 27, 2015 06:15 PM EDT Reads: 381
As more and more data is generated from a variety of connected devices, the need to get insights from this data and predict future behavior and trends is increasingly essential for businesses. Real-time stream processing is needed in a variety of different industries such as Manufacturing, Oil and Gas, Automobile, Finance, Online Retail, Smart Grids, and Healthcare. Azure Stream Analytics is a fully managed distributed stream computation service that provides low latency, scalable processing of streaming data in the cloud with an enterprise grade SLA. It features built-in integration with Azur...
Aug. 27, 2015 05:45 PM EDT
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Aug. 27, 2015 02:45 PM EDT Reads: 380
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
Aug. 27, 2015 02:15 PM EDT
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Aug. 27, 2015 01:00 PM EDT Reads: 285
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Treloar, President and COO of Bebaio, will explore examples of brands transforming their businesses by t...
Aug. 27, 2015 11:30 AM EDT
SYS-CON Events announced today that Micron Technology, Inc., a global leader in advanced semiconductor systems, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Micron’s broad portfolio of high-performance memory technologies – including DRAM, NAND and NOR Flash – is the basis for solid state drives, modules, multichip packages and other system solutions. Backed by more than 35 years of technology leadership, Micron's memory solutions enable the world's most innovative computing, consumer,...
Aug. 27, 2015 10:00 AM EDT Reads: 122
Through WebRTC, audio and video communications are being embedded more easily than ever into applications, helping carriers, enterprises and independent software vendors deliver greater functionality to their end users. With today’s business world increasingly focused on outcomes, users’ growing calls for ease of use, and businesses craving smarter, tighter integration, what’s the next step in delivering a richer, more immersive experience? That richer, more fully integrated experience comes about through a Communications Platform as a Service which allows for messaging, screen sharing, video...
Aug. 27, 2015 06:15 AM EDT Reads: 516
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevOps to advance innovation and increase agility. Specializing in designing, imple...
Aug. 26, 2015 08:00 AM EDT Reads: 159
Akana has announced the availability of the new Akana Healthcare Solution. The API-driven solution helps healthcare organizations accelerate their transition to being secure, digitally interoperable businesses. It leverages the Health Level Seven International Fast Healthcare Interoperability Resources (HL7 FHIR) standard to enable broader business use of medical data. Akana developed the Healthcare Solution in response to healthcare businesses that want to increase electronic, multi-device access to health records while reducing operating costs and complying with government regulations.
Aug. 26, 2015 07:00 AM EDT
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Aug. 3, 2015 06:45 PM EDT Reads: 778
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducted a live demonstration of how quickly application development can happen when the need to comply wit...
Aug. 2, 2015 11:15 AM EDT Reads: 538
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Aug. 1, 2015 10:00 AM EDT Reads: 468
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. 30, 2015 07:30 PM EDT Reads: 1,557
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with APIs within the next year.
Jul. 30, 2015 02:30 PM EDT Reads: 268
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, d...
Jul. 30, 2015 12:00 PM EDT Reads: 2,216
In his keynote at 16th Cloud Expo, Rodney Rogers, CEO of Virtustream, discussed the evolution of the company from inception to its recent acquisition by EMC – including personal insights, lessons learned (and some WTF moments) along the way. Learn how Virtustream’s unique approach of combining the economics and elasticity of the consumer cloud model with proper performance, application automation and security into a platform became a breakout success with enterprise customers and a natural fit for the EMC Federation.
Jul. 30, 2015 09:00 AM EDT Reads: 2,308
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. 29, 2015 03:00 PM EDT Reads: 1,437