YOQNEAM, Israel, Dec. 5 /PRNewswire-FirstCall/ -- Given Imaging announced today that it received clearance from the U.S. Food and Drug Administration to market the most advanced version of its patented RAPID(TM) software, RAPID 4, for use with the PillCam(TM) Platform. RAPID 4 offers new features and powerful diagnostic tools that aid in the reading and interpretation of the videos captured from the PillCam SB and PillCam ESO capsules.
"RAPID 4 demonstrates our global leadership in developing proprietary software solutions that enable physicians to manage their patients far more efficiently than ever before," said Gavriel D. Meron, president and CEO of Given Imaging. "We firmly believe that this new platform will support both the expansion of our installed base, together with increased utilization by our existing customer base worldwide."
RAPID 4's new and unique features include: -- Automatic Viewing Mode: Aids in more efficient diagnostic review of the video by regulating the rate of change so that images flow more smoothly and constantly. -- QuickView: Allows fast preview of the video and highlights potentially interesting images in the video stream. -- RAPID Atlas: Compares the on-screen case image with known reference images stored in the database. The reference images can be searched by findings, diagnosis, or using Capsule Endoscopy Standard Terminology (CEST). The PillCam Platform includes three components: -- The Given Workstation: Equipped with Given's proprietary RAPID Application Software which processes the data and produces a video of the GI tract. The software allows physicians to view the video, save individual images and short video clips, compare captured images to those stored in the RAPID Atlas, save the findings, and then write, edit, and print reports. -- PillCam SB and PillCam ESO Video Capsules: Disposable miniature video cameras contained in a capsule that are ingested by the patient. Once swallowed, the capsule passes naturally through the digestive tract, transmitting high quality color images of the patient's small bowel or esophagus. -- The DataRecorder 2: Similar to a personal MP-3 player, this is worn around the patient's waist to receive and record signals transmitted by the PillCam video capsule as it passes through the digestive track. Patients can normally continue their daily activities during the examination. 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 Given(R) Diagnostic System, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam(TM) SB capsule is the only 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 260,000 patients worldwide. The PillCam(TM) 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.
Given ImagingCONTACT: Mark Gilreath of Given Imaging Ltd.; or Fern Lazar,flazar@lazarpartners.com, or David Carey dcarey@lazarparters.com,+866-GIVEN-IR, both of Lazar Partners Ltd.
Web site: http://www.givenimaging.com/
