Given Imaging Ltd.(Nasdaq: GIVN; TASE: GIVN) a gastrointestinal medical devices and pioneer of capsule endoscopy, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval the third-generation for the PillCam SB 3 system.
Homi Shamir, President and CEO, Given Imaging said, “The approval of the PillCam SB 3 system in Japan builds upon our recent regulatory momentum that includes PillCam COLON in Japan and PillCam SB 3 in the U.S. Japan is the world’s second largest healthcare market , and a critically important . We look forward to working with physicians there to integrate PillCam SB 3’s benefits into clinical practice.”
Each component of the PillCam SB 3 system, including the capsule, recorder, sensor belt, and software, has been enhanced to work together to improve image quality, tissue coverage and efficiency. New adaptive frame rate technology also allows the capsule to automatically increase the rate at which images are taken when it senses it is moving more quickly through the digestive tract. Improvements in the new system’s RAPID® for PillCam software enable even smarter video compilation which is 40% more efficient than with PillCam SB 21. The company expects to begin recognizing sales of PillCam SB 3 in Japan in 2014.
“With its higher resolution and improvement in capturing images of the small bowel mucosa, the new PillCam SB 3 capsule endoscopy system provides us with enhanced performance and efficiency, ” said Tetsuya Nakamura, M.D., Ph.D., Professor and Director, Department of Medical informatics, Dokkyo Medical University. “With these improvements, along with recently receiving an expanded indication, PillCam SB will continue to play an important role in the diagnosis and treatment of small bowel diseases in Japan.”
On Friday, Given Imaging’s share price closed at $18.44 on Nasdaq, giving a market cap of $580 million. The company is controlled by IDB Holding Corp. Ltd. (TASE:IDBH), which has been planning to sell it for a long time.
Given Imaging will be participating in the upcoming Japan Digestive Disease Week (JDDW) conference taking place between October 9th -12th, 2013 in Tokyo.
The PillCam SB 3 capsule is a minimally invasive procedure to visualize and monitor small bowel abnormalities associated with Crohn’s disease, iron deficiency anemia (IDA) and obscure GI bleeding (OGIB). The PillCam measures 11 mm x 26 mm and weighs less than four grams. Now in its third generation, PillCam SB 3 contains an imaging device and light source and transmits images at a rate between two and six images per second. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB 3 builds on Given Imaging’s unique expertise and collaborative efforts as an industry leader that includes more than 2 million uses of PillCam capsules in patients worldwide and more than 1, 900 clinical studies.
The risks of PillCam capsule endoscopy include capsule retention, aspiration and skin irritation. 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.