Japan’s Pharmaceuticals & Medical Devices Agency approved the capsule for diagnosing colonic disease instead of a colonoscopy. Given Imaging’s PillCam(R). Japan, World’s Second Largest Healthcare Market
Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) today announced that Japan’s Pharmaceuticals & Medical Devices Agency (PMDA) has cleared the company’s PillCam Colon endoscopic capsule for diagnosis of colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy.
“The clearance of PillCam Colon in Japan, the world’s second largest healthcare market, represents an important accomplishment for Given Imaging, ” said Given Imaging president and CEO Homi Shamir. “The decision could expand our potential customer base in Japan from 1, 000 today to potentially 10, 000 and will help in enhancing adherence to screening guidelines for over one million potential patients.”
Screening guidelines in Japan call for everyone over 40 to undergo a fecal occult blood test (FOBT). Compliance with screening remains low and only approximately 25% of the population actually get tested. After a physician identifies blood in a patient’s feces (which can be a strong indication of colon cancer or other diseases), only 54.7%of these patients proceed to have a recommended colonoscopy to confirm the diagnosis due to a variety of reasons. PillCam Colon’s ease of use and minimally-invasive profile could appeal to those patients.
“Meaningful sales of PillCam Colon capsule will commence immediately after obtaining reimbursement, ” said Shamir, although he declined to provide specifics. “I do not want to discuss financial numbers at this time, because the level of indemnification is not known.”
Given Imaging also expects the US Food and Drug Administration (FDA) to approve the PillCam Colon by the end of September. It received EU CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, and parts of Asia.
Given Imaging’s parent company, IDB Holding Corp. Ltd. (TASE:IDBH), controlled by Nochi Dankner, wants to sell the company.
About PillCam® COLON
The PillCam COLON video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source; it measures 11 mm X 31 mm. PillCam COLON is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient. Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.
The risks of PillCam capsule endoscopy include capsule retention, aspiration and skin irritation. The risks associated with colon preparation are allergies or other known contraindication to any preparation agents or medications used for the PillCam COLON regimen, according to laxative medication labeling and per physician discretion. After ingesting the PillCam capsule and until it is excreted, patients should not be near any source of powerful electromagnetic fields, such as one created by an MRI device. Medical, endoscopic or surgical intervention may be necessary to address these complications, should they occur. A normal or negative capsule endoscopy examination does not exclude the possibility of colon polyps or colon cancer.
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, 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.