Good news from Japan boosted the share price of Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) by 5.5% on the TASE today. The company announced that Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for the PillCam SB 3 system for diagnosis of diseases of the small bowel. This is an improved version of the PillCam SB endoscopic capsule, which is already on the market, with higher resolution, greater coverage, and greater effectiveness than its predecessor. The US Food and Drug Administration (FDA) approved the PillCam SB 3 in August.
Japan and the US are the two biggest markets, the regulators of which Given Imaging has targeted this year. The PDMA recently approved the company's next generation PillCam Colon 2 capsule, and the company is now waiting for FDA approval, which it expects to obtain by the end of the year. These approvals are very important for Given Imaging, because they open a much larger market to it.
Commenting on what he calls the "regulatory momentum, Given Imaging president and CEO Homi Shamir said, "Approval of the PillCam SB 3 system in Japan underscores our global commitment to providing physicians with innovative tools to detect and monitor abnormalities of the gastrointestinal tract." He added, "Japan is a critically important healthcare market and we look forward to working with physicians there to integrate PillCam SB 3's benefits into clinical practice."
Given Imaging's share price closed at $18.44 on Nasdaq on Friday, 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.
Published by Globes [online], Israel business news - www.globes-online.com - on September 23, 2013
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