Israel's Given Imaging ($GIVN) saw its stock surge after filing for Japanese approval for its PillCam Colon 2 endoscopic capsule.
Given is filing in Japan on the strength of a pivotal study finding that the PillCam Colon 2 accurately identified 94% of the polyps found through traditional colonoscopy. As a result, shares rose 5.4% to $14.07 on the news, Bloomberg reports. Given's New York stock is now trading at a 52 cent premium over its Tel Aviv shares, according to the news service.
The jump in share value is a welcome respite from the shareholder ire Given faced last month. In August, Given announced it would seek FDA approval for the device, instead of a simpler general-screening indication, and investors punished the company by driving its stock price down to $12.69, a three-year low.
The device is a swallowable pill outfitted with a camera on each end and an LED bulb to light the way. Once ingested, the PillCam Colon 2 records and transmits video at about 35 frames per second with a 10-hour battery life, according to Given.
The PillCam Colon 2 got its CE mark in 2009 and is commercially available in Europe, Latin America, Canada and parts of Asia. Getting approval in Japan will be a huge boost for Given, CEO Homi Shamir said in a statement, with an estimated addressable market of about 1 million procedures each year.
- read Bloomberg's report
- check out Given Imaging's statement