Given Imaging Ltd. (Nasdaq: GIVN; TASE:GIVN) today announced that it has obtained the EU's CE mark for the sale of PillCam colon 2 in Europe. The company also announced positive trial results that it claims validate new features of the company's second-generation PillCam Colon video capsule and system.
The trial was conducted at five hospitals in Israel, and evaluated the performance of PillCam Colon 2 in 98 patients who had risk or warning symptoms of colon pathology. Like Given Image's other PillCam capsules, Colon 2 does not require the use of sedation or intubation during the procedure. The compny plans unveiling PillCam Colon 2 in Europe at the Gastro 2009 conference this fall, at which time it will disclose additional details, including product specifications and software enhancements.
Given Imaging CEO and president Homi Shamir said, "The main purpose of the trial was to evaluate the performance of new technologies embedded in the new capsule and PillCam platform. The results of this feasibility trial confirm the functionality of the system and give us increased confidence about the potential of PillCam Colon 2 as a useful tool for visualizing pathology in the colon. Despite statistical limitations resulting from the size of the trial and the relatively low prevalence of polyps, we are very pleased with the high degree of consistency in the sensitivity and specificity of the data, both of which were high and balanced."
He added, "We are now initiating additional multicenter clinical trials in Europe and Israel and intend to complete these trials over the next few months. Subsequently, we will begin a phased roll out of PillCam Colon 2 in Europe and a few other countries outside of the US in 2010. On a parallel track, we have initiated pre-registration studies in the US with leading key opinion leaders to prepare for a subsequent FDA pivotal trial."
PillCam Colon is not currently available for sale in the US. PillCam Colon enables the physician to directly see the colon mucosa in its natural state while not requiring sedation, intubation, air insufflation, hospitalization or radiation.
Given Imaging's share closed on Nasdaq yesterday at $11.82, giving a market cap of $345.83 million. The share was up 2.6% on the TASE today to NIS 45.42.
Published by Globes [online], Israel business news - www.globes-online.com - on September 14, 2009
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