Given Imaging Ltd. (NASDAQ: GIVN) today announced encouraging results from a trial that validated new features of the company's second-generation PillCam® Colon video capsule and system. The Company also announced that it has obtained the CE mark for the sale of PillCam COLON 2 in Europe.
Conducted by clinicians at five hospitals in Israel, the study evaluated the performance of PillCam COLON 2 in 98 patients who had risk or warning symptoms of colon pathology. Like other PillCam capsules in Given Imaging's suite of products, PillCam COLON 2 does not require the use of sedation, intubation or air insufflation during the procedure. The Company intends to reveal 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.
"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," said Homi Shamir, CEO and President of Given Imaging Ltd. "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 U.S. in 2010. On a parallel track, we have initiated pre-registration studies in the United States with leading key opinion leaders to prepare for a subsequent FDA pivotal trial."
AI models redefine TIL scoring in breast cancer but face challenges in real-world validation