The trial found that the InsuPatch used with insulin pumps made by Medtronic Inc. (NYSE: MDT) subsidiary Minimed Ltd. was as safe as use of the pump without the InsuPatch, in terms of hypoglycemia (low blood sugar) incidents. The trial included 113 patients in test and control groups, more than the 100 patients required under the FDA protocols.
InsuLine said that, on the basis of this safety trial and the efficacy trial completed in December 2011, it will apply to the FDA during the third quarter of 2012 to approve the InsuPatch.
InsuLine president and CEO Ron Nagar said, "We have proved the safety and efficacy of the InsuPatch under FDA protocols. This important achievement follows a series of successes in recent months. After obtaining FDA approval, InsuLine will be well positioned with its strategic partners to distribute the product in the US. We believe that the latest successes and business deals, such as the trial announced with Barmer in Germany, will continue to create value for the shareholders."
InsuLine's share price rose 4.1% by mid-afternoon to NIS 0.70, giving a market cap of 55 million.
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