InsuLine Medical Ltd. (TASE: INSL) today announced positive results in the efficacy and safety clinical trial of its insulin patch, InsuPatch for the treatment of Type 1 (juvenile) diabetes. The InsuPatch met its primary endpoint for obtaining US Food and Drug Administration (FDA) approval of the product.
The InsuPatch achieved a relative median increase of 29.7% in insulin levels in the blood within an hour compared with an insulin injection without the product. The FDA requirement was a median increase of at least 10%.
55 patients participated in the clinical trial, and the analysis was conduction on the 51 patients who met the FDA protocols for the trial.
100 patients are participating in the second part of the trial to test InsuPatch's safety. The trial, which began early in 2011, is due to be completed in April 2012. Following the completion of the trial and analysis of the results, InsuLine will submit a certification application for the product with the FDA.
InsuLine's share price rose 14.9% by early afternoon to NIS 0.88, giving a market cap of NIS 48 million.
Published by Globes [online], Israel business news - www.globes-online.com - on December 21, 2011
© Copyright of Globes Publisher Itonut (1983) Ltd. 2011
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