The medical device company expects to receive FDA approval in 2012.
InsuLine Medical Ltd. (TASE: INSL) reported to the stock exchange today that it has completed a first stage clinical trial to examine the effectiveness of its InsuPatch for adult type 1 diabetes patients, in order to receive FDA approval.
In the first part of the trial to investigate the device's effectiveness, which has been completed, 55 diabetes patients were tested in a controlled setting, and InsuLine estimates that statistical results will be published within six weeks.
The second part of the trial, examining safety issues for use of the InsuPatch, is being carried out in the US and in Israel, and is right on schedule. About 100 patients are being tested by comparing quality of daily life during three months when they are using the device compared with three months when the do not use the device. Upon completion of this stage of the trial, InsuLine will apply for FDA approval.
InsuLine CEO Ron Nagar said, "We are reaching our goals right on schedule. The completion of the device's effectiveness examination is an important milestone, and it brings us closer to our goal of offering a value-added medical device to patients, insurers and health systems worldwide."
Nagar added, "Our work plan for 2011-2012 includes a clear outline for receiving FDA approval in 2012, and commencing sales in Germany. Every stage of progress in realizing the company's strategic plan, including clinical trials, is expected to be valuable for InsuLine shareholders."
In afternoon trading on the TASE, InsuLine's share price was up 10.17% to NIS 0.98.
Published by Globes [online], Israel business news - www.globes-online.com - on July 3, 2011
© Copyright of Globes Publisher Itonut (1983) Ltd. 2011
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