InsuLine Medical Ltd. (TASE: INSL) has begun a clinical trial in the US to test the safety and effectiveness of its InsuPatch catheter for insulin pumps on type 1 diabetics. The trial is based on US Food and Drug Administration (FDA) protocols, and the company plans to shortly begin a corresponding trial in Israel based on the same protocols.
The trial will include 100 patients in Israel and the US, and the company believes that it will be completed in the third quarter of 2011. The trial will be conducted in two parallel parts: in the first part, 15 patients will test the InsuPatch's effectiveness in a controlled environment; and in the second part, 15 patients will test its safety in an uncontrolled day-to-day life environment.
The US trial will be conducted at the Mills Peninsula Health Center in California.
The InsuPatch is intended to enable faster insulin absorption.
InsuLine president and CEO Ron Nagar said, "The start of the clinical trial in accordance with FDA protocols is a critical milestone in the company's life, and follows previous clinical trials conducted by InsuLine, which have demonstrated the effectiveness and safety of the product."
InsuLine expects that if the trial succeeds, the company will gain US Food and Drug Administration (FDA) approval by the end of 2011.
InsuLine's share price rose 2.1% by early afternoon to NIS 0.79, giving a market cap of NIS 41 million.
Published by Globes [online], Israel business news - www.globes-online.com - on October 27, 2010
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