Biomedical company InsuLine Medical Ltd. (TASE: INSL) today reported that it had received new information about its registration request for its InsuPad product in the medical products catalogue in Germany. As a result InsuLine's share price rose 14.3% to NIS 27.47.
The company received a list of the reasons why the product cannot be registered from the responsible agency.
InsuLine said that the company had examined the objections together with its medical and legal advisors in Germany. The company believes that it possesses clinical information collected in Germany beyond what was included in its request, as well as other grounds, that is likely to change the registration agency's position without conducting any further clinical trials.
In coordination with the registration agency, Insuline plans to submit its response in the coming weeks in order to continue the registration process.
The InsuLine share crashed a month ago when the company reported that it had received a preliminary letter from the registration agency saying that the agency had completed most of its consideration of the request to register InsuPad in Germany. The letter stated that the request was not sufficient for inclusion of the product in the German medical products catalogue.
To the best of the company's understanding, its product had been rejected, among other reasons, for want of adequate information about its medical effectiveness and because it was a heating device, which did not justify its classification as a medical device.
Published by Globes [online], Israel business news - www.globes-online.com - on April 5, 2015
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