Sources inform ''Globes'' that medical device start-up EnzySurge Ltd., which develops and produces dressings for the debridement of chronic wounds, has completed a series of clinical trials and will be filing an application for approval with the US Food and Drug Administration (FDA) in the coming months. The company has also raised $2 million from private investors out of a planned funding round of $3 million.
EnzySurge's advisory board believes there is a good chance of the company obtaining approval to market its dressing as a "combined product" and will therefore be able to bring it onto the market as early as mid-2008. The company has already received FDA approval for a device it developed but not for a product that is combined with a solution, and has been unable to market it because of this.
EnzySurge says it conducted a trial on 16 patients, and while this was not conducted under FDA guidelines, the conditions were the same as those mandated by FDA requirements. EnzySurge CEO Amir Shiner said, "In 11 of the patients, the debridement of wounds were satisfactory (i.e. wounds typified by dead tissue, inflammation and infection generated new live tissue and could heal on their own). In some of these we also observed a partial closure of wounds. Given that the data has not been analyzed and that this was small trial group, we are unable to talk in terms of statistical significance. However, the results show a trend of effectiveness."
The uniqueness of EnzySurge's chronic wounds treatment product lies in its combination with a device and in the number of different treatments for wounds at different stages of healing. The company has developed both the product and the device, and both products compete against specialized products for each stage of the wound healing process.
Published by Globes [online], Israel business news - www.globes-online.com - on January 9, 2008
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