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news.Oculus Innovative Sciences has initiated its first US clinical trial on humans to gain approval for an antiseptic treatment to be marketed as an anti-microbial preoperative skin preparation. The company anticipates the technology to demonstrate both safety and efficacy, while remaining non-irritating and non-toxic.
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This phase I study includes 290 volunteers and is being conducted at BioSciences Laboratories in Montana to investigate the effectiveness of Microcyn Technology. Initial results are expected by the end of the year.
The company will also be initiating other clinical studies in Europe and the US that it intends to announce this summer. These studies are expected to provide supporting data for the technology’s anti-microbial claims as they relate to treatment of open wounds and will be submitted to the FDA.
The company believes this research is a critical step in improving upon the standard of care in healthcare institutions as a result of integrating the Microcyn Technology into traditional wound care regimens.
Microcyn Technology is a super-oxidized, pH-neutral solution that is ready for use with no dilution or mixing, and requires no special handling or disposal. It is manufactured using a sophisticated, multi-chamber electrolysis process in which ionic species are selectively produced and isolated. This process allows for the production of a pH-neutral solution while minimizing the level of chlorine in the final product.