PETALUMA, Calif. -- Oculus Innovative Sciences has filed its application with the U.S. Environmental Protection Agency (EPA) for approval of its Microcyn disinfectant as a hospital-grade disinfectant for use in households, hospitals and industrial environments. This is the first EPA submission for Microcyn technology in the United States.
In March 2003, Microcyn received CE approval under the European Medical Device Directive 93/42/EEC. The newly obtained CE Mark is based on compliance with the recently developed EN 13727 European test for bactericidal efficacy. Under the supervision of the Dutch notified body (TNO), Microcyn is one of the first disinfectants to meet these new, more rigorous standards in Europe.
The Mexican Ministry of Health approved Microcyn as a disinfectant, a sterilant, and an antiseptic. In Mexico, Microcyn has been used to treat a number of traumatic wounds including diabetic foot ulcers, varicose vein leg ulcers as well as second and third-degree burns.
"Our successful filing with EPA is the first step toward opening the U.S. market," said Alimi, who founded the company in 1999, "And we are excited at the prospect of introducing Microcyn technology as a powerful and user friendly disinfectant in the U.S."
Oculus Innovative Sciences is pioneering innovative life sciences and disruptive technologies that globally re-define the disinfectant and antiseptic markets. The company has employees and operations in Mexico, Europe and the U.S. and includes two wholly owned subsidiaries, Oculus Technologies of Mexico, S.A. de C.V., and Oculus Innovative Sciences Netherlands B.V.
Source: Oculus Innovative Sciences