US-based developer of wound care devices Oculus Innovative Sciences has obtained the CE Mark for the Microcyn-based GramaDerm solution and GramaDerm hydrogel.
According to the company, the two products are intended for use in the topical treatment of mild to moderate acne and are designed to complement other acne treatments.
This approval allows the company to market and sell the Microcyn-based GramaDerm Solution and GramaDerm Hydrogel in EU member countries that have adopted the medical devices directive without being subject to additional national regulations with regard to demonstration of performance and safety, although certain EU member countries may request or require additional performance and/or safety data from time to time, on a case-by case basis.
Oculus executive vice president of international operations Bruce Thornton said securing the CE Mark for company’s acne products is just the beginning of Oculus’ multiple product development initiatives in its continuing European growth strategy.
"With CE Mark approval, our EU partnering process has picked up considerably. In addition, we anticipate announcing regulatory approvals and commercialization of other Microcyn-based products, including those for new oral and advanced wound care indications, over the next few quarters," Thornton added.