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news.Oculus Innovative Sciences, a commercial healthcare company, has gained Chinese State Food and Drug Administration approval for its Microcyn Hydrogel for moistening, repairing and healing of acute and chronic wounds.
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With the approval, Shanghai Sunvic, Oculus’ Chinese partner, can market Microcyn Hydrogel in both the over-the-counter and professional healthcare markets in China. Shanghai Sunvic considers launching the Microcyn hydrogel in the third quarter of 2012.
Oculus international sales vice president Bruce Thornton said the randomized trials in China followed by the SFDA approval provides the company with a significant business opportunity underwritten by a strong partner in Shanghai Sunvic.
"With nearly 1.3 billion people, China represents a major healthcare market opportunity for Oculus and our partners," Thornton added.
The approval follows successful completion of randomized trials at five major Chinese hospitals for use of Microcyn Hydrogel in the treatment of acute wounds, diabetic foot care and post-surgical incisions.
Shanghai Sunvic president Water Chang said, "We see the SFDA’s rapid approval indicative of a marketplace eager for an anti-infective that works as promised without promoting bacterial resistance as is the case for many of today’s antibiotics."