BTW here are some interesting news:http://finance.yahoo...-121611309.html
Oculus enrolls 1st patient in study of Microcyn Hydrogel in management of scars
Thu, Aug 16, 2012 8:16 AM EDT
Oculus Innovative Sciences announced it has enrolled the first patients in its double-blind, randomized clinical study evaluating an advanced Microcyn® hydrogel for management of hypertrophic or keloid scars under an FDA-reviewed protocol. The company plans to complete its 40-patient trial and provide top-line data by mid-2013 calendar year. The study design calls for recruitment of up to 40 patients at four different U.S. sites, which are Albuquerque, NM, High Point, NC, Austin, TX and College Station, TX. Upon completion of the study, the data will be submitted to the FDA in support of the 510k application. The FDA's published key performance index indicates the standard review time from submission to clearance is ninety days, although industry averages suggest this process can take up to six months.
And their microcyn hydrogel is approved by chinese FDA, are there any photos from trials?
Oculus Innovative Sciences Receives Chinese SFDA Regulatory Approval of Microcyn® Hydrogel
PETALUMA, Calif., July 10, 2012 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (Nasdaq:OCLS) today announced that the Chinese State Food and Drug Administration (SFDA) has approved Microcyn® Hydrogel for moistening, repairing and healing of acute and chronic wounds in China. This approval allows Oculus' Chinese partner, Shanghai Sunvic, to market Microcyn Hydrogel in both the over-the-counter and professional healthcare markets in China. Shanghai Sunvic plans to launch the Microcyn hydrogel in the third quarter of 2012.This 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.
"The randomized trials in China followed by the SFDA approval provides Oculus with a significant business opportunity underwritten by a very strong partner in Shanghai Sunvic," said Bruce Thornton, vice president of international sales for Oculus Innovative Sciences. "With nearly 1.3 billion people, China represents a major healthcare market opportunity for Oculus and our partners."
Oculus Innovative Sciences entered into an agreement with Shanghai Sunvic in 2011 for the distribution of Microcyn-based products in China. The partnership allows Oculus and the Microcyn Technology to gain a foothold in China via new product launches supported by Shanghai Sunvic Technology Company's national sales network.
"As one of the major medical device groups in China, we believe our medical community will enthusiastically embrace an anti-infective technology that is proven both safe and effective in treating topical infection," said Water Chang, president of Shanghai Sunvic. "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."
Edited by Vladislav, 20 August 2012 - 03:09 PM.