Shares of Oculus Innovative Sciences, Inc. (Nasdaq: OCLS) were up more than 135 percent at mid-day on the Nasdaq.
The Petaluma-based company said U.S. health regulators approved its Microcyn skin and wound gel as both a prescription and over-the-counter formulation, sending shares up 70 percent before the bell.
The gel is intended to treat wounds such as leg ulcers, pressure ulcers, diabetic ulcers and mechanically or surgically debrided wounds.
“We understand the critical role that reimbursement plays in the successful commercialization of a medical product, and in that this is our first reimbursable product, we plan to aggressively market to the U.S. healthcare community,” said Oculus’ founder and CEO Hoji Alimi. “At the same time, we are taking all steps necessary to secure regulatory approvals outside North America so as to begin generating international sales through our existing distribution channels worldwide.”
Oculus, in partnership with its North American contract sales organization, Advocos, will market and sell the Microcyn® Skin and Wound Gel to the North American medical community as well as consumers beginning in June 2009.
Earlier this month, Oculus announced that its manufacturing facility in Mexico was working around the clock to meet the sudden product demand for Microdacyn™, a broad-spectrum antiseptic and sterilant approved by the Mexican Ministry of Health. Microdacyn has not been reviewed for similar indications by U.S. or European regulatory authorities nor has any regulatory body approved this technology for a specific swine flu indication. The Microcyn Technology is manufactured and marketed as Microdacyn™ in Mexico and is available through physicians and pharmacies as a non-toxic topical antimicrobial (antiseptic).
Regardless of the type of virus, it’s believed that Microdacyn’s mechanism of virus inactivation involves destruction of the proteins on the viral surface responsible for initial infection. Following destruction of these proteins, the viruses are no longer capable of causing any harm, according to a recent news release. Microdacyn has not been reviewed for similar indications by U.S. or European regulatory authorities nor has any regulatory body approved this technology for a specific swine flu indication.
Shares of Oculus were trading at $2.05 before the bell. They closed at $1.20 Tuesday on Nasdaq.