FDA Chimes in as Oculus Reportedly Preps Stock Sale

The U.S. Food and Drug Administration confirmed late Friday that Oculus Innovative Sciences (OCLS Quote) cannot make medical or drug-like claims about a diluted bleach product it sells to clean wounds.

The controversy over how Oculus markets Microcyn, an antiseptic sold over the counter for $20 a bottle, comes as the Petaluma, Calif.-based company, short on cash, is gearing up to raise money through a stock sale to investors, according to a source familiar with the plans.

Microcyn is a liquid- and gel-based antiseptic sold over the counter for $20 a bottle. The FDA allows Oculus to market Microcyn as a wound cleaner under the agency's regulation of simple medical devices known as 510(k) approvals.

TheStreet.com asked the FDA to explain what Microcyn could and could not say about Microcyn based on the product's approval as a medical device.

"Oculus only has FDA approval for Microcyn for the removal of debris after pouring on a wound," said FDA spokesperson Peper Long.

Long added that, "A medical device approved under a 510(k) is not a drug and therefore a manufacturer of such a device is not allowed to make therapeutic or drug-like claims."

As reported Thursday, Oculus is marketing Microcyn as a drug with specific medical claims that the product cures infections, accelerates wound healing and reduces inflammation in patients with serious diabetic ulcers, according to comments made by the company's CEO Hoji Alimi and CFO Bob Miller on a conference call with investors held on June 11.