WUNDECYTE ™

The company has made a gel from Oxycyte that we believe can be useful in treating wounds by supplying oxygen to injured tissue from the outside in. When a wound heals, the speed of healing is largely dependent on how much oxygen the key tissues get during their healing phase. We believe that Oxycyte can dramatically increase the speed of oxygen delivery, thereby increasing the speed of the healing.

In July 2009 the company filed a 510K medical device application for its wound product , Wundecyte™ with the U.S. Food and Drug Administration (FDA). The application has been classified as a combination device by the FDA. Since trials will be needed to substantiate claims, the company has decided to divide the regulatory path for that product into a device application (510K) for the self-oxygenating bandage, and a new drug application (IND) for the oxygen carrying gel. We have completed an initial study design for a preclinical trial to evaluate Wundecyte’s effectiveness at wound healing, with and without the bandage. This study will look at factors such as time to wound closure and reduction in scar tissue formation as compared to a control group and is to begin in 2010.