Durham, NC — Oxygen Biotherapeutics (OB) has announced it has signed a research contract with Hackensack University Medical Center (HUMC) to research the wound-healing properties of its Wundecyte perfluorocarbon (PFC) and its novel oxygen-producing bandage for
treatment of full-thickness excisional wounds and partial thickness burns. The preclinical study funded by the US Department of Defense will also evaluate Wundecyte’s ability to prevent scar formation and improve infection control.

Antoine Carlisle, a research scientist at HUMC, will be the principal investigator. Oxygen Biotherapeutics researchers will work closely with HUMC by participating in the study design and investigator meetings.

According to Oxygen Biotherapeutics Chief Medical Officer Gerald L. Klein, MD, "Wounds and burns are the most common injuries faced by our soldiers daily. We believe that providing additional oxygen may help heal wounds, fight infections and decrease scarring. Wundecyte, our PFC gel, used alone and in combination with a bandage that releases oxygen to the damaged tissue site, may be particularly useful in military applications. Naturally, if study results are favorable, it may also have applications for civilian injuries as well. We look forward to
working closely with HUMC on this important study."

OB has made a gel from Oxycyte that it believes 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. OB asserts 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 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.

SOURCE: Oxygen Biotherapeutics