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FDA Approves Cytori’s IDE to Evaluate Cell Therapy for Thermal Burn Injury

After tapping an all-time low of $1.35 on Friday to cap a week in which shares skidded 14.4%, shares of Cytori Therapeutics (NASDAQ:CYTX) are rebounding on a huge increase in trading volume on clinical trial news. Shortly after the opening bell on Monday, shares surged as high as $2.08 from Friday’s close at $1.37.

Cytori said that the FDA gave the green light to an Investigational Device Exemption, clearing the way for a pilot clinical trial of Cytori Cell Therapy ™ for thermal burn injury. Thermal burns result from contact with heated objects, such as boiling water, oils and fire. In the trial, up to 30 badly burned patients will be treated with Cytori’s intravenous cell therapy in addition to usual care, which includes dressings, skin grafts and skin substitutes.

The study, dubbed the “RELIEF” trial, is part of ongoing R&D by Cytori under a contract with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA. Cytori noted that the study is contingent upon BARDA executing a contract option to fund RELIEF, which shareholders obviously believe is going to happen given the government’s support already.

Burns are no small business. The American Burn Association reports that about 450,000 burn injuries happened in the U.S. in 2013, with about 40,000 of those burn victims requiring hospitalization.

Shares of CYTX have slid from the intraday high, but are still holding gains around 35% at $1.85 one hour into the trading session. More than 9 million shares have traded already, compared to an average volume of 145,240 per day over the last three months.