Cytori Rises on Crucial FDA Approval

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Cytori Therapeutics Inc. (NASDAQ: CYTX) saw its shares explode after it was reported that the firm received approval from the U.S. Food and Drug Administration (FDA) for its treatment of thermal burn injuries. Specifically, the agency approved an Investigational Device Exemption (IDE) for a pilot clinical trial to evaluate Cytori Cell Therapy.

The Relief trial is a continuation of Cytori’s ongoing research and development efforts under its contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.

The objective is for this trial to assess safety and feasibility of intravenous delivery of Cytori Cell Therapy as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. Currently, Relief is approved to enroll up to 30 patients in up to 10 U.S. sites. The initiation of the trial is dependent upon execution of a contract option by BARDA to provide the necessary funds.

The current standard of care consists of dressings, skin grafts and skin substitutes. Although these treatments are the standard, patients with severe burns commonly suffer from prolonged pain, aggressive scarring, skin contracture and reduced range of motion. The treatment offered by Cytori may have the potential not only to improve the quality and rate of wound healing and reduce scarring but also to be deployable in a cost-effective manner.

According to the American Burn Association, there were roughly 450,000 burn injuries in 2013 that required medical treatment in the United States, with around 40,000 requiring hospitalization.

Dr. Marc Hedrick, president and CEO of Cytori, commented:

This announcement is yet another milestone achieved as BARDA and Cytori continue to move this technology forward through the development process, from preclinical to clinical implementation. Approval of RELIEF is a major step towards the ultimate goal of making this technology available to our citizens as a national countermeasure against burn injuries potentially including those complicated by radiation exposure.

Shares of Cytori were last seen up nearly 34% at $1.83 on Monday, with a consensus analyst price target of $6.92 and a 52-week trading range of $1.35 to $5.40.