Shares of Cytori Therapeutics (NASDAQ: CYTX) are up 34% in morning trade after the company said that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for a pilot clinical trial to evaluate Cytori Cell Therapy™ in patients with thermal burn injury. The RELIEF trial continues the company’s ongoing research and development work 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 trial will 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. “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,” president and CEO Dr. Marc Hedrick stated in the news release.
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About Cytori Therapeutics, Inc.
Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. Cytori Nanomedicine™ is developing encapsulated therapies for regenerative medicine and oncologic indications. For more information, visit www.cytori.com.
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