FDA Grants Cytori Conditional Approval for a U.S. Pivotal Clinical Trial in Scleroderma

Author: Cytori
Date Published: December-2014
Source: BusinessWire

Cytori Therapeutics, Inc. (NASDAQ:CYTX) today announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval for an Investigational Device Exemption (IDE) for a pivotal clinical trial, named the ‘STAR’ trial, to evaluate Cytori Cell TherapyTM as a potential treatment for impaired hand function in scleroderma, a rare autoimmune disease affecting approximately 50,000 patients in the United States.