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Dignitana AB Receives FDA Approval for Multi-Center Pivotal Trial of New Treatment for Chemotherapy-Related Hair Loss


Wednesday, 5 Jun 2013 07:05am EDT 

Dignitana AB announced that the Company has received U.S. Food and Drug Administration (FDA) approval for its Investigational Device Exemption (IDE) application and is free to initiate a multi-center, pivotal trial of the patented DigniCap System. The trial is the second and final phase of study in the United States and paves the way for FDA market approval of the scalp-cooling device, which is already widely used overseas. Clinical trials will be conducted with 110 patients at prestigious major medical centers in the U.S. including University of California San Francisco, where the trial will be led by Principal Investigator Hope S. Rugo, MD, and Wake Forest Baptist Medical Center, led by Principal Investigator Susan Melin, MD. Several additional sites for the trial, including Medical Centers in New York City, will open throughout the summer. 

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17 Apr 2014