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Home » BioCardia wins FDA nod for chronic myocardial ischemia pivotal trial

BioCardia wins FDA nod for chronic myocardial ischemia pivotal trial

January 30, 2018 By Sarah Faulkner

BioCardiaThe FDA has approved a trial to test BioCardia‘s (OTC:BCDA) CardiAMP cell therapy in chronic myocardial ischemia patients with refractory angina.

The San Carlos, Calif.-based company could enroll up to 343 patients in the pivotal trial, which is designed to support benefit claims for the cell therapy product without the need for a second confirmatory trial.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: BioCardia

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