BioCardia (BCDA) said Monday its two-year phase 3 trial of its CardiAMP cell therapy to treat ischemic heart failure in patients with reduced ejection fraction reached no 'statistical significance' in its primary composite efficacy endpoint.
The double-blind randomized placebo-controlled trial, which involved 115 ischemic heart failure patients with reduced ejection fraction, maintained the patients on heart failure medication, while those treated with the CardiAMP minimally invasive cell therapy received a single dose adjunctive to medication.
The company said the trial results indicated increased survival and reduced major adverse cardiac and cerebrovascular events were observed throughout the study.
The company said it would share trial data with the US Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency to make the therapy available for physicians "as soon as possible."
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