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BioCardia, Inc. (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial.
Results from the open label roll-in cohort patients having chronic myocardial ischemia with refractory angina show that the minimally-invasive CardiAMP Cell Therapy procedure was well tolerated with no treatment emergent major adverse cardiac events. All patients were on guideline-directed medical therapy (GDMT) and responded positively to the autologous cell therapy. Patients experienced increased exercise tolerance of an average of 80 seconds and an average of 82% reduction in angina episodes at the six-month primary endpoint when compared to measurements prior to cell therapy treatment. Sixty percent of the patients showed substantial improvements in both measures.
These early, open-label results compare favorably to those demonstrated by current FDA approved therapies such as Ranolazine and Enhanced External Counter Pulsation (EECP). Patients already on Ranolazine experienced dramatic reduction in angina episodes at the six-month follow-up. These results are in line with previous compelling investigational trial results utilizing cost prohibitive cell therapy.
Posted In: BCDA
