BioCardia, an American regenerative medicine company, said that its CardiAMP Cell Therapy has shown patient benefits in key outcomes of a chronic myocardial ischemia trial.
The trial assessed CardiAMP Cell Therapy in patients with chronic myocardial ischemia and refractory angina. The primary endpoint results of the open-label roll-in cohort of the trial displayed promising findings.
On average, there was a 107-second increase in exercise tolerance and an 82% reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment.
Additionally, every patient responded well to the therapy, demonstrating improved exercise tolerance and reduced angina.
These initial, open-label results are comparable to outcomes achieved by existing US Food and Drug Administration (FDA)-approved treatments.
The findings also align with previous compelling investigational trials that employed cost prohibitive cell therapy.
CardiAMP uses a patient`s bone marrow cells, which are delivered to the heart through a minimally invasive, catheter-based procedure. The approach aims to activate the body`s innate healing mechanisms.
The therapy has gained breakthrough therapy designation for ischemic heart failure from the FDA.
BioCardia president and CEO Peter Altman said: “The clinical research results presented for the roll-in cohort from our CardiAMP CMI Trial highlight BioCardia’s continuing efforts to transform the treatment paradigm in refractory angina through the promise of a one‑time cost effective minimally invasive autologous cell-based therapy.
“These results strongly support our continued development of this novel therapeutic approach and enhance the value of our CardiAMP cell therapy platform for shareholders and future partners.”
Based in California, BioCardia is focused on advancing cellular and cell-derived treatments for cardiovascular and pulmonary conditions.
The company`s primary biotherapeutic platforms, CardiAMP autologous and CardiALLO allogeneic cell therapies, target heart disease.
Additionally, BioCardia forges collaborations to provide its biotherapeutic delivery system and supports preclinical and clinical development services for delivering biotherapeutics to the heart.
Last month, the biotechnology company announced positive results from the Phase 3 trial of its CardiAMP autologous cell therapy in patients with advanced chronic heart failure.
