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- BioCardia Inc (NASDAQ:BCDA) announced data from its CardiAMP Cell Therapy for Heart Failure pivotal trial.
- "The two-year outcomes for patients with heart failure receiving the investigational CardiAMP Cell Therapy in the roll-in cohort showed clinical improvement with 100% survival over two years. These outcomes surpassed our expectations in terms of patient benefit across prespecified primary and secondary endpoints," said Peter Altman, BioCardia's President & CEO.
- "While this smaller cohort is not a head-to-head comparison, the current state of the art therapies for these patients which have been successful in slowing disease, are assessed by us to have 79.9% survival after two years."
- Related: FDA Approves BioCardia's Phase 1 Trial With Cell Therapy In COVID-19, Shares Jump.
- Improvement in median functional capacity as measured by a six-minute walk distance was observed by six months (28.5 m), with a six-minute walk distance maintained through 24 months (31.0 m).
- In the study, 70% of patients reported improved or stable quality of life over 24 months.
- At 24 months, 50% of patients were improved by at least one NYHA class (n=4 at class I), 20% had unchanged NYHA class, and 30% deteriorated by one class, from class II to III.
- Price Action: BCDA shares are up 5.67% at $2.05 on the last check Monday.
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