tw0122
4 weeks ago
Watching news .. 08:17 AM EDT, 06/07/2024 (MT Newswires) -- BioCardia (BCDA) said Friday that the US Patent Office has granted a patent for the company's radial and transendocardial biotherapeutic delivery catheter through 2036.
The Helix biotherapeutic delivery system is being evaluated in ongoing clinical trials, according to BioCardia. It relates to medical procedures and systems for substance delivery to the heart through a radial artery and for the intracardiac delivery of cellular aggregates and other materials, the company said.
BioCardia's stock climbed more than 44% in recent Friday premarket activity.
Price: 6.3000, Change: +1.93, Percent Change: +44.16
subslover
8 months ago
BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure
SUNNYVALE, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the Food and Drug Administration (FDA) approval of its Phase III clinical trial of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure.
BioCardia announces that the Food and Drug Administration (FDA) has approved its proposed CardiAMP Heart Failure II study protocol. The currently ongoing CardiAMP Heart Failure trial has completed enrollment and it is anticipated that the final data analyses will be reported in Q4 2024. In an interim analysis of available data to date for study patients followed up through two years, those having N-terminal pro B-type natriuretic peptide (NT-proBNP) levels consistent as demarcating heart failure (>500 pg/ml) at screening-baseline showed meaningful clinical improvements over controls, including a 59% relative risk reduction in heart death and a 54% relative risk reduction of Major Adverse Cardiovascular or Cerebrovascular events (MACCE). Further, all clinical outcome measures evaluated at follow-up for this interim subset favored cell therapy over guideline directed medical therapy, including having improved quality-of-life as measured using the Minnesota Living with Heart Failure Questionnaire, reduced NT-proBNP levels, greater walk distance as measured using the 6-minute walk distance test, and improved cardiac measures such as left ventricular ejection fraction and left ventricular end systolic and end diastolic volumes. Statistical significance (p