BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]
BioCardia
BioCardia touts preliminary data from heart failure trial
BioCardia (OTC:BCDA) touted data today from the first 10 patients treated in its Phase III CardiAmp heart failure trial. The company’s investigational therapy uses a patient’s bone marrow cells to trigger the body’s natural ability to heal itself, according to BioCardia. These data are the first to be published from any pivotal trial of a stem […]
BioCardia wins FDA nod for chronic myocardial ischemia pivotal trial
The FDA has approved a trial to test BioCardia‘s (OTC:BCDA) CardiAMP cell therapy in chronic myocardial ischemia patients with refractory angina. The San Carlos, Calif.-based company could enroll up to 343 patients in the pivotal trial, which is designed to support benefit claims for the cell therapy product without the need for a second confirmatory […]
BioCardia files 2nd FDA IDE bid for CardiAMP chronic myocardial ischemia, refractory angina study
BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy for treating chronic myocardial ischemia and refractory angina as it seeks a second indication. The San Carlos, Calif.-based company’s CardiAMP therapy uses autologous cells to treat chronic myocardial ischemia, and is designed to stimulate […]
BioCardia treats 10-patient cohort in late-stage heart failure trial
BioCardia (NSDQ:BCDA) said today that it finished treating a 10-patient cohort in its pivotal Phase III CardiAmp heart failure trial. The company reported that it expects a review of the 30-day outcomes for this cohort in the third quarter of this year. The CardiAmp pivotal trial, which launched in December, is slated to enroll up to […]
BioCardia, Johns Hopkins treats first patient with CardiAmp cell therapy in Phase III trial
Johns Hopkins, the Maryland Stem Cell Research Fund and BioCardia (NSDQ:BCDA) said today that the 1st patient has been treated in a pivotal Phase III trial of the CardiAmp cell-based therapy for the treatment of ischemic heart failure. The investigational therapy was designed to deliver a dose of a patient’s own bone marrow cells directly […]
BioCardia launches pivotal trial for CardiAmp heart failure treatment
BioCardia (NSDQ:BCDA) initiated its CardiAmp pivotal trial this week to evaluate its cell therapy at 40 clinical sites across the U.S. The pivotal trial is a part of the company’s efforts for premarket approval, as regulated by the FDA’s Center for Biologics Evaluation and Research division. “We are honored to be working with the leading […]
