BioCardia (NSDQ:BCDA) said today it filed for a second FDA investigational device exemption to launch a trial of its CardiAMP cell therapy of 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 the […]
BioCardia
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. Get the full story at our sister site, Drug Delivery Business News.
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. Get the full story at our sister site, Drug Delivery […]
BioCardia closes Tiger X Medical merger
BioCardia said today it closed its merger with Tiger X Medical (OTC:CDOM), with the combined company retaining the BioCardia name and “BCDA” ticker. San Carlos, Calif.-based BioCardia said it converted all outstanding convertible promissory notes into shares of common stock before the merger, putting approximately $25 million in cash in their packets before the payment of […]
Opko Health gets in on BioCardia after merger with Tiger X Medical
BioCardia said today that Opko Health (NYSE:OPK) agreed to pick up a “significant” stake in its business after a merger with Tiger X Medical (OTC:CDOM). The new company will keep the BioCardia name and the development program for its CardiAMP cell therapy for heart failure patient’s who’ve had a heart attack. Stem cells derived from the bone marrow of […]
BioCardia touts positive outcomes for Helical stem cell therapy system
California-based BioCardia Inc. announced this week positive findings from a clinical trial of its Helical Infusion Catheter System for injecting stem cells into the heart in treatment of chronic ischemic cardiomyopathy.