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51 articles with BioCardia, Inc.
BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the AVANCE™ steerable introducer product family, designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum
BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported financial results for the fourth quarter and full year ended December 31, 2018, filed its annual 10-K with the Securities and Exchange Commission, and shared recent business highlights.
Alexander (Sasha) Opotowsky, associate professor at Harvard Medical School and a cardiologist at Boston Children’s Hospital and Brigham and Women’s Hospital took time out to speak with BioSpace about advances in heart health, congenital heart disease (CHD), biopharma, and the Adult Congenital Hea...
BioCardia Submits 510(k) Application to FDA for AVANCE Steerable Introducer for Transseptal Access to Heart
The AVANCE steerable introducer leverages new technology developed for BioCardia’s Morph family of steerable introducers and applies it for transseptal procedures.
Positive 12-Month Data on BioCardia’s Investigational CardiAMP Cell Therapy System for Heart Failure Presented at American Heart Association Scientific Sessions 2018
BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced positive 12 month data for the roll-in cohort of its pivotal CardiAMP™ Heart Failure Trial studying the investigational CardiAMP Cell Therapy System in adult patients experiencing heart failure following a heart attack
Enrollment in the pivotal CardiAMP™ Heart Failure Trial has expanded to 18 world class centers in the United States, as detailed on ClinicalTrials.Gov.
BioCardia Welcomes Cardiovascular Device Veteran Mark Schwartz as Vice President of Clinical Affairs
BioCardia® today announced that Mark Schwartz, a 25-year veteran of cardiovascular device development, has joined the company as Vice President of Clinical Affairs, effective November 1.
BioCardia and CellProThera Partner for Clinical Trial and Marketing in Singapore of Early Stem Cell Therapy for Patients Following Myocardial Infarction
The study will evaluate the safety and efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process and delivered via BioCardia’s Helix™ Biotherapeutic Delivery System for the treatment of patients soon after a heart attack.
Positive Data On BioCardia's Investigational CardiAMP Cell Therapy For Heart Failure Presented At Transcatheter Cardiovascular Therapeutics (TCT) Conference
CardiAMP Therapy Demonstrated Clinically Meaningful Patient Improvements at Nine Months Helix Delivery System for CardiAMP Therapy Shown to Have Best Safety Profile Compared to Leading Biotherapeutic Intramyocardial Delivery Approaches in Clinical Trial Use Today.
Preliminary Results From BioCardia's Phase III Pivotal CardiAMP Heart Failure Trial Reported In Circulation Research Journal
In a Viewpoint paper published in Circulation Research, the Phase III CardiAMP Heart Failure Trial studying the investigational CardiAMP stem cell therapy from BioCardia®, Inc. was highlighted as an example of personalized medicine, with promising results from the first 10 patients in the roll-in cohort reported.
BioCardia®, Inc. reported financial results and business highlights for the second quarter 2018 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2018 with the Securities and Exchange Commission.
BioCardia reported a net loss of $3.6 million for the first quarter of 2018, which compares to a net loss of $2.9 million for the first quarter of 2017.
Centers for Medicare and Medicaid Services Approves Reimbursement for BioCardia’s CardiAMP Cell Therapy in Pivotal Clinical Trial Studying Second Indication in Chronic Myocardial Ischemia
Medicare reimbursement in the pivotal trial of the CardiAMP Cell Therapy System significantly enhances the Company’s ability to complete this important trial
BioCardia Receives New Potency Assay Patent, Providing Further Protection to Autologous Cell Therapy Programs in Heart Failure and Refractory Angina
BioCardia®, Inc. announced the issuance of United States Patent No. 9,945,854 relating to methods of measuring therapeutic potency potential and defining dosages for autologous cell therapy.
BioCardia Presents at Alliance for Regenerative Medicine's (ARM's) Annual Cell & Gene Therapy Investor Day
BioCardia is a leader in cardiovascular regenerative medicine.
The paper describes the ongoing 260-patient clinical trial being conducted in up to 40 centers in the U.S. It was authored by the team of world-class clinician scientists who comprise the steering committee for the trial.
Leader in the development of comprehensive solutions for cardiovascular regenerative therapies, announced it filed its annual 10-K for the year ended December 31, 2017 with the Securities and Exchange Commission on Friday, March 16, 2018.
The trial has been approved to enroll up to 343 subjects at up to 40 U.S. centers.
BioCardia Submits Clinical Trial to FDA for New Indication of Chronic Myocardial Ischemia for CardiAMP Cell Therapy
BioCardia today reported filing a second Investigational Device Exemption with the Food and Drug Administration (FDA) for the CardiAMP Chronic Myocardial Ischemia Trial to treat patients with refractory angina.
BioCardia reported a net loss of $3.0 million for the third quarter of 2017, which compares to a net loss of $3.3 million for the third quarter of 2016.