November 28, 2014 10:37 PM ET

Healthcare Equipment and Supplies

Company Overview of BioCardia, Inc.

Company Overview

BioCardia, Inc., a medical device company, designs, develops, manufactures, and distributes minimally invasive tools for cardiovascular therapies. It offers devices to enable percutaneous delivery of biologics to treat cardiovascular diseases. It offers helix biotherapeutic delivery products, including percutaneous catheter delivery systems for cardiovascular regenerative medicine that enables local delivery of cell, gene, and protein based therapies to treat heart failure, myocardial infarction, ischemia, and cardiac conduction disorders. The company also provides advanced catheter products for interventional medicine, which include steerable thin walled catheter shaft technology solutions ...

125 Shoreway Road

Suite B

San Carlos, CA 94070

United States

Founded in 1999

Phone:

650-226-0120

Fax:

650-631-3731

Key Executives for BioCardia, Inc.

Chief Executive Officer
Age: 48
Chief Financial Officer
Age: 54
Director of Research and Development
Director Of Quality Assurance
Vice President of Operations
Compensation as of Fiscal Year 2014.

BioCardia, Inc. Key Developments

BioCardia, Inc. Announces FDA Acceptance of Phase III Clinical Trial Protocol Studying Bone Marrow-Derived Cell Therapy for Heart Failure Patients

BioCardia, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's application to begin a Phase III clinical trial of its bone marrow-derived CardiAMP Therapy for heart failure. The clinical trial is a randomized, controlled, multi-center study of 250 patients evaluating CardiAMP Therapy at up to 40 clinical sites. The CardiAMP Therapy for heart failure integrates a proprietary biomarker panel to identify candidates likely to respond to therapy, a cell processing system consisting of a proprietary, high-dosage formulation of autologous bone marrow-derived cells and a unique transendocardial delivery system that ensures efficient and consistent targeted delivery. This therapy will be reviewed under the PMA regulations by the FDA's Center for Biologics Evaluation and Research (CBER) division. The CardiAMP trial efficacy endpoints include improvements in functional capacity as measured by the Six Minute Walk Test, quality of life as measured by the Minnesota Living with Heart Failure Questionnaire, and survival. Safety endpoints include non-inferiority with respect to survival and freedom from major adverse cardiac events. Studies supporting the CardiAMP Therapy including the Phase I Transendocardial Autologous Bone Marrow in Myocardial Infarction Study, which was published in Eurointervention, and the Phase I/II Transendocardial Autologous Cells in Heart Failure Trial, which was published in the Journal of the American Medical Association (JAMA) - showed statistically and clinically significant results. Trial results have demonstrated an excellent safety profile, as well as functional and quality of life improvements.

CellProThera and BioCardia Sign Agreement to Partner on the EXCELLENT Trial

CellProThera and BioCardia announced an agreement to partner on the EXCELLENT (Expanded Cell Endocardiac Transplantation) Trial, controlled Phase I/IIb study to evaluate the safety and efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand(R) Automated Process and delivered via the BioCardia Helix(TM) Transendocardial Delivery System. The agreement calls for payments to BioCardia, which are creditable to a future clinical development program, and payments to CellProThera for timely completion of the Phase II study. The trial will study patients with an acute myocardial infarction (AMI) and a left ventricle ejection fraction (LVEF) remaining below or equal to 45% after percutaneous transluminal coronary angioplasty (PTCA) and stent(s) implantation versus standard of care. The study will encompass 44 patients treated at up to eight centers in the United Kingdom and France and followed for six months. Co-principal investigators are Jerome Roncalli, MD, PhD, Department of Cardiology, University Hospital of Toulouse, France, and David E. Newby, MD, PhD, University Centre for Cardiovascular Science of Edinburgh, Scotland. The primary endpoint of the study is no treatment emergent major adverse cardiac events (MACE) at 30 days post-procedure. Secondary endpoints will assess the first efficacy trends, the viability of the infarcted segments, safety of the Helix transendocardial delivery procedure and quality of life. In order to simplify and standardize the cell graft production process, CellProThera developed an Automated Process using a cell expansion automate StemXpand(R) and disposable kit StemPack(R). This enables GMP production of as many stem cells as those obtained with one leukapheresis, starting from a whole autologous blood sample simply drawn after G-CSF mobilization, thus avoiding leukapheresis sessions. In pre-clinical studies, the expanded CD34+ cells (Protheracytes(R)) have demonstrated the same therapeutic efficacy as naive cells with no chromosomic alteration, toxicity or tumorogenicity. The Helix Transendocardial Delivery System is a steerable, two-catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart. The system's unique performance advantages include crossing the aortic valve over a wire to prevent damage; enhanced navigation using the company's steerable Morph(R) guiding catheter; a helical needle which screws into the myocardium for stable delivery; and the use of contrast at the base of the needle to confirm tissue engagement.

BioCardia, Inc. Receives CE Mark for New Helix Transendocardial Delivery Catheter

BioCardia, Inc. announced receipt of the CE Mark for its Helix 953L Catheter as part of its Helix Transendocardial Delivery System for infusion of biologics to the heart. The new catheter is optimized for larger, dilated hearts, while maintaining compatibility with smaller hearts. It also does not require biotherapeutic programs already using the Helix system for delivery to develop new compatibility data. The Helix 953L catheter will be commercially available in the European Union in the coming months. The Helix Transendocardial Delivery System is a steerable, two-catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart. The catheter design minimizes the risks associated with navigating within the heart, while reducing procedure times. A helical-shaped needle screws into the myocardium for stable delivery, and contrast delivered from the needle confirms engagement with targeted tissue. The Helix Transendocardial Delivery System has received the CE Mark and is commercially available in the European Union. It is currently being used for investigational biotherapeutic programs in the United States and is not approved for sale in the U.S.

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