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June 30, 2015 4:37 PM ET

Biotechnology

Company Overview of BioCardia, Inc.

Company Overview

BioCardia, Inc., a clinical-stage regenerative medicine company, develops therapeutics for cardiovascular diseases. The company offers the Helix biotherapeutic delivery system product line that offers a catheter system for the local delivery of cells, gene, and protein therapeutics to the heart; and the Morph vascular access product line, which offers catheter products for interventional medicine. Its lead therapeutic candidate is the CardiAMP Cell Therapy System that is in Phase III pivotal trial for ischemic systolic heart failure. The CardiAMP Cell Therapy System comprises cell potency screening test, a point of care cell processing platform, and a biotherapeutic delivery system. BioCardi...

125 Shoreway Road

Suite B

San Carlos, CA 94070

United States

Founded in 2002

30 Employees

Phone:

650-226-0120

Fax:

650-631-3731

Key Executives for BioCardia, Inc.

Chief Executive Officer, President and Director
Age: 48
Chief Financial Officer
Age: 54
Vice President of Operations
Age: 48
Vice President of Clinical & Regulatory Affairs
Age: 59
Director of Research and Development
Compensation as of Fiscal Year 2014.

BioCardia, Inc. Key Developments

BioCardia Seeks Acquisitions

BioCardia, Inc. has filed an IPO in the amount of $57.50 million. BioCardia said, "We also may use a portion of the net proceeds to acquire complementary businesses, products, services or technologies. The amount and timing of these expenditures will vary depending on a number of factors, including competitive and technological developments and the rate of growth, if any, of our business."

BioCardia, Inc. Auditor Raises 'Going Concern' Doubt

BioCardia, Inc. filed its Annual on Jun 16, 2015 for the period ending Dec 31, 2014. In this report its auditor, KPMG LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.

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.

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