BioCardia Announces Issuance of European Patent for Breakthrough Diagnostic Assay for Patient Selection Prior to Cardiac Cell Therapy Delivery
August 07, 2019
SAN CARLOS, Calif. – BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the European Patent Office has issued the Company Patent No: 3063172 for “Methods of Measuring Potential for Therapeutic Potency and Defining Dosages for Autologous Cell Therapies.”
Today, autologous cardiac cell therapy – where a patient’s own cells are used – is challenged by patient variation, which makes outcomes unpredictable, and by the high costs associated with manufacturing single-batch therapy remotely for each patient. BioCardia’s new patent addresses a potential solution to these problems – a diagnostic approach for patient selection that identifies a specific biomarker signature in a patient’s bone marrow. This test enables a physician to determine if a patient is a good candidate for either of the Company’s two lead clinical indications of heart failure or chronic myocardial ischemia prior to treatment, allowing for point-of-care processing of the therapy and eliminating the significant expense of selecting and processing cells remotely.
“Our diagnostic assay is a potential breakthrough in improving outcomes and dramatically reducing costs for autologous cardiac cell therapy,” said BioCardia CEO Peter Altman PhD. “The assay serves as a quality control means of selecting the most appropriate patients for therapy and may in the future be used to set dosages for therapy. It also avoids the potential technical hurdles of allogenic cell therapy, using donor cells, which can create risks for patients.”
The Company has an issued United States patent covering this technology, as well as additional patents and patents pending for other proprietary technology related to its stem cell therapies in the U.S., Europe, Japan, China and India.
BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP™ and CardiALLO™ cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company's current products include the Helix™ Biotherapeutic Delivery System and the Morph® steerable guide and sheath catheter portfolio, including the new AVANCE™ Steerable Introducer family. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, our ability to develop and secure regulatory approval for the cell potency assay described in the issued patent, its ability to enhance outcomes, reduce costs, act as a quality control for cell therapy and act as a means to set dosage for these therapies, and statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, FDA regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on April 2, 2019, including under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Michelle McAdam, Chronic Communications, Inc.
David McClung, Chief Financial Officer
Henry Ford Health System
Cell & Gene
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