BioCardia Receives New Potency Assay Patent, Providing Further Protection to Autologous Cell Therapy Programs in Heart Failure and Refractory Angina

April 25, 2018

SAN CARLOS, Calif. BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today 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 CEO Peter Altman, PhD, stated, "This new patent reflects the personalized approach we are taking with CardiAMP cell therapy. It details aspects of performing pre-procedural screening of a patient’s bone marrow to determine if he or she is appropriate for the therapy. By selecting patients most likely to respond to therapy, we anticipate magnifying the efficacy signal in our CardiAMP cell therapy system clinical programs.”

The patent provides coverage for BioCardia’s CardiAMP Cell Therapy System, which is being studied in two FDA-approved pivotal clinical trials for the large unmet needs of heart failure and chronic myocardial ischemia with refractory angina. The heart failure trial is currently enrolling patients at 10 centers in the United States, while the refractory angina trial is expected to begin patient enrollment later this year.

In prior marrow heart failure studies, therapeutic benefit has been correlated to higher effective doses of specific cell types. One of the primary challenges with point-of-care autologous cell therapy is the variability of a patient’s own stem cells. The CardiAMP cell potency assay is designed to address this variability by assessing whether the amount of select cell types from a marrow sample meets a proprietary acceptance criterion derived from data from these past trials. The CardiAMP cell potency assay is an important element of the CardiAMP Cell Therapy System development and is believed to be the first assay of its kind proposed as a quality-based inclusion criterion for a non-cultured autologous cell therapy.

BioCardia Chairman Simon Stertzer, M.D., added, “This issued patent describes one important element of our comprehensive approach to advancing cell therapy for the treatment of heart disease. Data tells us that this personalized medicine element, in conjunction with other elements in the CardiAMP Cell Therapy System, should maximize our probability of clinical and commercial success.”

About BioCardia®
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™ transendocardial delivery system and the Morph® steerable guide and sheath catheter portfolio. 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, the efficacy and safety of our products and therapies, statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies, 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. We may find it difficult to enroll patients in our clinical trials, which could delay or prevent development of our therapeutic candidates. 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, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation 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 March 16, 2018, 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.

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biocardia takes a new and comprehensive
approach to heart failure

By introducing patient screening and highly-efficient delivery to stem cell therapy, the company seeks to increase the likelihood of treatment success, enabling more patients to return to the things they love.