BioCardia Announces New U.S. Patent Covering CardiAMP Cell Therapy and Issuance of Two Asian Patents Covering Radial Artery Approach for Cardiac Cell and Gene Therapy Delivery
January 08, 2020
SAN CARLOS, Calif. – BioCardia®, Inc. [NASDAQ: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of three new patents for the company’s technologies in the U.S., China and Japan.
The new U.S. patent relates to the cell potency assay used in its CardiAMP™ Cell Therapy System, issued as U.S. Patent No: 10,520,505. The patent is for “Methods of Measuring Potential for Therapeutic Potency and Defining Dosages for Autologous Cell Therapies.” The Company also has European patent coverage for this technology.
This CardiAMP patent addresses the problem of patient cell variability and high manufacturing costs associated with typical autologous cell therapy by identifying a specific biomarker signature in a patient’s bone marrow that is utilized in the CardiAMP pre-procedural selection diagnostic assay. The test enables physicians to determine if a patient is a good candidate for CardiAMP cell therapy prior to treatment, enabling point-of-care therapy processing and eliminating costly remote cell selection and processing.
“We are vigorously protecting the proprietary technologies that differentiate our CardiAMP Cell Therapy System from cardiac cell therapies that have been previously studied. By adding a pre-procedural assay for patient selection, we believe we have improved upon what has come before us,” said BioCardia CEO Peter Altman, PhD. “Our cell potency assay is currently being studied in our Phase III pivotal CardiAMP Heart Failure Trial and is part of our second Phase III pivotal trial of the CardiAMP cell therapy for the treatment of chronic myocardial ischemia, which has been FDA-approved and whose start is pending.”
“We are enthusiastic about the potential of CardiAMP cell therapy to improve the heart without requiring cells to become heart cells, avoiding the potential for cells to become ectopic foci causing life-threatening arrhythmias and eliminating the need for chronic immunosuppression drugs.”
Two additional, newly-issued patents relate to a Radial and Trans-Endocardial Delivery Catheter for intramyocardial delivery of cardiac cell therapy, a new delivery approach for the Company. The Japan Patent Office issued Patent No: 6600301 and the China National Intellectual Property Administration issued Patent No: XL 2014 8 00653862, both of which expire in September 2034.
The issued claims cover the Company’s new “Trillium” delivery catheter design for transradial arterial access that is distinct from, but built upon the design of, the company’s Helix™ Biotherapeutic Delivery System. In the new design, the penetrating element uses a straight needle system with perforation protection “petals” that deploy automatically from the guide catheter. The “petal” configuration is designed to prevent myocardial perforation, an issue that has been seen with other straight needle catheter systems. Additional transradial designs using BioCardia’s existing 5 French Helix platform are also disclosed in the patents.
Cardiac catheter insertion through the small transradial artery in the wrist is growing in popularity as a delivery approach for percutaneous coronary interventions (PCI). This is due to increasing evidence that it increases patient safety by reducing bleeding complications, and may help reduce costs by decreasing hospital admissions, length of stay and patient risk. Radial access is widely used outside the U.S. and has grown to more than 23 percent of PCIs, according to some estimates.
“Based on physician adoption and interest in transradial access to date, we believe that our new, patented Helix and Trillium transradial designs have implications for the future of local biotherapeutic intervention in cardiology, and may play a role in the further development of our CardiAMP and CardiALLO™ biotherapeutics,” said Dr. Altman. “In the future, we would like to enable our cell therapies as an outpatient transradial procedure where patients are sent home the same day with their arm in a sling and only a simple bandage on their wrists.”
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, including transradial intramyocardial delivery of cells, 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-Q filed with the Securities and Exchange Commission on August 9, 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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