Acute Myocardial Infarction Patients Treated Early With Cell Therapy Delivered With BioCardia's Helix Endocardial Delivery System Improved in Ejection Fraction and NYHA Class
May 23, 2019
Late-Breaking Trial Session at EuroPCR Featured Positive Data on Helix System
PARIS and SAN CARLOS, Calif. – BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced positive results from a study of the company’s Helix™ Biotherapeutic Delivery System for cell therapy used to treat patients early following acute myocardial infarction (AMI) to prevent long term heart failure. The results were presented yesterday at EuroPCR by Christina Paitazoglou, MD, with the Cardiologicum Hamburg, Germany during a Hot Line/Late Breaking Trials session of innovative first-in-man trials and early phase studies entitled “Early transendocardial injection of autologous bone marrow-derived mononuclear cells following ischaemic myocardial events: the Alster-Helix registry.”
The study was designed to determine if intramyocardial injection of autologous bone marrow-derived mononuclear cells using the Helix™ System two to four weeks after AMI is feasible, might block ventricular adverse remodeling and improve symptoms of heart failure.
Nine patients were treated with cell therapy delivered intramyocardially with the Helix™ system, and these results were reviewed relative to 11 patients previously treated with the NOGA XP delivery system and a control group of 11 patients treated with optimal standard care.
At 12 months, patients with Helix™-delivered cell therapy experienced a 7.33 percent improvement in ejection fraction at 12 months (p=0.017) compared to the control group. (There was no 12 month data available for the NOGA system at 12 months.) Helix™ patients also showed an improvement in NYHA class of more than one class over control at six months (2.55 ±0.1 vs. 1.33 ±0.1, p=0.0078), which was greater than both the NOGA-treated and control groups.
“Results suggest that intramyocardial cell therapy possibly improves left ventricular function and symptoms by attenuating myocardial remodeling on top of successful PCI and optimal standard care after AMI. Results (for the Helix™ system) are similar to the NOGA-treated patients, as previously observed in the ALSTER stem cell trial,” said Dr. Paitazoglou in her presentation.
“This is the first study of the Helix™ system used with patients early after a heart attack to prevent heart failure, and the results are very encouraging. The Helix system is currently part of a U.S. Phase III pivotal trial of our CardiAMP™ cell therapy used in patients with heart failure resulting from a heart attack, and 12-month results from a 10-patient roll-in group showed similar improvements in ejection fraction and patient symptoms, among other measures,” said BioCardia CEO Peter Altman PhD. “While the therapy studied in this current study is not the same as our CardiAMP cell therapy, it nonetheless demonstrates the promise of Helix™ delivery of autologous bone-marrow derived cells to improve the lives of patients with cardiovascular disease. We look forward to continued study of the Helix™ system to determine its success in delivering a variety of cell therapies, from those we develop ourselves to those from others.”
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, the intended outcomes of our trials, the efficacy and safety of our products and therapies, 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, 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 2, 2019, including those 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
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