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Acute Myocardial Infarction Patients Treated Early With Cell Therapy Delivered With BioCardia's Helix Endocardial Delivery System Improved in Ejection Fraction and NYHA ClassPARIS and SAN CARLOS, Calif., May 23, 2019 (GLOBE NEWSWIRE) -- 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 AI. 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.” About BioCardia 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. Media Contact: Investor Contact:
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