Benzinga | Dec 1, 2020 07:05AM EST

BioCardia Highlights Published Study Showing Helix Biotherapeutic Delivery System Used In CardiAMP Phase III Heart Failure Trial Has 'Fewest Adverse Events Among Competitive Delivery Systems'

SAN CARLOS, Calif., Dec. 01, 2020 (GLOBE NEWSWIRE) -- BioCardia(r), Inc. (NASDAQ:BCDA) today announced that the Company's proprietary Helix Biotherapeutic Delivery System (the Helix System) demonstrated the best safety profile among clinical transendocardial catheter injection systems used for cardiac cell therapy delivery in an in-press corrected proof published in the journal, Cardiovascular Revascularization Medicine. The Helix System is being used in the pivotal Phase III CardiAMP Heart Failure Trial currently enrolling nationwide for infusion of BioCardia's CardiAMP cell therapy to the myocardium.



The study, which can be accessed here, analyzed clinical trials encompassing 1,789 patients that underwent transendocardial injections using either a helical needle (BioCardia's Helix System), or one of three other clinical use designs developed by BioCardia competitors: an electro-anatomically tracked straight needle, a straight needle without tracking elements, or a curved needle. The paper, titled "Clinical safety profile of transendocardial catheter injection systems: a plea for uniform reporting,"1 was authored by Amish N. Raval, MD, of the University of Wisconsin and Carl J. Pepine, MD, of the University of Florida.

The article reported the combined transendocardial injection-associated serious adverse event (SAE) rate was 3.4% across all four catheters, with the Helix System demonstrating the lowest SAE rate of only 1.1%. The next-closest delivery system had three times as many reported adverse events as the Helix System, with one system having 8.3 times as many adverse events as the Helix System.

In the paper, the authors concluded, "the helical needle designed catheter is associated with a particularly low reported rate of death, myocardial infarction, stroke, cardiac perforation causing death or requiring surgical or percutaneous evacuation, serious arrhythmia, and vascular complications."

"This rigorous, independent review of the scientific literature follows earlier data showing that Helix has the lowest risk to patients2 and most efficient cell delivery3 compared to other leading delivery routes evaluated. Having the safest and highest performance delivery platform enhances the probability that our clinical cell therapy programs will become valuable therapies for millions of patients suffering from cardiac disease," said BioCardia Chief Executive Officer Peter Altman.