BioCardia Release: Study Shows Helix Transendocardial Delivery System Enables Greater Myocardial Retention Of Stem Cell Therapy

SAN CARLOS, Calif.--(BUSINESS WIRE)--BioCardia®, Inc. (OTC:BCDA) today announced publication of a study in the International Heart Journal.¹ According to the study, delivery of stem cell therapy to the heart using the Helix™ transendocardial delivery system results in superior cell delivery than either percutaneous intra-coronary infusion or direct injection in an open chest procedure.

Use of the Helix system resulted in 18 times higher retention of injected cells in the myocardium than intra-coronary artery infusion, and three times higher than direct injection to the heart using a straight needle. Yoshiake Mitsutake, MD from Stanford University’s Division of Cardiovascular Medicine was the lead author of the article.

The authors commented, “Our study indicated that the efficacy of cell delivery using a transendocardial helical infusion delivery system was more efficient than either transepicardial injection or intra-coronary infusion. The Helix transendocardial delivery system has the potential to improve local cell delivery and retention in cardiovascular cell-based therapy, thus potentially improving clinical outcomes.”

Recognizing that there have been variable results for stem cell therapies for cardiovascular disease to date, the authors, who included researchers from BioCardia and Stanford University, intended to study the impact of optimizing the delivery method on cell retention, as a potential strategy to improve patient outcomes. In this pre-clinical study, 12 swine subjects underwent collection of bone marrow cells and delivery of processed stem cells via one of the three delivery methods. PET-CT images were acquired one hour after cell injections to determine cell retention.

The Helix system is used in the company’s investigational CardiAMP® therapy, which is designed to deliver a high dose of a patient’s own bone marrow cells directly to the point of cardiac dysfunction, potentially stimulating the body’s natural healing mechanism after a heart attack. The therapy, including the Helix system, is currently being studied in the U.S. in the CardiAMP Heart Failure Trial, a phase III, multi-center, randomized, double-blinded, sham-controlled study which is enrolling up to 260 patients at up to 40 centers nationwide. For information about eligibility or enrollment in the CardiAMP Trial, please visit www.clinicaltrials.gov or ask your cardiologist.

The Helix system is actively being used, or has been used, in nine other clinical trials, including EXCELLENT (EXpanded CELL ENdocardiac Transplantation), RECARDIO (Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy), and TRIDENT (TRansendocardial Stem Cell Injection Delivery Effects on Neomyogenesis Study).

The company recently entered into new agreements, or amended existing agreements, with AstraZeneca and the University of Washington with respect to evaluating the Helix system for their therapeutic programs.

“The Helix system is an integral part of our investigational CardiAMP therapy, and we are pleased to see these promising results relative to how it may improve tissue retention of cell therapy,” said BioCardia Chief Executive Officer Peter Altman. “We look forward to continued enrollment in our CardiAMP Phase III trial to understand how the investigational therapy may help U.S. heart failure patients in need.”

1. Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart. Int Heart J. 2017. http://doi.org/10.1536/ihj. 16-179.

About BioCardia®

BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP® and CardiALLO® cell therapies are the company’s biotherapeutic product candidates in clinical development. For more information, visit www.BioCardia.com.

Forward Looking Statements

This press release contains forward-looking statements as that term is defined under the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, among other things, the potential efficacy and outcomes from use of our products and therapies and references to the enrollment of our Phase III trial. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, competition in the industry in which BioCardia operates and overall market conditions, and whether the combined funds will support BioCardia’s operations and enable BioCardia to advance its pivotal Phase 3 CardiAMP cell therapy program. 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.