BioCardia Signs Exclusive Development Agreement with AstraZeneca
July 25, 2019
SAN CARLOS, Calif. – BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced it has signed an extension to a 2017 development agreement with AstraZeneca [NYSE:AZN] for BioCardia’s Helix™ biotherapeutic delivery catheter system.
Under the terms of the initial pre-clinical phase of the relationship, BioCardia will receive a sizable upfront payment, a portion of which will be creditable to BioCardia biotherapeutic delivery systems, support and training. The agreement is exclusive with respect to a class of biotherapeutic agents that BioCardia is not currently developing on its own or with any other party and is time limited.
“We are delighted to continue our collaboration with AstraZeneca, a world-class therapeutics leader,” said BioCardia CEO Peter Altman, PhD. “As we advance our own CardiAMP cell therapy clinical programs that benefit from delivery with our Helix system, BioCardia is also leveraging its technology to make significant contributions to therapeutics development by others.”
The Helix Biotherapeutic Delivery System has been chosen for use in a total of 12 cell and gene therapy trials to date, nine of which are outside of the company. In September 2018, a presentation of the clinical safety experience of the Helix system used in 300 procedures showed that it presents the lowest risk to patients for cell and gene delivery to the heart, when compared to all other delivery systems in the scientific literature for which data is available.
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 book revenue from the transaction in 2019, 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, 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-K filed with the Securities and Exchange Commission on April 2, 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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