BCDAW BioCardia Inc

BioCardia®, Inc. [Nasdaq: BCDA] a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the issuance of U.S. Patent No: 10,780,248 for a “Radial and Transendocardial Delivery Catheter” that further protects the Helix™ Biotherapeutic Delivery System and enhances its cell therapy delivery capabilities. The patent does not expire until after September 29, 2034.

This patent covers a needle injection catheter system appropriate for transradial biotherapeutic delivery to the heart, and strengthens the Company’s clinical stage biotherapeutic programs in heart failure and chronic myocardial ischemia.

“Delivery is critically important to successful biotherapeutic treatment. You can have a promising cell therapy, but if sub-par delivery doesn’t facilitate biologic retention by the heart or has a poor safety profile, it can cause a therapy to fail,” said BioCardia CEO Peter Altman, PhD. “At BioCardia, we have always recognized the important role delivery plays in the overall success of our therapeutics and in their promise to improve the lives of millions of patients with heart disease. This additional patent protection for our Helix system used in a transradial approach accessing the heart through an artery in the wrist, in addition to the transfemoral approach, enables us to offer the most robust delivery capabilities of any cell therapy developer.”

Cardiac catheter insertion through the small transradial artery in the wrist is growing in popularity as a delivery approach for percutaneous coronary interventions (PCI). It is used outside of the U.S. in more than 23 percent of PCIs, according to some estimates.1 This level of adoption is due to increasing evidence that transradial delivery increases patient safety by reducing bleeding complications, and may help reduce costs by decreasing hospital admissions, length of stay and patient risk.2 Transradial artery PCI is expected to reduce costs to the healthcare system through same-day discharge, which costs nearly $3,700 less than transfemoral PCI without same-day discharge.3

About BioCardia®BioCardia, Inc., headquartered in San Carlos, California, is developing autologous and allogenic cell-based therapies to treat cardiovascular disease. CardiAMP™ and CardiALLO™ cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company has also developed a portfolio of approved enabling products that optimize delivery of its cell therapies.

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, references to the robustness the Company’s delivery system capabilities and the level of adoption and anticipated cost reductions associated with transradial procedures for PCI.

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 our documents filed with the SEC, including our recent filings on Form 8-K, Form 10-K and Form 10-Q, particularly any statements under the caption entitled “Risk Factors” therein.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. 

References

1. Valle JA, Kaltenbach LA, Bradley SM, et al. Variation in the adoption of transradial access for ST-segment elevation myocardial infarction: insights from the NCDR CathPCI Registry. JACC Cardiovasc Interv. 2017;10:2242-2254.
2. Ferrante G, Rao SV, Jüni P, et al. Radial versus femoral access for coronary interventions across the entire spectrum of patients with coronary artery disease: a meta-analysis of randomized trials. JACC Cardiovasc Interv. 2016;9:1419-1434.
3. Amin AP, Patterson M, House JA, et al. Costs associated with access site and same-day discharge among Medicare beneficiaries undergoing percutaneous coronary intervention: an evaluation of the current percutaneous coronary intervention care pathways in the United States. JACC Cardiovasc Interv. 2017;10:342-351.

Media Contact: Michelle McAdam, Chronic Communications, Inc.michelle@chronic-comm.com  (310) 902-1274

Investor Contact: David McClung, Chief Financial OfficerInvestors@BioCardia.com (650) 226-0120