BCDA BioCardia Inc

BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. commercial availability of its AVANCE™ Bi-Directional Steerable Introducer Sheath for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. The product became available in late September.

An introducer sheath is routinely used by electrophysiologists (EPs) and interventional cardiologists (ICs) to facilitate complex conditions such as atrial fibrillation and structural heart procedures. The AVANCE™ device addresses the shortcomings of currently available steerable introducers with its unique patent protected “Morph DNA” technology creating a high performance steerable introducer for superior control during complex procedures.

The AVANCE catheter is designed to have uniform bending characteristics in all directions by having the two tendon wires wrap helically around the catheter shaft, like the double helix in DNA.  The uniform bending characteristics where critically important are intended to reduce what EPs and ICs refer to as “whip” in catheter navigation, where the catheter jumps to a new location in an uncontrolled fashion.

The product is designed with a smooth tip-to-dilator transition which promotes ease of entry into the left atrium during transseptal access. Deflections of 180 degrees in both directions are designed to provide increased steerability, which may improve access to hard-to-reach sites.

The AVANCE™ device was recently used on a patient at John F. Kennedy Hospital (JFK) in West Palm Beach, Florida.

“One of our overall goals is to enhance procedural control by improving products used during procedures,” said Robert Fishel, MD, director of Electrophysiology at JFK. “The AVANCE product performed well in our hands and we found it competitive.”

“The AVANCE product incorporates a significant advance in catheter technology,” said BioCardia CEO Peter Altman, PhD. “ Our team developed the rotating pull wire technology for our cell therapy procedures in the left ventricle of the heart and recognized that it could also significantly benefit patients by enhancing physician control in complex cardiac procedures.”

The AVANCE device will have a limited launch while the company seeks feedback from EPs and ICs on real-world use and explores options for manufacturing at scale.

Procedures that leverage transseptal delivery include atrial fibrillation ablation, patent foramen ovale (PFO) and atrial septal defect (ASD) repair, percutaneous mitral valve repair, left atrial appendage closure, and percutaneous left ventricular assist device placement, among others. The global transseptal access systems market value is currently estimated at $490 million and is expected to increase at a compound annual growth rate (CAGR) of 10.4 percent from 2017 to 2024.1

About BioCardia®

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 statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies, 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, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. 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-Q filed with the Securities and Exchange Commission on August 9, 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.

1. Persistence Market Research (2017). “Transseptal Access Systems Market: Global Industry Analysis (2012-2016) and Forecast (2017-2025).” New York, NY. Persistence Market Research Pvt. Ltd.

INVESTOR CONTACT: David McClung, Chief Financial Officer investors@BioCardia.com (650) 226-0120

MEDIA CONTACT: Michelle McAdam, Chronic Communications, Inc. michelle@chronic-comm.com (310) 545-6654