mardi 22 septembre 2020

BioCardia Submits 510(k) Application to FDA for AVANCE Steerable Introducer for Transseptal Access to Heart

Par Rédaction , dans Communiqués , le 11 décembre 2018

Tuesday, December 11th 2018 at 12:00pm UTC

 [OTC: BCDA], a leader in the development of comprehensive
solutions for cardiovascular regenerative therapies, today announced its
510(k) submission for U.S. Food and Drug Administration (FDA) clearance
of the AVANCE™ steerable introducer, designed for introducing various
cardiovascular catheters into the heart, including via the left side of
the heart through the interatrial septum.

The AVANCE steerable introducer leverages new technology developed for
BioCardia’s Morph family of steerable introducers and applies it for
transseptal procedures. The bidirectional AVANCE is designed to be
virtually whipless around curves, due to its helically arranged
pull-wires, and provides exceptional torsional stiffness. AVANCE also
offers a rotating hemostasis port. These features are intended to enable
greater predictability, stability and control during procedures.

“The best-in-class design that underlies AVANCE was developed to enhance
delivery of our investigational CardiAMP and CardiALLO cell therapies,”
said BioCardia CEO Peter Altman, PhD. “We are excited about making this
product available to the broader transseptal market, and expect it to
favorably impact revenues in the second half of 2019.”

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
size is currently estimated to be valued at over $550 million and is
expected to increase at a compound annual growth rate (CAGR) of 11.7
percent from 2018 to 2028.1

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. 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, the efficacy and safety of our products and
therapies, 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, regulatory approvals, future
revenues, 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
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 16, 2018, including those 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. Bekryl Market Analysts (2018). Global Transseptal Access Systems
Market Size Analysis, 2018-2028. New York, NY.


Media Contact:
Michelle McAdam, Chronic Communications, Inc.

Investor Contact:
David McClung, Chief Financial Officer

Source: BioCardia, Inc.

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