BioCardia Announces United States Patent Issuance on Morph DNA Multi-Directional Steerable Catheter Transseptal Application
July 17 2024 - 6:00AM
BioCardia, Inc. [Nasdaq: BCDA], a company focused on cellular
and cell-derived therapeutics for the treatment of cardiovascular
and pulmonary diseases today announces that the Unites States
Patent Office has granted Patent No: 12,036,371 titled “Method of
Accessing the Left Atrium with a Multi-Directional Steerable
Catheter,” with a patent term that will expire in 2035.
The present invention relates to medical methods for transseptal
access to the heart using steerable introducers based on the
Company’s Morph DNA technology. This additional patent protection
for BioCardia’s current and future products in this important
existing market enhances shareholder value.
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. Worldwide revenue from the transseptal
access systems market was $941.3 million in 2022, with the global
market estimated to expand at a Compound Annual Growth Rate of
7.3%, reaching $2.1 billion by the end of 2033(1).
Morph DNA designs enable the tensioning elements in the catheter
to rotate around the catheter shaft, allowing consistent catheter
performance in any direction. The DNA name reflects this design, as
these tensioning elements appear as a double helix like that in a
strand of DNA. This design is intended to enable smooth navigation
and prevent “whip,” when the build-up of mechanical forces in the
device causes a catheter to suddenly jump from one orientation to
another.
“All of the biotherapeutic interventions we support for
treatment of heart failure, refractory angina, and acute myocardial
infarction going forward are expected to utilize this same
introducer technology platform,” said Peter Altman, PhD,
BioCardia’s President and Chief Executive Officer. “This is an
elegant solution to a long-standing technical issue. The solution
enhances the level of physician control in our procedures, and
BioCardia is working to provide or partner this solution for the
roughly five hundred thousand transseptal procedures performed in
the United States each year, and for other vascular access markets
that can benefit from the advantages our patented solution
provides.”
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is
developing cellular and cell-derived therapeutics for the treatment
of cardiovascular and pulmonary disease. CardiAMP® autologous and
CardiALLO™ allogeneic cell therapies are the Company’s
biotherapeutic platforms with three clinical stage product
candidates in development. These therapies are enabled by its Helix
biotherapeutic delivery and Morph vascular navigation product
platforms.
For more information visit: www.BioCardia.com.
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 Company’s
investigational product candidates, the advantages of the Morph DNA
design, and the potential transseptal access delivery vascular
market for the Morph DNA steerable introducer product Family. 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 March 27, 2024,
under the caption titled “Risk Factors” and in its subsequently
filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims
any intent or obligation to update these forward-looking
statements, except as required by law.
(1) Persistence Market Research
(2022). “Transseptal Access Systems Market Outlook (2023-2033).”
New York, NY. Persistence Market Research Pvt. Ltd.
Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
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