BioCardia Submits for FDA Approval of Morph® DNA™ Steerable Introducer Product Family
July 30 2024 - 6:00AM
BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today reported it has submitted a 510(k) for
approval of its patented Morph® DNA™ Steerable Introducer Sheath.
This product family is intended to provide a pathway through which
medical instruments, such as balloon dilatation catheters,
guidewires, or other therapeutic devices, may be introduced into
the peripheral vasculature or chambers and coronary vasculature of
the heart.
The filing for approval of this product family follows the FDA
approval of BioCardia’s Helix biotherapeutic delivery Morph DNA
guide system and its Avance transseptal steerable introducer, both
of which incorporate Morph DNA technology. 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.
This potential vascular market for this product family is
measured in millions of procedures per year, including cardiac
interventions such as structural heart procedures and
electrophysiology procedures, peripheral vascular interventions
including renal interventions, endovascular aortic repair, and
carotid artery interventions. The product family approval is
intended to span the range of sizes and lengths to accommodate many
of these procedures.
“All of the biotherapeutic interventions we support for
treatment of heart failure, refractory angina, and acute myocardial
infarction are expected to utilize this same introducer technology
platform,” said Peter Altman, PhD, BioCardia’s President and Chief
Executive Officer. “This submission for approval of the Morph DNA
Steerable Introducer Sheath product family for broader clinical
usage in other complex clinical procedures is in line with our
mission to enable and advance therapeutic solutions for
cardiovascular and pulmonary diseases.”
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 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.
Media Contact: Miranda Peto, Marketing /
Investor RelationsEmail: mpeto@BioCardia.comPhone:
650-226-0120
Investor Contact: David McClung, Chief
Financial OfficerEmail: investors@BioCardia.comPhone:
650-226-0120
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