BioCardia Announces Helix™ Biotherapeutic Delivery Patent Issuance in Japan
08 Junho 2023 - 8:00AM
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 Japan Patent Office
has granted Patent No: JP7282649B2 titled “Radial and
Transendocardial Delivery Catheter” with a patent term that will
expire on September 30, 2034.
This patent describes interventional biotherapeutic delivery
catheters to deliver biologics to specific target sites from within
the heart chamber. The allowed claims cover BioCardia’s helical
needle tipped catheter technology platform in existing products and
in future products in active development with enhanced
features.
“Our Helix™ minimally invasive biotherapeutic delivery platform
enables the successful development of cell and gene-based therapies
for the heart,” said Dr. Peter Altman, BioCardia CEO. “The Helix
platform underlies BioCardia’s cell therapy clinical programs and
is actively enabling important therapeutic strategies for select
partners. This recent patent issuance provides additional
protection to our technology and product offerings in Japan.
Developers of cardiac cell-based therapies, including BioCardia,
are seeking first approvals to begin marketing for the treatment of
heart failure in Japan. A cardiac cell therapy has already been
approved in Japan, but it requires surgical open chest delivery,
whereas the Helix catheter system delivers the cell therapies it
enables in a minimally invasive fashion.”
The Helix transendocardial biotherapeutic delivery system has a
small helical needle which engages the heart tissue and is stable
within the dynamic beating heart. The platform is believed to be
the safest, easiest, and most efficient way to locally deliver
biotherapeutics to the heart. It has demonstrated increased
effective dosing by three-fold over surgical access intramyocardial
biotherapeutic delivery1 and has demonstrated enhanced procedural
safety in its clinical experience2.
BioCardia’s cardiac biotherapeutics under development include:
BCDA-01, the pivotal CardiAMP® autologous cell therapy in ischemic
heart failure with next DSMB scheduled for July 12, 2023, BCDA-02,
the pivotal CardiAMP® autologous cell therapy in chronic myocardial
ischemia expected to complete its roll in cohort this year, and
BCDA-03, the CardiALLO™ allogeneic mesenchymal cell therapy which
is expected to treat first patients soon.
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is a
developer of two biotherapeutic platforms – the
CardiAMP autologous bone marrow derived mononuclear cell
therapy for cardiovascular indications, and the NK1R+ allogeneic
bone marrow derived mesenchymal stem cell therapies for
cardiovascular and pulmonary diseases. These platforms
underlie four product candidates, each with the potential to
meaningfully benefit millions of patients. Three of these
investigational therapies are enabled by the Company’s proprietary
biotherapeutic delivery platforms, which the Company also
selectively licenses to other biotherapeutic development firms.
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, efforts in having cell
therapies initially approved in Japan, the scheduled DSMB review
for BCDA-01, the completion of the roll in cohort for BCDA-02, and
the treatment of first patients with BCDA-03. 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 29,
2023, 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) Mitsutake Y, Pyum WB, Rouy D, Wong Po Foo
C, Stertzer SH, Altman P, Ikeno F. Improvement of local cell
delivery using Helix Transendocardial Delivery Catheter in a
porcine heart, Int Heart J. 2017.
(2) Raval AN and Pepine CJ. Clinical Safety
Profile of Transendocardial Catheter Injection Systems: A Plea for
Uniform Reporting, Cardiovasc Revasc Med, 2021.
Media Contact:Anne Laluc,
MarketingEmail: info@biocardia.comPhone: 650-226-0120
Investor Contact:David McClung, Chief Financial
OfficerEmail: investors@biocardia.comPhone: 650-226-0120
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