BioCardia, Inc. (“BioCardia” or the “Company”) (Nasdaq: BCDA),
a biotechnology company focused on advancing late-stage cell
therapy interventions for cardiovascular disorders, is targeting
heart failure and chronic myocardial ischemia as potential
indications for its biotherapeutic candidates: autologous CardiAMP
cell therapy and allogeneic CardiALLO cell therapy.
The Company announces that two scientific abstracts on its
CardiAMP and its CardiALLO clinical stage therapeutic programs have
been accepted for presentation at the Technology and Heart Failure
Therapeutics Conference (THT) being held on March 4-6, 2024, in
Boston, MA. Both abstracts will be presented in the Late-Breaking
Clinical Science/First-In-Human & Early Feasibility Studies
session on Monday March 4, 2024.
The first scientific abstract is entitled: “Interim
Results from Adaptive Randomized Controlled Trial of Autologous
Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy
System in Patients with Ischemic Heart Failure due to Reduced Left
Ventricular Ejection Fraction (HFrEF).” The data to be
presented are from the Company’s CardiAMP Phase 3 autologous cell
therapy study, an international, randomized, double blind,
controlled study that enrolled 125 patients with New York Heart
Association Class II and III ischemic heart failure. The primary
endpoint is the Finkelstein-Schoenfeld composite difference between
groups based on all-cause heart death, major adverse cardiac and
cerebrovascular events, and functional capacity as measured by
six-minute walk distance. Dr. Amish Raval, Professor of Medicine at
the University of Wisconsin at Madison is the lead author on the
abstract.
As previously reported, the study showed benefits of reduced
all-cause heart death equivalents and reduced major adverse cardiac
events without safety concerns, but study was halted as it was not
likely to meet its primary endpoint. This scientific presentation
will provide detailed trial data including results supporting the
design of the CardiAMP Heart Failure II Phase III Trial, recently
approved by the FDA and soon to begin enrolling.
The second scientific abstract is entitled: “First in
Man CardiALLO NK1R+ MSC Phase I/II Trial in Ischemic NYHA II and
III HFrEF”. The data to be presented are from the
Company’s CardiALLO Phase I/II allogeneic mesenchymal stem cell
therapy study, which began enrollment in a 3+3 dose escalation
design in December. The study is enrolling patients with New York
Heart Association Class II and III ischemic heart failure,
including those who were not eligible for the CardiAMP autologous
cell therapy trial. Dr. Carl Pepine, Professor of Medicine at the
University of Florida at Gainesville is the lead author on the
abstract.
As previously reported, the CardiALLO Heart Failure study
follows the Company’s earlier co-sponsored clinical studies of
allogeneic mesenchymal stem cells for patients with ischemic heart
failure of reduced ejection fraction. This scientific presentation
will provide details on the early safety experience from this
ongoing clinical study.
“BioCardia is pleased to share these analyses of its ongoing
clinical autologous and allogeneic cell therapy studies at the THT
Conference,” said Dr. Peter Altman, BioCardia Chief Executive
Officer and President. “The positive results in these two
development efforts as previously reported have included reduced
mortality, enhanced heart function, and improved quality of life
with no significant safety concerns with either of these cell
therapy product candidates. Both cell therapy candidates are
delivered with our proprietary minimally invasive Helix
transendocardial biotherapeutic delivery system which is approved
for use in Europe and approved for investigational use in the
United States. Cell therapies with the unique profiles we are
advancing in both the CardiAMP and CardiALLO programs have great
promise as valuable therapeutics for the treatment of ischemic
heart failure of reduced ejection fraction. We look forward to the
presentations and discussions at the conference.”
About the CardiAMP Autologous Cell Therapy
Program
CardiAMP Cell Therapy – FDA designated as a Breakthrough therapy
– uses a patient’s own (autologous) bone marrow cells delivered to
the heart in a minimally invasive, catheter-based procedure to
potentially stimulate the body’s natural healing response. CardiAMP
Cell Therapy incorporates three proprietary elements not previously
utilized in investigational cardiac cell therapy: a pre-procedural
cell analysis for patient selection, a high target dosage of cells,
and a proprietary delivery system that has been shown to be safer
than other intramyocardial delivery systems and exponentially more
successful in cell retention. The CardiAMP HF trial is supported by
the Maryland Stem Cell Research Fund and the Centers for Medicare
and Medicaid Services. The proprietary CardiAMP cell procedure kits
and their dedicated proprietary catheter delivery system are
manufactured at BioCardia’s facility in Sunnyvale,
California. CAUTION - Limited by United States law to
investigational use.
About CardiALLO Allogeneic Cell Therapy
Program
CardiALLO™ Allogeneic Cell Therapy provides an “off the shelf”
mesenchymal stem cells (MSC) typically from a younger donor. These
cells are immunomodulatory with potential for impact on
inflammatory processes in heart failure and have been shown to
release multiple critical angiogenic factors that can enhance
microvascular function and capillary networks in ischemic tissues.
The CardiALLO study is a dose escalation Phase I safety study to be
followed by a Phase II randomized double-blind controlled study to
assess therapeutic benefit or efficacy. The proprietary CardiALLO
human cells and their dedicated proprietary catheter delivery
system are manufactured at BioCardia’s facility in Sunnyvale,
California. CAUTION - Limited by United States law to
investigational use.
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 for the treatment of heart disease.
BioCardia also acts as a biotherapeutic delivery partner supporting
other cell, gene, and protein therapies for the treatment of heart
failure, chronic myocardial ischemia and acute myocardial
infarction. 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, the presentation of abstracts at the
THT conference, 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, unexpected expenditures, the ability to raise the
additional funding needed to continue to pursue BioCardia’s
business and product development plans, the ability to enter into
licensing and partnering arrangements, 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. Factors that could cause or contribute to such
differences include, but are not limited to, the Company’s
liquidity position and its ability to raise additional funds, as
well as the Company’s ability to successfully progress its clinical
trials. 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” 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 Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
BioCardia (NASDAQ:BCDA)
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BioCardia (NASDAQ:BCDA)
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