BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA
February 08 2024 - 6:00AM
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 activation of CardiAMP HF II, a randomized
controlled pivotal trial of its CardiAMP autologous cell therapy
for patients with ischemic heart failure. The study was approved by
FDA in Q4 2023 for the treatment of ischemic etiology heart failure
of reduced ejection fraction (HFrEF). Study activation includes
study-wide Institutional Review Board (IRB) approval for proceeding
with the study as well as formally addressing the many requirements
of performing a double blinded randomized controlled multi center
interventional biotherapeutic study.
The data supporting the design of CardiAMP HF II is from the
interim results of the ongoing CardiAMP Heart Failure autologous
cell therapy study (CardiAMP HF), a randomized, double blind,
controlled study that enrolled 125 patients with New York Heart
Association Class II and III ischemic heart failure. The interim
results of the study will be shared at the upcoming Technology and
Heart Failure Therapeutics meeting on March 4, 2024, with final
results expected in Q4 2024.
The primary endpoint for CardiAMP HF II is a
Finkelstein-Schoenfeld composite difference between groups based on
all-cause heart death, major adverse cardiac and cerebrovascular
events, and quality of life as measured by Minnesota Living with
Heart Failure Questionnaire at a minimum of one year and a maximum
of two-year follow-up. The FDA approved trial size is 250 patients
which has greater than 90 percent power (statistical probability of
success).
“Now that the study is activated, we are working with our
interventional heart failure network and individual clinical sites
to complete the final steps to begin patient enrollment,” said Dr.
Peter Altman, BioCardia Chief Executive Officer, and President.
“The potential for rapid enrollment in this trial is significant.
There are enormous operational benefits from experience with our
interventional heart failure network, efficiencies in the CardiAMP
II protocol design, and both physician and patient motivation based
on the clinical results to be presented next month. We
are developing plans to complete enrollment within 24 months of
first patient randomization.”
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 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 activation of clinical sites and
the enrollment of patients in the CardiAMP II Trial, 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, 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 RelationsEmail: mpeto@BioCardia.comPhone:
650-226-0120
Investor Contact:David McClung, Chief Financial
OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
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