BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company
focused on advancing late-stage cell therapy interventions for
cardiovascular disorders, today announced positive interim
results from the Phase III randomized controlled trial of its
CardiAMP® autologous cell therapy in 110 randomized patients
with advanced chronic heart failure at a mean 20-month follow-up,
(CardiAMP HF). Results showed reductions in heart death equivalents
and MACCE, with a magnified reduction among patients with elevated
NTproBNP, a common marker of heart distress. The data was presented
today by Amish Raval, MD, Director of Clinical Cardiovascular
Research and Professor of Medicine at the University of
Wisconsin-Madison at the Technology and Heart Failure Therapeutics
(THT) 2024 annual meeting.
Over a mean 20 months of follow-up, patients with advanced
chronic heart failure who received a single endomyocardial dose of
autologous CardiAMP cell therapy while on maximal medical therapy
had a 37% relative risk reduction in all-cause heart death
equivalents and a 9% relative risk reduction in non-fatal incidence
of heart attacks, strokes, and hospitalization due to heart failure
(MACCE). Patients treated with CardiAMP cell therapy saw an almost
5% lower rate of heart death equivalents at up to two years
compared to control patients treated with heart failure medication
alone (8.3% vs. 13.2%, respectively). CardiAMP cell therapy was
also associated with trends toward reduced ventricular
tachyarrhythmias, enhanced heart function as measured by left
ventricular ejection fraction, and improved NTproBNP.
In a subgroup analysis of patients with elevated NTproBNP at
baseline – encompassing 59% of total enrolled randomized patients –
patients treated with CardiAMP cell therapy experienced an 86.2%
relative risk reduction in heart death equivalents and a 23.9%
relative risk reduction in MACCE. These patients saw more than a
17% lower rate of heart death equivalents at up to two years
compared to control patients treated with heart failure medication
alone (2.9% vs. 21.1%, respectively).
“These positive results for CardiAMP cell therapy are very
encouraging, especially for patients with elevated NTproBNP, who
encompass the majority of heart failure patients that we see in our
daily practice,” said trial co-principal investigator Dr. Raval.
“While the trial’s data safety monitoring board determined that the
study would not meet its composite primary endpoint that included
six-minute walk distance per the trial design, the positive results
for reduced heart death equivalents, reduced MACCE, and safety
indicate potential for this therapy to improve outcomes for
patients with advanced chronic heart failure. Despite improvements
with current medications and devices, heart failure remains at
epidemic proportions and we now have an exciting opportunity for a
therapy to improve important, objective outcomes, such as mortality
and hospital re-admissions rates. I am excited to be part of a
terrific team to validate the promise of this therapy in this high
responder group in the follow-on trial that is now FDA-approved and
soon to treat its first patient.”
“We thank the FDA for its speedy review and approval of the
important follow-on Phase III trial. We are encouraged by the
totality of today’s results and anticipate that both the final
24-month data analysis and follow-on trial outcomes would be
consistent with this highly positive data,” said BioCardia CEO
Peter Altman.
Also at the THT scientific meeting, first enrollment for
the dose escalation safety phase of BioCardia’s Phase I/II study of
the CardiALLO™ allogeneic mesenchymal stem cell (MSC) therapy in
heart failure patients was reported. The cohort receiving the
lowest dose of 20 million cells has been initiated with no
treatment-emergent adverse events, arrhythmias, rejection, or
allergic response. The first author of the study is R. David
Anderson, MD, Professor of Medicine at the University of Florida at
Gainesville. Following completion of the dose escalation safety
phase of the study, a Phase II randomized double-blind controlled
study is planned to assess efficacy.
About BioCardia’s CardiAMP
Autologous Cell Therapy Program*
Designated by the FDA as a Breakthrough Therapy, CardiAMP Cell
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 has reimbursement from the Centers for Medicare and
Medicaid Services (CMS) for both treatment and control procedures.
The CardiAMP HF II trial is expected to similarly secure CMS
reimbursement.
About BioCardia’s CardiALLO
Allogeneic Cell Therapy Program*
CardiALLO allogeneic cell therapy provides an “off the shelf”
mesenchymal stem cell therapy typically derived from younger
donors. These cells are immunomodulatory, with the potential to
impact 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 tissue.
CardiALLO therapy for heart failure uses BioCardia’s new MSC
manufacturing process, which builds on the experience of three
completed co-sponsored MSC clinical trials encompassing 84 treated
patients in the same indication with the same delivery
platform.
*CardiAMP and CardiALLO therapies are considered investigational
and limited by U.S. law to investigational use only.
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 works with partners to provide its proprietary
biotherapeutic delivery system, as well as preclinical and clinical
development services for biotherapeutic delivery to the heart.
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, whether the final 24-month analysis
and follow-on trial outcomes would be consistent with the interim
results presented here as expected, whether CardiAMP HF II receives
CMS reimbursement as expected, whether CardiAMP HF II validates the
results of the interim data from CardiAMP HF, and 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:Michelle
McAdammichelle@chronic-comm.com, 310-902-1274
INVESTOR CONTACT:David McClung, Chief Financial
Officerinvestors@biocardia.com, 650-226-0120
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