BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure
November 14 2023 - 7:15AM
BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today announced the Food and Drug
Administration (FDA) approval of its Phase III clinical trial of
its CardiAMP autologous cell therapy for the treatment of patients
with ischemic heart failure.
BioCardia announces that the Food and Drug Administration (FDA)
has approved its proposed CardiAMP Heart Failure II study protocol.
The currently ongoing CardiAMP Heart Failure trial has completed
enrollment and it is anticipated that the final data analyses will
be reported in Q4 2024. In an interim analysis of available data to
date for study patients followed up through two years, those having
N-terminal pro B-type natriuretic peptide (NT-proBNP) levels
consistent as demarcating heart failure (>500 pg/ml) at
screening-baseline showed meaningful clinical improvements over
controls, including a 59% relative risk reduction in heart death
and a 54% relative risk reduction of Major Adverse Cardiovascular
or Cerebrovascular events (MACCE). Further, all clinical outcome
measures evaluated at follow-up for this interim subset favored
cell therapy over guideline directed medical therapy, including
having improved quality-of-life as measured using the Minnesota
Living with Heart Failure Questionnaire, reduced NT-proBNP levels,
greater walk distance as measured using the 6-minute walk distance
test, and improved cardiac measures such as left ventricular
ejection fraction and left ventricular end systolic and end
diastolic volumes. Statistical significance (p<0.05) was noted
for both the reduced heart death equivalents measure (p=0.028) and
the improved quality of life measure (p=0.016).
The FDA has approved the proposed CardiAMP Heart Failure II
study which includes an eligibility requirement that patients
demonstrate a pre-specified NT-proBNP level at baseline. The
proposed primary efficacy endpoint is also modified from that in
the currently ongoing study. The CardiAMP Heart Failure II endpoint
is a similar hierarchical composite assessment but consists of
all-cause death, the cardiac death equivalents of heart transplant
and left ventricular assist device (LVAD) implantation, heart
failure hospitalizations, worsening heart failure events treated as
an outpatient, and change in quality-of-life, with a follow-up
duration ranging from a minimum of 12 to a maximum of 24 months.
Statistical power calculations using the interim data analyses
support a modestly sized clinical trial would demonstrate efficacy
if the interim data it is based on is representative of future
study patients enrolled into the trial. Additional modifications
from the ongoing trial include enhancements to simplify clinical
site logistics and reduce costs of the study. Medicare’s
reimbursement support for the trial currently in place for both the
control and treatment arms is anticipated to significantly offset
clinical costs of the trial.
“CardiAMP Heart Failure II has strong support from our clinical
investigators who have reviewed the interim trial results in detail
and have first-hand knowledge of this great unmet clinical need,”
said Peter Altman, PhD., BioCardia’s President and Chief Executive
Officer. “We expect that we can perform this study efficiently at
world class clinical centers based on the extensive experience of
the ongoing trial and its positive clinical outcomes.”
About the CardiAMP 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. The
CardiAMP Heart Failure II Trial builds on positive clinical
experience with this autologous cell therapy in almost 200 patients
and has potential to provide the primary evidence to support FDA
approval and marketing registration. The trial is supported by the
Maryland Stem Cell Research Fund and the Centers for Medicare and
Medicaid Services. 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
NK1R+ allogeneic cell therapies are the Company’s biotherapeutic
platforms that enable four product candidates in development.
BioCardia also partners with other biotherapeutic companies to
provide its delivery systems and development support to their
programs studying 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, statements relating to completing
follow-up in the CardiAMP Heart Failure Trial, the probability of
success of the CardiAMP Heart Failure I and II trials, ability to
offset clinical costs utilizing established Medicare reimbursement,
anticipated milestones and events, and the ultimate success of our
clinical cell therapy programs. These forward-looking statements
are made as of the date of this press release.
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 advance 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.com Phone:
650-226-0120
Investor Contact: David McClung, Chief
Financial OfficerEmail: investors@BioCardia.comPhone:
650-226-0120
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