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BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Heart Failure Study as Designed

Thu 17th December, 2020 1:30pm
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SAN CARLOS, Calif., Dec. 17, 2020 (GLOBE NEWSWIRE) -- BioCardia
(Nasdaq: BCDA), a leader in the development of comprehensive solutions for
cardiovascular regenerative therapies, today announced that the independent
Data Safety Monitoring Board (DSMB) has completed its prespecified data review
for the Phase III pivotal CardiAMP
Heart Failure Trial. The DSMB based its review on all available data for the
86 patients enrolled in the trial, including 60 randomized patients who have
reached their one-year follow-up. The DSMB performed a risk-benefit
assessment, indicated no safety concerns, and recommended that the study
continue as designed.

“I am delighted with the positive recommendation from the distinguished
CardiAMP DSMB to continue this important study,” said BioCardia CEO Peter
Altman, PhD. “The successful risk-benefit review is a testament to the
dedication of the many CardiAMP investigators and clinical teams at leading
institutions across the U.S. The DSMB was able to review the primary efficacy
data from twice as many patients at one-year follow-up as were available in
our Phase II study to arrive at their positive recommendation, with no change
or action required. We believe that the DSMB recommendation further enhances
the probability of our clinical cell therapy program becoming a valuable
therapy for millions of patients suffering from cardiac disease.”

“In addition to the DSMB report, we are enthusiastic about the significant
momentum we are seeing in CardiAMP HF Trial enrollment, with a dozen patients
currently in the pipeline for randomization. The trial is also generating
compelling data on the high CD34+ cell dosage being studied that we intend to
submit to an upcoming scientific conference or journal for publication,”
Altman added.

The ongoing multi-center, double-blinded, randomized (3:2), controlled pivotal
CardiAMP Heart Failure Trial is expected to enroll 260 patients at up to 40
centers nationwide. The trial’s primary endpoint is an outcomes composite
score based on a three-tiered Finkelstein-Schoenfeld (FS) hierarchical
analysis, an established outcomes design that has been used in other leading
heart failure programs. The FS procedure is a ranked analysis that first
compares each subject to each other subject for occurrence of first-tier
events (time to death, in this case) and then compares patient outcomes for
subsequent tiers. The tiers, starting with the most serious events, would be
(1) all-cause death, including cardiac death equivalents such as heart
transplant or left ventricular assist device placement, ordered by time to
event; (2) non-fatal Major Adverse Coronary and Cerebrovascular Events
(MACCE), excluding those deemed procedure-related occurring within the first
seven days post-procedure (heart failure hospitalization, stroke or myocardial
infarction), ordered by time to event; and (3) change from baseline in Six
Minute Walk Distance at 12 months. Data submitted to the DSMB provided the
group with visibility into the risks and benefits of the trial at its primary

The DSMB consists of two world renowned cardiologists with experience in heart
failure and interventional cardiology, as well as a world renowned
biostatistician with considerable experience evaluating trial data for chronic
diseases, including heart failure. Their primary responsibility is to ensure
patient safety and to halt or pause the clinical investigation if the risk of
the therapy appears to outweigh its potential benefit. Such risk-benefit
analysis typically includes an analysis of futility to reach the primary
endpoint of the clinical trial as designed.  

Patients interested in learning about the study can visit or
for more information.

About the CardiAMP Therapy Program
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. The CardiAMP Heart Failure Trial is the
first multicenter clinical trial of a stem cell therapy to prospectively
screen for stem cell therapeutic potency in order to improve patient

About BioCardia®
BioCardia, Inc.
headquartered in San Carlos, California, is developing regenerative biologic
therapies to treat cardiovascular and respiratory disease. CardiAMP autologous
and Neurokinin-1 Receptor Positive allogenic cell therapies are the
Company’s biotherapeutic platforms in clinical development. The Company's
products include the Helix Biotherapeutic Delivery System and its steerable
guide and sheath catheter portfolio. BioCardia also partners with other
biotherapeutic companies to provide its Helix system and clinical support for
their programs studying therapies for the treatment of heart failure, chronic
myocardial ischemia and acute myocardial infarction. For more information,

Forward Looking Statements:
This press release contains forward-looking statements that are subject to
many risks and uncertainties. Forward-looking statements include statements
regarding our intentions, beliefs, projections, outlook, analyses or current
expectations. These forward-looking statements include, without limitation,
statements relating to study enrollment expectations and the likelihood of
success and the value of our clinical cell therapy programs.

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. These forward-looking statements reflect our view
as of the time such statement is made and are not guarantees of future
performance or developments. You are strongly cautioned that reliance on any
forward-looking statements involves known and unknown risks and uncertainties.
Actual results and events may differ materially from information contained in
the forward-looking statements as a result of a number of factors including,
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. As a result of these factors, we cannot assure you that the
forward-looking statements in this presentation will prove to be accurate.
 Additional factors that could materially affect actual results can be found
in our documents filed with the SEC, including our recent filings on Form 8-K,
Form 10-K and Form 10-Q, particularly any statements under the caption
entitled “Risk Factors” Therein.” BioCardia expressly disclaims any
intent or obligation to update these forward-looking statements, except as
required by law. 

David McClung, Chief Financial Officer, (650) 226-0120

Michelle McAdam, Chronic Communications, Inc., (310) 545-6654


GlobeNewswire, Inc. 2020
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