BioCardia Announces Positive DSMB Recommendation to Continue Phase 3 Pivotal CardiAMP Heart Failure Study as Planned
September 16 2019 - 8:00AM
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, which included safety
follow-up results on 35 patients and all additional data available
on the 50 patients randomized in the trial as of August 31,
2019. The DSMB indicated there were no safety concerns with
the CardiAMP study results and recommended that the trial continue,
as planned.
The ongoing multi-center, double-blinded, randomized (3:2),
sham-controlled pivotal CardiAMP Heart Failure Trial is expected to
enroll 260 patients at up to 40 centers nationwide. The trial’s
primary efficacy endpoint is Six Minute Walk distance at 12 months’
post-treatment, a measure of a patient’s exercise capacity, and
incorporates the impact of MACE and other clinically meaningful
events. Secondary efficacy endpoints include quality of life as
measured by the Minnesota Heart Failure Quality of Life
self-assessment, and superiority relative to MACE and survival. The
national co-principal investigators are Amish Raval, MD, of the
University of Wisconsin and Carl Pepine, MD, of the University of
Florida, Gainesville.
“We are pleased that the comprehensive data
achieved to date has led to a positive recommendation from the DSMB
to continue the CardiAMP Heart Failure Trial. We are
focused on accelerating enrollment with our world class clinical
partners and delivering the evidence necessary to bring CardiAMP
Cell Therapy to U.S. patients,” said Eric Duckers, MD, PhD, Chief
Medical Officer of BioCardia.
Patients interested in learning about the study can visit
www.cardiamp.com or www.clinicaltrials.gov for more
information.
The next prespecified DSMB review is anticipated
in the first quarter 2020.
About the CardiAMP Therapy ProgramCardiAMP 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
outcomes.
About BioCardia®BioCardia,
Inc., headquartered in San Carlos, California, is developing
regenerative biologic therapies to treat cardiovascular disease.
CardiAMP™ and CardiALLO™ cell therapies are the Company’s
biotherapeutic product candidates in clinical development. The
Company's current products include the Helix™ Biotherapeutic
Delivery System and the Morph® steerable guide and sheath catheter
portfolio, including the new AVANCE™ Steerable Introducer family.
BioCardia also partners with other biotherapeutic companies to
provide its Helix systems and clinical support to their programs
studying therapies for the treatment of heart failure, chronic
myocardial ischemia and acute myocardial infarction.
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. Such factors 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, and
the development of the industry in which we operate may differ
materially from the forward-looking statements contained in this
presentation. 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 BioCardia’s
Form 10-Q filed with the Securities and Exchange
Commission on August 9, 2019, including under the caption titled
“Risk Factors.” BioCardia expressly disclaims any intent or
obligation to update these forward-looking statements, except as
required by law.
INVESTOR CONTACT: David McClung, Chief
Financial Officer investors@BioCardia.com, (650) 226-0120
MEDIA CONTACT:Michelle McAdam, Chronic
Communications, Inc.michelle@chronic-comm.com, (310) 545-6654
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