BIOCARDIA ANNOUNCES POSITIVE DSMB RECOMMENDATION TO CONTINUE PHASE III PIVOTAL CARDIAMP HEART FAILURE STUDY, AS PLANNED
31 Marzo 2020 - 2:00PM
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, based on a review of all
available safety data for all patients randomized in the trial. The
DSMB indicated there were no safety concerns with the CardiAMP
study results and recommended that the trial continue, as planned.
To date, 74 patients have been enrolled in the trial.
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 efficacy endpoint is a composite of death,
major adverse cardiovascular and cerebrovascular events (MACCE),
and six minute walk distance (a measure of a patient’s exercise
capacity) at 12 months’ follow-up. Secondary efficacy endpoints
include quality of life, as measured by the Minnesota Living with
Heart Failure Questionnaire, and superiority relative to MACCE and
survival.
The national principal investigators are Amish Raval, MD, of the
University of Wisconsin and Carl Pepine, MD, of the University of
Florida, Gainesville.
BioCardia will host a conference call/webcast today at 4:15 p.m.
ET featuring the principal investigators to provide updates on the
CardiAMP Heart Failure Trial. To participate in the conference
call, dial 1-877-270-2148. To access the live webcast of the call,
please visit:
www.biocardia.com/investors/events-presentations/id/1036. A replay
of the webcast will be available for a limited time on the
BioCardia website following the presentation.
“We are pleased with the progress on the
CardiAMP Heart Failure Trial that has led to a positive
recommendation from the DSMB to continue the study. We are
currently assessing the impact of COVID-19 on patient recruitment
for the trial, as trial sites focus on patient care and delay
elective procedures, in accordance with guidance from the Centers
for Medicaid Services, as well as trial-related patient follow-up
visits. We have seen an increase in informed patient consents to
participate in the study, which is an indication that enrollment in
the study will continue to accelerate after the COVID-19 situation
resolves. We look forward to continuing to work closely with our
clinical partners to build the high-quality evidence that will
support CardiAMP Cell Therapy as an important option for heart
failure patients in need,” said BioCardia Chief Medical Officer
Eric Duckers, MD.
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 last quarter of 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 November 19, 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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