BioCardia Announces CardiAMP Heart Failure Pivotal Trial Continues with First Patient Randomized in COVID-19 Era
29 June 2020 - 10:00PM
BioCardia®, Inc., (OTC: BCDA), a leader in the development of
comprehensive solutions for cardiovascular regenerative therapies,
today announced that the Company has resumed cases in the CardiAMP
Heart Failure Trial. The first patient procedure completed since
elective procedures were paused due to COVID-19 took place at
Morton Plant Hospital in Clearwater, Florida this month. New
consents have also taken place at additional centers.
“We are pleased to be able to resume enrollment at
several sites for our lead clinical program and look forward to
cases taking place in July and August,” said BioCardia CEO Peter
Altman, PhD. “As study centers resume elective procedures, we are
working closely with our clinical partners to implement new FDA
recommendations for clinical trials with respect to COVID-19 in
order to minimize the impact on our patients, as well as the trial
ahead. COVID-19 has been reported to cause heart damage, and some
of our clinical investigators are seeing an increased amount of
heart damage in patients who have avoided treatment due to fear of
COVID-19 exposure. Our cardiac programs have the potential to
help address this growing clinical need and are even more important
in the current clinical landscape.”
The CardiAMP Heart Failure Trial is
studying CardiAMP cell therapy, an autologous bone
marrow-derived mononuclear cell formulation designed to stimulate
the body’s natural healing response in treating heart failure which
develops after a heart attack. The trial is evaluating the cell
therapy’s ability to improve patient survival, exercise capacity
and quality of life, as well as its safety. The CardiAMP Heart
Failure Trial is the first multicenter clinical trial of an
autologous cell therapy to prospectively select patients based on
cell potency to maximize the probability of patient benefit.
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 national co-principal investigators are Amish Raval, MD, of the
University of Wisconsin and Carl Pepine, MD, of the University of
Florida, Gainesville.
In March 2020, the Data Safety Monitoring Board
indicated there were no safety concerns with the CardiAMP study
results and recommended that the trial continue, as
planned. To date, 75 patients have been enrolled at 25 active
centers. The trial is sponsored, in part, by the Maryland Stem Cell
Research Foundation and has reimbursement from the Centers for
Medicare and Medicaid Services (CMS).
For additional resources and to learn more about
the CardiAMP Heart Failure Trial, visit www.biocardia.com.
About BioCardia®: BioCardia, Inc., headquartered
in San Carlos, CA, 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 products include the Helix
transendocardial 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 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
references to progress in enrollment in our ongoing pivotal
clinical trial, the efficacy of our products and therapies, and
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 and obtaining regulatory approvals.
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.
INVESTOR CONTACT: David McClung,
Chief Financial Officerinvestors@BioCardia.com, (650) 226-0120
MEDIA CONTACT:Michelle McAdam,
Chronic Communications, Inc.michelle@chronic-comm.com, (310)
902-1274
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