BioCardia Announces CardiAMP Heart Failure Pivotal Trial Continues with First Patient Randomized in COVID-19 Era
01 Juli 2020 - 2:00PM
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
BioCardia (NASDAQ:BCDAW)
Historical Stock Chart
Von Sep 2024 bis Okt 2024
BioCardia (NASDAQ:BCDAW)
Historical Stock Chart
Von Okt 2023 bis Okt 2024