BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular
and cell-derived therapeutics for the treatment of cardiovascular
and pulmonary diseases, announced today that the confirmatory Phase
3 trial of its autologous CardiAMP cell therapy product candidate
for patients with ischemic heart failure of reduced ejection
fraction (HFrEF) has commenced enrollment in the United States.
BioCardia previously confirmed alignment with the United States
Food and Drug Administration (FDA) on the design of the 250-patient
randomized, controlled trial and the minimum of 12-month primary
composite endpoint of all cause death, reduction in major adverse
cardiovascular events, and improvement in quality of life. FDA
granted CardiAMP Cell Therapy a Breakthrough Device
Designation for the treatment of ischemic heart failure.
Breakthrough designation provides for FDA to expedite
development and prioritize review of regulatory submissions
intended to help patients have more timely access to these product
candidates.
“The CardiAMP cell therapy has the potential to be
groundbreaking and life changing for patients with heart failure,”
said Dr. Leslie Miller, MD, trial investigator at the CHF Heart
Function Clinic at BayCare Morton Plant Hospital in
Clearwater, Florida and a member of the CardiAMP Heart Failure II
Study Executive Steering Committee. “As the principal
investigator of the first site activated to enroll patients in this
important study, I have identified many patients who may benefit
from inclusion in this clinical trial, including nine patients in
my clinic in active screening to participate after meeting the
important NTproBNP inclusion criterion.”
BioCardia Chief Executive Officer, Peter Altman, PhD said “We
are looking forward to expeditious enrollment in the trial ahead
working with world class clinical heart function teams with the
objective of confirming the trends of enhanced survival, reduced
major adverse events, and improved quality of life observed in
previous studies. There is a significant need for a safe,
effective, and durable treatment for patients with ischemic heart
failure, in particular one that positively impacts patient survival
and quality of life.”
About Chronic Heart Failure of Reduced Ejection Fraction
(HFrEF)
Heart failure of reduced ejection fraction (HFrEF) is a clinical
condition in which the output of blood from the heart is
insufficient to meet the metabolic demands of the body. In 2022,
the American Heart Association report on heart disease statistics
estimated that 3 million American adults ages 20 and older have
heart failure of reduced ejection fraction with a prevalence
expected to increase to more than 4 million people by 2030. During
heart failure progression, the heart steadily loses its ability to
respond to increased metabolic demand, and mild exercise soon
exceeds the heart’s ability to maintain adequate output. Towards
the end stage of the disease, the heart cannot pump enough blood to
meet the body’s needs at rest. At this stage, fluids accumulate in
the extremities or in the lungs making the patient bedridden and
unable to perform the activities of daily living.
Despite guideline-directed therapies employing a wide range of
pharmacologic, device, and surgical options, many patients
deteriorate over time and develop advanced heart failure symptoms
that cannot be effectively managed by existing medical
therapies.
About CardiAMP Cell Therapy
Granted Breakthrough Designation by the FDA, the CardiAMP Cell
Therapy uses a patient’s own bone marrow cells delivered to the
heart in a minimally invasive, catheter-based procedure to
potentially stimulate the body’s natural healing response. CardiAMP
Cell Therapy incorporates three proprietary elements not previously
utilized in investigational cardiac cell therapy: a pre-procedural
cell analysis for patient selection, a high target dosage of cells,
and a proprietary delivery system that has been shown to be safer
than other intramyocardial delivery systems and exponentially more
successful in cell retention. Clinical development to date in
randomized controlled double blinded trials has shown trends
towards enhanced patient survival, reduced major adverse cardiac
events, and improved quality of life. The CardiAMP clinical
development for heart failure is supported by the Maryland Stem
Cell Research Fund and is reimbursed by Center for Medicare and
Medicaid Services (CMS) for both treatment and control procedures.
CAUTION - Limited by United States law to investigational
use.
About CardiAMP Heart Failure Clinical
Development
BioCardia expects final study results from the randomized double
blinded controlled one hundred and twenty-five subjects CardiAMP
Heart Failure I Study in November 2024. Interim results
demonstrated a 37% relative risk reduction in all cause death with
90% of the follow-up data available. BioCardia’s clinical team is
actively working with investigational sites performing source data
verifications with the goal of sharing final results with both the
FDA and Japan’s Pharmaceutical and Medical Device Agency.
The confirmatory CardiAMP Heart Failure II study focuses on
patients in active heart failure who demonstrated the greatest
benefits in the interim results of the CardiAMP Heart Failure I
study. This subgroup of patients showed strong signals of benefit
with 86% relative risk reduction in mortality and the primary
outcome measure approaching statistical significance at two
years.
The CardiAMP Heart Failure II study also uses a validated
quality of life patient self-assessment instrument as the third
component of the primary endpoint instead of the distance walked in
six minutes. This endpoint would have been statistically
significant in the patients with active heart failure that are the
focus of the CardiAMP Heart Failure II study (p=0.03). The study
design has > 90% power or probability of demonstrating
statistical significance based on the CardiAMP HF I interim
results.
The world class cardiologists who comprise the Co-National
principal investigators, Executive Steering Committee Members,
Clinical Events Committee and the Data Safety Monitoring Board from
the CardiAMP Heart Failure I study are all continuing with the
CardiAMP Heart Failure II study with world class additions. Many
clinical sites are in active stages of being onboarded and
activated.
About BioCardia
BioCardia, Inc., headquartered in Sunnyvale, California, is
global leader in cellular and cell-derived therapeutics for the
treatment of cardiovascular and pulmonary disease. CardiAMP®
autologous and CardiALLO™ allogeneic cell therapies are the
Company’s biotherapeutic platforms with three clinical stage
product candidates in development. These therapies are enabled by
its Helix™ biotherapeutic delivery and Morph® vascular navigation
product platforms. 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, among other things, references to the Company’s
investigational product candidates, the potential benefits of
CardiAMP cell therapy for patients with ischemic HFrEF, and the
rate of enrollment in clinical trials ahead. 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 may
differ materially from the forward-looking statements contained in
this press release. As a result of these factors, we cannot assure
you that the forward-looking statements in this press release will
prove to be accurate. Additional factors that could materially
affect actual results can be found in BioCardia’s Form 10-K filed
with the Securities and Exchange Commission on March 27, 2024,
under the caption titled “Risk Factors” And in its subsequently
filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims
any intent or obligation to update these forward-looking
statements, except as required by law.
Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
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