BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study
12 Mars 2024 - 12:00PM
BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today announced Centers for Medicare &
Medicaid Services (CMS) approval for reimbursement coverage of the
confirmatory Phase III clinical trial of CardiAMP autologous cell
therapy for the treatment of patients with ischemic heart failure.
CMS has reviewed the CardiAMP Heart Failure II Trial and
approved the investigational product, related and routine items and
services for purposes of Medicare coverage. CMS previously
published a New Technology APC (Ambulatory Payment Classifications)
code that covers the CardiAMP Cell Therapy investigational study
procedure, including the BioCardia investigational products
utilized to perform the study procedure, allowing the study centers
to be reimbursed for the study procedure and products.
The CardiAMP Heart Failure II Trial is FDA approved to enroll up
to 250 patients at up to 40 clinical centers. The study includes an
eligibility requirement that patients demonstrate a pre-specified
NT-proBNP level at baseline. The primary endpoint is a hierarchical
composite assessment consisting of all-cause death, the cardiac
death equivalents of heart transplant and left ventricular assist
device (LVAD) implantation, heart failure hospitalizations,
worsening heart failure events treated as an outpatient, and change
in quality-of-life, with a follow-up duration ranging from a
minimum of 12 to a maximum of 24 months.
The CMS coverage approval is supported by the scientific rigor
of the protocol design and the results from the interim data from
the CardiAMP Heart Failure Trial recently presented at the
Technology and Heart Failure Therapeutics 2024 annual meeting.
Across all patients there was a reduction in cardiac death
equivalents and major adverse cardiac and cerebrovascular events.
In the subgroup of patients targeted in the CardiAMP Heart Failure
II Trial, results showed large absolute and relative risk reduction
of heart death equivalents of the patients in the treated group.
Treated patients also had reduced major adverse cardiac events and
greatly improved quality of life.
“We are pleased that CMS has provided coverage support for the
confirmatory CardiAMP Heart Failure II study.” said Peter Altman,
PhD., BioCardia’s President and Chief Executive Officer. “To my
knowledge, no therapy has been proven to reduce mortality in these
patients, and CardiAMP Heart Failure II has great potential to
achieve this outcome by confirming our CardiAMP Heart Failure Trial
results.”
About the CardiAMP Cell Therapy Program
Designated by the FDA as a Breakthrough Therapy, 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. The CardiAMP clinical development for
heart failure is supported by the Maryland Stem Cell Research Fund
and is reimbursed by CMS for both treatment and control
procedures.
CAUTION - Limited by United States law to investigational
use.
About BioCardia®
BioCardia, Inc., headquartered in Sunnyvale, California, is
developing 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 for the treatment of heart disease.
BioCardia also works with partners to provide its proprietary
biotherapeutic delivery system along with preclinical and clinical
development services for biotherapeutic delivery to the heart.
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, statements relating to completing
follow-up in the CardiAMP Heart Failure Trial, the probability of
success of the CardiAMP clinical trials, ability to offset clinical
costs utilizing Medicare reimbursement, anticipated milestones and
events, and the ultimate success of our clinical cell therapy
programs. These forward-looking statements are made as of the date
of this press release.
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. Factors that could cause or contribute to such
differences include, but are not limited to, the Company’s
liquidity position and its ability to raise additional funds, as
well as the Company’s ability to successfully advance its clinical
trials. 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 29, 2023, 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 RelationsEmail: mpeto@BioCardia.comPhone:
650-226-0120
Investor Contact: David McClung, Chief
Financial OfficerEmail: investors@BioCardia.comPhone:
650-226-0120
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