BioCardia Announces Expected CardiAMP Heart Failure Japan Approval Timeline Based on Pharmaceutical and Medical Device Agency Consultation Minutes
18 Diciembre 2023 - 6:16AM
BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today announced that Japan Pharmaceutical and
Medical Device Agency (PMDA) minutes support the Company’s
understanding that CardiAMP autologous cell therapy may be approved
for the treatment of patients with ischemic heart failure with
reduced ejection fraction (HFrEF) based on follow-up data from the
patients currently enrolled in the CardiAMP Heart Failure Trial
(CardiAMP HF) that will be available in Q4 2024.
BioCardia has previously reported that although the primary
endpoint of CardiAMP HF would most likely not have been met at one
year; there was both reduced mortality and reduced major adverse
cardiovascular events in treated patients compared to controls at
two years follow-up. PMDA and its medical advisors have seen these
and additional results that will be presented and published in the
appropriate peer reviewed scientific forums. The FDA reviewed this
data and recently approved the CardiAMP Heart Failure II Study
protocol.
BioCardia will follow PMDA’s process to confirm the regulatory
pathway ahead. This is expected to include a clinical consultation
with PMDA in the second or third quarter of 2024 on clinical data
from its three sponsored trials: TABMMI1, TAC-HFT2, and CardiAMP
HF3. These studies include almost two hundred patients followed-up
for an average of 1.9 years and each has shown benefit to patients
with no treatment emergent safety concerns. With PMDA confirmation,
BioCardia expects to submit for approval in Japan based on the data
available in late Q4 2024.
“As CardiAMP cells are autologous and delivered in a minimally
invasive manner with our proprietary catheter system, the therapy
has no requirements for immunosuppression, antiarrhythmic drugs, or
open chest surgery,” said Peter Altman, PhD., BioCardia’s President
and Chief Executive Officer. “We aim to partner with Japanese heart
failure cardiologists and their interventional cardiology
colleagues to be able to offer this therapeutic option for heart
failure patients.”
About the CardiAMP Cell Therapy Program
CardiAMP Cell Therapy – FDA designated as a Breakthrough 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. 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 HF trial is supported by
the Maryland Stem Cell Research Fund and the Centers for Medicare
and Medicaid Services. 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 acts as a biotherapeutic delivery partner supporting
therapies for the treatment of heart failure, chronic myocardial
ischemia, and acute myocardial infarction. For more information
visit: www.BioCardia.com.
Anticipated 2023 Q4 Milestones:
- BCDA-03: NK1R+ MSC
Allogeneic Cell Therapy in Ischemic HFrEF Phase I/II Trial
Enrollment
- Helix Biotherapeutic
Delivery System Update on Licensing / Partnerships
1 Transendocardial Autologous Bone Marrow Myocardial Infarction
Trial, NCT005074682 Transendocardial Autologous Cells in Heart
Failure Trial, NCT NCT007680663 CardiAMP Heart Failure Trial, NCT
02438306
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 our ability to
meet the preclinical and clinical requirements for PMDA to approve
CardiAMP Cell Therapy, whether PMDA will ultimately require data in
Japan for approval, whether PMDA will require more data than that
available in Q4 2024, whether CardiAMP HF will have a data readout
in Q4 2024 as well as each of the anticipated catalysts ahead.
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 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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