BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval
29 Noviembre 2023 - 6:00AM
BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today provided an update after its recent
consultation with Japan’s Pharmaceutical and Medical Device Agency
(PMDA) towards approval of its CardiAMP autologous cell therapy for
the treatment of patients with ischemic heart failure of reduced
ejection fraction (HFrEF).
Japan’s PMDA asked for further details on a number of elements
included in BioCardia’s CardiAMP preclinical and clinical packages
in order to gain approval. For the points raised with respect to
the pre-clinical package, BioCardia management believes that these
can be readily addressed. In the request for additional details
with regard to the clinical package, PMDA has signaled that they
would not require additional studies in Japan and could approve
CardiAMP Cell Therapy based on data from overseas. PMDA indicated
they would like to see detailed interim and the final results from
the CardiAMP Heart Failure Trial, which has completed patient
enrollment and is finishing up study patient follow-up visits.
There was discussion that approval of any initial indication may be
limited to patients with NT-pro BNP levels > 500pg/ml, which is
an eligibility criterion for the CardiAMP Heart Failure II study as
recently approved by the U.S. FDA. Formal minutes from the PMDA
meeting are expected in four weeks and a follow-up consultation is
being planned.
“We are thankful that PMDA has signaled that data from outside
Japan is likely to be sufficient for approval” said Peter Altman,
PhD., BioCardia’s President and Chief Executive Officer. “We
continue to work with PMDA to demonstrate that the evidence of
patient benefit with low risk from this minimally invasive
autologous cell therapy for a life-threatening condition should be
sufficient for approval. PMDA approval would enable physicians and
patients to consider the CardiAMP cell therapy option alongside
other cell therapy approaches for the treatment of heart failure
already in clinical use in Japan requiring open heart surgical
administration of the cells.”
About the CardiAMP Cell Therapy Program
CardiAMP Cell Therapy – FDA designated as a Breakthrough therapy
for HFrEF – 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. Clinical trials for this therapy, including the CardiAMP
Heart Failure Trial, have demonstrated positive clinical experience
with this autologous cell therapy in almost 200 patient procedures.
The 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
NK1R+ allogeneic cell therapies are the Company’s biotherapeutic
platforms that enable four product candidates in development.
BioCardia also partners with other biotherapeutic companies to
provide its delivery systems and development 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, among other things, statements relating to our ability to
meet the preclinical and clinical requirements for PMDA to approve
CardiAMP Cell Therapy, formal minutes from the consultation, the
future consultations and follow-up meetings, and whether PMDA will
ultimately require data in Japan for approval. 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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