BioCardia Completes Enrollment of CardiAMP Cell Therapy for the Treatment of Chronic Myocardial Ischemia Trial Open Label Roll-In Cohort
25 Avril 2024 - 3:00PM
BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today announced completion of enrollment and
collection of the primary endpoint results of the open label
roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial
Ischemia Trial.
The Company will report results from this trial and host a call
with study clinical cardiology leadership to review the
opportunity, early positive results, and randomized study on
Tuesday, April 30, 2024, at 3:00 PM ET.
Participants can register for the conference by navigating
to https://dpregister.com/sreg/10188810/fc71df44d6. Please
note that registered participants will receive their dial-in number
upon registration. For those who have not registered, to
listen to the call by phone, interested parties within the U.S.
should call 1-833-316-0559 and international callers should call
1-412-317-5730. All callers should dial in approximately 10 minutes
prior to the scheduled start time and ask to be joined into the
BioCardia call. The conference call will also be available through
a live webcast, which can be accessed through the following
link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=neFatBOQ.
About Chronic Myocardial Ischemia with Refractory
AnginaChronic myocardial ischemia occurs in the setting of
coronary artery disease when there is reduced blood flow to the
heart. This causes angina, a type of chest pain which is
characterized as refractory angina when this pain cannot be
controlled by a combination of optimal medical therapy, angioplasty
or bypass surgery, and is estimated to impact 600,000 to 1.8
million patients in the United States. Included in these patients
are up to 15% of patients undergoing cardiac catheterization who
have ischemia or angina and are suboptimal candidates for
conventional revascularization. Although prognosis of refractory
angina has improved in recent years, patients with refractory
angina experience a significantly impaired quality of life with
disproportionately high utilization of healthcare services. These
observations reflect the great need for new therapies for these
patients. Promising results in treating this patient population
with an autologous bone marrow derived cell therapy have been shown
previously(1).
Reference: |
(1) |
Henry TD, Losordo DW, Traverse JH, Schatz RA, Jolicoeur EM, Schaer
GL, Clare R, Chiswell K, White CJ, Fortuin FD, Kereiakes DJ, Zeiher
AN, Sherman W, Hunt AS, and Povsic TJ. Autologous CD34 cell therapy
improves exercise capacity, angina frequency and reduces mortality
in no-option refractory angina: a patient-level pooled analysis of
randomized double-blinded trials, European Heart Journal,
2018. |
|
|
About the CardiAMP Cell Therapy
ProgramDesignated by the FDA as a Breakthrough Therapy for
Ischemic Heart Failure, 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 cell therapy trials for
the indications of both chronic myocardial ischemia and ischemic
heart failure are covered by the Center for Medicare and Medicaid
for both treatment and control procedures. CAUTION - Limited by
United States law to investigational use.
About BioCardia, Inc.BioCardia, Inc.,
headquartered in Sunnyvale, California, is developing cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases. 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 may include, among
other things, statements relating to having a conference call with
Key Opinion Leaders of the CardiAMP Chronic Myocardial Ischemia
Trial, initiating the randomized pivotal cohort of the CardiAMP
Chronic Myocardial Ischemia 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 27, 2024, under the
caption titled “Risk Factors”. 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.com Phone:
650-226-0120
Investor Contact: David McClung, Chief
Financial OfficerEmail: investors@BioCardia.comPhone:
650-226-0120
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