BioCardia’s CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial Results Show Patient Benefits in Important Outcomes
May 01 2024 - 6:00AM
BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and
cell-derived therapeutics for the treatment of cardiovascular and
pulmonary diseases, today announced the primary endpoint results of
the open label roll-in cohort of the CardiAMP® Cell Therapy in
Chronic Myocardial Ischemia Trial.
Study clinical cardiology leadership and members of the
Executive Steering Committee, Dr. Carl Pepine, Professor of
Medicine at the University Florida at Gainesville, and Dr. Amish
Raval, Professor of Medicine at the University of Wisconsin at
Madison, presented the early positive results on Tuesday, April 30,
2024 in a webcast sponsored by BioCardia.
Results from the open label roll-in cohort of patients having
chronic myocardial ischemia with refractory angina showed an
average increase in exercise tolerance of 107 seconds and an
average of 82% reduction in angina episodes at the primary
six-month follow-up endpoint compared to before receiving the study
treatment. All of the patients responded positively to therapy, as
measured by increased (improved) exercise tolerance and greatly
reduced angina.
These early, open-label results compare favorably to those
demonstrated by current FDA approved therapies, and are in line
with previous compelling investigational trial results utilizing
cost prohibitive cell therapy. The webcast can be accessed through
the following
link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=neFatBOQ
and the presentation slides are available on BioCardia’s
website.
“The clinical research results presented for the roll-in cohort
from our CardiAMP CMI Trial highlight BioCardia’s continuing
efforts to transform the treatment paradigm in refractory angina
through the promise of a one-time cost effective minimally invasive
autologous cell-based therapy,” said Peter Altman, President and
CEO. “These results strongly support our continued development of
this novel therapeutic approach and enhance the value of our
CardiAMP cell therapy platform for shareholders and future
partners.”
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 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 may include, among
other things, statements relating to the continued development and
cost of BioCardia’s autologous cell-based therapies, the
probability of success of the CardiAMP clinical trials, ability to
offset clinical costs utilizing Medicare reimbursement 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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