BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership
2024年3月13日 - 8:00PM
BioCardia, Inc. (Nasdaq: BCDA), a biotechnology company
focused on advancing late-stage cell therapy interventions for
cardiovascular disorders, and StemCardia, Inc., a biotechnology
company focused on cell and gene therapy to re-muscularize the
failing heart, today announced a long-term partnership to advance
StemCardia’s investigational pluripotent stem cell product
candidate for the treatment of heart failure.
Under the partnership, BioCardia is the exclusive biotherapeutic
delivery partner for StemCardia’s cell therapy candidate through
studies expected to result in FDA approval of an investigational
new drug application (IND) and the anticipated Phase I/II clinical
development to follow.
“BioCardia has established safe and minimally invasive delivery
of cellular medicines directly into the heart,” said Chuck Murry,
MD, PhD, StemCardia’s Founder and CEO. “Having worked with
BioCardia to successfully deliver our bona fide cardiac muscle
cells in large animal models of heart failure, we are excited for
this partnership to accelerate clinical development and broaden
future commercial access to an off-the-shelf heart regeneration
treatment.”
“StemCardia’s team encompasses recognized leaders in the field
of cardiac regenerative medicine who are pursuing an elegant
strategy to repair the failing heart. We look forward to supporting
their efforts with our experienced team and proven, proprietary
Helix™ biotherapeutic delivery system,” said BioCardia CEO Peter
Altman, PhD. “This partnership is expected to enhance future
treatment options for millions of people suffering from heart
failure, offset the costs of biotherapeutic delivery development
for our own programs, and provide our investors with meaningful
revenue sharing should our efforts together contribute to
StemCardia’s successful therapeutic development.”
About StemCardia
StemCardia, Inc., is developing cell and gene therapies
engineered to repair the heart. The company’s mission is to advance
off-the-shelf treatments for heart failure, bringing together
leading experts in heart regeneration, cell manufacturing, and
genetic medicine. Few treatments are available today, and none are
curative. Inspired by the observation that the heart does not
regenerate itself, our unique approach is to manufacture and
transplant cardiac muscle cells to directly re-muscularize the
failing heart and restore its function.
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 Helix
transendocardial biotherapeutic delivery system, as well as
technology and services for the development and commercialization
of partners’ therapeutic agents.
About Helix
The Helix transendocardial biotherapeutic delivery system is a
therapeutic-enabling platform for minimally invasive targeted
delivery of biologic agents to the heart. Helix empowers a seamless
transition from bench to commercialization for partners.
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, the potential for the therapy and the
partnership, future revenues and cost offsetting and future
clinical trials. Such risks and uncertainties include, among
others, the inherent uncertainties associated with developing new
products or technologies, regulatory approvals, unexpected
expenditures, the ability to raise the additional funding needed to
continue to pursue BioCardia’s business and product development
plans, and overall market conditions. These forward-looking
statements are made as of the date of this press release, and
BioCardia assumes no obligation to update the forward-looking
statements.
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 progress 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.
BioCardia Investor Relations and Media
Contact:David McClung, Chief Financial
Officerinvestors@biocardia.com, 650-226-0120
StemCardia Investor Relations and Media
Contact:Raj Mistry, Chief Financial Officer
info@stemcardia.com
BioCardia (NASDAQ:BCDA)
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BioCardia (NASDAQ:BCDA)
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