BioCardia, Inc. Signs Merger Agreement with Tiger X Medical, Inc., Secures Funding to Support Further Development of CardiAMP® Cell Therapy System for the Treatment of Heart Failure

SAN CARLOS, Calif. & MIAMI–(BUSINESS WIRE)–BioCardia, Inc., a clinical-stage regenerative medicine company
developing novel therapeutics for cardiovascular diseases, announced
today that it has entered into a definitive agreement to merge with
Tiger X Medical, Inc. (OTCPink: CDOM). The combined entity, which will
change its name to BioCardia following the closing, will trade on the
OTC Markets and will focus solely on the business of BioCardia.
The combined entity is expected to have $23 million in cash at closing,
which will be used to support the ongoing Phase III Heart Failure Trial,
for the commercialization and development of other product candidates,
and for general corporate purposes. OPKO Health Inc. (NASDAQ: OPK) will
become a significant stockholder in Tiger X Medical and will also serve
as an advisor to the business.
“Our CardiAMP cell therapy is seeking to address an enormous unmet need
– a treatment for heart failure that develops after a patient has had a
heart attack. The merger will provide resources necessary to continue
our Phase III development of CardiAMP,” said Dr. Peter Altman,
BioCardia’s CEO.
BioCardia is commencing a Phase III study of its CardiAMP cell therapy
system for the treatment of heart failure. The Food and Drug
Administration (FDA) has approved the study under an Investigational
Device Exemption (IDE). The Centers for Medicaid and Medicare Services
(CMS) have approved this IDE Nationally as qualified for CMS
reimbursement.
The CardiAMP cell therapy for heart failure integrates a proprietary
biomarker panel to identify candidates likely to respond to therapy, a
cell processing system which prepares a proprietary, high-dosage
formulation of autologous bone marrow-derived cells and a unique
transendocardial delivery system that ensures efficient and consistent
targeted delivery.
The CardiAMP clinical trial is a randomized, controlled, multi-center
study of 250 patients evaluating CardiAMP Therapy at up to 40 clinical
sites in the United States. It follows two previous clinical studies
sponsored by BioCardia supporting the CardiAMP Therapy. Additional
details are available via ClinicalTrials.gov,
using identifier: NCT02438306.
Results from the trial will be reviewed under the PMA regulations by the
FDA’s Center for Biologics Evaluation and Research (CBER) division.
About BioCardia®:
BioCardia, Inc., headquartered in San Carlos, CA, is a privately-held
company developing regenerative biologic therapies to treat
cardiovascular disease. The Company’s current products include
the Helix™ transendocardial delivery system and the Morph® steerable
guide and sheath catheter portfolio. CardiAMP® and CardiALLO® cell
therapies are the company’s biotherapeutic product candidates in
clinical development. BioCardia also partners with other biotherapeutic
companies to provide its Helix systems and clinical support to their
programs studying therapies for the treatment of heart failure, chronic
myocardial ischemia and acute myocardial infarction.
Forward Looking Statements:
This press release contains forward-looking statements. Such
forward-looking statements include, among other things, references to
anticipated cash balance, use of funds and product development plans.
Actual results could differ from those projected in any forward-looking
statements due to numerous factors. Such factors include, among others,
the inherent uncertainties associated with developing new products or
technologies, unexpected expenditures, the ability to raise the
additional funding needed to continue to pursue BioCardia’s business and
product development plans, competition in the industry in which
BioCardia operates and overall market conditions, whether OPKO Health
becomes a significant stockholder of Tiger X Medical, and whether the
merger between BioCardia and Tiger X Medical will close. These
forward-looking statements are made as of the date of this press
release, and BioCardia and Tiger X Medical assume no obligation to
update the forward-looking statements.