BioCardia Receives CE Mark Renewal For Helix Biotherapeutic Delivery Catheter And Morph Guide Catheter Through May 2024
October 08 2019 - 8:00AM
BioCardia (Nasdaq: BCDA), a leader in the development of
comprehensive solutions for cardiovascular regenerative therapies,
today announced renewal of the CE Mark for the Helix™
Biotherapeutic Delivery Catheter and Morph® Universal Deflectable
Guide Catheter, both used in the delivery of biotherapeutics to the
heart. CE Mark renewal enables BioCardia to continue supporting
partners conducting biotherapeutic clinical trials outside of the
U.S., such as CellProThera and Centro Cardiologico Monzino, as well
as commercial sales in the European Union and other countries that
recognize the CE Mark through May 2024.
“Renewal of the CE Mark for our innovative biotherapeutic
delivery products ensures that we can continue participating in a
variety of biotherapeutic research programs with the potential to
drive the field forward and respond to very ill patients,” said
BioCardia CEO Peter Altman.
“In light of sweeping European regulatory changes associated
with the transition from the MDD directive to the new MDR
regulation, it has been a challenging time for both notified
bodies, who are working to become certified to grant CE Mark under
the new system, and for companies, who are trying to meet the new
requirements and move their CE Mark applications forward. It is a
significant achievement for BioCardia to have received CE Mark
renewal in this environment, when many other companies are
struggling to do the same or even abandoning the region.”
Published literature has shown that the Helix™ Biotherapeutic
Delivery System - which includes the Morph guide product - presents
the lowest risk to patients for biotherapeutic delivery compared to
other delivery methods evaluatedi, and is three to six times more
efficient at delivering cells to the heart muscle than other
methodsii. The Helix system is currently being evaluated in the
U.S. Phase III pivotal CardiAMP™ Heart Failure Trial along with the
company’s lead cell therapy candidate (CardiAMP™)iii, which uses a
patient’s own (autologous) bone marrow cells delivered to the heart
in a minimally-invasive procedure to potentially stimulate the
body’s natural healing response.
About BioCardia®BioCardia,
Inc., headquartered in San Carlos, California, is developing
regenerative biologic therapies to treat cardiovascular disease.
CardiAMP™ and CardiALLO™ cell therapies are the Company’s
biotherapeutic product candidates in clinical development. The
Company's current products include the Helix™ Biotherapeutic
Delivery System and the Morph® steerable guide and sheath catheter
portfolio, including the new AVANCE™ Steerable Introducer family.
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 that are subject to many risks
and uncertainties. Forward-looking statements include statements
regarding our intentions, beliefs, projections, outlook, analyses
or current expectations. Such factors 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, and
the development of the industry in which we operate may differ
materially from the forward-looking statements contained in this
presentation. 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-Q filed with the Securities and Exchange
Commission on August 9, 2019, including under the caption titled
“Risk Factors.” BioCardia expressly disclaims any intent or
obligation to update these forward-looking statements, except as
required by law.
i Duckers HJ, Raval A, Pepine C, Johnston PV, Traverse JH,
Emery J, Miller L, Abraham WT, Altman PA. Performance of Helix
transendocardial biotherapeutic delivery system after 300 cases,
Transcatheter Therapeutics, San Diego 2018.
ii Mitsutake Y, Pyum WB, Rouy D, Wong Po Foo C, Stertzer SH,
Altman P, Ikeno F. Improvement of local cell delivery using Helix
Transendocardial Delivery Catheter in a porcine heart. Int Heart J.
2017.
iii Raval AN, Cook TD, Duckers HJ, Johnston PV, Traverse JH,
Abraham WT, Altman PA, Pepine CJ. The CardiAMP Heart Failure trial:
A randomized controlled pivotal trial of high-dose autologous bone
marrow mononuclear cells using the CardiAMP cell therapy system in
patients with post–myocardial infarction heart failure: Trial
rationale and study design, American Heart Journal 201 (2018)
141–148.
INVESTOR CONTACT:David McClung, Chief Financial
Officerinvestors@BioCardia.com(650) 226-0120
MEDIA CONTACT:Michelle McAdam, Chronic
Communications, Inc.michelle@chronic-comm.com(310) 902-1274
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