BioCardia Awarded New U.S. Patent Covering Helix System for Local Biotherapeutic Delivery of Autologous and Allogenic Cells t...
28 Aprile 2020 - 9:08PM
BioCardia®, Inc., (OTC: BCDA), a leader in the development of
comprehensive solutions for cardiovascular regenerative therapies,
today announced the issuance of United States Patent No.
10,632,281, entitled “Drug Delivery Catheters that Attach to Tissue
and Methods for Their Use.” This new patent provides additional,
broad protection for the Helix™ Biotherapeutic Delivery System and
covers the use of the helical needle delivery system with a
deflectable guide catheter. The U.S. Patent Office has extended the
life of this patent for 2.8 years beyond the usual 20-year term.
Published literature has shown that the Helix System presents
the lowest risk to patients for biotherapeutic delivery compared to
other delivery methods evaluated,1 and is three to six times more
efficient at delivering cells to the heart muscle than other
methods.2 The Helix System is believed to be the only CE Marked
intramyocardial delivery system and the only intramyocardial
delivery system in clinical use today.
“The Helix System is a key element in our CardiAMP® and
CardiALLO™ cell therapy programs and is also being used by partners
such as AstraZeneca, CellProThera and leading academic institutions
in their biotherapeutic development programs,” said Peter Altman,
PhD, chief executive officer of BioCardia. “This is just one of
many patents that protect our signature delivery system, allowing
us to provide physicians with compelling -- and differentiated --
technology they need to enable safe and efficient local
biotherapeutic delivery to the heart.”
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), 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,
CA, 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 approved products include
the Helix transendocardial delivery system and its steerable
guide and sheath catheter portfolio. BioCardia also partners
with other biotherapeutic companies to provide its Helix System and
clinical support to their programs studying therapies for the
treatment of heart failure, chronic myocardial ischemia and acute
myocardial infarction. For more information, visit
www.BioCardia.com.
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 the status of other
intramyocardial delivery systems and the protection provided by
patents. 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.
- Duckers, HJ, Raval A, Pepine C, et al. Performance of Helix
transendocardial biotherapeutic delivery system after 300 cases,
Transcatheter Therapeutics, San Diego 2018.
- Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell
delivery using Helix Transendocardial Delivery Catheter in a
porcine heart. Int Heart J 2017;58(3):435-440.
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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