BioCardia Awarded New U.S. Patent Covering Helix System for Local Biotherapeutic Delivery of Autologous and Allogenic Cells t...

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.

1. Duckers, HJ, Raval A, Pepine C, et al. Performance of Helix transendocardial biotherapeutic delivery system after 300 cases, Transcatheter Therapeutics, San Diego 2018.
2. 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. 

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