BioCardia Awarded U.S. Patent for Imaging System

The U.S. Patent Office has granted BioCardia Inc. a 12-year patent for its image-guided cardiac treatment technology. 

Patent Number 11,357,463 is titled, “Target Site Selection, Entry and Update With Automatic Remote Image Annotation.” The patent describes advances for image-guided delivery of treatments for the heart, describing procedures using interventional biotherapeutic delivery technologies to deliver biologics to specific target sites in the heart. The patented imaging system is designed to enable physicians to bring a previously obtained three-dimensional image of a patient’s heart from either magnetic resonance imaging or computed tomography scan into a procedure, predefine target sites and annotate the heart images to prepare for therapeutic intervention, and then deliver therapy to these target sites in a controlled fashion.
 
“A BioCardia fusion imaging system for cardiac biotherapeutics builds on the work of other respected scientists and is expected to be regulated by a 510(k) pathway, be inexpensive to develop, and work well with all of our approved and development stage delivery catheter systems, including those designed to use electrical signals to position and target therapies in the heart,” said Dr. Peter Altman, BioCardia’s president and CEO. “The imaging system product enhancement offering we are working towards is expected to benefit both our autologous and allogeneic cardiac cell therapies as well as the biologic therapies in development by respected partners using BioCardia catheter biotherapeutic delivery solutions.”
 
The patent claims a system for fluoroscopic imaging of a patient’s heart and means for registering and transposing a three-dimensional image of the heart onto two orthogonal, two-dimensional images which can be marked to show anatomical details as well as treatment planning information in the preoperative three-dimensional image. This new patent is expected to strengthen the protection of BioCardia efforts with respect to its cardiovascular therapeutic approaches already afforded by issued patents. 
 
BioCardia’s cardiac cell therapies under clinical development include: the CardiAMP autologous cell therapy in ischemic heart failure (BCDA-01), the CardiAMP autologous cell therapy in chronic myocardial ischemia (BCDA-02), and the CardiALLO NK1R+ allogeneic cell therapy (BCDA-03).
 
Headquartered in Sunnyvale, Calif., BioCardia develops cellular and cell-derived therapeutics for treating cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the company’s biotherapeutic platforms that enable four product candidates in development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the U.S. Food and Drug Administration, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS Reimbursement. The company’s current products include the Helix Transendocardial Biotherapeutic Delivery System, which it partners selectively with other biotherapeutic companies requiring local delivery to the heart.