BioCardia Issued Two New Patents

BioCardia Inc. has been issued two patent grants for its enabling technologies in delivering its investigational autologous and allogeneic cell therapies.
 
The U.S. Patent Office issued BioCardia Patent Number 11,716,859, entitled “Multi-Directional Steerable Catheter,” with a patent term that will expire in 2035. The patent claims a fundamental design for steerable introducer sheaths, such as those used for BioCardia’s autologous and allogeneic cell therapy procedures, and for transseptal procedures for the treatment of cardiac arrhythmias. The design enables the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. This design is intended to enable smooth navigation and prevent “whip,” when a catheter in the heart suddenly jumps from one orientation to another due to the build-up of mechanical forces in the device. This patented design is incorporated in the company’s U.S. Food and Drug Administration (FDA)-cleared Morph DNA product, a 5 French sheath equivalent, and in the company’s FDA-cleared Avance product, an 8.5 French introducer sheath indicated for transseptal procedures.
 
The Indian Patent Office granted the company Patent Number 424579, entitled “Steerable Endoluminal Devices and Methods for Use,” with a patent term that will expire in late 2031. The patent claims a fundamental design for steerable introducer sheaths. The design is for a coil with a braid disposed coaxially about the coil, all embedded within the wall of an introducer sheath. The coil enables a robust, kink-resistant design with enhanced column support, while the braid in the catheter shaft provides for excellent torque transmission. This patent design feature has demonstrated excellent performance in the company’s Morph Access Pro product family and has been used to treat approximately 10,000 patients to-date, ranging from a two-year-old girl to a 90-year-old man.
 
“This positive experience with the Morph DNA, Avance, and Morph AccessPro underlies our understanding of catheter navigation that informs the delivery of our higher-value biotherapeutic interventions, where we utilize steerable guide sheaths in every procedure,” BioCardia CEO Peter Altman, Ph.D., said. “The acquisitions of Baylis by Boston Scientific for $1.5 billion and the acquisition of the Acutus sheath portfolio by Medtronic for $87 million last year were focused on enabling transseptal access devices, like these, that enable ablation therapies to treat cardiac arrhythmias. These acquisitions show that these steerable catheter assets are nontrivial to develop and that the intellectual property that underlies these assets has the potential to enable large market opportunities and be quite valuable.”
 
These new patents are anticipated to strengthen the protection of BioCardia’s efforts with respect to its cardiovascular therapeutic approaches and provide enhanced value for all therapies developed with the Helix biotherapeutic delivery system product family.
 
Headquartered in Sunnyvale, Calif., BioCardia is developing 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 FDA, 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.