BioCardia announces issuance of two patents by USPTO

BioCardia announced the issuance of two patent grants related to enabling technologies for delivery of its investigational autologous and allogeneic cell therapies. The United States Patent Office, USPTO, 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 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.