BioCardia Announces US Patent for Morph DNA Multi-Directional Steerable Catheter

BioCardia, Inc., a company headquartered in Sunnyvale, California, and focused on developing cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has announced the granting of a new patent by the United States Patent Office. The patent, numbered 12,036,371 and titled "Method of Accessing the Left Atrium with a Multi-Directional Steerable Catheter," will remain in force until 2035. This patent pertains to medical methods utilizing steerable introducers based on BioCardia's Morph DNA technology for transseptal access to the heart.

Transseptal access procedures play a crucial role in various medical interventions, including atrial fibrillation ablation, patent foramen ovale (PFO) and atrial septal defect (ASD) repair, percutaneous mitral valve repair, left atrial appendage closure, and the placement of percutaneous left ventricular assist devices. The global market for transseptal access systems was valued at $941.3 million in 2022 and is projected to grow at an annual rate of 7.3%, reaching an estimated $2.1 billion by 2033.

The Morph DNA technology incorporated in BioCardia's catheter designs enables the tensioning elements to rotate around the catheter shaft, ensuring consistent performance in all directions. This design mimics the double helix structure of DNA, allowing smooth navigation and eliminating the “whip” effect, where mechanical forces cause the catheter to abruptly change orientation.

Peter Altman, PhD, President and Chief Executive Officer of BioCardia, explains that the company's biotherapeutic interventions for heart conditions, such as heart failure, refractory angina, and acute myocardial infarction, will utilize this advanced introducer technology. Altman highlights that this innovation addresses a long-standing technical challenge by enhancing physician control during procedures. BioCardia aims to provide or partner this solution for the approximately 500,000 transseptal procedures performed annually in the United States, along with other vascular access markets that could benefit from the technological advantages of their patented solution.

BioCardia's core mission involves developing cellular and cell-derived therapies for treating cardiovascular and pulmonary diseases. The company's main therapeutic platforms include CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, which are supported by its Helix biotherapeutic delivery and Morph vascular navigation product platforms. With three clinical-stage product candidates in development, BioCardia continues to focus on innovative therapeutic solutions.

The patent grant enhances BioCardia’s intellectual property portfolio, providing additional protection for its current and future products in a significant market. This development is expected to increase shareholder value, aligning with the company's long-term strategic objectives.

In essence, BioCardia's new patent underscores its commitment to advancing medical technology and improving outcomes in cardiovascular and pulmonary disease treatments. The Morph DNA technology not only represents a significant technical achievement but also holds the potential to revolutionize the field of transseptal procedures by improving safety and efficacy.