BioCardia, Inc. has announced the commercial availability of its Morph DNA steerable introducer product family, a device currently utilized in the company’s ongoing cell-therapy clinical trials. This launch signals BioCardia's intent to improve the precision and control of biotherapeutic delivery, particularly within the cardiovascular system.
Morph DNA Steerable Introducer: Design and Functionality
The Morph DNA steerable introducer is engineered with bidirectional steering capabilities and a proprietary layup for enhanced torque response. Its design incorporates ergonomic actuation, an adjustable brake for fine control, and a swiveling side port in its hemostasis valve to mitigate tangling issues during procedures. The device's tensioning elements rotate around the catheter shaft, ensuring consistent performance and preventing abrupt catheter jumps, a phenomenon known as "whip."
Commercial Strategy and Clinical Focus
BioCardia is pursuing an organic sales approach for the Morph DNA introducer, foregoing a direct sales force or third-party partners to minimize operating costs. According to BioCardia CEO, Peter Altman, PhD, the company aims to demonstrate the value of the Morph DNA product family to physicians for procedures throughout the vascular system.
Despite the commercial launch, BioCardia remains primarily focused on its CardiAMP Heart Failure I and II clinical trials. These trials are investigating the company's FDA-designated breakthrough cell therapy product candidate for the treatment of ischemic heart failure. Final results from the CardiAMP Heart Failure I Trial, along with updates from five actively enrolling centers in the CardiAMP Heart Failure II Trial, are anticipated by the end of the first quarter of 2025.
CardiAMP Trials and Ischemic Heart Failure
The CardiAMP trials are evaluating a cell therapy approach to treating ischemic heart failure, a condition characterized by reduced blood flow to the heart muscle. This impacts millions worldwide and often leads to debilitating symptoms and reduced quality of life. Current treatments primarily focus on managing symptoms and improving blood flow, but new approaches like cell therapy offer the potential to regenerate damaged heart tissue and improve cardiac function.
BioCardia's investigational cell therapy has received FDA breakthrough designation, highlighting its potential to address a significant unmet need in ischemic heart failure treatment. The Morph DNA steerable introducer plays a crucial role in these trials by enabling precise delivery of the cell therapy to the targeted areas within the heart.
Looking Ahead
BioCardia's strategic focus remains on advancing its CardiAMP clinical trials while leveraging the Morph DNA introducer to enhance biotherapeutic delivery. The company's decision to pursue an organic sales strategy reflects a commitment to cost-effective operations while exploring the commercial potential of its innovative vascular navigation technology.
