BioCardia Launches Morph DNA Steerable Introducer Product Family

December 17, 2024—BioCardia, Inc. announced the commercial availability of its Morph DNA steerable introducer product family. The company noted that the devices are currently utilized in the company’s ongoing cell-therapy clinical trials.

FDA clearance of the Morph DNA family was announced in August 2024.

According to BioCardia, Morph DNA was developed initially to provide enhanced control for biotherapeutic delivery procedures within the heart. Features of the Morph DNA family include bidirectional steering, a layup for torque response, ergonomic actuation, an adjustable brake for fine control, and a swiveling side port in its hemostasis valve to solve tangling issues and enhance procedures.

The “DNA” in the product name refers to the tensioning elements of the device design, which resembles the double helix in a strand of DNA, noted the company.

BioCardia further stated that the tensioning elements in the catheter rotate around the catheter shaft, which is intended to allow for consistent catheter performance in any direction, enable smooth navigation, and prevent “whip” when the build-up of mechanical forces in the device cause a catheter to suddenly jump from one orientation to another.

In the press release, Peter Altman, PhD, CEO of BioCardia, discussed the company’s commercial plans for the Morph DNA family.

“Our team is exploring an initial sales pipeline organically, without expending the operating costs associated with engaging a direct sales force or third-party medical device commercial partners,” commented Dr. Altman. “We look forward to demonstrating the value of the Morph DNA product family to physicians for procedures throughout the vascular system.

“BioCardia remains focused on our CardiAMP Heart Failure I and II clinical trials, studying our investigational FDA-designated breakthrough cell therapy product candidate to treat ischemic heart failure. We anticipate final results in the CardiAMP Heart Failure I trial and five actively enrolling world-class centers in the CardiAMP Heart Failure II trial by the end of the first quarter of 2025.”