BioCardia Receives CE Mark Renewal for Helix and Morph Devices Through May 2024

October 8, 2019—BioCardia announced renewal of the European CE Mark for the Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter, both used in the delivery of biotherapeutics to the heart.

In addition to marketing its products, BioCardia also partners with other biotherapeutic companies to provide Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction.

CE Mark renewal enables BioCardia to continue supporting partners conducting biotherapeutic clinical trials outside of the United States and commercial sales in the European Union and other countries that recognize the CE Mark through May 2024.

The Helix system is currently being evaluated in the CardiAMP heart failure trial (the United States phase III pivotal trial) along with the company’s lead cell therapy candidate (CardiAMP), which uses autologous bone marrow cells delivered to the heart in a minimally invasive procedure to potentially stimulate the body’s natural healing response.