BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart.
With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems in Europe and other locations that recognize the CE Mark through May 2024.
The Helix system, which includes the Morph guide product, is currently under evaluation in the U.S. Phase III pivotal CardiAMP heart failure trial. The CardiAMP cell therapy candidate is designed to deliver a patient’s own bone marrow cells to the heart in a minimally invasive procedure to potentially stimulate the body’s natural healing process.
The FDA approved the trial in January 2018 and in August 2018, and in August 2018, BioCardia announced data showing that the first 10-patient cohort of patients from the 260-patient trial saw improvements in their six-minute walk distance and 40% of patients improved by one class in the New York Heart Association Heart Failure Class scoring system.
BioCardia also partners with other companies to provide the Helix systems and support to programs looking for therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
“Renewal of the CE Mark for our innovative biotherapeutic delivery products ensures that we can continue participating in a variety of biotherapeutic research programs with the potential to drive the field forward and respond to very ill patients,” CEO Peter Altman said in prepared remarks. “In light of sweeping European regulatory changes associated with the transition from the MDD directive to the new MDR regulation, it has been a challenging time for both notified bodies, who are working to become certified to grant CE Mark under the new system, and for companies, who are trying to meet the new requirements and move their CE Mark applications forward. It is a significant achievement for BioCardia to have received CE Mark renewal in this environment, when many other companies are struggling to do the same or even abandoning the region.”
Shares of BCDA were up 6.4% to $3.51 per share in late-morning trading today.