BioCardia Inc. (BCDA), a clinical-stage regenerative medicine company, on Friday announced alignment with the U.S. food and drug administration after a pre-submission meeting on the Helix transendocardial delivery catheter system.
Helix was designed for the minimally invasive, targeted delivery of therapeutic and diagnostic agents to the heart intra-myocardially, allowing for precise injection, superior retention, and delivery to hard-to-reach areas.
The FDA raised no concerns regarding Helix's safety data and agreed that there are two possible pathways for its marketing clearance.
The alignment comes at the same time as approval for the CardiAMP investigational cell therapy for the treatment of heart failure. CardiAMP uses a patient's bone marrow cells to repair heart tissue by increasing capillary density and reducing tissue fibrosis. It was previously granted a breakthrough therapy designation by the FDA.
FDA also suggested a follow-on pre-submission to enable Helix approval via the DeNovo pathway.
BCDA is trading at $1.12, up 2.75%.
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