BioCardia Inc. (BCDA), a clinical-stage regenerative medicine company, on Monday stated that the outcome of a pre-submission meeting for the Helix Transendocardial Delivery Catheter System was confirmed by the U.S. Food and Drug Administration (FDA).
The Helix system was designed to deliver various therapeutic agents intramyocardially with precision to the heart in minimally invasive procedures. The catheter consists of a helical distal needle that can engage tissue within the beating heart and reportedly proved superior in retention and accessibility when compared to other methods.
The pre-submission meeting was disclosed by the company on May 8, 2026, and the reported outcome supports a pre-submission amendment as per the FDA, planned for the third quarter of this year.
Additionally, the company expects to submit an application to gain approval for its Cardi-AMP stem cell therapy in Japan by the fourth quarter of 2026, while its Heart 3D Fusion Imaging system is set to begin a first-in-human trial by early 2027.
BCDA is currently trading at $1.01.
See also:
Stereotaxis initiates study on robotic system for minimally invasive cardiac procedures
For comments and feedback contact: editorial@rttnews.com
Business News
August 21, 2026 14:42 ET The minutes of the latest policy meeting of the Federal Reserve, housing market data and manufacturing sector survey results were the main news for the U.S. economy this week. In Europe, inflation data from the U.K. was the highlight, while consumer price data from Japan drew attention in Asia.