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FDA Q2 meetings scheduled for both Helix catheter review and CardiAMP accelerated approval; $2.5M cash at year-end 2025
BioCardia's campaign to win the first FDA clearance for a catheter that injects cell and gene therapies directly into heart muscle cleared a pivotal regulatory hurdle in March 2026. The U.S. Food and Drug Administration accepted the company's pre-submission package for the Helix Transendocardial Delivery Catheter, confirming it contains all the necessary elements for substantive review and scheduling a formal meeting for the second quarter of 2026. The Helix device, backed by safety and efficacy data from fifteen clinical trials, uses a small helical needle that anchors within the beating heart to precisely deliver therapeutic agents to damaged muscle tissue. CDRH will lead the review in consultation with CBER.
Updated May 7
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