---
title: "Key facts: CardiAMP advances in US, Japan; FDA flags two Helix paths"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/286637684.md"
description: "BioCardia (BCDA) has launched a CardiAMP Phase III trial and advanced the CardiALLO Phase 1/2 study, reporting no safety issues. The FDA has flagged two potential clearance paths for the Helix system, preferring simultaneous approval with CardiAMP. The company reported a Q1 2026 net income of negative $2.259 million and has cut R&D costs following the closure of the CardiAMP HF Trial."
datetime: "2026-05-16T07:14:55.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/286637684.md)
  - [en](https://longbridge.com/en/news/286637684.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/286637684.md)
---

# Key facts: CardiAMP advances in US, Japan; FDA flags two Helix paths

-   BioCardia (BCDA) launched a CardiAMP Phase III trial and advanced the CardiALLO Phase 1/2 dose-escalation study after no safety signals in the low-dose CardiALLO cohort.1
-   BioCardia (BCDA): FDA pre-submission flagged two possible clearance paths for the Helix delivery system, raised no safety/performance issues, and prefers simultaneous approval with CardiAMP.2
-   BioCardia (BCDA) reported regulatory progress for CardiAMP in Japan and the U.S., citing clinical data on the therapy’s safety and efficacy as the program moved toward market approval.3
-   BioCardia, Inc. reported financial results for Q1 2026: net income of negative $2.259 million, operating loss of $2.266 million, and basic loss per share of $0.21 for the quarter.4
-   BioCardia (BCDA) cut R&D costs after closing the CardiAMP HF Trial; early enrollment in CardiAMP HF II and Japan regulatory work partly offset the drop.5

### Related Stocks

- [BCDA.US](https://longbridge.com/en/quote/BCDA.US.md)

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