---
schema_version: "secwatch.filing_event.v1"
accession: "0001214659-25-005814"
form_type: "8-K"
ticker: "EBRCZ"
cik: "0001347123"
company_name: "EBR Systems, Inc."
filed_at: "2025-04-14T23:59:59+00:00"
generated_at: "2026-05-23T15:21:18.694297+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# FDA approves EBR Systems' WiSE CRT System for commercial distribution in US

## Summary
- FDA approved WiSE CRT System for left ventricular endocardial pacing; target initial US addressable market ~$3.6B.
- Indicated for previously untreatable (failed CS lead) and high-risk upgrade patients aged ≥22.
- Limited market release in late 2025; full commercial launch expected early 2026.
- Post-approval study of 320 patients over 5 years required; NTAP/TPT reimbursement effective Oct 1, 2025.
- Contraindications include triple anticoagulant therapy and allergy to procedural agents.

## SEC filing metadata
- accession: 0001214659-25-005814
- form_type: 8-K
- ticker: EBRCZ
- cik: 0001347123
- company_name: EBR Systems, Inc.
- filed_at: 2025-04-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1347123/000121465925005814/0001214659-25-005814-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1347123/000121465925005814/e4132508k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001214659-25-005814
- JSON: https://secwatch.observer/filing/0001214659-25-005814.json
- Plain text: https://secwatch.observer/filing/0001214659-25-005814.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.