---
schema_version: "secwatch.filing_event.v1"
accession: "0000784199-22-000171"
form_type: "8-K"
ticker: "AORT"
cik: "0000784199"
company_name: "ARTIVION, INC."
filed_at: "2022-09-23T23:59:59+00:00"
generated_at: "2026-06-23T07:51:17.933322+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Artivion stops PROACT Xa trial; apixaban fails non-inferiority vs warfarin for On-X aortic valves

## Summary
- DSMB recommended stopping PROACT Xa due to lack of evidence supporting non-inferiority of apixaban to warfarin.
- Blood clots causing stroke occurred more frequently in patients receiving apixaban; trial continuation unlikely to achieve primary endpoint.
- Physicians notified to switch apixaban-arm patients back to warfarin.
- Successful trial would have significantly increased addressable market beginning in 2025; that opportunity is now lost.
- Company reaffirms 2022 double-digit top-line growth and redirects ~$10M annual trial funding to other development and EBITDA.

## SEC filing metadata
- accession: 0000784199-22-000171
- form_type: 8-K
- ticker: AORT
- cik: 0000784199
- company_name: ARTIVION, INC.
- filed_at: 2022-09-23T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/784199/000078419922000171/0000784199-22-000171-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/784199/000078419922000171/aort-20220923.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000784199-22-000171
- JSON: https://secwatch.observer/filing/0000784199-22-000171.json
- Plain text: https://secwatch.observer/filing/0000784199-22-000171.txt

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