- Artivion Inc AORT has stopped the PROACT Xa trial to determine if patients with an On-X mechanical aortic valve can be maintained safely and effectively on apixaban rather than on warfarin.
- The decision was based on the recommendation of the independent Data and Safety Monitoring Board (DSMB) of the trial due to a lack of evidence supporting the non-inferiority of apixaban to warfarin for valve thrombosis and thromboembolism.
- The PROACT Xa trial randomized patients having an On-X aortic valve replacement to receive either warfarin or apixaban as their anticoagulant to prevent blood clots.
- The trial began enrolling in April 2020. The DSMB found that blood clots occurred more frequently in patients receiving apixaban.
- Continuing the trial was unlikely to achieve the primary endpoint while possibly exposing patients to increased risk.
- Physician investigators are being notified to change patients in the apixaban arm of the trial back to warfarin.
- The company reiterated the FY22 outlook of delivering double-digit top-line growth, expanding gross margins, and accelerated adjusted EBITDA growth through 2024.
- "We had committed approximately $10 million in annual funding to this study through 2024 and will now redirect these funds to other development opportunities and incremental EBITDA and cash flow in 2023 and 2024," said Pat Mackin, Chairman, President & CEO.
- Price Action: AORT shares are down 17.9% at $15.18 on the last check Friday.
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