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BiVACOR

Huntington Beach, California, United Statesbivacor.com ↗

Ownership: Private
Development stage: Other

Overview

BiVACOR has developed a fully implantable, magnetically levitated Total Artificial Heart designed to replace both ventricles in patients with end-stage biventricular or univentricular heart failure. The device has shown promising early results in first-in-human studies with no strokes or device-related complications reported among initial recipients. The TAH received FDA Breakthrough Device Designation in mid–2025 and the Early Feasibility Study was expanded after positive safety/performance data from the first five patients.

Therapeutic areas: Cardiovascular
Modalities: DeviceNon-pharmacological therapy
Industry: Implantable Medical Devices

Partnerships

Texas Heart Institute (clinical collaboration/equity interest)Baylor St. Luke’s Medical Center/Baylor College of Medicine (clinical trial site/partner)Calnetix Technologies (strategic partner for magnetic levitation tech)

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