BiVACOR — Stock, Pipeline & Market Cap

Is this your company? Claim your profile to update info and connect with investors.

Private Company

Funding information not available

Overview

BiVACOR is developing a next-generation Total Artificial Heart (TAH) that represents a significant technological leap over existing volume-displacement devices. Its key innovation is a single, magnetically levitated rotor that simultaneously pumps blood to both the lungs and body, aiming for greater durability, smaller size, and improved physiologic control. The company achieved a major milestone in July 2024 with its first-in-human implant as part of an FDA-approved Early Feasibility Study, positioning it as a leader in the advanced heart failure device space. With heart transplant availability severely limited, BiVACOR's TAH targets a large and growing unmet need for patients with end-stage biventricular failure.

CardiovascularHeart Failure

Technology Platform

Magnetically levitated (MAGLEV) rotary blood pump with a single, dual-sided impeller rotor designed to provide total biventricular heart replacement.

Opportunities

The severe global shortage of donor hearts creates a massive, unmet need for a durable mechanical replacement.

BiVACOR's compact, durable design could address a broader patient population, including many women, and aims for long-term destination therapy, representing a larger market than temporary bridge devices.

Risk Factors

The development carries extreme clinical and technological risk, as device failure is fatal.

The regulatory path for a novel, life-sustaining Class III device is long, expensive, and uncertain.

Future commercialization faces challenges in surgical adoption, reimbursement, and potential competition.

Competitive Landscape

Primary competition includes SynCardia's temporary Total Artificial Heart (the only FDA-approved TAH) and Abbott's Left Ventricular Assist Devices (LVADs) for unilateral support. BiVACOR's rotary MAGLEV technology differentiates it as a potential next-generation, more durable solution aimed at permanent use rather than temporary bridging.

More companies in Regenerative Medicine →More companies in United States →