BiotechTube
EvaHeart

EvaHeart

Houston, United States· Est.
evaheart-usa.com
Is this your company? Claim your profile to update info and connect with investors.
Claim profile

Private Company

Total funding raised: $70M

Overview

EvaHeart is a private medical device company developing the EVAHEART®2 Left Ventricular Assist System, a novel LVAD designed to provide gentle, high-flow circulatory support while retaining physiological pulsatility. The company is currently conducting the COMPETENCE trial, a large-scale, randomized study comparing its device to the market-leading HeartMate 3, aiming for FDA approval in the US. With its technology already approved and used clinically in Japan since 2010, EvaHeart is positioning itself as a potential competitor in the global advanced heart failure device market by addressing key complications associated with traditional LVADs, such as pump thrombosis and bleeding events.

Cardiovascular

Technology Platform

Centrifugal LVAD pump with hydraulic impeller levitation, open-vane impeller for low shear stress, and pump speed modulation to preserve native pulsatility.

Funding History

2
Total raised:$70M
Series B$45M
Series A$25M

Opportunities

The EVAHEART®2 addresses persistent complications in LVAD therapy, such as pump thrombosis and bleeding, offering a differentiated product in a market dominated by a single player.
Successful FDA approval would provide access to the large North American and European advanced heart failure markets.
The device's long-term clinical use in Japan provides a robust safety and durability record to support its value proposition.

Risk Factors

The company faces high clinical and regulatory risk, as its pivotal COMPETENCE trial must demonstrate non-inferiority to the established market leader, HeartMate 3.
As a pre-revenue private company, it is dependent on external funding to complete the costly trial and launch commercially.
Post-approval, it will face significant commercial execution challenges against a deeply entrenched competitor with extensive market access.

Competitive Landscape

The LVAD market is a high-barrier duopoly, currently dominated by Abbott's HeartMate 3. Medtronic's HVAD was withdrawn from the market, effectively leaving Abbott as the sole major player. EvaHeart's primary competition is therefore Abbott, and its success depends on demonstrating comparable survival with advantages in reducing specific adverse events like stroke and bleeding to gain surgeon adoption and market share.

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