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Vdyne

ApplicationMaple Grove, Minnesota, USAFounded 2017· One of 381 Application companies tracked by AMPulse

A clinical-stage medical technology company developing a next-generation transcatheter tricuspid valve replacement (TTVR) system designed to treat severe tricuspid regurgitation.

CEO / Founder
Mike Buck
Team Size
11-50
Stage
Growth Stage
Total Funding
$80.2M
Latest Round
Series D
Key Investors
Jean Boulle Group

Technology & Products

Key Products

Vdyne is developing a next-generation transcatheter tricuspid valve replacement (TTVR) system and repair technology.

Technological Advantage

Features a unique side-delivery system that allows for repositioning and recapture during deployment, along with a 'pop-off' mechanism to manage afterload mismatch, significantly reducing procedural risk.

Differentiation

Value Proposition

Provides a minimally invasive, transfemoral solution that preserves the natural asymmetric shape of the tricuspid annulus and right ventricle, offering a safer alternative for high-risk surgical patients.

How They Differentiate

Utilizes a proprietary asymmetric valve design specifically engineered to match the non-circular anatomy of the tricuspid annulus, combined with a unique side-delivery system (28 Fr) that allows for vertical crimping and full repositioning/recapture during deployment.

Market & Competition

Target Customers

Interventional cardiologists, structural heart centers, and patients suffering from severe to torrential tricuspid regurgitation (TR).

Industry Verticals

["Medical Devices","Cardiovascular Health","Structural Heart Therapy","Additive Manufacturing (MedTech)"]

Competitors

Edwards Lifesciences (EVOQUE), Abbott (TriClip/Tendyne), Medtronic (Intrepid)

Growth & Milestones

Growth Metrics

Clinical-stage with over 25 successful human cases completed across 7 global sites; currently advancing toward CE Mark approval and pivotal U.S. trials.

Major Milestones

["Series D led by Undisclosed Strategic Investor in Oct 2022","FDA Breakthrough Device Designation received in 2023","FDA Investigational Device Exemption (IDE) granted for TRIVITA1 pivotal trial in Mar 2025","Appointment of Mike Buck as Chairman and CEO to lead next phase of TTVR program in Mar 2025"]

Notable Customers

Structural Heart Centers in Australia (VISTA clinical study sites), Structural Heart Centers in Europe (VISTA clinical study sites)

https://www.vdyne.com

Why this company matters

Vdyne is a clinical-stage medical technology company focused on treating severe tricuspid regurgitation (TR) with a next-generation transcatheter tricuspid valve replacement (TTVR) system. Based in Maple Grove, Minnesota, the company targets a high-growth structural heart market where existing circular implants can distort right ventricular geometry. Its asymmetric valve design is engineered to preserve the natural shape of the tricuspid annulus, addressing a key limitation of traditional circular prostheses.

The core technology is a 28 Fr side-delivery TTVR system that enables vertical crimping, full repositioning, and recapture during deployment. A proprietary 'pop-off' mechanism manages afterload mismatch, reducing procedural risk. Vdyne also develops repair technology alongside its replacement platform. The system relies on metal additive manufacturing for the valve frame, allowing complex geometries that support the asymmetric orifice shape.

Target customers include interventional cardiologists and structural heart centers treating patients with severe to torrential TR. Vdyne's VISTA clinical study is active at sites in Australia and Europe, with over 25 successful human cases completed across seven global sites. The company received FDA Breakthrough Device Designation in 2023 and an Investigational Device Exemption (IDE) for its TRIVITA1 pivotal trial in March 2025. Key partnerships include the Jean Boulle Group, whose founders originally developed the Tendyne mitral valve technology acquired by Abbott.

Vdyne competes with Edwards Lifesciences (EVOQUE), Abbott (TriClip/Tendyne), and Medtronic (Intrepid) in the TTVR space. Its asymmetric design and side-delivery mechanism provide differentiation, but the company remains clinical-stage with no approved product. The appointment of CEO Mike Buck, a cardiovascular device veteran, signals a push toward CE Mark approval and U.S. pivotal trials. Total disclosed funding is $80.2 million, led by the Jean Boulle Group with an undisclosed strategic investor leading the Series D in 2022.