JenaValve Technology

Name

JenaValve Technology

Legal name

JenaValve Technology, Inc.

Website

https://jenavalve.com

Company type

Private

Founded year

2006

Operating status

Operating

Headcount range

101–250 employees

Ownership category

akta.pro rank

Product category

Transcatheter Heart Valve Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB)

akta.pro secondary industry

Vascular Access & Closure Devices (Sheaths, Guidewires, Closure Systems) (HLAHAFAK)

Keywords

• Transcatheter heart valves
• Structural heart devices
• Aortic regurgitation treatment
• TAVR systems
• Cardiac medical devices

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations, Infrastructure

Revenue model

1. Trilogy Transcatheter Heart Valve System Sales: One-time hardware sales of the Trilogy transcatheter heart valve system to hospitals and cardiac centers for treatment of aortic regurgitation and aortic stenosis. Revenue generated from device sales as the company begins US commercialization in April 2026 following FDA approval.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core offering

JenaValve Technology develops and manufactures the Trilogy Transcatheter Heart Valve (THV) System, a transcatheter aortic valve replacement (TAVR) platform designed to treat symptomatic, severe aortic regurgitation (AR) and aortic stenosis (AS) in patients at high surgical risk. The system comprises the Trilogy Valve (self-expanding nitinol frame with proprietary locator technology and porcine pericardial tissue), the Trilogy Delivery System (single-action deployment catheter), and the Trilogy Introducer Sheath System (85 cm hydrophilically-coated sheath). It is the first and only FDA-approved TAVR device for aortic regurgitation and the first transfemoral TAVR approved for both AR and AS in Europe.

Product overview

JenaValve Technology offers the Trilogy Transcatheter Heart Valve (THV) System, a comprehensive TAVR (Transcatheter Aortic Valve Replacement) solution designed for treating symptomatic, severe aortic regurgitation. The system comprises three integrated components: the Trilogy Valve (self-expanding nitinol frame with porcine pericardial tissue and proprietary locator technology), the Trilogy Delivery System (for precise catheter-based deployment), and the Trilogy Introducer Sheath System (85cm sheath extending to the sinotubular junction). The proprietary locator technology differentiates the system by enabling secure anchoring to native anatomy without requiring calcification, making it the first and only FDA-approved TAVR device for aortic regurgitation and the first TAVR system with true dual-disease treatment capability (AR and aortic stenosis) approved in Europe.

Differentiator

Problem solved

Functional benefit

Brands

• Trilogy System: The Trilogy Transcatheter Heart Valve System - a TAVR system FDA-approved for treatment of symptomatic severe aortic regurgitation in high surgical risk patients.

Products and services

• Trilogy Transcatheter Heart Valve (THV) System A transcatheter aortic valve replacement (TAVR) system designed for transfemoral delivery to treat symptomatic, severe aortic regurgitation. Features proprietary locator technology that clips onto native anatomy for secure anchoring without requiring calcification, enabling treatment of AR patients who cannot undergo open-heart surgery. Sold to hospitals and cardiac centers.
• Trilogy Delivery System Catheter-based delivery component engineered for stability, precision and reliability from access to deployment. Features catheter deflection to center the valve above the annulus, integrated rotation and axial positioning for commissural alignment, and a simple one-step deployment mechanism. Sold to hospitals as part of the Trilogy THV System.
• Trilogy Introducer Sheath System 85 cm pre-shaped, hydrophilically-coated introducer sheath that extends to the sinotubular junction, protecting the Trilogy Valve and patient through deployment. Sold to hospitals as part of the Trilogy THV System.

Quantifiable outcome

• 95.0% technical success rate (Pivotal + CAP, n=700) compared to 74-86% with off-label TAVR devices
• +6 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Three partnerships are on record, tiered strategic and core.

• American Society of Echocardiography (ASE)strategicStrategic or Co-development Partner · 16 November 2023Partnership announced November 2023 to advance detection and diagnosis of aortic regurgitation. Collaboration with leading professional society in echocardiography to improve patient identification and care pathways.
• egnite, Inc.strategicStrategic or Co-development Partner · 10 June 2023Strategic partnership announced June 2023 to uncover trends in care for patients with aortic regurgitation. Leverages egnite's AI-driven database and industry-leading cardiovascular data to quantify prevalence and treatment patterns. First study presented at TVT Structural Heart Summit estimated over 500,000 US patients with moderate or severe AR.
• Peijia MedicalcoreChannel Partner/ Reseller/ Distributor · 18 January 2022License and development agreement signed December 2021 (announced January 2022). Peijia Medical granted exclusive license to develop, manufacture, and commercialize Trilogy System in greater China region. First commercial implants performed in Hong Kong in May 2023.

Scale indicators10 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Edwards Lifesciences: Global TAVR market leader with the Sapien platform (transfemoral and transapical delivery). Most direct competitor in transcatheter aortic valve replacement; attempted acquisition of JenaValve blocked by FTC in 2026.
• Medtronic: Major TAVR competitor with the Evolut self-expanding platform. Competes head-to-head with JenaValve in transcatheter aortic valve replacement across both AR (off-label) and AS indications.
• Abbott: TAVR competitor with the Navitor (self-expanding) and Portico platforms. Directly comparable transcatheter aortic valve portfolio targeting overlapping patient populations and cardiac centers.

Emerging players

• Boston Scientific: Structural heart player with the ACURATE neo2 TAVR platform. Competes in the same transcatheter aortic valve space but with a smaller installed base than Edwards, Medtronic, or Abbott.
• 4C Medical Technologies: Structural heart startup developing transcatheter mitral and tricuspid valve therapies. Comparable early-stage structural heart medtech player with novel transcatheter valve technology, though focused on mitral rather than aortic disease.
• Ancora Heart: Structural heart company developing transcatheter mitral valve repair technology. Comparable early-stage transcatheter valve company targeting underserved valvular disease patient populations.

Regional players

• Peijia Medical: China-based structural heart company that is both an investor and exclusive distributor for JenaValve's Trilogy in greater China. Also develops its own TAVR technologies, creating a partner/competitor hybrid relationship.
• Venus Medtech: Chinese TAVR developer with approved transcatheter aortic valve products in greater China. Comparable structural heart franchise focused on the Chinese market with overlapping technology to Trilogy.
• MicroPort CardioFlow: Subsidiary of MicroPort Scientific developing the VitaFlow TAVR system. Comparable transcatheter aortic valve technology with focus on the Chinese market.

Broad incumbents

• CryoLife (Artivion): Cardiac and vascular surgery company with tissue heart valves and surgical valve repair products. Adjacent competitor in the structural heart space, focused more on surgical (open) rather than transcatheter valves.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/JenaValve
• LinkedInlinkedin.com/company/jenavalve

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries2 records

Funding overview

Funding rounds11 records

Investors21 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about JenaValve Technology