What Cardiovalve does

Cardiovalve is a clinical-stage medical device company developing a transcatheter valve replacement system designed for transfemoral (percutaneous) delivery, enabling treatment of both mitral and tricuspid valve disease without open-heart surgery. The flagship device is engineered with a short profile to minimize left ventricular outflow tract (LVOT) obstruction, a robust anchoring mechanism for secure positioning in the native anatomy, and an enhanced sealing solution to prevent paravalvular leaks — addressing the most common failure modes in transcatheter valve procedures. The system is currently restricted to research use only and is supported by two clinical programs: the TARGET study for transcatheter tricuspid valve replacement (TTVR), which completed enrollment of 150 patients across Europe, the UK, and Canada in October 2025, and the AHEAD trial for transcatheter mitral valve replacement (TMVR), with preliminary data planned for TCT 2025.

The company operates as a wholly-owned subsidiary of Venus Medtech (Hangzhou) MedTech Co., Ltd., a China-based leader in structural heart solutions, and is headquartered in Or Yehuda, Israel. Cardiovalve generated revenue, when it commences, through hardware sales of valve replacement devices to hospitals and cardiac specialty centers via enterprise field sales and direct procurement relationships. The company submitted its CE Mark technical file in November 2025, with commercial launch in Europe projected for 2027. Target end-users are patients with severe tricuspid or mitral valve disease who are high-risk candidates for conventional open-heart surgery, an underserved segment where the transfemoral approach offers faster recovery and lower procedural risk.

Name

Cardiovalve

Legal name

Cardiovalve

Website

https://cardiovalve.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

1–10 employees

Short description

Cardiovalve develops a transfemoral transcatheter valve replacement system for both mitral and tricuspid anatomies, targeting high-risk cardiac surgery patients through hospitals and cardiac specialty centers following CE Mark approval.

Ownership category

akta.pro rank

Product category

Structural Heart Medical Devices

NAICS

Surgical and Medical Instrument Manufacturing (339112)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

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

akta.pro secondary industry

Interventional Cardiology (PCI/Structural Heart) (HLAKABAB)

Keywords

• Transcatheter valve replacement
• Mitral valve system
• Tricuspid valve system
• Transfemoral delivery device
• Structural heart devices

Headquarters

HQ city

Or Yehuda

HQ country

Israel

HQ region

Middle East

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Personnel, Others

Revenue model

1. Transcatheter Valve Devices: Cardiovalve is developing and preparing to commercialize its transcatheter valve replacement systems (tricuspid and mitral). As a medical device company, revenue will be generated through the sale of valve replacement devices to hospitals and cardiac centers following regulatory approvals.
2. Regulatory Milestones: The company is pursuing CE Mark approval in Europe, planning commercial launch in 2027. This regulatory pathway will enable market access across European territories.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Cardiovalve develops a novel transcatheter heart valve replacement system delivered via a transfemoral (catheter-based) approach, engineered to fit both mitral and tricuspid anatomies. The device avoids open-heart surgery and is currently in clinical/regulatory stage, restricted to research use only.

Product overview

Cardiovalve offers a novel transcatheter valve replacement system designed for both mitral and tricuspid valve replacement. The flagship Cardiovalve System uses transfemoral delivery to avoid open heart surgery, featuring a short profile to minimize LVOT obstruction risk, a robust anchoring mechanism, and enhanced sealing to prevent paravalvular leaks. The company's product portfolio is supported by two clinical programs: the TARGET Study for Transcatheter Tricuspid Valve Replacement (TTVR) and the AHEAD Trial for Transcatheter Mitral Valve Replacement (TMVR). The system is currently restricted to research use only.

Differentiator

Problem solved

Functional benefit

Products and services

• Cardiovalve System A novel transcatheter valve replacement system designed for transfemoral delivery, eliminating the need for open heart surgery. It fits both mitral and tricuspid anatomies and features a short profile to minimize ventricular protrusion and LVOT obstruction risk, a robust anchoring mechanism, and enhanced sealing to prevent paravalvular leaks. Intended for patients with valve disease who are high-risk for open-heart surgery.
• Transcatheter Tricuspid Valve Replacement (TTVR) The tricuspid application of the Cardiovalve system, evaluated in the TARGET study. Designed for patients with severe tricuspid regurgitation at high risk for open-heart surgery. The TARGET study enrolled 150 patients across Europe, the UK, and Canada, demonstrating effective reduction of tricuspid regurgitation with an acceptable safety profile.
• Transcatheter Mitral Valve Replacement (TMVR) The mitral application of the Cardiovalve system, evaluated in the AHEAD trial for future regulatory approval. Targets patients requiring mitral valve replacement who are high-risk for conventional surgery. Preliminary data planned for presentation at TCT 2025.

Quantifiable outcome

• 150 patients treated in TARGET study demonstrated effective reduction of tricuspid regurgitation with acceptable safety profile

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• Venus MedtechcoreStrategic or Co-development PartnerCardiovalve operates as a subsidiary of Venus Medtech, a leading Chinese medical device company specializing in structural heart disease solutions. Venus Medtech provides strategic support, resources, and infrastructure for Cardiovalve's transcatheter valve development and clinical programs. The relationship enables technology transfer and shared expertise in transcatheter valve technologies.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Edwards Lifesciences: Edwards is the dominant structural heart incumbent with the SAPIEN platform for aortic, transcatheter mitral repair (PASCAL), and an active transcatheter tricuspid program. It is the most consequential competitor in transcatheter valve replacement and shares Cardiovalve's transfemoral, catheter-based approach to mitral and tricuspid disease.
• Medtronic: Medtronic's Intrepid TMVR program is a leading transcatheter mitral valve replacement system in clinical development, directly comparable to Cardiovalve's mitral offering. Medtronic also has structural heart and tricuspid efforts, placing it in head-to-head competition for structural heart procedure share.
• Abbott: Abbott's Tendyne is a leading transcatheter mitral valve replacement system targeting the same high-risk mitral regurgitation patient population as Cardiovalve, and Abbott has growing tricuspid ambitions (TriClip for repair). It competes with Cardiovalve for the same hospital customers and procedures.
• Venus Medtech: Venus Medtech is Cardiovalve's parent company and China's leading structural heart company, developing transcatheter aortic, mitral, and tricuspid valve replacement systems. It validates the structural heart TAM and provides manufacturing and commercial reach relevant to assessing Cardiovalve's opportunity set.
• Boston Scientific: Boston Scientific has expanded aggressively into structural heart through acquisitions (e.g., Bolt, Apollo) and Watchman for adjacent structural procedures, competing with Cardiovalve for hospital structural heart budgets and interventional cardiology workflow.
• MicroPort Scientific: MicroPort's structural heart division develops transcatheter and surgical valve technologies (e.g., Columbus, Vitaflow), making it a comparable structural heart company with a broader portfolio than Cardiovalve and global commercial reach that Cardiovalve could aspire to in Asia.

Direct peers

• JenaValve Technology: JenaValve develops transcatheter aortic and mitral valve replacement systems, including transfemoral delivery devices for structural heart disease. As a focused structural heart company with a transcatheter valve portfolio, it is a close analog to Cardiovalve in technology approach and target market.
• NeoVasc: NeoVasc is developing the Tiara transcatheter mitral valve replacement system for high-risk mitral patients, positioning it as a direct competitor in TMVR. Its clinical-stage status, mitral focus, and North American/European regulatory pathway align closely with Cardiovalve's profile.
• Artivion (CryoLife): Artivion (formerly CryoLife) operates in the structural heart space with surgical heart valves and is expanding into transcatheter technologies. Its heart valve portfolio competes with Cardiovalve in treating valve disease patients and shares the structural heart commercial footprint.

Emerging players

• LuX-Valve (Peijia Medical): LuX-Valve is a Chinese developer of transcatheter tricuspid valve replacement systems, directly competing with Cardiovalve in the TTVR space. Its early commercial activity in China and emerging European ambition make it a relevant emerging peer for Cardiovalve's planned 2027 European launch.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/cardiovalve

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds2 records

Investors1 record

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 Cardiovalve