CroíValve
CroíValve is a clinical-stage medical device company developing the DUO™ System, a transcatheter tricuspid coaptation valve that works with the native valve to treat severe Tricuspid Regurgitation, currently in FDA early feasibility studies targeting an estimated 4M+ patients in the US and EU.
- Company typePrivate
- Founded2016
- HeadquartersDublin, Ireland
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What CroíValve does
CroíValve is a clinical-stage medical device company developing the DUO™ System, a transcatheter tricuspid coaptation valve for the minimally invasive treatment of severe or greater symptomatic Tricuspid Regurgitation (TR). The device is designed to fill the regurgitant leak by working in tandem with the native tricuspid valve leaflets, preserving native anatomy and remaining independent of annulus size and coaptation gap. It is anchored in the Superior Vena Cava (SVC) via a stent, leaving the right heart and native valve apparatus untouched, and is compatible with pre-existing cardiac implantable electronic device (CEID) leads. The product line now includes the DUO Adapt System, which introduces "Adaptive Coaptation" capable of treating very large leaks up to 35mm.
The company's go-to-market is structured around clinical evidence generation rather than commercial sales. Two ongoing studies support the technology: TANDEM I (first-in-human, completed in Europe with 10 patients showing 89% KCCQ improvement, 100% NYHA Class I/II at 6 months, zero pacemaker events, and 100% survival) and TANDEM II (FDA-approved Early Feasibility Study underway at US and EU sites including Piedmont Heart Institute, with more than 15 patients treated and expanding). The DUO System is not commercially available in any geography, and the company has stated no pricing. Future commercialization is planned through direct sales to hospitals and heart valve centers following regulatory approval.
CroíValve is headquartered in Dublin, Ireland with R&D and Operations in Galway, and Clinical/Regulatory functions in the United States. Founded in 2016 by Dr. Martin Quinn (an interventional cardiologist who performed Ireland's first TAVI in 2008) and Dr. Lucy O'Keeffe (ex-Medtronic transcatheter aortic program), the company has raised approximately $43 million including grants through a Series A (€8M, 2022), Series B ($16M, 2024), an EIC Accelerator award (€2.5M grant + €10M equity commitment, 2025), and a Series B expansion ($20M + $7M grants, 2026). Key investors include MedTech Syndicate, BGF, the European Innovation Council, Broadview Ventures, HBAN MedTech, Irrus Syndicates, Enterprise Ireland, IAG Capital Partners, Ascentifi, Furthr, Atlantic Bridge University Fund, Elkstone, and SOSV.
CroíValve firmographics
Firmographics- Name
- CroíValve
- Legal name
- CroíValve
- Website
- https://croivalve.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- CroíValve is a clinical-stage medical device company developing the DUO™ System, a transcatheter tricuspid coaptation valve that works with the native valve to treat severe Tricuspid Regurgitation, currently in FDA early feasibility studies targeting an estimated 4M+ patients in the US and EU.
- Ownership category
- akta.pro rank
CroíValve industry classification
Industry- Product category
- Structural Heart Medical Devices
- NAICS
- Computer Systems Design and Related Services (54151)
- SIC
- Services-General Medical & Surgical Hospitals, Nec (8062)
- akta.pro primary industry
- Structural Heart Valves (TAVR/SAVR) & Valve Repair (HLAHAFAB)
- akta.pro secondary industry
- Critical Care Nephrology (ICU/CRRT Services) (HLAKAHAN)
Keywords
Where CroíValve is headquartered
LocationHeadquarters
- HQ city
- Dublin
- HQ country
- Ireland
- HQ region
- Europe
Offices3 records
Markets served
CroíValve business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain
Revenue model
- Medical Device Sales (Future): The company is in clinical stage and has not yet generated revenue. The DUO™ System is under clinical investigation and not commercially available in any geography. Upon regulatory approval, the company plans to commercialize its transcatheter tricuspid valve system through direct sales to hospitals and medical centers.
- Grant Funding: The company receives grant funding from government and EU programs including the European Innovation Council (EIC) and DTIF (Disruptive Technologies Innovation Fund) to support R&D and clinical trials.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels3 records
CroíValve product offering
Product offeringCore offering
CroíValve develops the DUO™ System, a transcatheter tricuspid coaptation valve designed for the minimally invasive treatment of severe+ tricuspid regurgitation. The system combines a coaptation valve that works in tandem with the native tricuspid valve leaflets and a novel SVC-anchored stent that leaves the right heart and native valve apparatus untouched, enabling treatment of a broad patient population including those with large annulus sizes, pre-existing CEID leads, large coaptation gaps, and advanced disease.
Product overview
CroíValve develops the DUO™ System, a transcatheter tricuspid coaptation valve system designed for the minimally invasive treatment of tricuspid regurgitation. The core DUO™ System consists of a coaptation valve, adjustable catheter system, and novel anchor mechanism that works in tandem with the native tricuspid valve. The company has evolved the technology with the DUO Adapt System, which introduces Adaptive Coaptation—a next-generation approach where the coaptation valve optimizes to fill larger, complex leak profiles by adapting to each patient's individual leak shape. Both systems are currently under clinical investigation through the TANDEM I (first-in-human, Europe) and TANDEM II (early feasibility, US/EU) clinical studies.
Differentiator
Problem solved
Functional benefit
Brands
- DUO™ System: A novel transcatheter tricuspid coaptation valve system that works in tandem with the native tricuspid valve to restore valve function while preserving native anatomy. Designed for treating severe+ tricuspid regurgitation (TR).
- DUO Adapt System
Products and services
- DUO™ System The DUO™ System is a transcatheter tricuspid coaptation valve system consisting of a coaptation valve that fills the leak and adapts to varying anatomy, an adjustable catheter delivery system, and a novel SVC stent-based anchor that preserves the right heart and native valve apparatus. It is designed for interventional cardiologists and cardiac surgeons treating patients with severe or greater symptomatic tricuspid regurgitation.
- DUO Adapt System The DUO Adapt System is an enhanced iteration of the DUO System with an optimized coaptation valve that adapts to each patient's individual leak shape, introducing a new treatment category called Adaptive Coaptation. It is designed to fill larger, more complex leak profiles and is under clinical investigation in the expanded TANDEM II Study.
Quantifiable outcome
- 89% of patients experienced >15-point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ)
- +7 more outcomes
Companies that use CroíValve
Customer profileNamed customers5 records
Segments2 records
Ideal customer profiles1 record
CroíValve technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
CroíValve partnerships and signals
Strategic signalScale indicators7 records
Recent moves6 records
Expansion highlights5 records
CroíValve competitors and assessment
Company assessmentBroad incumbents
- Edwards Lifesciences: Global structural heart leader with the Evoque transcatheter tricuspid valve replacement system (FDA-approved 2024). Competes directly with CroíValve in the tricuspid regurgitation market but operates across a much broader portfolio including TAVR and mitral valve devices.
- Abbott: Major medtech incumbent with the TriClip transcatheter tricuspid repair system (FDA-approved 2024). Also offers MitraClip and a comprehensive structural heart portfolio. Competes directly with CroíValve's DUO System in the TR treatment market.
- Medtronic: Large medtech incumbent with structural heart programs and historical involvement in tricuspid interventions. Serves as both a potential competitor and benchmark; multiple CroíValve executives are Medtronic alumni (CEO O'Keeffe, VP R&D Kenny, board members Ryan).
- Boston Scientific: Major medtech incumbent with structural heart programs and historical acquisition activity in tricuspid space (acquired Claret Medical). Multiple CroíValve board members are Boston Scientific veterans (Chairman Collins was VP International Operations). Represents both a competitive threat and potential strategic acquirer.
Direct peers
- 4C Medical Technologies: Emerging structural heart company developing the AltaValve system for mitral and tricuspid regurgitation. Directly comparable as a clinical-stage transcatheter tricuspid device developer pursuing the same market opportunity as CroíValve.
- InnovHeart: Clinical-stage medical device company developing transcatheter tricuspid valve replacement (Saturn TMVR system applicable to tricuspid). Comparable as a peer-stage competitor in transcatheter tricuspid therapy with board representation from industry veterans (Azin Parhizgar also serves on InnovHeart board).
- Cardiac Dimensions: Developer of the Carillon System for functional tricuspid and mitral regurgitation. Comparable as a transcatheter tricuspid intervention company pursuing the same patient population with a different mechanical approach (annuloplasty-based).
- Anteris Technologies: Clinical-stage structural heart company developing the DurAVR THV system for aortic stenosis and tricuspid applications. Comparable as a clinical-stage transcatheter valve developer with similar regulatory pathway and structural heart focus.
Emerging players
- Micro Interventional Devices: Early-stage company developing transcatheter solutions for tricuspid and mitral regurgitation. Comparable as a smaller emerging player in the structural heart space with overlapping target indications though currently less advanced in clinical development.
Others
- Corvia Medical: Interventional heart failure company developing transcatheter devices for structural heart disease. Comparable as an adjacent structural heart device developer with similar clinical-stage profile and regulatory pathway, though focused on interatrial shunting rather than tricuspid repair.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks1 record
Key highlights6 records
Customer concentration
CroíValve social profiles
Digital presenceCroíValve financial estimates
Financial estimateRevenue estimate
Valuation estimate
CroíValve leadership team
Management profileNumber of profiles
Profiles11 records
CroíValve funding detail
Funding detailFunding overview
Funding rounds12 records
Investors19 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
CroíValve M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about CroíValve
What does CroíValve do?
CroíValve develops the DUO™ System, a transcatheter tricuspid coaptation valve designed for the minimally invasive treatment of severe+ tricuspid regurgitation. The system combines a coaptation valve that works in tandem with the native tricuspid valve leaflets and a novel SVC-anchored stent that leaves the right heart and native valve apparatus untouched, enabling treatment of a broad patient population including those with large annulus sizes, pre-existing CEID leads, large coaptation gaps, and advanced disease.
Is CroíValve a public or private company?
CroíValve is a private company. It is classified as venture growth investor backed and is currently operating.
When was CroíValve founded?
CroíValve was founded in 2016. It employs 11 to 50 people.
Where is CroíValve based?
CroíValve is headquartered in Dublin, Ireland, in the Europe region.
How does CroíValve make money?
Two revenue lines are on record. Medical Device Sales (Future) is the primary driver. The others are grant Funding.
Who are CroíValve's main competitors?
Broad incumbents on record are Edwards Lifesciences, Abbott, Medtronic and Boston Scientific. Direct peers are 4C Medical Technologies, InnovHeart, Cardiac Dimensions and Anteris Technologies. Micro Interventional Devices is listed as an emerging player. Corvia Medical is listed as an others.
Does CroíValve have an API?
No public API is recorded for CroíValve.
What industry is CroíValve in?
CroíValve's product category is Structural Heart Medical Devices. Its primary akta.pro industry code is HLAHAFAB, Structural Heart Valves (TAVR/SAVR) & Valve Repair, with a secondary code of HLAKAHAN, Critical Care Nephrology (ICU/CRRT Services). Its NAICS code is 54151 and its SIC code is 8062.