DUO 4 ALL

Información del proyecto

DUO 4 ALL

Identificador del acuerdo de subvención: 101247655

DOI

10.3030/101247655

Fecha de la firma de la CE 24 Octubre 2025

Fecha de inicio 1 Agosto 2025

Fecha de finalización 31 Enero 2027

Financiado con arreglo a

• The European Innovation Council (EIC)

Coste total

Sin datos

Aportación de la UE

€ 2 493 375,00

Coordinado por

CROIVALVE LIMITED
Ireland

Periodic Reporting for period 1 - DUO 4 ALL (DUO 4 ALL)

Período documentado: 2025-08-01 hasta 2026-04-30

Resumen del contexto y de los objetivos generales del proyecto

Tricuspid Regurgitation (TR) is a debilitating condition of the right heart valve that causes it to leak, making the heart work harder and leading to disease progression. Patients suffer with severe symptoms that drastically impact their quality of life and mortality. However, less than 1% receive treatment due to limited therapeutic options. The TR market is severely underserved and therefore offers significant market potential, estimated at €5Bn+ in the US and Europe alone. The objective of the 18-month grant program is the optimisation of the design to ensure the design is suitable for commercialisation and broad market adoption. This is to provide a wider treatable population and more scalable procedure, based on learnings from the feasibility clinical study, will ensure the potential of this groundbreaking design is realised.

The project is structured into 5 workpackages. WP1 consists of coordination activities to deliver the project results on time, to cost and to the expected contractual requirements. WP2 focuses on the design optimisation activities for the system. This is to provide a wider treatable population and more scalable procedure, based on learnings from our feasibility clinical study, will ensure the potential of this groundbreaking design is realised. WP 3 is the verification and validation testing necessary to support implementing these changes into the TANDEM II clinical study, followed by clinical validation. WP 5 covers the design control deliverables to ensure compliance with ISO 13485.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

Work Package 1 Project Management
- Ensure the project is managed to provide execution of deliverables on time and within budget
- To control the project to maximise outcomes; coordinating legal, contractual and administrative requirements
Status: Ongoing - Project management will continue throughout the course of the project.

Work Package 2 System Optimisation
Completion of design updates to
- Accommodate the anatomic variability in patients
- Ensure a fully scalable procedure
Status: Ongoing - The design work was grouped into 3 design programs to deliver project objectives:
- Accommodate anatomic variability (includes anchor system updates to accommodate variability in SVC size and curvature & coaptation valve updates to accommodate variability in regurgitant orifice)
- Ensure a fully scalable procedure (includes anchor system updates to ensure predictable procedure and reduce positioning sensitivity & coaptation valve updates to ensure predictable outcomes and reduce positioning sensitivity)
The projects were separated into coaptation valve updates, stent updates and anchor system/delivery system updates.The System Optimisation for the coaptation valve updates and stent are complete, while the anchor system/delivery system Design Freeze is being prepared and will be completed within the next 2 months.

Work Package 3 Verification and Validation Testing
- Completion of all testing for submission to the Ethics Committee to verify the device and
- Validation the device in the clinic.
Status: Ongoing - The Verification testing for the coaptation valve updates and stent are complete, while the anchor system/delivery system testing is outstanding. Additionally, the Clinical Validation for the coaptation valve and stent updates have been initiated.

Work Package 4 Market and Commercial Readiness
- Expand IPR portfolio in conjunction with FTO and
- Secure regulatory and clinical approvals for clinical study
Status: Ongoing - The expanded IP protection is progressing, with a number of associated fillings. The Clin/Reg strategy for implementing the system optimisation is complete, with Regulatory approvals secured for the coaptation valve and stent updates.

Work package 5 Design History File Preparation
Objectives:
- Prepare and maintain design history file for design updates

Status: Ongoing - Design & Development planning is complete, risk analysis is ongoing, along with the completion of the Design History File

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

CroíValve’s innovative DUO System is the only solution designed to comprehensively address Tricuspid Regurgitation (TR) with a safe, effective, and easy-to-use approach that accommodates a broad range of patient anatomies. Validated through an EU-based First-in-Human clinical study, the DUO System has demonstrated superior outcomes compared to competing devices, confirming its transformative potential. This project is critical to scaling these successful results into a commercial setting, ensuring broader patient access to this breakthrough technology. The novelty of the DUO System represents a fundamental advancement over recently commercialized technologies, offering a unique approach that preserves native anatomy to improve clinical outcomes.

This project will deliver on the key areas of improvement to ensure the DUO System realizes its potential as a breakthrough device by:
- Accommodating the anatomic variability in patients and
- Ensuring a fully scalable procedure
This will help ensure DUO can provided a treatment for 600,000 patients who suffer daily with tricuspid valve disease and ultimately die.