Horizon Europe EIC Accelerator Grants Funding to CroíValve

CroíValve has been awarded funding from Horizon Europe’s European Innovation Council (EIC) Accelerator Programme for its tricuspid regurgitation (TR) treatment.

Part of the EU’s Horizon Europe 2021-2027 Research and Innovation Programme, the EIC Accelerator Programme provides transformational funding to high-potential, high-risk startups, scale-ups and subject matter experts. The award includes €2.5 million in grant funding and a €10 million equity investment in CroiValve’s next financing. The latest competition included 959 applications, with only 40 awards across 16 countries. Almost one-third of the selected companies are led by a woman (CroiValve included).

“Securing European Innovation Council (EIC) funding is instrumental in expanding clinical validation of the DUO System, a minimally invasive, transcatheter device to treat severe+ tricuspid regurgitation. There is a significant unmet clinical need to treat the heterogeneous patient population who are not suitable for first-generation transcatheter tricuspid devices. It is CroiValve’s mission to innovate a better way to help more patients suffering with this disease and we are honored to have EIC support for this journey,” CroíValve CEO Lucy O’Keeffe said.

More than 4 million people in Europe and the United States suffer from tricuspid regurgitation, a severe heart condition that occurs when the tricuspid valve in the right side of the heart fails to close properly. This results in blood being pumped backwards into the heart causing debilitating symptoms. It is associated with significant morbidity and reduced life expectancy.

CroíValve’s DUO System is a transcatheter heart valve that preserves the patient’s native anatomy while treating tricuspid regurgitation. It works in tandem with the native tricuspid valve to restore valve function while leaving the patient’s right heart and native valve apparatus untouched through an innovative anchoring mechanism. Designed to treat a broad patient population, the DUO System accommodates the heterogeneity of patient anatomies while avoiding contact with critical structures in the right heart which could lead to complications.

The DUO System is also designed to enable a straightforward procedure and reduce the procedural complexity seen with other devices. The procedure is less reliant on expert intraprocedural imaging, enabling a short learning curve with predictable and stable outcomes. The DUO System is currently under clinical investigation through the TANDEM II Study, a multicenter, prospective early feasibility study including centers in Poland and the United States.

CroíValve is a clinical stage medical device company developing a transcatheter device for tricuspid regurgitation treatment. The company has research, development and operations based in Ireland and clinical, regulatory and marketing services based in the United States.

The DUO System is an investigational device and not for sale in any geography.