CroíValve Awarded €12.5M in Horizon Europe EIC Accelerator Funding to Advance Novel Treatment for Tricuspid Regurgitation
CroíValve, a Dublin-based medical device company committed to transforming the treatment of tricuspid regurgitation (TR), has secured a major funding boost through the European Innovation Council (EIC) Accelerator Programme, a flagship initiative under Horizon Europe. The funding comprises a €2.5 million grant and a €10 million equity investment earmarked for CroíValve’s upcoming financing round. This support will accelerate the clinical development of the company’s pioneering DUO™ System—a minimally invasive transcatheter device designed to treat severe cases of tricuspid regurgitation.
The EIC Accelerator Programme is part of the broader Horizon Europe 2021–2027 Research and Innovation framework, which provides non-dilutive and equity funding to breakthrough, high-risk innovations with global market potential. In the latest round, the competition saw 959 applications from across Europe, of which only 40 companies from 16 countries were selected for funding. Notably, nearly one-third of these awardees are led by women, and CroíValve proudly represents this cohort with CEO Lucy O’Keeffe at the helm.
“Securing funding from the EIC Accelerator is a transformative milestone for CroíValve,” said O’Keeffe. “This funding allows us to expand clinical validation of the DUO™ System and bring our innovative solution closer to the patients who need it most. There remains a large, underserved population suffering from tricuspid regurgitation, and existing treatment options are not suitable for many of them. At CroíValve, our mission is to deliver a better, safer way to treat this disease, and the EIC’s support is instrumental in achieving that goal.”
Tricuspid regurgitation is a serious cardiac condition that affects more than 4 million individuals in Europe and the United States. It occurs when the tricuspid valve fails to close properly, leading to the backflow of blood into the right atrium. This can result in fatigue, swelling, liver congestion, and other life-limiting symptoms. The disease is often associated with other cardiac conditions and remains under-treated, with many patients deemed unsuitable for conventional surgical repair or replacement.
CroíValve’s DUO™ System presents a novel approach to TR treatment. Unlike traditional valve replacement technologies, the DUO™ System works in tandem with the native tricuspid valve, enhancing function without disrupting the existing anatomy. The device features an innovative anchoring mechanism that avoids critical structures in the right heart, thereby minimizing the risk of complications and enabling treatment of a broad and heterogeneous patient population.
One of the key advantages of the DUO™ System is its procedural simplicity. By reducing reliance on advanced intraprocedural imaging and complex deployment techniques, the system shortens the learning curve for physicians and promotes consistent, reproducible outcomes. These attributes are expected to make the therapy more accessible in routine clinical practice.
Currently, the DUO™ System is being evaluated in the TANDEM II Study, an early feasibility clinical trial taking place in leading cardiology centers in Poland and the United States. The multicenter, prospective study is focused on assessing the safety, performance, and initial clinical outcomes of the device in patients with severe tricuspid regurgitation.
As CroíValve continues its journey toward regulatory approval and commercialization, the support from Horizon Europe and the EIC Accelerator positions the company to make a significant impact in the field of structural heart interventions. With strong clinical momentum and increasing recognition on the international stage, CroíValve is poised to become a key player in the next generation of transcatheter heart valve therapies.
