CroíValve's $43M Surge Signals New Hope for Neglected Heart Condition

DUBLIN, Ireland – June 23, 2026 – A significant injection of capital into an Irish medical device company is poised to accelerate a new chapter in the treatment of a common, yet historically overlooked, heart condition. CroíValve, a clinical-stage innovator, has announced a $27 million expansion of its Series B financing, combining $20 million in venture capital with $7 million in grant financing. This brings the company's total Series B round to an impressive $43 million when including all grants, a powerful vote of confidence from new investors BGF and the European Innovation Council (EIC) Fund, alongside existing partners.

The funding is earmarked to expand the TANDEM II clinical study, a pivotal trial evaluating the company's novel DUO™ Adapt System for treating severe tricuspid regurgitation (TR). This expansion will scale the study across additional sites in the United States and Europe, marking a critical step in bringing a potentially transformative, less invasive therapy to a large and vulnerable patient population.

Addressing the 'Forgotten Valve'

Tricuspid regurgitation occurs when the tricuspid valve—the gatekeeper between the two right chambers of the heart—fails to close properly, causing blood to leak backward. For decades, it was often dubbed the “forgotten valve,” a secondary concern to issues on the left side of the heart. However, recent data has cast a harsh light on this misconception. TR is now recognized as the most prevalent valve disease, affecting over 4 million people in the U.S. and Europe, with studies showing 3.7% of individuals over 65 develop a moderate or greater form of the condition.

Left untreated, severe TR is debilitating. It overloads the right side of the heart, leading to symptoms like severe fatigue, fluid retention, and shortness of breath, ultimately reducing life expectancy. The traditional solution, open-heart surgery, carries substantial risks, particularly for the typically elderly and frail patients who suffer from TR. This high-risk profile means a vast number of patients are left with only medical management, which often fails to halt the disease's progression. This significant unmet need has created a fertile ground for innovation, spurring a race to develop effective, minimally invasive transcatheter solutions.

A New Paradigm: How 'Adaptive Coaptation' Works

CroíValve’s DUO™ Adapt System enters this arena with a fundamentally different philosophy. While some competing technologies focus on clipping valve leaflets together or replacing the valve entirely, the DUO system is designed to work in tandem with the patient’s native valve. The device consists of a coaptation valve that is positioned between the tricuspid leaflets, effectively filling the gap and preventing backward blood flow. Crucially, its novel anchor system is designed to leave the native valve apparatus and surrounding right heart structures untouched, a key distinction aimed at minimizing complications.

The system’s most innovative feature is what the company calls “Adaptive Coaptation.” The DUO Adapt valve is engineered to conform to the patient’s specific leakage shape, a critical advantage given the highly variable and often complex anatomy of a failing tricuspid valve. This adaptability allows it to treat very large and complex leaks—up to 35mm—that may be challenging for other therapies. Early clinical data from the European TANDEM I study has been promising, with 89% of patients showing significant quality-of-life improvements and 100% improving their functional capacity to a less severe classification. These results were achieved through a procedure noted for its relative simplicity, one that does not rely on the complex intraprocedural imaging often required by other devices, suggesting a smoother learning curve and potential for wider adoption.

Navigating a Competitive Field with a Unique Compass

The landscape for transcatheter TR therapies has recently become validated by major regulatory milestones. In 2024, the U.S. FDA approved both Abbott’s TriClip™, a repair device, and Edwards Lifesciences’ EVOQUE™, a full valve replacement system. While these approvals have opened the door for minimally invasive TR treatment, they also highlight the need for a range of solutions to address the diverse patient population.

This is precisely where CroíValve aims to position its technology. By preserving the native anatomy and offering a customizable fit for complex leaks, the DUO Adapt System could provide a vital option for patients who are not ideal candidates for existing repair or replacement technologies. The focus on a straightforward, scalable procedure could also be a powerful differentiator in a healthcare system eager for solutions that are not only effective but also efficient to deploy.

European Innovation and Investment Fueling Global Impact

The substantial financial backing from BGF, a major UK and Ireland growth capital investor, and the EIC, the European Commission’s flagship innovation fund, underscores the technology’s promise. The inclusion of Tim Rea, Co-Head of Early Stage Investments at BGF, on CroíValve’s board further solidifies this strategic partnership.

Tim Rea commented on the decision, stating, “The team’s commitment to finding solutions to a major clinical problem is hugely impressive, treating a debilitating disease without the need to resort to invasive surgery. CroíValve’s differentiated technology positions it well to address a large and growing market for structural heart devices.”

This sentiment was echoed by Hermann Hauser, a Board Member of the EIC Fund. “Healthcare innovation matters most when it helps address challenges that affect millions of people. CroíValve is developing a novel approach to treating a serious heart condition that remains difficult to manage with existing therapies... This is precisely the kind of breakthrough innovation the EIC supports.”

This funding is more than just capital; it's the fuel for the next crucial phase of clinical validation. The enlarged TANDEM II study, operating under an FDA Investigational Device Exemption, will generate the robust data needed to navigate the path toward regulatory approval. For the millions living with tricuspid regurgitation, this Irish-born innovation, powered by strategic European investment, represents a significant step forward and a tangible source of hope.