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CroíValve, a clinical-stage medical device company developing a transcatheter solution for tricuspid regurgitation (TR), has announced the completion of a $20 million Series B expansion financing round alongside $7 million in grant funding from the European Innovation Council (EIC) and the Disruptive Technologies Innovation Fund (DTIF).
The latest investment brings CroíValve’s total Series B financing to $36 million and overall funding from the round and grants to $43 million. New investors include BGF and the EIC Fund, while existing backers, including MedTech Syndicate, also participated in the financing. As part of the investment, Tim Rea, Co-Head of Early Stage Investments at BGF, has joined the company’s Board of Directors.
The proceeds will support the expansion of the TANDEM II Study, a prospective, multicentre clinical trial being conducted across the United States and Europe. The study is evaluating the safety and performance of the DUO™ Adapt System in patients with severe or greater symptomatic tricuspid regurgitation. Having already treated 15 patients, the trial will now expand to additional sites across both regions.
CroíValve’s DUO™ Adapt System is designed to treat tricuspid regurgitation while preserving the patient’s native valve anatomy. The transcatheter device works alongside the existing tricuspid valve to restore function without making contact with critical structures in the right side of the heart that can contribute to procedural complications.
The technology introduces what the company describes as Adaptive Coaptation, a treatment approach that enables the device to adjust to the shape of an individual patient’s valve leak. According to CroíValve, the system has demonstrated the ability to treat large and complex leaks, including those measuring up to 35mm, while achieving meaningful reductions in regurgitation.
Tricuspid regurgitation occurs when the tricuspid valve fails to close properly, allowing blood to flow backwards through the heart. The condition has recently been identified as the most prevalent valvular heart disease, affecting approximately 3.7% of people over the age of 65. More than four million people across Europe and the United States are estimated to be living with moderate or greater TR, a condition associated with significant symptoms and reduced life expectancy.
Commenting on the investment, Tim Rea, Co-Head of Early Stage Investments at BGF, said: “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 and we’re excited to partner with them as they accelerate the trials and testing process.”
Hermann Hauser, Board Member of the EIC Fund, highlighted the broader impact of the technology, stating: “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, particularly for patients who aren’t suitable candidates for invasive surgery.”
Headquartered with research, development and operations in Ireland, and clinical and regulatory functions in the United States, CroíValve continues to advance its investigational DUO™ System as it seeks to expand treatment options for patients living with tricuspid regurgitation.
The DUO™ System is currently an investigational device and is not approved for commercial sale in any geography.
Funding milestones continue to play a key role in advancing medical technologies from development to clinical adoption. At MedTech World Asia 2026, taking place from 26–28 August at HKCEC, Hong Kong, founders, investors, clinicians and industry leaders will come together to discuss the latest developments shaping the MedTech sector, from early-stage innovation through to commercialization and growth. Learn more and secure your place today.
