Dublin — CroíValve has secured $27 million in additional financing to support an expanded clinical study of its DUO Adapt System for treating tricuspid regurgitation.
The funding includes a $20 million expansion of the medical device company’s Series B financing and $7 million from European Innovation Council and Disruptive Technologies Innovation Fund grants. The latest investment brings CroíValve’s Series B total to $36 million and its overall funding, including grants, to $43 million.
New investors include BGF and the EIC, while existing investors, including the MedTech Syndicate, also participated. Tim Rea, co-head of early-stage investments at BGF, has joined CroíValve’s board of directors.
CroíValve plans to use the proceeds to expand its TANDEM II Study, a prospective, multicenter trial in the United States and Europe evaluating the safety and performance of the DUO Adapt System in patients with severe or greater symptomatic tricuspid regurgitation.
The study will be expanded beyond the 15 patients already treated and will include additional clinical sites in the United States and Europe.
The DUO System is a transcatheter heart valve designed to treat tricuspid regurgitation while preserving the patient’s native anatomy. The device works alongside the native tricuspid valve to restore function without contacting critical structures in the right side of the heart.
Its coaptation valve is positioned between the tricuspid valve leaflets to reduce backward blood flow. The DUO Adapt System is designed to conform to larger and more complex leaks based on an individual patient’s anatomy, an approach the company calls adaptive coaptation.
CroíValve said early clinical use has demonstrated the system’s ability to treat leaks as large as 35 millimeters while significantly reducing tricuspid regurgitation.
Tricuspid regurgitation occurs when the tricuspid valve on the right side of the heart does not close properly. The condition affects more than 4 million people in Europe and the United States and is associated with significant symptoms and reduced life expectancy.
“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,” said Tim Rea, Co-Head of Early Stage Investments at BGF.
“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. This is precisely the kind of breakthrough innovation the EIC supports: technologies with the potential to improve quality of life, strengthen Europe’s medical technology leadership and deliver meaningful societal impact,” said Hermann Hauser, Board Member of the EIC Fund.
