CroíValve announced that it has closed $20 million in Series B expansion financing, along with $7 million in European Innovation Council and DTIF grant financing. The additional capital brings CroíValve’s Series B total to $36 million and $43 million, including grant financing.
CroíValve is a medical device company developing a transcatheter device for the treatment of tricuspid regurgitation.
The financing includes new investors BGF and the European Innovation Council, along with participation from existing investors, including the MedTech Syndicate.
CroíValve said the proceeds will be used to fund an expanded TANDEM II Study, a prospective, multicenter study in the U.S. and Europe evaluating the safety and performance of the DUO Adapt System in patients with severe or greater symptomatic tricuspid regurgitation.
The study is being expanded beyond the 15 patients already treated and will include additional U.S. and European sites.
The DUO System is a transcatheter heart valve designed to preserve the patient’s native anatomy while treating tricuspid regurgitation. The system works with the native tricuspid valve to restore valve function while avoiding contact with critical structures in the right heart.
CroíValve said the DUO Adapt System is designed to treat a broad range of tricuspid regurgitation patients, including those who are challenging for other transcatheter therapies.
The system includes a coaptation valve positioned between the leaflets of the tricuspid valve to prevent backward blood flow. The DUO Adapt System also optimizes the coaptation valve to fill larger and more complex leaks by adapting to each patient’s individual leak shape.
CroíValve described this approach as a new category in treating tricuspid regurgitation known as Adaptive Coaptation.
The company said early clinical use of the DUO Adapt System has shown the ability to treat very large leaks up to 35 millimeters with significant reduction in tricuspid regurgitation.
Following the seed extension, representatives from BGF and the European Innovation Council will join CroíValve’s Board as non-executive directors.
KEY QUOTES:
“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.”
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.”
Hermann Hauser, Board Member of the EIC Fund
