CroíValve raises $27 Million to Fund DUO Adapt in an Enlarged TANDEM II Study
CroíValve, a pioneering medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation, announced today the closing of $20 million Series B expansion financing, along with $7 million European Innovation Council (EIC) and DTIF grant financing. Bringing the total for Series B to $36 million, and $43M including grant financing. The financing includes new investors BGF and EIC, along with participation from current investors including the MedTech Syndicate. CroíValve welcomes Tim Rea, Co-Head of Early Stage investments at BGF, to its Board of Directors.
Proceeds from the financing will be used to fund an expanded TANDEM II Study, a US and EU based prospective, multicenter study to evaluate the safety and performance of the DUOTM Adapt System in patients with severe or greater symptomatic tricuspid regurgitation (TR). This study is being expanded beyond the 15 patients already treated, to include additional US and EU sites.
The DUOTM System is a novel transcatheter heart valve that preserves the patient’s native anatomy while treating TR. It works in tandem with the native tricuspid valve to restore valve function while avoiding contact with critical structures in the right heart which could lead to complications. Designed to treat the heterogeneity of the TR patient population, this includes patients who are challenging for other transcatheter therapies to treat. It enables a straightforward procedure to reduce the procedural and imaging complexity seen with other devices. The novel technology includes a coaptation valve that is positioned between the leaflets of the tricuspid valve to prevent blood flowing backgrounds. The DUO Adapt System includes optimization of the coaptation valve to fill larger, complex leaks by adapting to the patient’s individual leak shape, introducing a new category in treating TR known as Adaptive Coaptation. Promising early clinical use with the DUO Adapt System highlights the ability to treat very large leaks, up to 35mm, with significant reduction in TR.
Tricuspid regurgitation is a severe heart condition that occurs when the tricuspid valve in the right side of the heart fails to close properly. Recently highlighted as the highest prevalence valve disease, with 3.7% of people over 65 developing moderate or greater TR. It affects over 4 million people in Europe and the U.S. and is associated with significant symptoms and reduced life expectancy.
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.
‘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.