CroíValve has announced the closing of US$20 million series B expansion financing, along with US$7 million European Innovation Council (EIC) and Disruptive Technologies Innovation Fund (DTIF) grant financing.
Proceeds from the financing will be used to fund an expanded TANDEM II study, a US and EU-based prospective, multicentre study to evaluate the safety and performance of the Duo 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 Duo 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, CroíValve says in a press release.
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 optimisation of the coaptation valve to fill larger, complex leaks by adapting to the patient’s individual leak shape.
The financing includes new investors BGF and EIC, along with participation from current investors including the MedTech Syndicate. CroíValve has welcomed Tim Rea, co-head of early-stage investments at BGF to its board of directors.
“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,” Rea said. “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,” Hermann Hauser, board member of the EIC Fund said. “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.”
