CroíValve, a medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation, closed a $16 million Series B financing. The round, led by the MedTech & Irrus Syndicates, included participation from all current investors, Ascentifi, Furthr, Broadview Ventures, Atlantic Bridge University Fund, Enterprise Ireland, Elkstone & SOSV, along with a new investor, IAG Capital Partners.
CroíValve welcomes Daniel Gottlieb, a Director with Broadview Ventures, to its Board of Directors. Gottlieb has 20 years of experience with medical device and biotechnology companies in business development, marketing and strategy and previously served as an Observer on the CroíValve Board. Additionally, as a Venture Partner with IAG Capital Partners, Ehsan Jabbarzadeh will join the CroíValve Board as an observer.
The new financing follows a successful European First in Human study, the TANDEM I study, which demonstrated sustained reductions in tricuspid regurgitation and marked improvements in patients’ quality of life metrics for patients treated with the DUO System:
- 89% of patients experienced > 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ)
- 100% of patients achieved a New York Heart Association (NYHA) classification of I or II post treatment
- substantial (+63m average) improvement in the 6-minute walk distance (6MWD)
Proceeds from the financing will be used to fund the TANDEM II Early Feasibility Study, an FDA-approved, prospective, multicenter study to evaluate the safety and performance of the DUO System in patients with severe or greater symptomatic tricuspid regurgitation (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. TR affects over 1.6 million people in the US and is associated with significant morbidity and reduced life expectancy.
The DUO System is a novel transcatheter heart valve that works in tandem with the native tricuspid valve to restore valve function while leaving the patient’s right heart and native valve apparatus untouched through an innovative anchoring mechanism. Designed to treat a broad patient population, the DUO System accommodates the heterogeneity of patient anatomies while avoiding contact with critical structures in the right heart which could lead to complications. The DUO System is also designed to enable a straightforward procedure and reduce the procedural complexity seen with other devices. The procedure is less reliant on expert intraprocedural imaging, enabling a short learning curve with predictable and stable outcomes.
