07th August, 2024
To fund study evaluating performance of device in severe tricuspid regurgitation patients
image credit- shutterstock
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 $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. 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.
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).
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.
“This financing is a testament to the unmet need for treating tricuspid regurgitation and the potential of the DUO System to treat more patients with a reproducible and intuitive procedure. We are excited to bring this technology to the US, with strong support from our shareholder base who are committed to our mission to transform the lives of patients suffering from tricuspid regurgitation,” said Lucy O’Keeffe, CEO of CroíValve.
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