CroíValve’s DUO tricuspid coaptation valve system. Credit: CroíValve / Business Wire.

CroíValve, a medical device company specialising in innovative heart valve technology, has successfully closed a $16m Series B financing round.

The funds will primarily support the TANDEM II early feasibility study, which commenced earlier this year to evaluate the safety and performance of the DUO system, a novel transcatheter device for treating tricuspid regurgitation (TR).

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TR is a critical heart condition that manifests when the tricuspid valve in the right side of the heart fails to properly close.  This condition affects more than 1.6 million people in the US and is related to significant morbidity and reduced life expectancy.

The financing was led by MedTech & Irrus Syndicates and included contributions from existing investors such as Ascentifi, Atlantic Bridge University Fund, Broadview Ventures, Elkstone, Enterprise Ireland, Furthr, and SOSV. New investor IAG Capital Partners also participated in the round.

Daniel Gottlieb, a director from Broadview Ventures with two decades of experience in the medical device sector, has joined the CroíValve board of directors. Ehsan Jabbarzadeh from IAG Capital Partners will serve as a board observer.

The Series B funding follows the successful European first-in-human study called TANDEM I, which showed significant improvements in patients with TR treated with the DUO System. The study reported more than 89% of patients experienced a notable improvement in the Kansas City Cardiomyopathy Questionnaire and all patients achieved a New York Heart Association classification of I or II after treatment.

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The DUO system is designed to work with the native tricuspid valve to restore its function while leaving the right heart and native valve apparatus untouched due to an innovative anchoring mechanism. It is tailored for a broad patient population and aims to avoid contact with critical structures in the right heart, potentially reducing complications.

CroíValve CEO Lucy O’Keeffe said: “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.”