CroíValve Receives Financing to Support TANDEM II EFS of Duo Tricuspid Valve System

August 7, 2024—CroíValve, an Ireland-based developer of the Duo transcatheter device for the treatment of tricuspid regurgitation (TR), announced the closing of $16 million Series B financing.

According to the company, proceeds from the financing will be used to fund the TANDEM II early feasibility study of the Duo system. The FDA-approved, prospective, multicenter study will evaluate the safety and performance of the Duo system in patients with severe or greater symptomatic TR. The company announced the initiation of the study in January 2024.

In the press release, CroíValve stated the Duo transcatheter heart valve 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. The Duo system is an investigational device and not for sale in any geography, advised the company.

CroíValve stated that the financing round was led by MedTech Syndcates and Irrus Investments. It included participation from all current investors—Ascentifi, Furthr, Broadview Ventures, Atlantic Bridge University Fund, Enterprise Ireland, Elkstone, and SOSV—along with a new investor, IAG Capital Partners. Daniel Gottlieb, a director with Broadview Ventures, has been named to its Board of Directors. Ehsan Jabbarzadeh, a venture partner with IAG Capital Partners, will join the CroíValve Board as an observer.

The company noted that the new financing comes after the European TANDEM I first-in-human study demonstrated sustained reductions in TR and improvements in quality-of-life metrics for patients treated with the Duo system. In TANDEM I, 89% of patients experienced > 15-point improvement in the Kansas City Cardiomyopathy Questionnaire; 100% of patients achieved a New York Heart Association classification of I or II post treatment; and patients experienced substantial improvement (average, +63 m) in the 6-minute walk distance test.

On June 10, the company announced that the 6-month TANDEM I findings were presented by Professor Wojtek Wojakowski, MD, at New York Valves 2024: The Structural Heart Summit held June 5-7 in New York, New York.