New investors BGF have joined the round, which will fund an expanded US and EU clinical study of CroíValve’s Duo Tricuspid Coaptation Valve System.

Trinity College Dublin medical device spin-out company CroíValve has closed a $20m Series B expansion, to add to its $7m million European Innovation Council (EIC) and DTIF grant financing, bringing the total for its Series B to $36 million, and $43M including grant financing.

CroíValve’s new financing includes new investors BGF, along with participation from current investors including the MedTech Syndicate.

CroíValve is a clinical-stage medtech developing a minimally invasive device to treat tricuspid regurgitation – a severe cardiac disease.

Currently, only a small portion of elderly patients receive surgical treatment to treat the condition due to age-associated risks. The start-up’s flagship product, called the Duo Tricuspid Coaptation Valve System, aims to provide a non-surgical way to treat the disease.

The deal will see Tim Rea, co-Head of Early Stage investments at BGF, join CroíValve’s 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,” said Rea. “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,” said said Hermann Hauser, board member of the EIC Fund. “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. 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.”

CroíValve says 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 DUOTM Adapt System in patients with severe or greater symptomatic tricuspid regurgitation (TR). The study will be expanded beyond the 15 patients already treated, to include additional US and EU sites.

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