CroíValve Expands Series B to $36 Million for Larger TANDEM II Tricuspid Study

CroíValve, a developer of a transcatheter device for tricuspid regurgitation, has closed a $20 million expansion of its Series B financing along with $7 million in grant financing from the European Innovation Council (EIC) and the DTIF, the company said on June 23 in a release distributed by Business Wire, read via finanznachrichten.de.

The company said the expansion brings its Series B total to $36 million, or $43 million including the grant financing. New investors BGF and the EIC Fund joined existing investors including the MedTech Syndicate. Tim Rea, co-head of early stage investments at BGF, joins CroíValve's board of directors.

CroíValve describes itself as a clinical stage medical device company with research, development and operations in Ireland and clinical and regulatory functions in the US.

Money for an enlarged study

The proceeds will fund an expanded TANDEM II study, a prospective, multicenter study in the US and EU evaluating the safety and performance of the DUO Adapt System in patients with severe or greater symptomatic tricuspid regurgitation. The company said the study is being expanded beyond the 15 patients already treated to include additional US and EU sites.

Tricuspid regurgitation occurs when the tricuspid valve on the right side of the heart fails to close properly. CroíValve said it affects more than 4 million people in Europe and the US.

The DUO System is a transcatheter heart valve that works in tandem with the patient's native tricuspid valve, according to the company. It uses a coaptation valve positioned between the native valve's leaflets, and the DUO Adapt version is designed to adapt to the shape of an individual patient's leak. The company said early clinical use of DUO Adapt has shown the ability to treat leaks of up to 35mm with significant reduction in regurgitation; those observations are company-reported and come from a small number of cases.

The DUO System is an investigational device and is not for sale in any geography, the company said.

What the investors said

"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," said BGF's Rea.

Hermann Hauser, a board member of the EIC Fund, said 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."

BGF says it has invested £5 billion in 650 businesses since 2011 as a minority equity partner. The MedTech Syndicate, an Irish investor group founded in 2014, has backed CroíValve since 2018, according to the release.

The company did not disclose its valuation or a timeline for completing enrollment in the expanded study.