CroíValve raises $20M Series B expansion to fund enlarged TANDEM II tricuspid trial
What's the deal? Irish medical device company CroíValve has raised $20 million in a Series B expansion, backed by new investors BGF and the European Innovation Council (EIC) Fund, plus existing backer the MedTech SyndicateDealroom has a profile for this one. Try Dealroom →.
A further $7 million in grant funding from the EIC and DTIF brings the total raised to $43 million.
The money will fund an enlarged TANDEM II study, a US and EU trial testing CroíValve's DUO Adapt System in patients with severe tricuspid regurgitation (TR).
Why now? The company has already treated 15 patients and wants to expand to more sites across the US and EU.
Early results show the device can treat very large leaks — up to 35mm — with significant reduction in TR.
The DUO System is a transcatheter heart valve that preserves the patient's native anatomy, working alongside the tricuspid valve to restore function without invasive surgery.
What could go wrong? CroíValve remains a clinical-stage company, meaning its device is still being tested rather than sold.
The expanded trial must prove the system is both safe and effective across a wider, more varied patient group before regulators approve it.
The signal: Tricuspid regurgitation was recently flagged as the highest-prevalence valve disease, affecting over 4 million people across Europe and the US, with 3.7% of those over 65 developing moderate or greater TR. Many are unsuitable for invasive surgery, leaving a large underserved market that CroíValve — now at breakout stage — is positioning its less invasive transcatheter approach to capture.
Read more: finanznachrichten.de
Image credit: "A cardiac catheterization procedure in the Naval Medical Center San Diego hospital's cardiac catheterization laboratory" by NavyMedicine is marked with Public Domain Mark 1.0. To view the terms, visit https://creativecommons.org/publicdomain/mark/1.0/.
