Dublin-based medical technology developer CroíValve has successfully closed a $27 million Series B expansion round, bringing its total Series B funding to $43 million when including previously awarded development grants.
The expansion comprises $20 million in new equity, led by growth capital investor BGF, with significant participation from existing MedTech syndicates and institutional investors. An additional $7 million was secured via the European Innovation Council (EIC) Accelerator and the Irish government's Disruptive Technologies Innovation Fund (DTIF).
Addressing a Multi-Million Patient Need
CroíValve is pioneering solutions for tricuspid regurgitation (TR), a severe heart valve disorder where the tricuspid valve fails to close properly, causing blood to flow backward into the right atrium. TR affects over 4 million patients across Europe and the United States, yet the majority are deemed too high-risk for open-heart surgery, leaving them with limited treatment options.
The company's proprietary DUO Coaptation Valve System is a transcatheter device that anchors inside the heart without requiring invasive surgery. The system works by adapting to the patient’s individual leak profile, stabilizing the valve function and restoring healthy blood flow.
Funding Clinical Acceleration
The newly injected capital will be deployed to expand CroíValve’s ongoing TANDEM II clinical study across multiple sites in the EU and US. The clinical trial will generate the critical safety and efficacy data required for regulatory approval and commercialization in Western markets.
CroíValve’s progress highlights the continued global competitiveness of Ireland’s MedTech cluster, which continues to attract substantial international growth equity despite broader market headwinds.
Clinical and Commercial Impact of Tricuspid Valve Innovation
CroíValve's $27 million Series B funding round marks a critical milestone in the development of transcatheter therapies for tricuspid regurgitation (TR). The tricuspid valve, often referred to as the "forgotten valve," has historically been difficult to treat surgically due to high operative risks. CroíValve's Duo System provides a minimally invasive solution, combining a coaptation valve with an anchor system to restore valve function without open-heart surgery.
The funding will be used to expand clinical trials in the US and Europe, paving the way for regulatory approvals. The Dublin-headquartered company plans to increase its research and development facilities, creating high-value roles in medical device engineering, quality assurance, and clinical affairs.
Frequently Asked Questions
What condition does CroíValve's Duo System treat?
The Duo System is designed to treat tricuspid regurgitation, a severe condition where the heart's tricuspid valve does not close properly, causing blood to flow backward and leading to heart failure.
Who participated in the $27 million Series B funding round?
The funding round was led by specialized medical technology venture capital funds, with participation from existing investors, syndicates, and Enterprise Ireland.
What are the benefits of transcatheter heart valve treatments?
Transcatheter treatments are minimally invasive, delivered via a catheter through a blood vessel. This avoids open-heart surgery, reduces recovery time, and offers treatment options to high-risk patients.
Clinical Trials and the Duo System's Technical Design
The Duo System developed by CroíValve addresses the unique anatomical challenges of the tricuspid valve. Unlike the aortic or mitral valves, the tricuspid valve has a highly variable, non-circular shape and fragile leaflets, making secure anchoring difficult for transcatheter devices. The Duo System solves this by utilizing a unique coaptation valve that sits in the orifice and is secured by a separate anchor positioned in the superior vena cava, preventing displacement and tissue damage.
The $27 million Series B funding will support the execution of the US Early Feasibility Study and the European CE Mark clinical trials. The company's engineering team in Dublin is working closely with clinical centers in the US and Europe to gather the real-time data needed to secure regulatory approvals and launch the device globally.
Frequently Asked Questions
Why is tricuspid valve repair historically difficult?
The tricuspid valve is anatomically complex, thin-walled, and variable in shape. Conventional surgical repair carries high risk, and early transcatheter devices struggled to anchor securely without damaging surrounding tissue.
What is a coaptation valve in heart treatment?
A coaptation valve is a device that fits into the leaking valve opening, providing a surface for the patient's existing leaflets to close against, thereby stopping the backward leak of blood.
What clinical trials will be funded by the Series B capital?
The funding will finance clinical trial sites in the US (under FDA Early Feasibility guidelines) and European multi-center trials to gather safety and efficacy data for regulatory submissions.
Clinical Trials and the Duo System's Technical Design
The Duo System developed by CroíValve addresses the unique anatomical challenges of the tricuspid valve. Unlike the aortic or mitral valves, the tricuspid valve has a highly variable, non-circular shape and fragile leaflets, making secure anchoring difficult for transcatheter devices. The Duo System solves this by utilizing a unique coaptation valve that sits in the orifice and is secured by a separate anchor positioned in the superior vena cava, preventing displacement and tissue damage.
The $27 million Series B funding will support the execution of the US Early Feasibility Study and the European CE Mark clinical trials. The company's engineering team in Dublin is working closely with clinical centers in the US and Europe to gather the real-time data needed to secure regulatory approvals and launch the device globally.
Frequently Asked Questions
Why is tricuspid valve repair historically difficult?
The tricuspid valve is anatomically complex, thin-walled, and variable in shape. Conventional surgical repair carries high risk, and early transcatheter devices struggled to anchor securely without damaging surrounding tissue.
What is a coaptation valve in heart treatment?
A coaptation valve is a device that fits into the leaking valve opening, providing a surface for the patient's existing leaflets to close against, thereby stopping the backward leak of blood.
What clinical trials will be funded by the Series B capital?
The funding will finance clinical trial sites in the US (under FDA Early Feasibility guidelines) and European multi-center trials to gather safety and efficacy data for regulatory submissions.
Clinical Trials and the Duo System's Technical Design
The Duo System developed by CroíValve addresses the unique anatomical challenges of the tricuspid valve. Unlike the aortic or mitral valves, the tricuspid valve has a highly variable, non-circular shape and fragile leaflets, making secure anchoring difficult for transcatheter devices. The Duo System solves this by utilizing a unique coaptation valve that sits in the orifice and is secured by a separate anchor positioned in the superior vena cava, preventing displacement and tissue damage.
The $27 million Series B funding will support the execution of the US Early Feasibility Study and the European CE Mark clinical trials. The company's engineering team in Dublin is working closely with clinical centers in the US and Europe to gather the real-time data needed to secure regulatory approvals and launch the device globally.
Frequently Asked Questions
Why is tricuspid valve repair historically difficult?
The tricuspid valve is anatomically complex, thin-walled, and variable in shape. Conventional surgical repair carries high risk, and early transcatheter devices struggled to anchor securely without damaging surrounding tissue.
What is a coaptation valve in heart treatment?
A coaptation valve is a device that fits into the leaking valve opening, providing a surface for the patient's existing leaflets to close against, thereby stopping the backward leak of blood.
What clinical trials will be funded by the Series B capital?
The funding will finance clinical trial sites in the US (under FDA Early Feasibility guidelines) and European multi-center trials to gather safety and efficacy data for regulatory submissions.
