CroíValve Secures $43M in Series B Extension to Advance Fully Retrievable Transcatheter Tricuspid Valve System
CroíValve
Medical Device Developer
'%20fill='%23FFFFFF'%3E%3Crect%20x='249'%20y='126'%20width='1'%20height='1'%3E%3C/rect%3E%3C/g%3E%3C/g%3E%3C/svg%3E)
Tricuspid regurgitation is currently the most closely watched segment in the heart valve field, yet it has the fewest commercialized products. According to Frost & Sullivan data, the global market size for transcatheter tricuspid valve interventions was approximately USD 2 billion in 2026 and is projected to exceed USD 5 billion by 2028.
Against the backdrop of this rapidly expanding market, on June 23, 2026, CroíValve, an innovative medical device company specializing in structural heart disease, announced the completion of$20 million (approximately RMB 145 million)Series B extension financing. Meanwhile, the company also secured a total of $7 million in non-dilutive grants from the European Innovation Council and the Disruptive Technology Innovation Fund, bringing the total amount raised in this round to$43 million (approximately RMB 310 million)。
Top-Tier Capital Increases Bets as “Official Capital” Enters the Market
BGF：This is one of the largest and most active growth capital investment firms in the UK and Ireland. CroíValve itself is a medical device company headquartered in Dublin, Ireland, and BGF’s entry represents a significant capital infusion from top-tier domestic investors into a homegrown unicorn.
European Innovation Council (EIC) Accelerator：This is the European Union’s official innovation incubator. It not only provided direct grant funding to CroíValve, but also participated directly in its Series B equity investment through its official fund. This signifies that the technology has been elevated to the level of strategic innovation for medical devices within the EU.
Tim Rea, Co-Head of Early Stage Investments at BGF
Tim Rea commented on the investment, stating, “CroíValve’s differentiated technology positions it well to address the large and growing market in the field of structural heart devices.”
Innovative Anchoring Technology
CroíValve DUO™ Transcatheter Tricuspid Valve ReplacementThe system pioneers a unique anatomical design featuring a "dual-axis, split-type" configuration:
Innovation 1: “Suspension-style” implantation with zero radial force
The DUO™ system consists of two independent components. Its supportive anchoring frame is positioned at the relatively robust and non-deformable junction of the right atrium and the superior vena cava, while the actual bioprosthetic valve is “suspended” in the center of the tricuspid annulus via a precision connecting shaft. This design ensures that the valve exerts minimal stress on the fragile tricuspid annulus during operation.Zero Radial Support Forcecompression, fundamentally reducing the compression on the conduction bundle.
Innovation 2: Dynamic Adaptation and “Supplemental” Replacement
Traditional replacement involves "circularizing" the right ventricular outflow tract to accommodate the valve. In contrast, the centrally suspended DUO™ valve moves in synchrony with the native leaflets throughout the cardiac cycle, sealing regurgitant gaps. By preserving the original anatomical configuration of the right ventricle, this approach provides a highly safe option for high-risk, end-stage patients with severely compromised right ventricular function who cannot tolerate the significant volumetric load changes associated with conventional replacement.
Innovation 3: Fully Retractable
Since the anchoring frame does not rely on friction with the annulus for fixation, if echocardiographic assessment reveals suboptimal positioning or a risk of paravalvular leak before complete valve deployment during the procedure, the operator can achieve 100% complete retrieval, repositioning, or safe withdrawal. This “safety net” feature enhances procedural fault tolerance, reducing the trial-and-error burden for operators when dealing with complex anatomical structures.
Initiation of the TANDEM II Pivotal Clinical Study
According to CroíValve, the $43 million raised in this funding round will be entirely dedicated to supporting and accelerating its pivotal TANDEM II clinical study. DUO Adapt is poised to transition from early feasibility studies to pivotal clinical trials, paving the way for its market approval applications in the United States and Europe.
TANDEM II is a prospective, multicenter study conducted in the United States and the European Union to evaluate the safety and performance of the DUO Adapt system in patients with severe or greater symptomatic tricuspid regurgitation.
By the end of 2024, the TANDEM II study had completed treatment for the first cohort of 15 patients. Preliminary clinical results demonstrated the DUO Adapt system’s capability in treating large annular gaps (up to 35 mm) and achieved a significant reduction in tricuspid regurgitation. Based on these positive findings, CroíValve has decided to expand the study to additional centers in the United States and the European Union, with plans to enroll more patients.
Conclusion
CroíValve’s recent completion of a significant financing round marks the acceleration of next-generation overseas “tricuspid valve replacement” technology into key multi-center clinical validation phases across China, the United States, and Europe.We will continue to monitor closely.TANDEM II Study Data of the DUO™ System: Timely Sharing of the Latest Updates.
Copyright and Disclaimer: MedTF YiKan aims to establish a platform for academic dissemination and media expression. The copyright of the information contained herein belongs to the respective owners, and we provide it solely for the purpose of information transmission. If you have any questions or concerns, please contact us.