CroíValve Secures $27M Funding to Accelerate Global Pivotal Trial of Duo Adapt System for Refractory Tricuspid Regurgitation

Jun 26, 2026 07:00 CST Updated 07:00

CroíValve

Medical Device Developer

In the field of valvular heart disease, there has long been a thorny and persistent challenge: severe tricuspid regurgitation.

After diagnosis, many patients either cannot withstand the significant trauma of open-chest surgery or experience suboptimal outcomes with conventional interventional therapies. They suffer for years from chest tightness, fatigue, and heart failure, leading to a markedly reduced quality of life. There remains a substantial unmet need in clinical treatment.

But just recently, a major medical breakthrough has taken the global cardiovascular field by storm!

International Innovative Medical Company CroíValve Officially Announces Completion of $27 Million Major Financing! This Includes a $20 Million Series B Extension Round, as Well as €7 Million in Special Grants from the European Innovation Council (EIC) and the Disruptive Technology Innovation Fund (DTIF).

This substantial funding is not merely a capital boost; rather, it presses the “accelerator button” for the clinical adoption of a disruptive cardiac technology, holding the promise to fundamentally reshape the treatment landscape for tricuspid regurgitation!

This time, countless patients with refractory tricuspid regurgitation have finally welcomed a new lease on life.

01. Clinical Dilemma: The Neglected Critical Cardiac Conditions, Leaving Countless Patients Without Effective Treatment

Many people are familiar with mitral valve disease, yet know little about tricuspid regurgitation (TR).

The tricuspid valve is located in the right heart system and serves as the “key valve” regulating the return of systemic venous blood. Once valvular closure becomes incompetent, blood will regurgitate; prolonged persistence of this condition increases right ventricular load, potentially inducing right heart failure, which in severe cases can directly threaten the patient’s life.

What is even more daunting is that the clinical treatment of this disease faces extremely prominent challenges:

Extremely High Surgical Risk: Traditional open-chest surgery involves significant trauma and a prolonged recovery period; the majority of elderly patients with severe conditions and comorbidities are entirely ineligible for surgery.

Conventional interventional approaches have significant limitations: existing interventional devices on the market are only suitable for some simple cases, and are often ineffective when dealing with complex, individualized regurgitant lesions.

Poor Patient Prognosis: Due to the long-term lack of optimal treatment regimens, a large number of patients can only receive conservative management, leading to continuous disease progression and establishing the condition as a recognized “refractory and critical” disorder in the cardiovascular field.

For a long time, the medical community has lacked a minimally invasive, safe treatment solution adaptable to all complex cases, until the advent of the Duo Adapt system broke this impasse.

02. A Decade of Deep Cultivation and Iteration! The Complete R&D Journey of Duo Adapt

This cutting-edge, minimally invasive technology, specifically designed to treat refractory tricuspid regurgitation, did not emerge overnight. Rather, it is the culmination of over a decade of dedicated clinical expertise and continuous iteration by our team. Each R&D milestone has been precisely targeted at addressing the critical clinical challenges in the treatment of tricuspid regurgitation.

2016: Technological Emergence, Deepening Expertise in Specialized Tracks

CroíValve originated from the technology transfer team at the Centre for Biomedical Engineering, University College Dublin. From its inception, the company precisely targeted a global clinical unmet need: minimally invasive treatment for refractory and complex tricuspid regurgitation. Addressing industry pain points such as the high risks associated with right-heart surgery and the poor adaptability of traditional interventional devices, CroíValve officially launched a dedicated R&D program for a novel collaborative tricuspid valve repair system.

2022: Initial Deployment, Launching Preliminary Clinical Exploration

The team secured €8 million in Series A financing to aggressively advance the technical refinement and feasibility clinical studies of the first-generation DUO valve system. In November of the same year, it successfully performed the world’s first human implantation, pioneering the clinical validation of the safety and feasibility of its innovative concept of “preserving the native valve with synergistic assisted repair,” thereby filling a market gap in minimally invasive treatment for complex tricuspid regurgitation.

2024: Approved and certified, global clinical trials launched

Achieving a pivotal clinical breakthrough, the Duo System has successfully secured U.S. FDA IDE approval for clinical research, officially commencing early feasibility studies in the United States. The system has completed minimally invasive implantation procedures in multiple patients with severe tricuspid regurgitation, fully demonstrating its procedural safety and clinical compatibility.

2025: Technological Iteration + Official Empowerment

The team has completed a comprehensive iteration and upgrade of its core technologies, optimizing and developing the Duo Adapt Adaptive Repair System, which is adaptable to complex leakage lesions. Meanwhile, it has received special funding support from the European Innovation Council, significantly enhancing product maturity and lesion adaptability, thereby enabling coverage of more patients with difficult and severe conditions that traditional therapies cannot treat.

2026: Financing Expansion, Accelerating Towards Widespread Adoption

The successful closure of this $27 million major financing round will primarily support the comprehensive expansion of the TANDEM II multicenter clinical trials in Europe and the United States, marking a formal transition from earlier small-scale exploratory studies to large-scale, multicenter, prospective clinical validation, thereby accelerating the clinical implementation and commercialization of the product.

From academic research incubation and the first clinical breakthrough to multi-country clinical implementation and significant capital investment, CroíValve has long focused on the niche segment of tricuspid regurgitation. After multiple rounds of technological iteration, it has ultimately refined a breakthrough treatment solution that is suitable for complex cases, safe and minimally invasive, with distinct differentiation.

03. Breakthrough Technology Unveiled! Preserving Native Heart Structure for Precise Minimally Invasive Treatment

The funds raised in this round will be entirely allocated to strengthening core clinical projects, with a full-scale expansion and acceleration of the TANDEM II global multicenter clinical trial.

As a prospective clinical study spanning the United States and the European Union, the project builds on 15 previously successful implantation cases to continuously expand into multiple top-tier clinical centers worldwide. It aims to conduct large-scale, systematic validation of the safety and clinical efficacy of the Duo Adapt heart valve system in patients with severe to very severe symptomatic tricuspid regurgitation, thereby establishing a solid clinical foundation for the broad implementation of this technology.

Compared with traditional treatment options, the most disruptive advantage of the Duo Adapt system is that it repairs without causing damage, perfectly avoiding all the drawbacks of conventional surgery!

✅Preserves native cardiac anatomical structures

Unlike traditional valve replacement and destructive repair procedures, the Duo Adapt system does not require resection or damage to the patient’s native valve. The device works in synergy with the native tricuspid valve to assist its function and restore valvular coaptation, thereby preserving the heart’s native anatomical structure and physiological function to the greatest extent. This approach fundamentally reduces the risk of postoperative complications and long-term adverse events.

✅ Avoids critical cardiac structures, maximizing safety

The right heart system features intricate anatomical structures and densely packed critical adjacent tissues, making traditional interventional procedures highly prone to inadvertent tissue injury and various intraoperative and postoperative complications. In contrast, this innovative valve enables precise targeting of the lesion and directional repair, while fully avoiding core critical structures of the right heart, thereby significantly enhancing procedural safety in complex cases.

✅ Suitable for all complex and challenging cases

Tricuspid regurgitation exhibits significant individual variability in regurgitant location, defect morphology, and leak size. Various irregular, large-area complex leaks represent a core therapeutic blind spot for traditional interventional devices. Equipped with intelligent adaptive conforming technology, Duo Adapt can autonomously deform and adapt to the patient-specific morphology and size of regurgitant defects, precisely occluding various complex and refractory valvular leaks. This thoroughly addresses industry pain points associated with traditional devices, including poor adaptability, narrow indications, and the inability to treat challenging cases.

✅ Ultra-simplified surgical procedure with minimal trauma

The entire interventional procedure workflow is streamlined and efficient, significantly reducing intraoperative operational difficulty and the complexity of intraoperative imaging monitoring. This not only effectively minimizes patient surgical trauma and intraoperative risks but also lowers the learning curve for clinical procedures, making minimally invasive repair surgeries more accessible, safer, and controllable.

04. Dual Endorsement from Capital and Authorities! Major Investment Surge in the Global Healthcare Sector

The $27 million in comprehensive financing secured in this round, comprising equity financing and official special grants, along with the dual endorsement from the European Innovation Council (EIC) and the Disruptive Technologies Innovation Fund (DTIF), fully attests to the robust strength, clinical scarcity, and significant industry value of Duo Adapt’s innovative technology.

This funding round features a prestigious and high-caliber investor lineup, with new participants including the top-tier investment firm BGF and the European Innovation Council (EIC), while established specialized healthcare investor MedTech Syndicate has continued to increase its follow-on investment. This comprehensively demonstrates the capital market’s strong recognition of the technology’s clinical implementation value, its capability to address complex and refractory diseases, and its global commercialization prospects.

Meanwhile, Tim Rea, Co-Head of Early Stage Investments at BGF, has officially joined the Board of Directors of CroíValve, leveraging his extensive industry experience to provide comprehensive support for the clinical implementation and global market promotion of its products.

Leveraging its robust technological barriers and broad clinical prospects, the project has garnered high recognition and endorsement from industry leaders:

Tim Rea, Co-Head of Early-Stage Investments at BGF, stated: “The team’s dedication and achievements in addressing critical clinical needs and tackling complex and severe cardiac conditions are remarkable. This technology offers effective treatment for disabling tricuspid regurgitation without the need for high-risk invasive open-heart surgery, providing a strong differentiated competitive advantage. CroíValve has strategically positioned itself in the vast and rapidly growing blue-ocean market of structural heart devices, demonstrating significant growth potential. We look forward to partnering with the team to accelerate clinical trials and the iterative development and commercialization of their product.”

Hermann Hauser, Director of the EIC Fund, commented: “High-quality medical innovation always focuses on addressing the diagnostic and therapeutic challenges faced by millions of patients. Currently, conventional therapies offer limited efficacy in treating severe tricuspid regurgitation, particularly for high-risk patients who are elderly, frail, or unable to tolerate open-chest surgery. Duo Adapt is a breakthrough innovation prominently supported by the EIC. It not only significantly improves the quality of life and prognosis for critically ill patients but also helps sustain Europe’s global leadership in medical technology, demonstrating substantial clinical and social value.”

05. A Promising Future! A New Era of Curative Treatment for Complex Heart Diseases

An overview of the global landscape in cardiovascular diagnosis and treatment reveals that minimally invasive, personalized, and organ-preserving reparative approaches have become the core developmental trends in the treatment of valvular heart disease.

CroíValve’s Duo Adapt system precisely aligns with this trend, filling the market gap for minimally invasive treatment of complex tricuspid regurgitation.

With the completion of this substantial financing round, the TANDEM II clinical trial is undergoing comprehensive expansion, signaling that this cutting-edge technology will rapidly complete large-scale clinical validation, accelerate its clinical adoption, and benefit patients worldwide.

In the past, countless patients with severe tricuspid regurgitation were deemed “ineligible for surgery”; in the future, with the widespread adoption of this innovative technology, these refractory patients will be freed from the constraints of their disease and usher in new hope for a cure.

The advancement of medicine has always been aimed at breaking through desperate situations and extending life.

We look forward to this groundbreaking, minimally invasive black-box technology, tailor-made for refractory and complex tricuspid regurgitation, completing large-scale clinical validation and achieving widespread clinical adoption as soon as possible, thereby lighting the way to new hope for countless critically ill patients trapped in diagnostic and therapeutic dead ends!

# Breakthroughs in Cardiac Medicine #Tricuspid Regurgitation #MicroPort # Medical Black Technology #Frontiers in Medicine