Dublin, Ireland, July 1, 2025 – CroíValve, a pioneering medical device company innovating a better way to help more patients suffering from Tricuspid Regurgitation (TR), were awarded funding from Horizon Europe’s European Innovation Council (EIC) Accelerator Programme.
Part of the EU’s Horizon Europe 2021-2027 Research and Innovation Programme, the EIC Accelerator Programme provides transformational funding to high-potential, high-risk start-ups, scale-ups and subject matter experts. This award includes grant funding of €2.5 million, combined with an equity investment of €10 million in CroiValve’s next financing. The latest competition included 959 applications, with only 40 awards across 16 countries. Almost one third of the selected companies are led by a woman and CroiValve are incredibly proud to be one of this group.
“Securing European Innovation Council (EIC) funding is instrumental in expanding clinical validation of the DUO™ System, a novel minimally invasive, transcatheter device to treat severe+ tricuspid regurgitation. There is a significant unmet clinical need to treat the heterogeneous patient population who are not suited to the first generation transcatheter tricuspid devices. It is CroiValve’s mission to innovate a better way to help more patients suffering with this disease and we are honoured to have EIC support for this journey,” said Lucy O’Keeffe, CEO of CroíValve.
More than 4 million people in Europe and the US suffer from tricuspid regurgitation, a severe heart condition that occurs when the tricuspid valve in the right side of the heart fails to close properly. This results in blood being pumped backwards into the heart causing debilitating symptoms. It affects over 4 million people in Europe and the U.S. and is associated with significant morbidity and reduced life expectancy.
The DUOTM System is a novel transcatheter heart valve that preserves the patient’s native anatomy while treating tricuspid regurgitation. It works in tandem with the native tricuspid valve to restore valve function while leaving the patient’s right heart and native valve apparatus untouched through an innovative anchoring mechanism. Designed to treat a broad patient population, the DUOTM System accommodates the heterogeneity of patient anatomies while avoiding contact with critical structures in the right heart which could lead to complications.
The DUOTM System is also designed to enable a straightforward procedure and reduce the procedural complexity seen with other devices. The procedure is less reliant on expert intraprocedural imaging, enabling a short learning curve with predictable and stable outcomes. The DUO™ System is currently under clinical investigation through the TANDEM II Study, a multicenter, prospective early feasibility study including centers in Poland and the US.
About CroíValve
CroíValve is a clinical stage medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation with Research, Development and Operations based in Ireland and Clinical, Regulatory and Marketing based in the United States.
Caution: The DUOTM System is an investigational device and not for sale in any geography.
CroíValve, a pioneering medical device company focused on the development of a novel transcatheter device for the treatment of severe+ tricuspid regurgitation (TR), announced the first patient treated with the DUO™ System as part of the TANDEM II Early Feasibility Study in the U.S. The DUO™ System is a transcatheter valve that works in tandem with the native tricuspid valve to restore valve function while preserving the native valve apparatus.
The TANDEM II Study is a prospective, multicenter study in the US to evaluate the safety and performance of the DUO™ System in patients with severe+ symptomatic tricuspid regurgitation, a severe heart condition that occurs when the tricuspid valve in the right side of the heart fails to close properly. This results in blood being pumped backwards into the right atrium and venous system causing debilitating symptoms. It affects over 1.6 million people in the U.S. and is associated with significant morbidity and reduced life expectancy.
The first implant was performed by interventional cardiologists Pradeep Yadav, MD and James Stewart, MD and cardiac surgeon Vinod H. Thourani MD, the Principal Investigator for the TANDEM II study, at Piedmont Heart Institute in Atlanta, GA. “The DUO™ System offers a unique benefit for patients suffering from TR as the device is designed to treat a broad patient population. The DUO™ procedure is straightforward, leveraging standard interventional techniques and has the potential to accelerate transcatheter tricuspid therapy adoption by more physicians due to the system’s simplicity and scalability. This is a limitation with many other devices. On behalf of the TANDEM II investigators, we look forward to advancing treatment options for patients suffering from tricuspid regurgitation,” said Dr. Thourani, MD, the Bernie Marcus Chairman, Department of Cardiovascular Surgery and Marcus Valve Center at Piedmont Heart Institute.
“Every patient has a unique tricuspid valve anatomy and disease etiology which can make device procedures complex. The DUO™ System is an important option in my treatment toolbox,” said Dr. Yadav, Director of Structural Heart Interventions at Piedmont Heart Institute.
The DUO™ System preserves native right heart anatomy, combining two powerful capabilities –simplification and scalability– to enable more physicians to improve patients’ lives.
The DUO™ System includes a coaptation valve, an adjustable catheter system and a stent for anchoring. The coaptation valve is positioned between the native tricuspid leaflets to fill the leaky area and prevent regurgitation. A novel anchor system leaves the right heart and native valve apparatus untouched. The DUO™ implant procedure uses standard imaging and is less reliant on expert intraprocedural imaging, enabling a scalable procedure for broad therapy adoption.
“We are excited to work with the leading heart valve centers in the U.S. to offer more patients suffering from tricuspid regurgitation a treatment option. The initiation of the TANDEM II Early Feasibility Study is an important milestone as we expand the clinical evidence for the DUO™ System,” said Lucy O’Keeffe, CEO of CroíValve.
About CroíValve
CroíValve is a clinical stage medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation with Research, Development and Operations based in Ireland and Clinical, Regulatory and Marketing based in the United States.
Caution: The DUO™ System is an investigational device and not for sale in any geography.
Contacts
CroíValve, a pioneering medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation, announced today the closing of $16 million Series B financing. The round, led by the MedTech & Irrus Syndicates, included participation from all current investors, Ascentifi, Furthr, Broadview Ventures, Atlantic Bridge University Fund, Enterprise Ireland, Elkstone & SOSV, along with a new investor, IAG Capital Partners. CroíValve welcomes Daniel Gottlieb, a Director with Broadview Ventures, to its Board of Directors. Daniel has 20 years of experience with medical device and biotechnology companies in business development, marketing and strategy and previously served as an Observer on the CroíValve Board. Additionally, as a Venture Partner with IAG Capital Partners, Ehsan Jabbarzadeh will join the CroíValve Board as an observer.
The new financing follows a successful European First in Human study, the TANDEM I study, which demonstrated sustained reductions in tricuspid regurgitation and marked improvements in patients’ quality of life metrics for patients treated with the DUO™ System:
- 89% of patients experienced > 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ)
- 100% of patients achieved a New York Heart Association (NYHA) classification of I or II post treatment
- substantial (+63m average) improvement in the 6-minute walk distance (6MWD)
Proceeds from the financing will be used to fund the TANDEM II Early Feasibility Study, an FDA-approved, prospective, multicenter study to evaluate the safety and performance of the DUO™ System in patients with severe or greater symptomatic tricuspid regurgitation (TR). Tricuspid regurgitation is a severe heart condition that occurs when the tricuspid valve in the right side of the heart fails to close properly. TR affects over 1.6 million people in the US and is associated with significant morbidity and reduced life expectancy.
The DUO™ System is a novel transcatheter heart valve that works in tandem with the native tricuspid valve to restore valve function while leaving the patient’s right heart and native valve apparatus untouched through an innovative anchoring mechanism. Designed to treat a broad patient population, the DUO™ System accommodates the heterogeneity of patient anatomies while avoiding contact with critical structures in the right heart which could lead to complications. The DUO™ System is also designed to enable a straightforward procedure and reduce the procedural complexity seen with other devices. The procedure is less reliant on expert intraprocedural imaging, enabling a short learning curve with predictable and stable outcomes.
“I believe the DUO™ system can simplify the treatment of TR patients, with a predictable procedure that can be performed with standard imaging techniques. Additionally, with minimal anatomical exclusions, it can reach a broad population. It has the potential to emerge as a meaningful advancement in the field of TR treatment,” said Martin B. Leon, MD, CroíValve’s Clinical Advisory Board Chair and Mallah Family Professor of Cardiology at the Columbia University Irving Medical Center College of Physicians and Surgeons as well as Director of the Columbia Center for Interventional Care (CICC) at New York-Presbyterian Hospital/Columbia University Medical Center.
“This financing is a testament to the unmet need for treating tricuspid regurgitation and the potential of the DUO™ System to treat more patients with a reproducible and intuitive procedure. We are excited to bring this technology to the US, with strong support from our shareholder base who are committed to our mission to transform the lives of patients suffering from tricuspid regurgitation,” said Lucy O’Keeffe, CEO of CroíValve.
About CroíValve
CroíValve is a clinical stage medical device company focused on the development of a novel transcatheter device for the treatment of tricuspid regurgitation with Research, Development and Operations based in Ireland and Clinical and Regulatory based in the United States.
Caution: The DUO™ System is an investigational device and not for sale in any geography.
Contacts
W. Wojakowski , New York Valves Jun 2024
Dublin, Ireland, June 10, 2024 – Favorable patient outcomes from the TANDEM I first-in-human clinical trial of the CroíValve DUO™ System for the percutaneous treatment of tricuspid regurgitation (TR) were presented today by Professor Wojciech Wojakowski at the New York Valves 2024 scientific conference. The DUO System is a novel transcatheter coaptation valve that works in tandem with the native tricuspid valve to restore valve function, using an anchor system which leaves the right heart and native valve apparatus untouched.
TR is a severe heart condition that occurs when the tricuspid valve, on the right side of the heart, fails to close properly. This results in blood being pumped backwards into the right atrium and venous system causing debilitating symptoms. It affects over 1.6 million people in the US and is associated with significant morbidity and reduced life expectancy.
The TANDEM I trial is a prospective, non-randomized, multicenter study designed to evaluate the safety and performance of the DUO System in patients with severe symptomatic TR. The study reported on 10 patients enrolled, showing sustained positive outcomes.
Following 30-day outcomes presented last year, the six-month results demonstrated significant TR reduction by an independent core lab assessment, with TR reduced to moderate or less in over 85% of patients, even with massive or torrential TR at baseline. Patients also experienced markedly improved functional and Quality of Life outcomes, with a notable significant increase in both KCCQ score and 6MWT over baseline. The trial reported a 100% survival rate at 6 months. No incidences of arrhythmia or conduction disorder requiring permanent pacing were reported, demonstrating the advantages of avoiding right heart contact. Additionally, this data shows stable long-term device positioning and function, while supporting natural reverse remodeling. The simplified procedural experience was highlighted by an average device time of 43 minutes, even with first use cases.
“The six-month results with the DUO System are highly promising, not only for its clinical safety and efficacy, but also for the procedure’s simplicity and the technology’s broad applicability,” stated Professor Wojtek Wojakowski, Chief, Division of Cardiology and Structural Heart Diseases at the Medical University of Silesia in Poland. “This system offers new hope for patients suffering from severe TR, providing a versatile and predictable treatment option that simplifies the procedural and imaging experience for operators.”
The DUO System is delivered using percutaneous techniques and is secured using a novel anchor system which leaves the right heart and native valve apparatus untouched. The implant procedure is straightforward, uses standard imaging and is suitable for a broad patient cohort as it is independent of annular diameter, coaptation gap, leaflet morphology and visibility.
“We are encouraged by these data, which demonstrate the DUO’s success in reducing TR and improving patients’ Quality of Life,” said Dr Martin Quinn, CMO of CroíValve. “Our goal is to expand the reach of treatment option for patients with tricuspid valve disease. We are committed to building strong evidence to support emerging therapies like the DUO System, with further clinical studies and patient follow-ups underway.”
About CroíValve
CroíValve is a clinical stage medical device company focused the development of a novel transcatheter device for the treatment of tricuspid regurgitation, with R&D & Operations activities based in Ireland and Clinical & Regulatory based in the U.S.
Caution: The DUO System is an investigational device and not for sale in any geography.
LINDA MACKEN – APRIL 25, 2024
With Edwards and Abbott making recent waves in the tricuspid regurgitation (TR) treatment space, CroíValve hopes to pave its own way.
Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an FDA nod. With Edwards’ device designed to replace the native valve and Abbott’s designed to repair it, CroíValve’s investigational Duo tricuspid coaptation valve system could bring the best of both to the table.
“We’re seen as sort of the best of both worlds,” CEO Lucy O’Keeffe told MassDevice in an interview.
Duo features a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is anchored in a novel way — it is secured across the annulus by a support catheter anchored to a stent in the superior vena cava. This anchor system leaves the right heart and native valve apparatus untouched.
The system won FDA investigational device exemption at the start of the year and kicked off an early feasibility study for the Duo system. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR).
“We’re really excited to get our technology into the hands of leading physicians,” O’Keeffe said. “We’ve been in the background preparing for this trial for a period and having those discussions at the leading U.S. centers. They’re really keen to get to use our technology and see the advantages that it can provide.”
CroíValve’s mission and technology
Co-founder Dr. Martin Quinn, an interventional cardiologist, first conceived the concept now undertaken by CroíValve. Quinn performed the first transcatheter aortic valve replacement (TAVR) implant in Ireland and saw the value of that type of technology. O’Keeffe, meanwhile, was working on early TAVR programs at Medtronic, also understanding the potential impact.
The Duo heart valve repair device. [Image from the CroíValve website]
The two met in 2016 and with funding for early-stage proof-of-concept work, they began working on what eventually became CroíValve and the Duo device.
O’Keeffe said the company set out to design something specifically for the challenges of the tricuspid valve, finding a suitable treatment option for TR.
Current solutions for the tricuspid valve often come in a repurposed form from original designs made for the mitral valve. However, that may not solve the entire problem.
“There are some unique challenges with the tricuspid valve,” O’Keeffe explained. “[Existing solutions] have some limitations.”
With the already fragile makeup of the tricuspid valve, the situation is made more difficult by the dilation of the right heart and valve as a result of the disease. It grows to about twice its original size, O’Keeffe said, presenting a challenge with appropriate sizing.
“Our device is designed to fit most patients as it’s not dependent on annulus sizing or leaflet gap,” O’Keeffe explained.
On top of that, the surrounding structures — some critical — are fragile, too. If disrupted, this can in turn disrupt the normal function of the heart. The CroíValve approach has these challenges in mind, potentially making a difference in a diverse patient population with a straightforward, consistent implant that doesn’t disrupt normal cardiac function.
“We still work with the functionality that’s still there with the native valves,” O’Keeffe said. “”We implant a valve within the native valve that still allows the native leaflets to function naturally in sealing around the device. So what we have is these two valves working in tandem together.”
What’s next
CroíValve already saw early clinical trial success in Europe and hopes to bring that to its FDA IDE trial in the U.S. Early data showed meaningful symptomatic improvements in diverse patients, with patients now beyond a year post-treatment.
An earlier study showed that 90% of patients experienced a 15-point or more improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) measuring patient quality of life.
“We see that as a really meaningful clinical improvement that the patients have reached that level of clinical improvement,” O’Keeffe said. “That, truthfully, surpasses the other technologies. That’s one of the data points that, for us, is really encouraging — that we consistently see most patients feeling better.”
Other measures showed improvements, too, with a six-minute walk test producing positive outcomes and highlighting potential quality of life enhancements beyond the TR symptoms.
“The really positive piece in terms of clinical data is the ability to treat the diverse range of the native anatomy and have a procedure that the physician can do right the first time,” O’Keeffe said. “That’s a core element that has been so encouraging from early clinical work.”
Expanding clinical validation to the U.S. marks the next key step on the journey for CroíValve. O’Keeffe said the company sees value in working with leading U.S. centers that “really understand this disease” along with the challenges of other technologies. This should, she said, highlight the value of the company’s own approach.
O’Keeffe said the company is keen to make sure more doctors and patients get to experience the valve as it works toward challenging the TR treatment market.
“Doctors who have used Duo give it top scores for ease of use,” she said. “They find it has virtually no learning curve and no precision imaging requirement like other technologies.”
“There are other technologies that are now commercially available in the U.S. and have large clinical programs. We’re looking to make sure we develop our clinical data to further validate the technology. That’s the real focus.”
BY SEAN WHOLLEY
CroíValve is set to challenge as the TR treatment space heats up (massdevice.com)
LINDA MACKEN – JANUARY 25, 2024
CroíValve, an Irish-U.S. based medical device company with a novel, transcatheter solution for tricuspid regurgitation (TR), today announced initiation of its Early Feasibility Study (EFS) for the DUO™ Tricuspid Coaptation Valve System, following FDA IDE and CMS approval. The TANDEM II trial is a prospective, multi-center, non-randomized single-arm study to assess the safety and performance of the DUO Tricuspid Coaptation Valve System in patients with severe or greater symptomatic TR.
DUO consists of a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. The device is delivered using percutaneous techniques and is secured using a novel anchor system which leaves the right heart and native valve apparatus untouched. The implant procedure is straightforward, uses standard imaging and is suitable for a broad patient cohort, accommodating the large anatomical variability seen in this patient population. The European First in Human TANDEM I trial showed strong symptomatic improvement in patients across all key measures. The treated population was highly symptomatic and represented the broad range of anatomies in TR patients. Additionally, these cases demonstrated the procedure is quick to learn and perform, without the need for complex imaging. The TANDEM II feasibility study will further develop the clinical validation of this novel technology.
“We are delighted to initiate TANDEM II, with strong interest in participation in the study from leading U.S. centers. This marks a significant step forward in our efforts to continue generating clinical evidence demonstrating the safety and effectiveness of DUO,” stated Lucy O’Keeffe, CEO of CroíValve. “We are confident it has the potential to revolutionize the standard of care by redefining how TR is treated, and ultimately enhancing the lives of patients in need.”
In addition to this significant milestone, CroíValve has appointed Martin B. Leon, M.D. as chair of its clinical advisory board. A distinguished pioneer in interventional cardiovascular medicine, Dr. Leon is the Mallah Family Professor of Cardiology at the Columbia University Irving Medical Center College of Physicians and Surgeons and Director of the Columbia Center for Interventional Care (CICC) at New York-Presbyterian Hospital/Columbia University Medical Center. He also serves on the Executive Board of the New York-Presbyterian/Columbia Heart Valve Center. Dr. Leon was the Founder of Transcatheter Cardiovascular Therapeutics (TCT) symposium and Chairman Emeritus of the Cardiovascular Research Foundation (CRF).
“I’m excited about the study bringing this uniquely designed device to patients in the U.S. and guiding it as Chair of the Clinical Advisory Board,” said Dr. Leon. “I believe the DUO system can simplify the treatment of TR patients, with a predictable procedure that can be performed with standard imaging techniques. Additionally, with minimal anatomical exclusions, it can reach a broad population. It has the potential to emerge as a meaningful advancement in the field of TR treatment.”
TR is a severe heart condition that occurs when the tricuspid valve, on the right side of the heart, fails to close properly. This results in blood being pumped backwards into the right atrium and venous system causing debilitating symptoms. TR can significantly impact quality of life. Despite these substantial risks, there are limited treatments available for patients with TR.
About CroíValve
CroíValve is a clinical stage medical device company focused the development of a novel transcatheter device for the treatment of tricuspid regurgitation, with R&D and Operations activities based in Ireland and Clinical based in the U.S.
Caution: The DUO System is an investigational device and not for sale in any geography.
LINDA MACKEN – JUNE 9, 2023
Wojciech Wojakowski presented First in Human Experience with the CroíValve DUO Novel Tricuspid Coaptation Valve TANDEM I Trial on 9th Jun ’23 at TVT, Phoenix, US.
The CroíValve DUO Tricuspid Coaptation Valve system consists of a prosthetic valve with coaptation skirt and an anchoring catherer system and stent.
The objective of the TANDEM I FIH Trial is to demonstrate safety and effectiveness of the DUO Coaptation Valve System in patients with severe symptomatic TR.
The investigators involved in the study found the procedure to be straightforward. Device delivery is simple, well tolerated and quick. There is no need for complex imaging and there is a very short learning curve.
Clinical outcomes: Significant symptom and QoL improvements out to 30d and 90d across all parameters (NYHA, KCCQ, 6MWT)
About Tricuspid Regurgitation
Tricuspid regurgitation (TR) is a severe heart condition that occurs when the tricuspid valve fails to close properly. This results in blood being pumped backwards into the right atrium and venous system causing debilitating symptoms.”
Full presentaion:https://www.tctmd.com/slide/first-human-experience-croivalve-duo-novel-tricuspid-coaptation-valve-ta…
LINDA MACKEN – MAY 30, 2023
Ignacio J Amat completed a successful First in Human implant of CroiValve’ s DUO Tricuspid Coaptation Valve technology for the treatment of Tricuspid Regurgitation as part of its TANDEM I study in Europe. The procedure went smoothly, and Ignacio tweeted “Orthotopic valve therapies for tricuspid regurgitation in HCU Valladolid – Pioneering for patients”.
Picture from left to right: Dr. Martin Quinn, CMO CroiValve, Greg Campion R&D Engineer, CroiValve and Ignacio J Amat Santos, Director, Cardiac Catheterization and Interventional Cardiology- Hospital Clínico Valladolid – Spain
LINDA MACKEN – MAY 23, 2023
On 23 May 2’23 Zenon Huczek , Prof. Medical University of Warsaw completed a successful First in Human implant of CroiValve’ s DUO Tricuspid Coaptation Valve technology for the treatment of Tricuspid Regurgitation as part of its TANDEM I study in Europe.
LINDA MACKEN – NOVEMBER 18, 2022
Dublin, Ireland, 18 November 2022 – CroíValve has announced the successful First in Human implants of its DUO Tricuspid Coaptation Valve technology for the treatment of Tricuspid Regurgitation as part of its TANDEM I study in Poland. The procedures were performed as part of an ongoing clinical trial at the National Institute of Cardiology, Warsaw by Prof Adam Witkowski and Dr Maciej Dąbrowski and the Medical University of Silesia in Katowice by Prof Wojciech Wojakowski.
Tricuspid Regurgitation (TR) is a severe heart condition that occurs when the tricuspid valve, on the right side of the heart, fails to close properly. This results in blood being pumped backwards into the right atrium and venous system causing debilitating symptoms. The DUO System consists of a coaptation valve implant that works in tandem with the native tricuspid valve to restore valve function. The device is delivered using minimally invasive techniques and is secured using a novel anchor system which leaves the frail right heart chamber and native valve apparatus untouched. The implant procedure is straightforward, uses standard imaging and is suitable for a broad patient cohort, including those who are challenging to treat with other valve repair and replacement technologies.
These early cases demonstrate that the DUO System is highly effective at treating TR and significantly improves patients’ symptoms. This is achieved with a straightforward, short procedure, that is easy for the patient to tolerate and for the physician to perform.
“The DUO System is unique in providing a solution that can effectively treat the dilated right heart anatomy that accompanies Tricuspid Regurgitation, while avoiding contact with the right heart to maintain normal cardiac motion,” commented Prof Adam Witkowski. “After 30 days, our patient has already experienced a transformative improvement in symptoms, highlighted by the KCCQ Quality of Life survey and a reduction from NYHA III to NYHA II and significant improvement in 6MWT. In addition, the device continues to exhibit excellent efficacy.”
“This early use of the DUO System shows it’s an easy to use, safe and effective device” added Prof Wojciech Wojakowski. “Even though it was our first use of the DUO System, the procedure was very straightforward, which is highlighted by the short procedure time. It is a stepwise, controlled approach using standard echo and fluoro imaging and allows us treat patients we would otherwise have no option for”.
“This achievement is an important milestone on our journey to implement the DUO System as the gold standard approach for treating Tricuspid Regurgitation. We’d like to thank the Heart Teams at the National Institute of Cardiology, Warsaw and the Medical University of Silesia in Katowice. We are excited by this early clinical experience in demonstrating a transformative treatment option for these patients.” said Lucy O’Keeffe, CroíValve’s CEO.
Caution: The CroiValve DUO System is an investigational device and not available for sale