LINDA MACKEN – JULY 22, 2022

“CroíValve, a Dublin based medical device company developing a novel treatment for tricuspid regurgitation, are pleased to announce that they have expanded their existing patent portfolio with the addition of two newly granted US Patents. 

This adds to the existing patent portfolio which protects the Company’s intellectual property surrounding a novel method to treat Tricuspid Regurgitation. In addition to these new patents, CroíValve are pursing global patent protection across multiple jurisdictions. CroíValve also has a number of new filings with the US Patent and Trademark Office (USPTO) to expand their IP protection as they continue to innovate their novel technology. 

Reacting to this news, CroíValve CEO Lucy O’Keeffe said “CroíValve is committed to developing a novel solution for Tricuspid Regurgitation to meet the large unmet need in patients today. This expansion of our IP portfolio further protects our highly novel technology”. 

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.”

LINDA MACKEN – FEBRUARY 4, 2022

CroíValve, a Dublin based medical device company developing a novel treatment for tricuspid regurgitation, has raised a Series A round to fund a Feasibility clinical study with its DUO Coaptation Valve system. This novel approach to treating tricuspid regurgitation combines the best of repair and replacement to provide the right solution for the right heart. Additionally, CroíValve welcomes Dr. Azin Parhizgar, Ph.D., a leading medical device entrepreneur in structural heart, to its Board of Directors. In addition, Helen Scotch has joined the Senior Leadership Team as Vice President of Clinical and Regulatory Affairs. 

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. 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 percutaneously and is secured using a novel anchor system which leaves the delicate right heart chamber and native valve apparatus untouched. It is designed to be implanted in a straightforward procedure using standard imaging and is suitable for a broad patient cohort, including those who are challenging to treat with other valve repair and replacement technologies. This innovative approach has already generated convincing pre-clinical and clinical data. Temporary clinical implants of the DUO Coaptation Valve have demonstrated the ability to significantly reduce TR in patients with torrential TR, large annuli and imaging difficulties. 

The investment round was led by the HBAN (Halo Business Angel Network) MedTech and Irrus Syndicates, alongside existing investors Atlantic Bridge University Fund, Broadview Ventures, SOSV and Enterprise Ireland and new investors Elkstone, Ascentifi and DBIC. The funding will support a European Feasibility Study of the CroíValve Transcatheter Tricuspid DUO Coaptation Valve System. 

Dr. Parhizgar is currently the Chairman of the Board of CVPath Institute, a Senior Venture Partner at 415 Capital and a Board member at Soundbite Medical Solutions, InnovHeart, Moray Medical, Vessl, and Women as One. She was CEO, President and Board Member at Claret Medical, an embolic protection device company acquired by Boston Scientific in 2018. Prior to Claret Medical, Dr. Parhizgar served as COO of Conor Medsystems, which was acquired by Johnson & Johnson in 2007 and EVP Regulatory and Clinical Affairs for Arterial Vascular Engineering (AVE), which was acquired by Medtronic in 2000. Dr. Parhizgar received both her Ph.D. in Cell, Gene and Tissue Engineering and her M.Sc. in Biomechanical Engineering and Artificial Organ Design from Brown University. 

Helen Scotch is a highly experienced leader of Regulatory, Clinical and Quality. Helen previously served in leadership roles in both start-ups (TriFlo and Cephea) and multinationals (Boston Scientific) across the full product development lifecycle in the structural heart space. Helen holds a BSc. in Industrial Chemistry and spent time as a R&D chemist prior to moving into Regulatory Affairs roles of increasing responsibility with Boston Scientific.

LINDA MACKEN – OCTOBER 20, 2020

On Friday October 16th 2020,  Lucy O’Keeffe, CEO CroíValve, participated as one of the finalists in the TCT Shark Innovation Competition presenting “Combined Repair and Replacement Solution for TR” to the distinguished panel of multidisciplinary panel during the Transcatheter Cardiovascular Therapeutics (TCT) Connect conference 2020.

Now in its seventh year, the TCT Shark Tank Innovation Competition was created to highlight the most innovative device concepts and technological developments with the potential to disrupt the cardiovascular field and dramatically change how patients are treated. Six companies were chosen from the extensive number of applicants to present their technology to a distinguished panel of multidisciplinary experts and judged on the following criteria: unmet clinical need, technology differentiation, IP position/viability, biological proof of concept, regulatory pathway, and commercialization potential. 

For the third year in a row, the TCT Shark Tank Innovation Competition partnered with the Jon DeHaan Foundation who provided a $200,000 award  to the winner.

“I was a great honour to be chosen as one of the six finalists in this prestigious competition and get the opportunity to showcase our novel technology” said Lucy O’Keeffe, CEO  CroíValve.  

LINDA MACKEN – MARCH 23, 2020

Dublin, Ireland,  23 March 2020 –  CroíValve announced today the successful first human use of its Duo Tricuspid Coaptation Valve technology for tricuspid repair. The procedure was performed by an experienced Heart Team in St. James University Hospital Dublin, led by Dr Stephen O’Connor, MD, Interventional Cardiologist and Mr. Michael Tolan, MD, Cardiac Surgeon, assisted by Dr. Andrew Maree, Dr. Charlie McCreery and Dr. Caroline Daly.   

The patient had severe tricuspid regurgitation (TR) with reduced heart function and was at risk of a further deterioration in heart function with treatment of the tricuspid valve. Based on this, the patient had been turned down for open surgical repair. Because the unique, atraumatic approach of the Duo device allows for temporary implantation of the device to restore function without any impact to the native anatomy, the Heart Team elected to assess the acute effect of tricuspid valve repair on heart function. The procedure was approved by the Irish regulatory body (HPRA) under their compassionate use program. 

“The unique capability of the Duo Coaptation Valve, to restore tricuspid valve function atraumatically, while facilitating straightforward percutaneous removal, enabled us to determine a strategy to treat the patient. Considering this patient has had significant suffering from this disease and had no other options, we are extremely proud the physicians and staff at St James University Hospital found an innovative approach to understanding the right treatment approach for this patient.” Mr. Michael Tolan added. 

The procedure, delivery and retrieval were completed fully percutaneously, with the device delivered in 5 minutes without complications. TR was reduced from torrential to mild and the mean right atrial pressure reduced from 26 to 13 mmHg, with an increase in systolic BP, while the device was in situ. No significant change in right ventricular function was noted during the 30 minutes that the device was in place. The patient is recovering well from the intervention and permanent transcatheter repair of her valve is planned due to the positive cardiac response to treatment. 

“Early use of the CroíValve system indicates it to be an easy to use, safe and effective intervention for patients with severe tricuspid regurgitation” stated Dr. Stephen O’Connor  

The Duo Tricuspid Coaptation Valve technology provides a simple and atraumatic approach for addressing severe TR in high risk patients. The device is currently being evaluated in a clinical study in Poland to assess the impact of correction of severe tricuspid regurgitation in patients, prior to surgical intervention. The system is also in development for permanent implantation, with clinical studies planned for early next year.  

 “We’d like to thank the Heart Team at St. James’ Hospital for their commitment to providing care to this patient, who would have otherwise gone untreated. We are excited by these early clinical results and the potential demonstrated in providing a meaningful treatment option for these patients.” said Lucy O’Keeffe, CroíValve’s CEO. CroíValve spun-out of Trinity College Dublin in early 2019 and is headquartered in Dublin, Ireland. 

LINDA MACKEN – FEBRUARY 20, 2020

Eit Health’s support of CroiValve has had a huge impact in helping us develop this transformational technology

February 20, 2020

LINDA MACKEN – SEPTEMBER 12, 2019

Dublin, Ireland, 12 September 2019 – €4 million in additional financing has been secured by CroíValve, a high potential start-up (HPSU) supported by Enterprise Ireland developing a treatment for tricuspid regurgitation (TR). This is an issue affecting over half-a-million people every year in the US and EU alone, for which there is currently no suitable solution. The financing includes €2.5 million from the European Union under their Horizon 2020 SME Instrument grant and €1.5 million from Broadview Ventures and current investors (HBAN MedTech and Irrus Syndicates, Atlantic Bridge University Fund and SOSV Ventures). The funding will accelerate the development of the company’s novel technology into First in Human studies.  

Tricuspid regurgitation (TR) is a severe heart condition that occurs when the tricuspid valve fails to seal properly, allowing blood to flow retrograde from the right ventricle into the right atrium, with progressive symptoms including fatigue, fluid retention leading to abdominal and leg swelling, liver and kidney failure and death. The vast majority of patients with advanced TR are elderly and too frail for open-heart surgery, the only currently available treatment. CroíValve’s technology – a Tricuspid Coaptation Valve – is delivered using a minimally invasive approach and seals the gap between native valve leaflets, thereby restoring valve function. The procedure has been proven safe, simple and effective in extensive pre-clinical testing completed.  

Broadview Ventures’ mission is to accelerate the development of promising technology for the diagnosis and treatment of cardiovascular, metabolic, and neurovascular disease. Broadview is based in Boston, MA, with a global investment footprint. They have been actively investing since 2009, with 40 portfolio companies funded to date, and notable exits including CardiAQ, Apama Medical, and Remedy Pharmaceuticals.  

Dr. Lucy O’Keeffe, CroíValve’s CEO, said: “We welcome this funding as further validation of our solution following a very detailed assessment by Broadview Ventures and their Scientific Advisory Board, as well as a team of EU experts through the highly competitive Horizon 2020 SME Instrument grant. We are excited to accelerate our development efforts and look forward to bringing this new solution to patients” 

“ Tricuspid regurgitation remains an undertreated condition, despite advances in valve repair and replacement for the left side of the heart. We believe CroíValve has come up with a differentiated approach to solving TR – one that accommodates the unique anatomy and hemodynamics of the tricuspid valve. We look forward to working with the CroíValve team to bring this solution into the clinic” said Dr. Maria Berkman of Broadview Ventures. 

About CroíValve

A spin-out from Trinity College Dublin, CroíValve (croí is Irish for heart) is a privately held company. It was founded by Dr Lucy O’Keeffe, Dr Martin Quinn, Dr Paul Heneghan and Prof Bruce Murphy to develop a percutaneous solution for tricuspid regurgitation. It is located in the Liffey Trust Enterprise Centre in Dublin, Ireland. www.croivalve.com;

LINDA MACKEN – MARCH 28, 2019

Dublin, 28th March 2019 – CroíValve, a medtech start-up providing a safe and effective treatment for tricuspid regurgitation, today announces that it has secured €3.2 million in an oversubscribed seed financing round. The round was led by the HBAN (Halo Business Angel Network) MedTech and Irrus Syndicates, alongside Atlantic Bridge University Fund, Enterprise Ireland, SOSV and a group of cardiologists who see the treatment’s transformative potential. The funding will support the continued development of CroíValve’s innovative technology. 

CroíValve, a spinout from the Trinity Centre for Bioengineering, has developed a minimally invasive treatment for tricuspid regurgitation (TR). The heart condition occurs when the leaflets or cusps of the tricuspid valve – the valve separating the heart’s right ventricle and right atrium – fail to close properly due to dilation of the right heart, allowing blood to leak backwards into the right atrium. This causes further expansion, and eventually failure, of the right side of the heart. It is a severe cardiac disease with progressive symptoms including fatigue, fluid retention leading to abdominal and ankle swelling, liver and kidney failure, and death. 

As the vast majority of patients are elderly and too frail for open-heart surgery, the only option available to them is medication that removes the excess fluid but does not cure the condition. CroíValve’s innovative technology specifically addresses the challenges associated with tricuspid heart valve disease. The device is delivered through the heart’s blood vessels and seals the gap between the native valve leaflets, therefore restoring the heart’s function and preventing regurgitation. The device is held in place with a unique anchoring system that removes the need for potentially traumatic anchoring into the right heart. The procedure is safe, simple and effective. With over half-a-million new cases annually in the US and EU alone, it is a significant unmet need and market opportunity. 

Dr Lucy O’Keeffe, CEO, CroíValve, said: “To date, all treatment options are either too invasive or merely symptom management. CroíValve was established from a desire to bring a new, safe treatment option that can change and save lives. 

“We welcome the investors’ support in accelerating our development efforts and look forward to working together to bring this exciting technology to patients. In doing so we are currently building our team, particularly in the area of R&D, and by year-end 2019 we will have grown to a company of 10. As part of this expansion, we are delighted to welcome Dr Ivan Vesely as our CTO, and the extensive knowledge that he brings. Additionally, we have established a great board, with Bernard Collins, one of our investors from the HBAN MedTech syndicate, bringing vast experience as chairman.” 

Dr. Martin Quinn, CMO, CroíValve, said: “The CroíValve technology will revolutionise the treatment of patients with severe tricuspid incompetence. It is extremely easy and safe to use and can be implanted without the need for general anaesthesia.” 

The funding round was led by 48 angel investors from HBAN, the all-island organisation responsible for the promotion of business angel investment, and an initiative of Enterprise Ireland, InterTradeIreland and Invest Northern Ireland. It is the largest ever number of HBAN members to contribute to one funding round and together they invested €1.5M in the company. 

Bernard Collins, CroíValve Chairman and HBAN MedTech Syndicate member, said: “As angel investors, we are not just providing capital to CroíValve, but also knowledge of, and contacts within, the medtech sector. This will help to open doors for CroíValve and enable the company to scale and commercialise its device. As chairman and an investor, I am extremely excited to be involved in this game-changing company dedicated to transforming the way tricuspid regurgitation is treated.”

“On behalf of Atlantic Bridge, I am pleased to welcome Trinity spin-out CroiValve to the University Bridge Fund portfolio and am also delighted to join the Board of the Company. We believe the CroiValve team has developed a truly novel device that represents a disruptive approach to the treatment of tricuspid valve regurgitation and is an excellent example of the commercialisation of ground-breaking Irish research.” said Helen Ryan, Senior Advisor, Atlantic Bridge.

LINDA MACKEN – NOVEMBER 2, 2018

LINDA MACKEN – SEPTEMBER 17, 2018

LINDA MACKEN – SEPTEMBER 9, 2018