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In CroiValve’s incongruously located laboratory at the edge of Dublin 1, a stone’s throw from the 3Arena, a white-coated technician takes a piece of pig tissue from a glass jar and uses a machine to attach it to a frame support.
Ultimately it is hoped that these so-called coaptation valves will be delivered through the neck of older patients suffering from heart failure who are too ill to undergo surgery. It aims to treat a severe heart condition called tricuspid regurgitation where the valve on the right side of the heart fails to close properly.
The condition results in blood being pumped backwards into the heart’s atrium. It effects more than 1.6 million people in America each year, significantly reducing life expectancy and eventually causing death.
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Seven years of research has been put into developing the medical device to date and about €30 million has been raised, yet Lucy O’Keeffe, chief executive of CroiValve, knows they are only in the foothills of creating a life-saving discovery.
“Developing a heart valve implant is probably on the more complex side of things that you can do, even in medical devices. It’s a slower and longer development journey but it is really impactful,” she says.
From its small headquarters in the Liffey Trust building on the North Wall, CroiValve’s solution is causing a stir within the Irish medical technology community. Investors have piled in to back the company and its “revolutionary” valve.
Within the industry cognoscenti it is being dubbed as the “next Neuravi”, following in the footsteps of a company that sold for €400 million to Johnson & Johnson in 2017.
It’s not too hard to see why the technology is causing excitement. CroiValve’s device essentially “fills the gap” between flaps of tissue in the right atrium and helps prolong lives, O’Keeffe says.
After a successful trial of the implant in Poland, O’Keeffe is gearing the company up to begin an early feasibility study in America — having secured approval from the US Food and Drug Administration and bagged €14.5 million in funding last month.
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Two years ago O’Keeffe said that “investors follow investors” when CroiValve raised €8 million with 64 angel investors contributing.
She’s beating the same drum after closing the series B funding round, in which even more high-net-worth individuals dug deep into their pockets to produce almost double the sum, alongside venture capital firms. Hban’s Medtech Syndicate, based in Galway, has delivered 73 investors, contributing €5.8 million to the round; members of another syndicate, Irrus Investments, also pitched in.
“We do have a mix of investment but the major proportion is down to angel,” O’Keeffe says. “I did think that at this stage of our journey that we would be taking funds from a different investor base, but most of this money has come out of Ireland and it really is a testament to the strength of the medtech sector here.”
Yet such a reliance on angel investment also shows how challenging it is for even well-regarded medtech start-ups to raise institutional money, O’Keeffe admits, adding: “It was a tough environment.”
Yet she sees the continued support from individual industry investors as an endorsement. “The fact existing investors chose to support us again shows that we did what we promised we would do and have stayed committed.”
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And if venture capitalists have been slow to the party, the company has amassed an impressive list of backers. Institutional investors include the Galway-based investment firm Ascentifi, the Dublin-based Atlantic Bridge and Alan Merriman’s Elkstone, while Enterprise Ireland and Sean O’Sullivan’s SOSV also contributed.
The latest round attracted two American investors, IAG Capital Partners and Broadview Ventures, with IAG partner Ehsan Jabbarzadeh and Broadview’s Daniel Gottlieb joining CroiValve’s board.
The company chairman is Bernard Collins, a medtech veteran and serial investor whose presence has helped to open doors. “Ireland is tiny but even globally the medical devices industry is small and reputation means everything.”
O’Keeffe, 42, has been steadily building her own medtech reputation over the years. Growing up “just outside” Limerick city, O’Keeffe says she always leaned towards science and maths subjects in school. Yet she never really saw herself going down the entrepreneurial route.
“I was always risk-averse and quite conservative,” she says. “When I think of an entrepreneur I think of someone like Richard Branson, but maybe my traits are better aligned to the medical device industry.”
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She studied mechanical engineering at University College Dublin where her final year project was “vaguely in the biomedical science sphere” — a study assessing the flow of blood in arteries.
After finishing university she travelled for a year, visiting southeast Asia, Australia, New Zealand and South America, before returning to Ireland and undertaking a fully funded PhD in biomedical engineering at the University of Limerick.
“That was where I really got into that interface between engineering and biology,” she says. “My PhD looked at why coronary heart arteries get diseased.”
O’Keeffe landed a job at Medtronic in Galway in 2006, working in research and development. “The company was treating heart failure with minimally invasive techniques,” she says.
Halfway through her time at Medtronic, the multinational started to acquire companies that developed devices to treat the aortic valve in the heart. “I guess I learnt a lot about heart valves there.”
O’Keeffe worked at Medtronic until 2011 before she moved to Dublin, leading research and development projects at Nypro, now Jabil Healthcare, and the publicly listed clinical research group Icon.
“They were typically global projects and gave me a strong skillset for project management,” she adds.
In what O’Keeffe describes as a “full circle moment”, she was approached by a lecturer at Trinity College Dublin, a collaborator on a project she undertook while studying for her PhD at the old National University of Ireland Galway.
The contact introduced O’Keeffe to Martin Quinn, a cardiologist at St Vincent’s hospital and Blackrock Clinic who is now CroiValve’s chief medical officer.
Quinn had come up with the concept of the coaptation valve technology and secured funding from Enterprise Ireland to run a two-year feasibility study at Trinity, she says.
“I joined the team as chief executive officer and we spent the first two years in Trinity before spinning out in 2019,” O’Keeffe adds.
Since then the company has expanded its headcount to 40 people and conducted a trial in Poland.
“We have seen very meaningful improvements in symptoms for patients that were part of the Polish study,” O’Keeffe says. “Post-treatment we are still assessing the improvement.”
After six months using the valve, patients are seeing improved quality of life. “It’s really encouraging and shows that the technology is working,” she adds.
The technology has also improved patients’ day-to-day lives. “Most of these patients retain a lot of fluid in their lungs and had to sleep sitting up at night,” O’Keeffe says. “With the new device patients can now lie down. It may seem a small thing but for a patient that’s a large increase in quality of life.”
O’Keeffe says the company’s journey to date has been “relatively efficient” and it has a “great team of people working behind it”.
Most hires are trained engineers and former employees at Boston Scientific and Medtronic. “We benefit from a really good ecosystem in Ireland, both in terms of the start-up scene and then the multinationals,” she says.
CroiValve has managed to leverage that expertise, O’Keeffe says, but also employs graduate engineers, passing on knowhow “to the next generation”.
Since closing the last round she has hired ten new staffers and rearranged the office to accommodate them. “You do need to execute quickly in this world.”
CroiValve now has 30 people based out of its Dublin office, with another five “around Ireland”, one in Canada and a team of four in the US gearing up for the next trial. In that study 30 patients over the age of 70 will test the valve.
O’Keeffe views the process as a marathon and not a sprint; even though the ink is just dry on CroiValve’s last funding round, she will have to go to the market in another 18 months to seek more investment.
At that point, the results of its US trials should be under her belt. The next step after the feasibility study will be a large-scale commercialisation study.
“Obviously our ultimate goal is to commercialise the valve,” she says. It’s hard for O’Keeffe to pinpoint when exactly that might be. For the Limerick woman and her loyal following of investors, for now it is a case of maintaining CroiValve’s impressive momentum.
Age: 42Home: Clonskeagh, DublinFamily: married to Manus with a two-year-old daughter, Cora, and dog RaffaEducation: mechanical engineering degree at UCD; PhD in biomedical engineering at the University of LimerickFavourite movie: The Usual SuspectsFavourite book: Down Under by Bill Bryson
Working day: Every day is different and pretty diverse. Whether there are tasks related to fundraising or if we are going through our clinical trials, I am across every part of the business. I normally start work at 8am and I am home by 6pm and take a break until 8pm to spend time with my daughter.
Downtime: I mostly spend time with my family and friends, and I exercise. Historically, I had a lot more time to take part in sports like swimming, cycling and tennis, but I can’t quite fit it in since having Cora. There’s never enough hours in the day.