The Dublin firm that gets to heart of the matter

Trish Dromey talks to CroíValve, a Dublin medical device firm at the cutting-edge of heart valve treatment.

DUBLIN-based company CroíValve is working on developing a medical device to treat tricuspid valve disease — a heart condition which is currently difficult to treat and has a significant impact on survival.

Expecting to have its device ready for human trials by 2020, the company initially plans to target markets in the US and Europe where over half a million new cases of the condition are identified each year. Ultimately, it intends to go after a global market estimated to be worth over €3bn.

A regional finalist in this year’s Intertrade Ireland Seedcorn competition, CroíValve is now engaged in a multimillion funding round with a view to spinning out from the Trinity Centre for Bioengineering and recruiting eight additional staff.

“We are currently at the pre-clinical stage carrying out animal and bench trials. This will demonstrate our solution is safe and effective at treating this unmet need. Comprehensive testing will then be conducted to provide us with the data to submit for submission to regulatory bodies,” said company CEO and co-founder Dr Lucy O’Keeffe one of the company’s two full-time staff members.

The CroíValve device was invented and patented by one of the company’s other three co-founders, Dr Martin Quinn, a consultant cardiologist at St Vincent’s Hospital in Dublin who had previously been involved in developing concepts for the mitral heart valve.

He joined forces with Professor Bruce Murphy at Trinity, who had developed a minimally invasive solution for the mitral valve and who had experience in securing early stage funding for this type of venture.

Securing Enterprise Ireland commercialisation funding, they then invited Ms O’Keeffe, who has led multiple large medical device development programmes, and biomedical engineer Paul Heneghan, who has significant experience with early stage device development and prototyping, to join them in setting up CroíValve in mid 2016.

Lucy O’Keeffe said she jumped at the chance to participate in a venture which provided a proprietary novel approach to an unmet clinical need. Devices had already been created for the other three heart valves, but to date none is commercially available for the tricuspid.

“The device is a minimally invasive solution that treats tricuspid valve regurgitation quickly and cost effectively without requiring a long hospital stay,” said Ms O’Keeffe, further explaining that, at present, patients suffering from this condition are too high risk for surgery and have no effective treatment option. She said that over the last year, pre-clinical trials have demonstrated that the device significantly reduces tricuspid regurgitation and is safe to use.

While there are a number of other companies around the world working on a solution for this disease, Ms O’Keeffe said the CroiValve device is easier to use. “It may not be the first to market as a device for tricuspid valve disease – but it has significant advantages over competitors and this is supported by leading clinical experts.”

Ms O’Keeffe added that Ireland’s growing ecosystem for medtech companies has been hugely beneficial for CroíValve and that the track record of successful medtech companies here creates a good climate and support for fundraising for this type of venture.

“We have had interest from large multinationals in this space who may acquire the company at a later stage as well as support from seasoned medtech professionals who have been involved in this type of start-up and who shared their experience and knowledge with us.”

Now actively engaged in fundraising, she has been talking to medtech investors, angel syndicates as well as private investors who provide funding for start-ups both nationally and internationally.

Support from Enterprise Ireland has included the initial commercialisation grant as well as ongoing assistance with the programme. Moving ahead to clinical trials, and subsequently to trials in humans, will be an extensive process for the company. Ms O’Keeffe said there is huge global interest in the CroíValve device and that discussions are already being held with hospitals here and internationally who are eager to participate in the first in-human trials in 2020.

Taking part in the Intertrade Ireland Seedcorn competition is now helping CroíValve become investor ready, Dr O’Keeffe said.

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