CroíValve is at the heart of the future of medtech

15 Apr 2019

From left: Helen Ryan, Atlantic Bridge; Bernard Collins, CroíValve; and Dr Lucy O’Keeffe, CroíValve. Image: CroíValve

Our Start-up of the Week is CroíValve, a spin-out from the Trinity Centre for Bioengineering that has developed a minimally invasive treatment for heart failure.

“CroíValve is developing a solution to fix one of the valves in your heart, the tricuspid valve, without the need for surgery,” explained CroíValve co-founder and CEO Dr Lucy O’Keeffe.

“Heart failure causes the tricuspid valve to stop functioning correctly. As these patients are elderly and sick, they are too frail for surgery so currently have no treatment option. This means they have very poor quality of life and three of five will die within three years.”

‘CroíValve is an innovative company with the mission to lead the treatment of tricuspid valve disease and transform the lives of patients’

The company recently raised €3.2m in a funding round involving a record number of angel investors. The round was led by the Halo Business Angel Network (HBAN) MedTech and Irrus syndicates, alongside Atlantic Bridge University Fund, Enterprise Ireland, SOSV and cardiologists who see the treatment’s transformative potential.

The market

“The past decade has witnessed a revolution in the treatment on heart valve disease,” O’Keeffe explained. “For aortic valve treatment, patients no longer need to have open heart surgery and most patients now receive non-invasive, catheter-based implantation of a prosthetic valve, restoring their quality of life within days.

“The tricuspid valve has remained largely forgotten due to the unique challenges required to treat it. But, with more than 500,000 new cases annually in the US and EU alone, it is a significant unmet need and multibillion-euro market opportunity.”

The founders

The original concept was invented by Dr Martin Quinn, a consultant cardiologist in St Vincent’s University Hospital who completed the first minimally invasive aortic valve implant in Ireland.

“Seeing this aortic valve technology transform patients’ lives, he developed a concept for minimally invasive treatment of the tricuspid valve, known as the forgotten valve,” O’Keeffe explained.

“This was then developed, with the support of Enterprise Ireland and EIT Health, within Trinity College Dublin when Prof Bruce Murphy, myself and Dr Paul Heneghan joined the team.

“I also had experienced the impact of minimally invasive heart valve treatment working on an aortic programme in a medical device multinational.”

Having spent more than a decade leading medical device/technology programmes in large multinationals, O’Keeffe was keen to put her leadership skills to use in a start-up.

“CroíValve, with an unmet clinical need, a novel concept and a great team, was the right opportunity for this.”

The technology

Heart failure causes the right ventricle to dilate, pulling apart the leaflets of the tricuspid valve so that they no longer seal and allowing blood to flow in the wrong direction with every heartbeat.

“CroíValve has developed a non-invasive device uniquely tailored to the challenges of the tricuspid valve,” O’Keeffe explained. “Delivered via a catheter through a vein in the neck, it is positioned between the tricuspid valve leaflets to restore function and help them seal. An innovative adjustable anchor holds the device in position and sits away from the fragile heart tissue, avoiding any tissue-penetrating hooks.

“CroíValve is an innovative company with the mission to lead the treatment of tricuspid valve disease and transform the lives of these patients.”

The heart of the matter

After raising one of the largest angel seed rounds in Irish start-up history, O’Keeffe said the real challenge that lies ahead is getting the technology through validation and to market.

“We’re delighted to close our seed round to accelerate our development efforts and bring this exciting technology to patients. We are currently building our team, particularly in the area of R&D, and will have grown to 10 within the next year. As part of this, 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, who bring vast experience in this space.

“This is a heart implant requiring detailed development, testing and clinical validation prior to taking it to market. With changing regulatory requirement, this will require our experienced, committed team and significant capital to secure regulatory approvals.”

O’Keeffe said that the Irish medtech start-up scene is growing, is very collaborative and supportive, and is becoming a dominant hub in Europe.

“Early medtech funding is challenging and so it’s important all options are explored to continue to make Ireland an attractive location for both investors and start-ups.”

Her advice to fellow founders? “Tap in to all the advice that is out there. There are a lot of experienced people willing to provide support, so make sure to make use of it.”

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John Kennedy is a journalist who served as editor of Silicon Republic for 17 years