Why We Invested: CroíValve

By Carl Murray, Venture Investment Associate at Elkstone.

In the modern ESG landscape, impact investing has a number of formal definitions composed of ever-increasing technical requirements and standards that must be followed. While important in their own right, when assessing investments of this nature, we tend to return to first principles and ask ourselves ‘Will this investment change somebody’s life for the better?’.

From our initial call with CroíValve CEO Dr. Lucy O’Keeffe and founder Dr. Martin Quinn, it was abundantly clear that the answer to this question was a resounding ‘Yes’. CroíValve are currently developing a minimally invasive solution for a heart condition called Tricuspid Regurgitation (TR).

The Problem – what is TR and why does it happen?

A quick reminder from your school biology curriculum is required – the main job of the valves in the heart is to keep the blood flowing in the right direction.

TR occurs when the valve on the right side of your heart doesn’t seal completely. This allows blood to flow backwards from the lower right chamber into the upper right chamber of the heart. TR can cause serious issues for patients who suffer from severe TR. These patients can experience symptoms such as shortness of breath, fatigue, weakness, and abdominal swelling. These patients can also require increased hospitalisation and experience a 4-fold increase in mortality.

TR itself also poses several unique challenges to treat. These challenges centre around the fact that TR occurs in the right side of the heart, where the heart tissue is thin and frail. Difficulty in imaging this area of the heart and the proximity of the relevant area to critical structures in the heart provide further complexities to be dealt with.

The Solution

CroíValve’s innovative solution to TR centres around its DUO System. The DUO device is delivered into the right side of the heart through a minimally invasive procedure. Once inserted, the DUO plugs a hole in the valve and works alongside the native valve in the heart. The device is held in place by a novel anchoring system which also forms part of the DUO System. This anchoring system ensures the device remains stable in the heart.

CroíValve’s DUO device combines the repair and replacement models that exist in the industry to provide a novel solution to TR. Some of the notable developments include:

  • TR reduction – throughout its clinical trials to date, the DUO device has consistently reduced TR to a mild level in all cases, surpassing the efficacy of similar devices in the market.
  • Safety Adverse Events – the DUO device has experienced no safety adverse events so far in its clinical trials.
  • Device Universality – the DUO device has been used in a broad range of patients in its clinical trials to date, providing a more flexible solution to TR patients than similar devices in the market.
What got us excited:

The quality of the existing investor group attracted us to the company with CroiValve already having the support of a Boston-based VC with extensive sector experience. CroiValve’s stellar team also excited us with CEO Lucy O’Keeffe having extensive experience managing R&D programs from concept to launch in the medical device industry having previously worked for Medtronic, ICON and Nypro Healthcare. In addition, Chief Medical Officer Dr. Martin Quinn is a practicing consultant Interventional Cardiologist in St. Vincent’s University Hospital and Blackrock Clinic and first patented the CroíValve concept in 2014.

CroíValve’s DUO System provides an innovative solution to a largely unaddressed problem in a large market. The prize for solving this problem is therefore a sizeable one. This investment also provided an opportunity to back another Irish MedTech business in  a true impact investment.

What’s next for CroíValve?

CroíValve are in the ‘Feasibility’ stage of their clinical trials and are currently preparing for their first in-human trials. This will involve implanting a device in at least 10 patients and assessing the performance of the device in the patient after 30 days. Following these trials, CroíValve will seek approval for the DUO device in the US and EU markets. We have an exciting journey ahead with Lucy, Martin and the CroíValve team and look forward to working together.

‘ With Elkstone’s track record of investing in high performing technology companies, we see their strong investment as great validation of CroíValve’s solution and team.’ – Lucy O’Keefe, CroíValve CEO

If you’d like to learn more about the CroíValve team or the team here at Elkstone, feel free to get in touch at venture@nullelkstoneprivate.com. Equally, if you’re a founder with a game-changing business, we’d love to hear from you.