Making It Work: Medical device start-up aims to carve own niche in €1bn market

Spiorad Medical claims its new device can improve outcomes for patients undergoing cardiovascular procedures

Judi O’Malley, a medical device expert who spent 11 years as a vascular physiologist with the HSE, founded Spiorad Medical in mid 2021. Picture by Fergal Phillips

An Irish medical device company is aiming to raise €2 million by the middle of this year, in a bid to bring its vascular closure products to market within three years.

Spiorad Medical, which has backing from Enterprise Ireland, has developed a device that it says can improve outcomes for patients who have catheters inserted into their femoral artery to assess or treat cardiac problems.

The company was founded in mid-2021 by Judi O’Malley, a medical device expert who spent 11 years as a vascular physiologist with the HSE, and Dr Samer Arnous, a cardiologist with particular expertise in complex coronary and structural heart interventions.

During her vascular work, O’Malley, who has studied intellectual property law as well as vascular physiology, noticed that there were often issues trying to close patients’ arteries after certain procedures.

“That gave me the idea, with Samer, to develop our own device that would give the patient better clinical outcomes, and that would also be easier for the cardiac interventionalists and vascular surgeons that use them,” she said.

The firm already has seven staff members on board and has ambitions to carve out a niche for itself in the vascular closure market, which is valued at more than €1 billion. It is planning to begin animal trials this year and conduct human trials by the end of 2023. By 2024, the company expects to employ 22 staff members.

“We would hope, all going well with the product, that we would be bringing it to market in 2025,” O’Malley, who also holds a Master’s degree in project management from University College Dublin (UCD), said.

O’Malley found time to develop a prototype of what subsequently became Spiorad Medical during the pandemic.

Patients with cardiovascular issues often undergo a procedure where a catheter is inserted into the femoral artery, the main blood vessel supplying blood to the lower body. After catheterisation, the artery has to be closed up, but O’Malley said the options available on the market come with issues.

The current offering is an intravascular device which closes the artery with a suture – a device commonly used to hold body tissues together after surgery.

“The problem with that is that it can be quite difficult to use, and it also has a high complication rate,” O’Malley said. Among those complications is the development of obstructions in the artery, which can have “devastating” results for patients.

“I really wanted to offer something that was easier to use, and that would mitigate that risk,” she said.

Spiorad’s device is extravascular, meaning it leaves nothing behind in a patient’s artery after surgery.

“Imagine something like an external plaster for the artery, on the outside,” O’Malley said. “It removes that risk of anything travelling down the artery into any of the blood vessels in the leg.”

"We aim to bring a product that is really valuable to patients and end users to market. We think it can be a big improvement on what’s available, and this is a very good market to go into,” O’Malley said.