A Belfast-based wireless health monitoring company is gearing up to have a tilt at the hard-to-crack US healthcare market after receiving regulatory approval for its technology.
Intelesens, a medical technology spinout company from the University of Ulster which is backed by private equity firm Enterprise Equity and other local investors, has created Aingeal, a device that enables patients to be monitored, continuously and wirelessly, from the moment they arrive in a hospital until the time they are discharged.
The firm's products have been developed over several years by local scientists Professor John Anderson (one of the men behind the first portable defibrillator) Professor Jim McLaughlin, and Professor Eric McAdams, and a team of predominantly local engineers.
After attaining CE approval certifying its products for use in Europe last year, it has now received formal confirmation that its wearable wireless hospital monitor has been awarded class 2 regulatory clearance by the Food and Drug Administration in the US.
Intelesens Chief Executive Michael Caulfield told Ulster Business the FDA approval means that Aingeal is likely to be deployed in US hospitals by early next year.
"We've been at this for a while, so it is deeply professionally satisfying to get this external endorsement from a body such as the US FDA," he said.
"We're ready to put this on to patients in Europe today but commercially we'll have it ready to put on patients in the US by early 2012."
The potential for Aingeal has not gone unnoticed across the Atlantic, where Intelesens has already been laying the groundwork with potential partners.
It has completed clinical trials at leading research hospital Mass General in Boston, and its stamp of approval should help open doors in the US in the way that successful trials at the Ulster Hospital and Tallaght Hospital in Dublin are expected to in the UK and Europe.
In addition, a group of respected technology big shots and investors recently recognised the company's commercial potential and awarded Intelesens the 'Most Promising Technology Award' in the 4th Annual Silicon Valley Technology Leaders Awards in California – further raising its profile.
With recent research predicting one in five babies born today will live to see their 100th birthdays, it is clear that providing healthcare to an aging population is going to be both a huge burden in years to come and a big business.
Caulfield says his company's low cost, portable, wearable vital signs monitoring system should appeal both to a hospital's doctors and accountants.
"If you can intervene at an early enough stage for those who are chronically ill at home, you have every good chance of preventing a serious health deterioration. Then you're in a position to prevent an expensive clinical intervention later that could result in hospitalisation," he explains.
Aingeal measures all the important vital signs, such as heart rate, respiration rate and blood pressure, but its software assesses them in combinations and beyond a simple rise and fall to detect early signs of deterioration in the patient's condition. The technology involves a re-usable monitor, which costs a few hundred pounds and a disposable part worn by the patient, which costs only a few pounds.
Caulfield says this will allow Intelesens to address the fact that 60% of people who are acutely ill in hospital but not in intensive care are currently not monitored.
"If you or one of your family are in that situation it is not a comfortable thought, that they are in there recovering from an operation or on a drug regime but not being monitored. That sadly comes down to economics. Hospital bedside monitoring today is very expensive and the economic model doesn't allow everyone to have a bedside monitor. That's where we come in," he said.
"We're using electrode technology to get really good signals out of the body. This was developed for the space missions back in the 1990s but now here we are making a £3 electrode patch you can wear for seven days and then dispose of. It looks like the most prosaic part of what we're doing but there's a huge amount of intellectual property in that," he adds.
"We've then built the embedded algorithms into that, pattern recognition software that can differentiate a good healthy heart beat from a dodgy one, and not only that, tell a GP what type of dodgy heart beat it is – for example was it an atrial fibrillation or a ventricular tachycardia. Our competitors would love to know how we've done that."
It has taken around £2m of investment to get Intelesens to its current strong position, and Caulfield is quick to praise Enterprise Equity for backing the company through three funding rounds: "A lot of commentators bemoan the lack of maturity of the local funding market but if you've got a good idea, if you've got a good management team, you can convince these guys to put the millions in."