When Jim Roche attended his first workshop with Enterprise Ireland, he didn't have a fledgling business plan to bring with him. The founder of medical devices firm Incereb was a little more vague than that. "I didn't even have a drawing, I just had an idea in my head," he said.
Back in 2011, that idea was for a new device that would make performing EEG tests on newborn babies a lot easier. It would be a niche market, but an important one. Current figures estimate one in 20 babies experiences a lack of oxygen during their birth, putting them at risk of developing brain injury and seizures.
It’s an area of the medical industry in which Roche has significant experience. Not only was he a lab technician in Irish hospitals carrying out EEGs, but he later worked selling the machines to hospitals. It was there that he first realised that an alternative to the current system was needed.
The problem is that existing methods of measuring brain activity in newborns require trained staff to fit the sensors. Roche explained that it can take more than an hour to fit all the sensors needed to accurately measure brainwaves, and hospitals don’t always have the staff on hand to carry out the task.
“Babies tend not to get born Monday to Friday, nine to five,” he pointed out.
When fitted to a newborn, it’s not hard to see why the end result could be terrifying to already traumatised parents.
“The machines we were selling were very very good. We were selling a huge amount into neonatal intensive care, and most of the time you’d get feedback from the consultant – the machine is very nice, but to set up the test takes an hour, we need someone trained and we don’t have them. We’re not going to have someone at 3am on Christmas morning to set up the test,” he said. “I thought somebody should come up with a better idea to put these electrodes on – there must be an easy way of doing it.”
There have been some previous attempts to make the process easier. A cap with the sensors fitted can be fitted reasonably easily, but doesn’t allow for treatments such as brain cooling, which has recently been adopted as a standard for treating babies who have been deprived of oxygen at birth. A mesh with the wires attached may also be easy to fit, but doesn’t solve the fear factor for parents. Both still require a trained staff member to fit the sensors properly.
“They’re always adult devices that are made smaller for babies. They kind of work and they kind of don’t,” said Roche.
The answer he came up with was a product called Neon – Neonatal EEG, optimised for NIC. It cuts the time required to fit the sensors to a baby’s head down to two minutes, and it can be done by any member of the nursing staff on the ward – no neurophysiology training necessary. It’s made specifically for babies too.
There are two devices: one for smaller babies and a larger one for bigger infants that has more sensors on it. It’s single use, so it’s disposable, and comes with a universal connector so it can hook up to whatever machine the hospital uses. The sensors are prepasted with the necessary glue to attach to the baby’s head, and there’s a card mount on the device that shows where the sensors need to be place, which can be discarded.
The device could have a potential market of millions. The previously mentioned difficulties with EEGs means they aren’t used as a matter of course in neonatal intensive care units.
But figures suggest that about three newborns out of every 1,000 have clinical seizures, which are caused by abnormalities in the brain’s electrical activity. That average can be eclipsed when it comes to premature babies, those with low birthweight and those born in developing countries.
Only a fifth of seizures are witnessed on the ward. Many more go unreported, for a number of reasons.
“A lot of the time babies don’t jerk or twitch when they’re having seizures, they just go quiet. You might get a slight flickering of their eyelids,” explained Roche. “That is why EEG is so important. If you’ve got 20 of these beds on a ward, not everyone is looking at the baby all the time.”
Incereb was founded as EEG Apps in 2011, starting life in IT Tallaght’s Enterprise Ireland supported Synergy Centre. Work on the product didn’t get started until 2012. Since then, the company has had a name change to Incereb – “cereb” for brain, “in” for infant and the whole thing fits well with “inchinn”, the Irish word for brain - and got its US FDA approval.
Neon has been well received, with hands-on trials in hospitals prior to its official launch. That launch came in October, with the product now on sale in nine countries through a network of distributors, and Roche says the firm is targeting a further seven by the end of the year.
“It’s designed for use on a ward where nurses are already very busy. These are very competent people, but they’re running ventilators and respiratory devices, taking bloods, measuring carbon dioxide and the rest,” he said. “They’re not neurology trained but if they had the time they’d easily master it. If a baby is born at 1am on Christmas morning, there are going to be nurses who can put these on.”
The company has been backed by Enterprise Ireland, ACT Venture Capital and Delta Partners, receiving funding from AIB's Seed Capital fund. A number of private investors have also got involved to get the company off the ground. To date, the firm has raised €1.7 million.
Now Incereb is looking to raise €2 million-€5 million and is turning to international venture capital funds too.
It is targeting a significant market worldwide. About 800,000 babies are born every year at risk of seizures, but Roche said EEGs could – and arguably should – be used on every baby admitted to intensive care units. That would make it more like two to three million babies a year.
“The ECG electrodes that every patient has put on, whether adult or child, aren’t there to find if they have a heart abnormality. They’re a wellbeing indicator to make sure the baby is healthy. It’s the same with brain monitoring. You’re not looking to make any weird and wonderful diagnosis with this, you just want to know is this baby having seizures or not,” he said.
“The barrier to doing that is it takes an hour. Now we have an offering that takes two minutes.”
There are two or three products in the pipeline. Next on the list is a project with the Infant perinatal research centre at Cork University Maternity Hospital to develop a sensor that can be attached to a baby’s head to record activity just before the baby is born, instead of current tests that rely on heart rate or inserting electrodes into the baby’s head. It incorporates the necessary sensors, and won’t break the skin.
The Cork centre, meanwhile, is working on an algorithm to decode the information into a readable format. It’s a four-year project, with a year already behind the team.
“The neonatal intensive and maternity market is an area that is ripe for devices to be made,” said Roche.
“If you properly look at babies and mother in the delivery room, you’ll come up with a lot better devices that are easier to use and look better.”