Five Irish start-ups with innovative solutions
THE X-BOLT GETS PEOPLE MOBILISED QUICKER AND HOME A DAY OR TWO EARLIER WITHOUT FEAR OF THE INTERNAL CONSTRUCT FALLING APART
While using an expanding bolt to secure a plasma screen to the wall of his apartment in 2007, founder of X-Bolt Orthopaedics Dr Brian Thornes had a lightbulb moment – that this type of device would be the perfect answer for fixation in osteoporotic bone such as hip fractures.
Having previously worked as a surgeon himself, he knew such procedures were problematic and believed that patients could be treated better. So he invented the X-Bolt, which is easily expanded by the surgeon using a standard orthopaedic screwdriver and is fully reversible and removable.
“While working as a surgeon I invented Tightrope, an ankle fracture implant that has since sold more than 180,000 units worldwide. But with X-Bolt I felt I had direction in my life and wanted to set up a business,” he says.
“The biggest impact the X-Bolt can make is in hospital wards. Typically one third of orthopaedic trauma beds are taken up by hip fracture patients who tend to stay in for two or three weeks. The X-Bolt gets people mobilised quicker and home a day or two earlier without fear of the internal construct falling apart,” Brian explains.
A clinical trial of 100 patients in the UK showed a zero re-operation rate after the X-Bolt device was used, when usually a 5-10% re-operation rate would be expected.
“The recovery time is roughly the same as before however the patient has a stronger leg to stand on,” Brian continues.
“An analogy with the traditional screw-based method is that it is like ‘wearing stilettos in mud’ so you tend not to walk heavily. The X-Bolt provides a wider anchorage to put more weight through the leg.”
Now fully patented in Europe with a patent pending in the US, the X-Bolt has been used successfully in over 200 cases in the UK and Ireland with the company now employing eight people.
SurgaColl Technologies Royal College of Surgeons of Ireland (RCSI) spin-out company SurgaColl Technologies recently received CE mark approval for its bone graft substitute HydroxyColl, which was used in the past year to rebuild a thoroughbred mare’s jaw - effectively saving her life and allowing her to win races again.
HydroxyColl and SurgaColl’s other innovation, a cartilage repair scaffold called ChondroColl, are based on technologies developed by the Tissue Engineering Research Group (TERG) at the RCSI, headed by Professor Fergal O’Brien.
A mechanical engineering graduate, SurgaColl CEO John Gleeson secured a position at TERG while doing his post-doctoral research and decided to set up a spin-out company when he and Fergal identified an enduring unmet need for the products that could be commercialised from their research.
In 2012 they raised €2m in seed funding from four main investors including Enterprise Ireland and the AIB Seed Capital Fund.
John explains why HydroxyColl improves on existing surgical techniques: “When a bone is damaged the standard treatment is an autograft, which involves taking a piece of the person’s bone from somewhere else in the body and implanting it into the site of the defect.
“The need to first carry out a surgical procedure to harvest healthy bone, and a subsequent implantation of this harvested bone, creates an unnecessary risk of chronic pain and infection for the patient. Alternatively, if a surgeon decides to implant artificial repair materials instead of using an autograft, the body’s own repair process has to regenerate new tissue while also facing the challenge of healing the body using materials that are not naturally compatible.
“Orthobiologics [the technology field HydroxyColl belongs to] uses naturally derived biomaterials designed to form a scaffold to encourage regeneration supported by dissolvable healing processes – which means the healing process is much faster.”
Now based at the Invent Centre at Dublin City University, SurgaColl employs seven people and expects to double to over 15 employees in 2016. HydroxyColl EU sales started this quarter and SurgaColl expects European market approval for ChondroColl in the first half of 2016. It is also applying for US approval for both of its products.
Founders of Galway-based Embo Medical Wayne Allen, Colin Forde and Liam Mullins expect that their product innovation Caterpillar will change the whole model in terms of how blood flow in diseased blood vessels and organs (known as embolisation) is shut down during surgery.
Having worked in the med-tech industry for a combined 40 years, they left their jobs in three different medical device companies – Vysera Biomedial, Creganna-Tactx Medical and Veryan Medical, respectively – to become members of the first ever BioInnovate Ireland Fellowship in 2011.
Based on the Biodesign programme in Stanford University in the US, this ten-month specialist medical device innovation programme sponsored by Enterprise Ireland involves teams spending three months in hospitals observing surgical procedures and health care professionals in a clinical setting – an aspect which particularly appealed to Wayne.
“I would recommend anyone interested in starting a medtech company to check out the BioInnovate programme. Recruiting takes place on a yearly basis; it’s a solid framework, with great access to help you get started,” he says.
“Embolisation is used in a variety of diseases including cancer. During our three months in St James’s Hospital in Dublin we observed that the existing technology used for the procedure was not ideal and could have clinical issues and we felt there was an opportunity to improve things for both the physician and patient.”
The three partners formed the company in December 2012 with the help of grant funding from Enterprise Ireland, developed prototypes and assessed the technology on animals. Last summer they raised €3m in seed funding and are now preparing to make a submission for US Food and Drug
Administration (FDA) approval and their first in-human study.
“The objective of the Caterpillar technology is to achieve higher safety outcomes in a shorter procedure time. We found that 5-6pc of existing embolisation procedures currently have issues, which would be addressed with our technology,” says Wayne.
“The standard of care with this procedure today is to use an average of nine metallic coils per blood vessel per procedure, whereas the Caterpillar solution requires one device per treatment. This reduces the time of the procedure and is therefore more cost effective.
“In terms of safety, there are two issues with the existing standard of care – coils can move and migrate, whereas our device locks into place once it is delivered into a blood vessel. It also has features to prevent recanalisation, which is where the body tries to break down a clot formed by stopping the blood flow. This can cause problems after surgery.”
Embo Medical currently employs 12 people at its facility in NUI Galway’s Business Innovation Centre.
Established in Dublin in 2011 by Jim Roche, Incereb has come up with a device to facilitate the monitoring of babies’ brain activity that can be put on a baby’s head by anyone in a neonatal ward in a couple of minutes with no training required.
The Neon uses an array of sensors, which are attached to the scalp in a single application and connected to recording equipment to monitor the infant’s brain activity to ascertain function and identify seizures.
It is used during therapeutic brain cooling, the standard of care for babies which have experienced oxygen deprivation at birth.
With a background as a neurology technologist, Jim first recognised the need for such a product while working in Temple Street Children’s Hospital in the 1990s testing babies born with a lack of oxygen, some of which suffered brain damage as a result of not getting treatment.
“The indication is that 5 per 1,000 term babies are witnessed clinically to have experienced oxygen deprivation. But three times that number of seizures occur in the brain only with no-one to witness them. Electroencephalography [EEG] is the only way to record brain activity but it is a cumbersome test involving 20 sensors that takes around two hours to set up.”
He got in touch with Professor Ger Boylan at the Irish Centre for Fetal and Neonatal Translational Research (INFANT) in Cork whose team has been developing an algorithm which can detect adverse events in the brain and present data to doctors in useful terms.
“This technology is the best of its kind in the world. I realised the market could explode and the only other hindrance to it that existed was the fact that it takes two hours and a trained person to get the information in the first place through the EEG. I spoke with Ger who said no product existed to address this problem and I wondered could I come up with something.”
Having approached Enterprise Ireland with a loose concept, Jim went on the New Frontiers programme at Institute of Technology Tallaght and has raised €1.7m in venture capital funding to develop the product, which now has US FDA approval and should have CE certification for Europe next January.
Jim also found a mentoring programme run by Ibec group the Irish Medical Devices Association and Enterprise Ireland beneficial.
“Incereb was fortunate to have a very experienced and internationally respected mentor in John Power, founder of Aerogen. His advice to date has been critical to the success of Incereb thus far and to the securing of our first international distribution agreements,” he says.
Based in Little Island Co Cork on the site of a former Pfizer facility, Metabolomic Diagnostics is well on the way to introducing a revolutionary blood test which can predict at 15 weeks whether a woman will develop preeclampsia later on in her pregnancy.
Professor Louise Kenny of University College Cork (UCC) and Professor Phil Baker of the University of Leicester pioneered the technology behind Metabolomic Diagnostics’ solution.
With over 40 years’ combined experience in the life sciences industry, the company’s founders serial entrepreneurs Charles Garvey, Diarmuid Cahalane and Paul Hands – had been looking for a technology which could have revenue potential in terms of becoming a standard of care for a particular condition.
The pre-eclampsia screening test fitted the bill and UCC agreed to license the technology to them to develop the product and continues to collaborate with the company on it.
Experienced by about 5% of expectant mothers, preeclampsia is the co-occurrence of high blood pressure and elevated protein in the urine leading to restricted blood supply to the foetus. Global research cited by Metabolomic Diagnostics shows that it has been the most significant cause of maternal death over recent decades and is responsible for around 20% of total neonatal intensive care costs.
“There is no cure for preeclampsia apart from an emergency Caesarean section, which can create high risks for the baby in particular. At the moment there is no means of predicting preeclampsia,” explains operations manager at the company Hillary Cronin.
“Our simple blood test involves the blood being put into an instrument which indicates whether the condition is present or about to become critical. That instrument then uploads the information into an algorithm we’ve developed which can establish the chances of the woman developing it later.”
Cahalane adds: “Our low-risk preeclampsia test is now part of an EU-wide study of 5,000 women to analyse its efficacy and we expect to introduce it at the start of 2017. There is already huge interest in it from healthcare providers in the US and Europe.”
Eric Reed, non-executive director of SurgaColl Technologies, John Gleeson, CEO of SurgaColl Technologies and Dr Caroline Curtin, postdoctoral researcher with the Tissue Engineering Research Group (TERG) in RCSI
The Neon device developed by Incereb
Bill Liao, SOS Ventures, Frank Walsh, Enterprise Equity AIB Seed Capital Fund, Charles Garvey cofounder and CEO of Metabolomic Diagnostics and Diarmuid Cahalane, co-founder and regulatory affairs director, Metabolomic Diagnostics
Embo Medical co-founders Wayne Allen, Colin Forde and Liam Mullins
Dr Brian Thornes, founder of X-Bolt Orthopaedics