Improving confidence and quality of life
Urinary incontinence affects hundreds of millions of people around the world and often goes untreated and unreported due to the embarrassment involved and the stigma felt by patients. As many as one in three women and one in 10 men suffer from leaks every day, primarily due to weakened pelvic floor muscles caused by pregnancy, menopause, high-impact exercises and pelvic or prostate surgery.
But there is a non-invasive, clinically proven technological solution for many sufferers. Innovo, from Galway company Atlantic Therapeutics, is a wearable device which provides an effective therapy to strengthen the pelvic floor.
The device, which is similar in style and feel to a pair of standard cycling shorts, works by compressing and releasing the pelvic floor 180 time during a half-hour session. This has the effect of strengthening and rebuilding the muscles, helping them retake control of bladder function over a number of weeks.
"The company was founded in 2015 when it spun out of Bio-Medical Research, the company behind Slendertone," says global product manager Danny Forde. "The technology for Innovo has been around for about 10 years but Bio-Medical Research realised it needed a standalone company with its own management structure solely focused on it to realise its potential."
The embarrassment factor is one of the main issues to be addressed, he adds. “A certain percentage of sufferers speak to a clinician but quite a few are too embarrassed. This is a major problem. Sufferers try to manage it themselves by buying pads week in, week out. There are treatments like surgery, but these can have side effects. Pelvic-floor exercises can take a long time to have any effect and many people give up.”
There are also social consequences. “When you look at a group like a Zumba class you will see a certain number of participants stepping out of some sections as they feel they may not be able for them due to incontinence problems,” says Forde. “Innovo will help them deal with those problems and give them the confidence to participate fully.”
The company raised €15 million in a series A funding round in 2017. This was used for further development work on the innovation. “We evolved the technology from a wrap-based approach to a wearable,” says Forde. “It now looks like a pair of cycling shorts which can be worn very comfortably by the user.”
A pilot study on Innovo found that after four weeks of treatment, 93 per cent of research participants found a significant improvement to the amount of involuntary urine leakage, and after 12 weeks, 86 per cent were defined as dry or almost dry.
In late 2018, Atlantic Therapeutics received de-novo approval from the US Food and Drug Administration (FDA) for the device, enabling the company to launch the device onto the US market earlier this year.
“There are two routes to access the US market,” Forde says. “You can point to a similar device and demonstrate yours is similar or, if it is considered novel, you demonstrate its safety and efficacy through randomised clinical trials to get de-novo approval. The trials, which involved 180 women, found 87 per cent were dry within four weeks and 90 per cent had achieved the FDA quality of life improvement threshold after 12 weeks.”
Building on this success, the company has just closed a €28 million series B round. “This is the largest fundraising round by any Irish company this year,” Forde notes.
"Business is very, very healthy," he says. "It's a prescription-only device in the US at the moment and our aim is to achieve over-the-counter status this year. We are also up and running in a number of European markets including the UK, France, Germany, Spain and Ireland for a number of years and we recently finalised a distribution deal in Saudi Arabia. Our primary sales channel is ecommerce. We want people to be able to purchase the product directly and avail of its benefits as quickly and easily as possible."
Further innovation is planned. "We also have a healthy product pipeline looking at all types of incontinence. We want to help people achieve better pelvic health which will help their confidence and quality of life. Our focus is on realising the product's potential in the US. After that, we will look at other markets including China and Japan. "
Applying AI to the peptide discovery process
Peptides are naturally occurring biological substances which can possess beneficial health and wellness properties. They are typically used for preventative health and therapeutic purposes. They can be incorporated into foods and personal-care products to deal with conditions such as diabetes and can be developed into drugs to treat diseases.
The difficulty has been in finding and isolating the beneficial peptides and figuring out exactly what they do. Billions of peptides exist in nature and the traditional method of finding the beneficial ones has involved a degree of guesswork coupled with an exhaustive – not to say exhausting – process of elimination through laborious testing.
This problem has been addressed by Dublin-based Nuritas, which is bringing the power of artificial intelligence (AI) to bear on it. "The company was founded in 2014 by Dr Nora Khaldi, " says chief executive Emmet Browne. "Her background was in pure mathematics and she then moved into bioinformatics. Nature provides a very deep resource of bioactive ingredients, so bountiful that it runs into billions if not trillions of options. Dr Khaldi developed a platform which utilises AI and machine learning to open new smarter, faster and more accurate pathways to discovery of these bioactive ingredients. The platform lifts the blanket on nature to identify what the peptides do."
The platform enables the reversal of the traditional discovery process which targeted the peptides to find out what they might be useful for. “The first question is what illness or disease you are looking to target,” says Browne.
“The machine is learning everything that is known about peptides and utilises that knowledge by looking at nature to find the best-matching bioactive ingredients for the target. Instead of using the traditional discovery method, Nuritas starts with the identification of a target for which a peptide may be useful. We then deploy the discovery engine to identify candidate molecules that are tested directly in our integrated wet lab in Dawson Street in Dublin. After that we move from animal and on to human testing. If successful we can license the bioactive substance to an industry partner for further preclinical testing and clinical trials.”
Each process further adds to the efficacy of the platform. “We test the results in the real world to validate the platform’s predictions. We feed back the results of those tests into the system to further improve its prediction capability. The prediction rate has improved greatly over the past five years as a result.”
Brown joined Nuritas in late 2014 when it employed just four people. “I had been working in the pharmaceutical industry for 25 years at that time but what Nuritas was doing blew my mind. The company was using 21st-century technology to solve age-old problems. The company produced its first bioactive ingredients around that time and what has happened since is that the accuracy rate has improved greatly. Very importantly, the platform is able to predict scalability as it can often be the case that a promising peptide is not scalable.”
The company has since grown to 60 staff, most of whom are based in its Dawson Street headquarters. “We have an office in the UK and recently opened one in Boston. We are now looking at opening China within the next six months.”
The company has three main lines of business, he explains. The first is to partner with industry to find peptides for targets identified by the customer. The second is to identify bioactives which can then be either licensed to an industry partner or further developed by Nuritas. The third is the development of consumer products such as ingredients for functional and health foods, again either on behalf of partners such as Nestlé and BASF or on its own account.
“We have a number of our own assets discovered by ourselves and we incubate them internally,” says Browne. “For example, we have discovered an interesting product which has shown potential for the treatment of fatty liver disease. We bring this through the pre-clinical phase and then move on to license it to a partner or do the clinical trials ourselves.”
Business is good, according to Browne. “Companies recognise that they need to innovate and to speed up the discovery process. We are not profitable yet, but we are well ahead of target and will be profitable in a short number of years. We are going to change the face of healthcare using AI. We are using it to bring better treatments to a lot of unmet medical need. We want to grow to deal with some of the big problems out there. For example, a number of years ago we discovered a peptide with potential for treating diabetes. We are now using that to help people with pre-diabetes. The peptide can help prevent the slide into diabetes. That can make a meaningful difference to people’s lives.”
A breathalyser to assess digestive health
FoodMarble has developed what can best be described as a breathalyser to assess an individual’s digestive health. The Aire – pronounced air – is a connected breath analysis device and app which measures the hydrogen content of the user’s breath to help find the foods most compatible with their specific digestive system.
The name comes from a combination of words, according to co-founder and chief technology officer Peter Harte. "We breath air, aire is the Irish for care and it is also the Japanese word for gut," he says.
The innovation has its origins back in the founders’ days as postgraduate students in UCD. “One of the founders’ partners suffered from irritable bowel syndrome,” Harte explains. “Being typical scientists we wanted to solve the problem rather than just sympathise. We looked at dietary information and food science and used our engineering and scientific backgrounds to create a hydrogen testing device. The early prototypes were made with components we got off the internet.”
The problem being addressed by the Aire is widespread. “One in eight people worldwide struggle with digestive problems,” says Harte. “It is not going to kill them, but it has a hugely negative impact on their quality of life. A lot of the therapies in use are not all that effective and there is a lot of evidence to show that dietary interventions are not working either.”
The problem is that everyone’s digestive problems tend to be unique to them.
At its simplest, the Aire device is a hydrogen breath tester but its use goes a lot further than that. “It measures hydrogen levels in the breath,” he adds. “This gives an indication of fermentation in the gut. If you struggle with digestion, it’s often due to fermentation in the gut. But foods that ferment for me might not ferment for someone else. Hydrogen breath testing gives objective data to help with digestive analysis. This was already an established science, but big, expensive machines were required to measure it up until now.”
The company began with the founders either working part-time in it or finding time to devote to it outside of their PhD studies. “In 2016 we applied for Seán O’Sullivan’s HAX Accelerator in China and were accepted on to the programme,” he says. “That come with $100,000 in investment. We went out to China and learned about design, prototyping, manufacturing, marketing and so on. That really helped us bring the company forward.”
The company then found a novel way to fund early-stage growth. “The nature of hardware is that there are a lot of up-front costs to be met in terms of design and initial manufacturing,” Harte says. “We made the device available on a pre-order basis at a reduced price. People were able to order the device and pay for it in advance knowing they wouldn’t get it for a while. By late 2018 we had received $1 million in revenue from people pre-ordering the product who were willing to wait for it to be delivered. That was an indication of just how big the problem it is that we are addressing. That gave us the revenue to further develop the product. In August 2017, we followed that up with a €1.7 million funding round from Breed Reply in London and SOSV and a few others.”
That funding supported ongoing growth. “We used it to build out the team and we now have 16 employees and are selling into over 50 countries around the world.”
"We eventually shipped all the pre-orders by the second quarter of 2018," he adds. "We launched the device in December 2018 and caught the tail end of the Christmas market; 2019 has been very good and we are on target for sales of €1 million for our first full year. We are also busy refining the product and have already begun working on products two and three. We are hoping to test for further chemicals involved in digestive health. We sell to everywhere in the EU as well as the US, Australia and New Zealand. Our main focus has been English-speaking markets and we are just in process of running a series A funding round."
With a total addressable market estimated to be worth $12.9 billion, $2 billion in the US alone, the future looks bright for FoodMarble and the Aire device.