Every year over 11 million people worldwide are treated for venous leg ulcers. From the patient’s perspective they are distressing to live with and slow to heal.
From a medical economics perspective the cost of treating the condition runs into billions and from a clinical perspective little about the go-to treatment of compression bandaging has changed much in centuries, according to Dr Andrew Cameron, co-founder of FeelTect whose disruptive Tight Alright technology can speed healing and significantly cut the number of treatment interventions required.
"Most current treatments for venous leg ulcers (VLUs) centre on compression therapy, which uses bandages to apply pressure to overcome venous insufficiency. If it's applied too loosely it is ineffective. If it's applied too tightly it is dangerous and clinical practitioners face a difficulty in verifying how much pressure is really being applied. Roughly 30 per cent of ulcers are still not healed after a year of treatment," Cameron says.
“With Tight Alright there is a five-week reduction in healing times, a 30 per cent reduction in treatment costs and a 34 per cent reduction in patient visits, which is really important in minimising the exposure of older and vulnerable people to healthcare settings, especially in situations such as Covid-19.”
Compression therapy may be an old treatment but it’s a good one if it’s done correctly. As of now however, its effectiveness can be undermined by the human factor. In a nutshell, some clinical practitioners are more skilled at applying the “right” pressure than others and there is also a wide variation in patients’ perception of discomfort and what constitutes a bandage that is “too tight”.
With FeelTect’s Tight Alright pressure sensing technology these human variables are removed and replaced with a sensor arm that slides down the inside of the bandage. It is then wirelessly connected to a mobile app and digital platform that measures and monitors bandage pressure. This monitoring can be carried out remotely if required.
“Known levels of safe and effective pressure are only applied 10 per cent of the time and that pressure can be rapidly lost for many reasons,” Cameron says. “Even if the compression is applied correctly these are chronic wounds and they are often treated in multiple care settings. You can lose up to 50 per cent of pressure in the first 72 hours because of a reduction in swelling, for example.
“With conventional bandaging there’s no feedback from the product and no objective way to measure the pressure,” he adds. “With Tight Alright patients can physically see the pressure level – as in they can see a number on a screen – so they know what it’s at. This can help with compliance and also to encourage patients to aim for a higher pressure to speed up the healing. As of now the level of pressure applied is largely a negotiation between the patient and the healthcare professional and it is tricky for the person applying the compression to know when to insist on more pressure and when to back off.”
FeelTect is a spinout from NUI Galway and its co-founders, Dr Andrew Cameron and Dr Darren Burke, are alumni of the university's BioInnovate programme, which is focused on finding solutions for unmet clinical needs. Cameron came to Ireland from Australia in 2012 to work as a commercialisation lead and research fellow at the Royal College of Surgeons in Ireland.
He is a chemical and biological engineer by training with a doctorate in tissue engineering. Dr Darren Burke comes from a quality, R&D and data science background and has a PhD in regenerative medicine. He has also worked in industry with companies such as Boston Scientific and Merit Medical.
The initial two-year development phase of the technology was supported with €460,000 in commercialisation funding from Enterprise Ireland and since the spin-out last May a further €200,000 has gone into the company from various sources including founder equity, backing from the NDRC and support from the EU's EIT health innovation programme. FeelTect is now in the process of raising a seed round of €500,000 that Cameron is hoping will be matched by funding from State agencies.
Cameron says the estimated addressable market for Tight Alright's point of care technology is around €1.35 billion in Europe and the US alone. In addition valuable new markets are opening up in Asia, he says, and there are also other potential applications for the technology where compression therapy is used.
As Tight Alright is a medical device it has to meet (different) regulatory requirements in the US and Europe but Cameron expects this process to be complete by the third quarter of 2021 at which point the device will have a soft commercial launch with selected pilot customers.
FeelTect will licence the IP on the product from NUIG and the target market for Tight Alright is public and private healthcare providers, especially integrated facilities that are both the care provider and bill payer. The US, Germany and The Netherlands will be the first markets to be tackled.
Validation of the technology is already underway through collaborations with St James's Hospital Dublin, University Hospital Galway and Galway Community West and Cameron says negotiations with potential manufacturers have begun. "One of the big advantages of starting a business like this in Ireland is access to world class medical device manufacturers on our doorstep," he says.
“The 2021 launch will comprise the wearable device and mobile app and we’ll use the insights from this market release to finalise the development of the digital platform with the intention of launching the full product suite at the beginning of 2023,” he adds. “We’re already engaged with a number of interested strategic partners who see the benefits of the Tight Alright technology in complementing their existing or pipeline products and in return these potential partners represent valuable channels to market for us.”
Cameron points out that VLUs are typically associated with factors such as age, obesity and other co-morbidities predominantly affecting the population currently at highest risk from Covid-19. This means any decision to continue with normal treatment involving weekly visits to healthcare facilities would now carry a significant risk. “Early research shows a 40 per cent decrease in wound centre attendance following mandated lockdowns in the USA and untreated wound patients are 20-times more likely to require hospitalisation due to complications such as sepsis,” he says.
“Major health crises such as Covid require new treatment approaches that will protect patients while still delivering essential care. Our technology, with its remote monitoring capabilities, has a role to play in meeting the changing market by empowering patients to self-manage their treatment and in the case of VLUs to safely and effectively apply their own compression therapy.”