Based in High Wycombe in the UK, Sky Medical has developed a technology – OnPulse – which can stimulate the common peroneal nerve activating the calf and foot muscle pumps to increase blood flow in patients. This can prevent and treat a wide range of acute and chronic medical conditions.
The company has manufactured wearable therapy devices in which the OnPulse technology is embedded – these include the geko and firefly that can treat vascular related conditions. These devices work by mimicking the body’s own nerve signals and induce muscle contraction by using electrical stimulation of the peroneal nerve.
The technology is very different from what has traditionally been used to stimulate muscles whereby the muscle itself has been stimulated – a technique that has often required considerable effort and often proved painful for patients.
Sky Medical’s OnPulse low frequency nerve stimulation delivers current transcutaneously via non-invasive skin surface electrodes which are placed on the peroneal nerve that can be found near to the knee.
The company’s CEO and founder is Bernard Ross, who began his career in the pharmaceutical industry working on licensing and taking early-stage ideas through to the development process.
“The genesis of OnPulse came from work that was being undertaken at a couple of London hospitals back in the 1990s by doctors who had come up with the concept of stimulating nerves to get muscles to work. Sky Medical was founded to support that research and to drive product development as well as to the evaluation and regulatory work associated with the technology which was conducted in the UK,” Ross explained.
“I came from a pharmaceutical background in which vast clinical trials are undertaken in the development of drugs and I initially thought that with medical technology it would be more straightforward. That is, it would either work or it didn’t – it would be a simple binary decision. However, I soon realised that wasn’t going to be the case. What we were proposing was a radical change in treatment and so the level of evidence needed to be a lot higher.”
Ross’s experience and track-record in raising funds made it relatively easy for Sky Medical to attract the backing of investors.
“I had a good track record that I could point to, and funding was relatively straightforward. But as you progress a business from the start-up phase to attracting venture capital that is challenging, and I think it’s more challenging today than it was when we set up the business. While Covid froze the availability of venture capital, there are now certainly signs, especially in the US, that the market is once again opening up and the flow of funding is beginning to increase.”
When it comes to new medical technology and its adoption companies need to follow a specific pathway, according to Ross. “You have to prove the technology, provide supporting data, target a patient group and engage with the specialists working in that field. We had to show that not only did the technology work but that by increasing blood flow it would benefit the patient.”
Consequently, Sky Medical focused on reducing the risks associated with blood clots or deep vein thrombosis.
“We knew that the platform technology could help many other patient groups and we could go as broad as we wanted to. We decided to focus on treating stroke victims, wound healing and sports injuries. By accelerating the blood flow, you can accelerate recovery rates.
“In sport the ability to recover after training is critical. We created the firefly device to address that demand and today our sports division has grown dramatically. In the US we’re seeing quarter on quarter growth of more than 20 per cent. The US is a massive market for sports related technology and any incremental gain in the performance of a player is attractive.
“The device is easy to use. The firefly sends a small electrical pulse to stimulate the peroneal nerve. Users will feel a slight foot ‘flutter’ but we’ve shown that it increases blood flow by as much as 400%.”
Sky Medical’s geko device has been clinically proven to increase blood flow for the promotion of wound healing and the reduction of oedema.
Around 3.8 million people in the UK alone suffer from wounds and leg ulcers are one of the most common forms of chronic wound with venous leg ulcers (VLUs) making up approximately 80% of all leg ulcer cases.
VLUs tend to be caused by issues with blood circulation and patients often suffer a lot of pain, discomfort and embarrassment.
“Wounds are a significant financial burden to the NHS and are estimated to cost £8.3 billion per year – £5.6 billion of which is spent on the management of wounds that are hard-to-heal,” said Ross.
The treatment of venous leg ulcers usually involves compression therapy. That comprises of compression bandaging which can be extremely uncomfortable and cumbersome, impacting patients’ ability to endure the treatment. It can extend from many months to many years, and can involve hospital, clinic and home visits.
“It’s labour intensive for wound care nurses and so our wearable geko device can play a significant role in not only reducing the cost of treatment but in actually healing the wound more effectively.”
A number of hospitals have trialled the geko and one, the Welsh Wound Innovation Centre (WWIC) having evaluated the therapeutic effect of the device found that all patients treated gained benefit from using it.
According to Professor Keith Harding, “Many patients saw a reduction in ulcer size after only a short period of therapy. Perhaps the most important observation was the notable improvement in patient quality of life and a reduction of pain. We had not been expecting to see such a dramatic improvement using the geko device.”
Embracing solutions that accelerate wound healing will help healthcare professionals save considerable time, money and resources – especially where home visits can be reduced and community nurse time refocused. In addition, patients can spend less time immobile, uncomfortable, and unwell and can feel more like themselves again.
Along with its focus on wound treatment the geko is also being used in the treatment of strokes. In fact, within the NHS 50 specialist stroke centres are now using the technology and the geko is now considered standard care.
“The most important aspect of the technology is its ease of use, which in turn encourages patient compliance. The technology doesn’t interfere with their daily lives unlike compression treatments which tie the patient to a bed. The geko enables greater mobility, while reducing the risk of blood clots,” said Ross. “In fact, according to some experts, the take-up of our technology could be among the fastest ever seen in the history of the NHS. Whether that’s true, or not, the take up has been staggering.”
Looking to the future
Sky Medical’s technology has been disruptive, challenging an accepted and widely used treatment in the form of compression.
“The work required to change a care pathway is significant, but we’ve succeeded in showing that our technology not only works, but that it effectively treats patients – which means that for every pound spent more value is delivered. That’s a critical metric when it comes to healthcare.
“One thing I’d advise anyone bringing a new technology to the healthcare system is to keep it simple. It can also be a real challenge to bring doctors, specialists, nurses and patients with you especially if you are looking to disrupt an existing procedure. While deploying geko did initially add costs, we were able to show that those costs were offset by much bigger savings.”
The geko and firefly are currently manufactured at a facility in South Wales.
“We want to remain a UK business, but that will be a big challenge going forward,” concedes Ross. “We’ve been approached by a large number of big players who want to help us to get to market, but we’ll resist that.”
Whatever the future holds, Sky Medical has demonstrated the impact that technology can have on the healthcare sector – saving money, delivering better treatments and providing much better quality of life for patients.