As a long-term diabetic, my father has been worried about his sight for years.
In a conversation with PolyPhotonix CEO Richard Kirk recently, I was finally able to understand why.
The Sedgefield-based company has developed a patented non-invasive treatment for diabetic retinopathy, a condition considered to be the leading cause of preventable blindness among people of working age in the Western world.
“When you turn off the lights at night, you can’t see anything. But when you go to the bathroom at 3am, you can see everything, ”Kirk tells BusinessCloud. Known as “dark adaptation”, this process takes about 40 minutes.
“You have two types of photoreceptors in your eye – the cone and the rod – which are used for your central and peripheral vision, respectively,” continues Kirk. “We use our reeds to see at night, which is evolutionary: if you need to escape a saber-toothed tiger in the dark, you need night vision!
“It’s only in the last 100 years or so that we’ve had electric light, which means we don’t have to use our poles anymore… most people don’t actually use them other than to trip over the bathroom.
“Your rods have adapted to the dark, but they need oxygen to do so. So at night, counterintuitively, your eye uses more oxygen than it does during the day. When you go to sleep, suddenly you get this huge demand for oxygen, which is your joint saying ‘get ready, we may need to run away from a predator!’ “
This is not a problem in healthy individuals, but it can cause a huge problem for elderly or diabetic people.
“As the oxygen demand doubles, the body responds by creating new vessels in the eye; if you are diabetic, these new vessels are compromised and start to leak, ”she explains. “This causes the back of the eye, the macula, to swell and thicken.
“This damages your eyesight and you start going blind.”
There are now around four million diabetics in the UK. Nine out of 10 of those with type 1 diabetes will develop diabetic retinopathy within 10 years, while two-thirds of those with type 2 diabetes will do so within the same amount of time.
The most common treatment is to laser a few square millimeters of the vessel to cauterize it, also damaging the underlying photoreceptors. Kirk says people who have undergone multiple laser treatments may begin to lose peripheral vision and then night vision. “You see more and more people in their 30s with diabetes losing their driving license, the ability to work and their sight – and all because of the treatment.”
When the patient’s central vision is affected by the disease, the common approach is to inject into the eye. “The back of the eye is actually brain tissue that has been pushed forward,” says Kirk. “The problem when trying to treat anything inside the brain is the blood barrier that surrounds it, which prevents drugs taken orally from entering. That’s why you need to inject.
“Repeatedly injecting in the eye is not a good thing.”
PolyPhotonix Noctura 400 Sleep Mask reduces and reverses the effects of diabetic retinopathy by administering phototherapy into the eye during the patient’s normal sleep hours, reducing the risk of hypoxia and retinal damage.
“We check the type of light that enters the eye with very, very precise wavelengths that only the rod sees. If the cone could see it, it would be like trying to fall asleep in full sun, ”says Kirk. “It prevents the barrel from adapting in the dark.
“Let’s break the vicious circle by tricking the brain into thinking it’s not asleep when it really is.”
PolyPhotonix raised approximately $ 25 million in total funding, including $ 14 million through the NHS and government grants. After more than a decade in the making, its mask is already in use in Europe, including the UK, France and Portugal, as the company has entered into a global strategic alliance with Prevail InfoWorks to conduct FDA-regulated human clinical trials in the United States.
You can read Kirk’s journey from celebrated artist to medical entrepreneur – and how he built this business in a less dysfunctional way until his first venture – in the following story.
Despite NHS funding and estimated cost savings in the hundreds of millions of pounds, it may take a few years before it becomes available on the health service.
“The NHS funds innovation and research, but doesn’t adopt new technologies quickly – and that’s a big deal for us because it’s our historic market,” sighs Kirk.
“It always amazes me when I talk to people with this disease, I see them make a calculation and then choose to wait a few years before our treatment becomes available on the NHS. Once your sight is gone, you can’t get it back. “
Meanwhile my father, who developed type 2 diabetes about 30 years ago, started using the mask a few days ago and says he is already quite comfortable with it.
1.7 million hours
“We have had approximately 1.7 million hours of patient use so far and have not reported a serious event,” says Kirk. “After the first two weeks, patients begin to prefer the use of the mask. They get into the routine.
“We have a patient who has been with us for about six years. After the first year, when she was about 60, she called me a little distressed to say, ‘Richard, the mask doesn’t work. My eyesight is getting worse! ‘
“We measured his eyes and the ophthalmologist said, ‘You don’t need to wear glasses anymore.’ Because she had been wearing glasses since she was 17, she was so used to waking up in the morning and putting on her glasses right away that she was still doing it!
A key function of the mask is its intelligence. “Anyone who keeps a sleep diary during a trial will tell you what they think you want to hear: that they wore the mask every night. We realized years ago that if we had a chance to do a proper test, we needed to know if they actually used it. It is very specific: we can tell when you went to the bathroom and if you slept late at night or slept.
“It means our data is really accurate; but it is also an important tool for selling the business. If you don’t use a treatment, you don’t get any benefit: if you are an insurer or someone who prescribes the mask and administers it to patients who simply don’t use it, you need to know that. “
Kirk believes that PolyPhotonix can become a future unicorn, which in turn will help more people with sight.
“We hope to be out in the next 3-5 years. This has the potential to be a billion dollar business, but it will be very difficult for PolyPhotonix to get that far.
“We are hoping to partner with a global major and deliver it worldwide. All we have to do is run a good process, get FDA approval, and we’re in a market that’s worth billions and billions.
“In most of the world, outside the Western world, if you have this disease, you go blind because you can’t afford the other treatments. The advantage of our treatment is that it is a fraction of the cost of other treatments ”.
How the light therapy sleep mask is saving the sight of diabetics
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