Retinal implant company Bionic Vision Technologies (BVT) has raised $18m to develop and commercialise its ‘bionic eye’. BVT will use the new funds to begin a human clinical trial of its ‘bionic eye’ implant in patients with retinitis pigmentosa. We find out more about the company’s retinal devices and its plans to bring them to global markets.
In April, the Australian medical device company Bionic Vision Technologies (BVT) announced an important milestone: it had raised US$18 million to develop and commercialise its ‘bionic eye’. This device could hold potential for the thousands of people worldwide with retinitis pigmentosa, in short restoring sight to the blind.
The device was first conceived in 2010, when Bionic Vision Australia (BVA), a consortium of five leading universities and research institutes, received a A$50million grant from the Australian Research Council. The hope was that BVA might be able to do for retinal implants what Cochlear Limited (another Australian medical device company) had done for hearing aids.
Over the course of the next six years, BVA designed an early prototype and tested the device in its Melbourne laboratory. Although the implant was not yet commercial, the consortium was careful to capture the intellectual property that resulted. BVT was duly established to hold the rights to the technology.
“Throughout the course of our research programme, we had a successful clinical trial of our first prototype device,” says Julie Anne Quinn, CEO of BVT. “We were able to successfully prove that the approach we took could elicit a sense of vision in three patients who had blindness due to retinitis pigmentosa. So armed with that data we developed our next device. But commercial funding was necessary in order to take this device to a clinical trial.”
After pursuing a number of potential investors, the company eventually struck gold in the form of Hong Kong-based China Huarong International Holdings Ltd and State Path Capital Limited. Alastair Lam, chairman of State Path Capital Limited, has stated the technology has the potential to transform the lives of millions of people and meet a large unmet need.
Tackling retinitis pigmentosa
At present, patients with retinitis pigmentosa have no treatment options. One of the leading causes of inherited blindness, the condition is characterised by the progressive loss of photoreceptor cells and peripheral vision, and affects around 1.5 million people worldwide.
“The incidence of this condition varies depending on where you live in the world, with the highest rates in India and China,” says Quinn. “Generally, people with this condition start having poor eyesight in their teens and into early adulthood, and progressively their vision deteriorates. Usually by their 30s, or even earlier in some cases, they may not be able to see anything at all.”
BVT hopes its bionic eye will be able to reverse this trajectory, allowing sufferers to navigate their environments without reliance on a guide dog or cane.
“We believe our device in the first stage will help them become more independent, and certainly that’s what our prototype studies showed,” says Quinn. “They won’t see vision perfectly, but there’ll be shapes and outlines and contrasts and dark and light, and ultimately we hope they can read large print. Hopefully one day technology will give them the ability to see faces, but that’s a way off yet.”
How it works
BVT’s devices work via a complex technology, with several steps involved.
“The patient wears a pair of glasses with a camera attached, and that camera then signals through to a processing unit about the size of a cellphone, which the patient wears externally,” says Quinn. “The message is then transmitted through a wire up to a stimulator that is implanted just above the ear, which in turn gives a message through to an implant that is planted just behind the eye.”
The implant in question contains electrodes, which pulse once the message arrives. This stimulates the remaining retinal nerve cells to communicate with the visual cortex. Over time, the patient learns to interpret the corresponding visual patterns, enabling them to ‘see’ what’s in front of them. This outcome is only possibly thanks to the immense plasticity of the brain.
Although this is not, in itself, a novel technique – all bionic eyes function similarly – BVT believes its technology is both safer and more effective than what has come before. According to Quinn, the product has two clear advantages over its competitors.
“One is the fact we use a much safer and more straightforward surgical procedure,” she says. “Other companies tack their device on top of the retina, meaning there’s the potential for air interference, and it’s hard to remove the device without causing damage to the eye. Because ours is placed behind the eye, in the suprachoroidal space, we believe surgeons will like the procedure a lot more.”
When BVT tested its prototype device, there were no reports of serious adverse events. If this holds true of its current device, it will represent a clear upgrade from other bionic eyes on the market, for which the surgery has caused risky increases in intraocular pressure and a high rate of infection.
“Another advantage is in our vision processing software,” says Quinn. “Having had the benefit of a government research grant, we have put a lot of effort into developing computer vision algorithms which we believe will be far superior.”
What comes next
At present, BVT is negotiating with its research partners to commence its next clinical trial. Like the proof of concept study, the trial will recruit a handful of patients and monitor them for up to two years. However, while the proof to concept study only monitored patients in the clinic, this time round they will be able to use the device in a real-world setting, with a view to assessing their mobility and independence.
“Over the coming months, the patients will be implanted with their device here in Melbourne, and then once they’ve recovered from the surgery they’ll come back into the laboratory,” says Quinn. “At this stage, we have to tailor the signals for every patient and train them in how to use the system, and then they’ll be able to use the device at home. They will continue to come into the laboratory periodically just so we can check their eye health and make any tweaks that are needed.”
BVT will also continue to work on its broader technology pipeline, which revolves around novel approaches to electrode arrangement and stimulation. The data that comes out of the clinical trial will help inform the product development.
The next step will be to set up larger scale manufacturing, as well as seeking a larger cohort of patients for the next round of testing. This will most likely be conducted outside Australia. Should everything go according to plan, BVT will then seek regulatory approval across key markets, paving the way for a commercial launch.
“Obviously we’ll start in Australia but we really need to get international regulatory approval,” says Quinn. “We would like to get the CE mark approval initially, which would mean we could sell into Europe and would enable us to move pretty swiftly through the regulatory bodies in Asian countries.”
She adds that, because the investment has come from Hong Kong, the investors are particularly interested in the health of the Chinese population, making China an obvious market to head into. Broadly, though, the company is hoping to bring the device to the communities that need it most.
“The device could hit these markets within the next three years,” says Quinn. “But let’s see how it goes.”
This article appears in the July 2017 edition of Medical Technology