For poets, the eyes are the window to the soul. For scientists, they are the window to the brain. The eye is a lens that receives light, which is then converted into electric signals that the brain processes and interprets. Many vision disorders are therefore caused by neurological disorders, not by a faulty eye. In other words, faulty neurons cause a variety of eye problems, including amblyopia (commonly known as "lazy eye").
Amblyopia most often is caused by either a misalignment of the eyes, such as crossed eyes, or a difference in image quality between the two eyes i.e. one eye focuses better than the other. As a result, the brain cannot properly integrate the two images from the eyes, causing the vision of one eye to be suppressed and eliminating the picture it delivers. Amblyopia affects spatial vision, causes headaches and can affect learning abilities and a victim's choice of profession.
Even though 5% of children suffer from amblyopia, the only treatment available for the past 200 years has been to wear an eye-patch for several months. This treatment is not only primitive, and distressful to the child, it is also inadequate. Even after this childhood treatment, 2-4% of adults still have the disorder, and must live with only one good eye. NeuroVision states that over 100,000 people in Israel have amblyopia, and more than 5 million Americans suffer from the disorder.
How does NeuroVision treat the disorder? It stimulates the visual cortex through the use of an interactive, computer-based treatment. This simple method involves the placement of a computer screen at a specific distance from the patient. A software program causes grey images to flicker on the screen. With one eye covered, the patient uses the mouse to signal each time he or she distinguishes the image, thereby improving the eye's ability to focus. Three, half-hour sessions a week over three months can bring the eye to within the normal range of vision. The company has developed a colorized computer game, intended for children, that livens up the boring exercises by giving them points for shooting down alien invaders.
The technology NeuroVision developed is based on 20 years of research by NeuroVision founder and CSO, Dr. Uri Polat, a graduate of the Weizmann Institute of Science. After conducting research with Professor Dov Sagui on the brain's processing of vision, he developed a systematic method to alleviate visual disorders. Polat investigated how neurons communicate to form an integrated image, and he developed a method to measure the connections in the brain. He realized that amblyopia was caused by distortions in neuron communications. The objective of the treatment is to revitalize these neuroconnections, and bring them back to normal, releasing them from their long-standing repression, activating them, and letting them contribute to image processing by the brain.
"Globes": Is the process irreversible?
Polat: "It's training, like riding a bicycle. The neural connections that are created remain."
NeuroVision president Dov Sella says, "The optometrist industry deals only with the lens and retina. But vision is a neurological process that's developed during childhood along with all the other senses, as the child learns to see." This period is called "plastic" and lasts up to about the age of nine. Problems become increasingly difficult to correct afterwards. NeuroVision is proud that it can apply its treatment to adults as well, something previously considered impossible. It turns out that even 40-year olds can carry out a "simulation of the plastic period", i.e. give the neurons the information they should have received 20-30 years earlier, during childhood. "We revitalize the entire process to allow people (to become) as close as possible to normal," says Sella.
Participants in clinical trials have achieved better than 6:6 (20:20) vision
NeuroVision was founded in late 1999. It has already conducted clinical trials and has received approval from the US Food and Drug Administration (FDA) to market its first application for treating adult amblyopia. Before the company was founded, Polat had personally used the technology to treat 20 patients in his lab. "All that was necessary was to convert it into a product and develop algorithms to replace some of the manual labor," he says.
The results of the clinical trials were so good that fewer than 100 trials were needed. "Participants in clinical trials have achieved better than 6:6 (20:20) vision, which is the average, not the optimal, condition," says Polat. The company has also received Helsinki Approval for clinical trials of the amblyopia treatment for children aged 6-9.
After the clinical trials for market development in the US are over, the adult amblyopia treatment will reach the commercial marketing stage, scheduled for mid-2002 in the US and earlier in Israel. The company mentions negotiations with "serious concerns", but declines to disclose names.
The plan is to storm the high-end market. Optometrists and doctors would buy a complete station from the company, including the terminal and software. The work station will not remain a shelf product. "We won't simply sell hardware and move on," says NeuroVision CEO Bernard Haffey. "We'll install the work station, and provide doctors with clinical training and support. We'll sell franchises." The trick is to adapt the computer exercises to the individual’s rate of progress. The results of each session will be sent to the company via the Internet, where algorithms developed by Polat will process them. The computer will then determine which target to attack next, and prepare for the patient's next session. A human examination of the results will be carried out every few sessions.
The cost to the company per amblyopia treatment is $40, while the cost to the end user is $2,500-3,000. "If a clinic treats 60 patients a year, they earn $100,000," calculates Haffey. "There's no alternative treatment, and under the business model, it's critical for the company to protect its high-end position, and maintain ethical treatment under FDA approval, which has a high added value that will be offered only to clinics."
NeuroVision has raised $6 million to date from Concord Ventures, Shamrock Holdings, AG Tech, and private investors in its seed and first financing round. The company is now planning its $10 million second financing round, which will include all existing shareholders. The present aim is to implement the business model, develop new applications, and build a sales and marketing system in the US. The next objective is to reach the break-even point in the first or second quarter of 2004.
Have you received offers for strategic partnerships?
Haffey: "We're not far from (receiving) offers from major companies in the industry. There are high-level talks now. We'd prefer to not carry out the marketing and distribution alone."
Pre-clinical research for the Holy Grail
The above tale is small change compared to the really serious application that is still only in the development stage. Sella says, "What we have is a platform." This technology improves neurological connections in the brain, and can be used to correct other visual disorders, such as squinting, and even nearsightedness, the commonest eye problem of all, the ophthalmologist’s Holy Grail.
A narrow, specific range of nearsightedness - 2-2.5 - can be eliminated by correcting the way information is processed by the brain, in a manner that compensates for the physical problem. This treatment is still only in the pre-clinical, research stage.
Sella aims to reach people who want to improve their normal vision, as well as sufferers of presbyopia (adult nearsightedness). "This is a huge market. The population is aging, and we'll all end up there."
Why aren't you aiming for the Holy Grail now?
Sella: "We decided to begin with treating amblyopia. We're heading for a revolution, but we wanted to begin in a field that was seen as clinical. We want to position ourselves as a high-end treatment. There are all kinds of companies that claim to improve vision by 'strengthening the eye muscles' and the like. We're not in that category."
It sounds wonderful. What can go wrong?
Haffey: "We can fail to raise more capital. We have developed the technology. That's behind us. We're very sure about our business model."
Eye glasses and contact lens manufacturers will not like you.
Sella: "You can't kill the railway with horses. We see ourselves as supplementing laser treatments. Laser treatments can be used on much more severe nearsightedness; someone with level 2 myopia will not go for laser surgery. Laser surgery promises approximately 6:12 vision, which brings patients within range. We do the fine-tuning."
"While it's true that eye glasses manufacturers will not like us, the suppliers will, because our business model benefits them. We're the back-office, and they're the infrastructure."
Published by Israel's Business Arena on 20 November 2001