For patients who suffer from sleep apnea, today’s treatments are a necessary evil, admits Nimrod Lev, CEO of sleep disorder start-up SleepUp.
At present, the most common way to treat the disturbing and life threatening condition, is for patients to wear a large and uncomfortable device, which resembles an oxygen mask, as they sleep. This device, called a CPAP, pulls the lower jaw forward enabling sleepers to breathe through their mouths. The device is unpleasant to wear, however, dries the mouth, irritates the skin on the face, and is difficult to take on and off if the patient needs to get up briefly in the night.
Lev, however, believes that his Israeli SleepUp has the solution. The company has developed a family of devices for patients suffering mild, moderate and severe sleep apnea, which are smaller, lighter, and more comfortable to use than existing methods.
They also, according to Lev, cause less damaging side effects to the teeth, which are often used as an anchor for existing treatments, and to the Temporal Mandibular Joint, the hinge for the lower jaw. Finally the treatments are cheaper than traditional methods because they can be customized by the patient himself, making expensive fittings with the dentist redundant.
Sleep apnea is a condition where people repeatedly stop breathing in their sleep and the brain rouses them briefly to resume breathing. It is surprisingly common, as common in fact, as adult diabetes. In the US alone, up to 20 million Americans suffer from sleep apnea according to the National Institute of Health.
People with untreated sleep apnea can stop breathing hundreds of times a night, and often for a minute or longer at a time. Most patients with the condition suffer extreme fatigue and hypertension because they wake so many times during the night. They also suffer high blood pressure, heart attacks, and other cardiovascular problems, memory problems, weight gain, impotency, and headaches. In some cases the condition can be responsible for job impairment, and severe accidents caused by tiredness.
“People fall asleep at the wheel and wake to find themselves crashing into a tree,” the 39-year-old Lev told ISRAEL21c. Those most likely to suffer sleep apnea are men, who are obese, and over 40, though even children can suffer from the problem.
There are three types of apnea, obstructive, central and mixed. Of these, obstructive – a blockage to the airway – is the most common. In central sleep apnea, the airway is not blocked, but the brain fails to signal the muscles to breathe. Mixed apnea, is a combination of the two. The only way to diagnose the condition is at a sleep clinic, where a patient is monitored throughout the night.
SleepUp offers solutions to treat mild, moderate and severe cases of Obstructive sleep apnea. The AICOT, Airway Collapse Treatment, for mild and moderate sleep apnea, is an adjustable oral device that the patient can insert into his mouth before he goes to sleep. Lev describes the device as a bit like a pacifier. The patient inserts the device into his mouth before he goes to sleep and inflates a balloon to fit the size of his mouth. This balloon restrains the tongue, and opens up a free airway. When the user breathes, the air inhaled is filled with natural moisture, preventing dryness in the mouth and lungs, and also preventing salivation.
For more severe cases, the company offers the AICOT device connected to a small, battery-operated air compressor, the FPAP, (Free positive Air Pressure generator). The SleepUp air compressor is quieter than usual CPAP devices and lacks the cumbersome tubing that connects traditional compressors to the mains.
“It’s like comparing a cellular phone to a land-line phone,” says Lev.
SleepUp has also developed an electronic monitoring and analysis system called the STEMA -Sleep Trend Electronic Monitoring and Analysis system, which is combined with the SleepUp AICOT to monitor and collect physical data during the patient’s sleep. When the AICOT is removed from the mouth and put into the socket, the unit transmits data to a remote server, enabling a physician to analyze the data and determine the patient’s quality of sleep. Together these two devices can be used as a diagnostic device.
“The major problem with sleep apnea treatments is low compliance,” says Lev. “There’s no way that a doctor can know if a patient is or is not using a device unless the patient admits it. Many patients try the treatment and then hide it away in a cupboard. The next time someone notices there is a problem is when the patient comes to ER with a heart attack or has a car accident caused by the side effects of sleep apnea.
“We monitor the process and give feedback automatically. If a patient is not using the device then the monitoring system will immediately pick this up and send the feedback to the physician. We can also see automatically if the treatment is working, or whether it needs to be changed at all,” he adds.
SleepUp was founded by Lev, in 2002 at the Targetech Innovation Center in Netanya. Initially the company raised $400,000, from the incubator and from private investors. The company, which has already graduated from the incubator, later raised a further $100,000 from private investors.
SleepUp’s main competition today comes from traditional devices. There are about 40 different treatments out on the market today, many developed by dentists. SleepUp’s most serious rivals are Respironics, a US giant that dominates about half of the world’s market, and ResMed, an Australian company, which currently holds about 25% of the market. There are also other companies like Sunrise Medical, and Tyco.
Alternatively, surgery is sometimes used to cure sleep apnea. This, however, brings all the drawbacks of any surgical operation, and in many cases, says Lev, is not successful.
Lev insists that today there are no companies with any product remotely similar to that developed by SleepUp.
Sleep apnea is a growing market. Lev estimates that the market for sleep apnea equipment in the US is currently about $1.3 billion a year, and is growing by about 25-30% a year. “This is a very promising area,” he says. “Patients are looking for more convenient devices. They don’t like the devices now on the market, but they have no choice but to use them.”
SleepUp completed its Phase II clinicial trials at Assaf Harofe Hospital in Tel Aviv in July last year, and plans to start Phase III trials in two to three months. These will be completed in two months and Lev says he hopes the company will get FDA approval and begin market penetration by the end of this year.
The US is the largest market for sleep apnea products, and SleepUp regards it as its main market. Though sales are smaller in Europe, the company aims to begin penetrating the market at much the same time.
Lev plans to market SleepUp’s products through strategic partnerships with medical monitoring companies, manufacturers of sleep control equipment in the US, and sleep clinics. The company is already in negotiations with organizations in both the US and Europe.