Sleep apnea, a condition that causes a person to stop breathing while they are sleeping, affects more than 12 million Americans, according go the National Institutes of Health. That makes it as common as adult diabetes. The majority of sleep apnea is obstructive, meaning it is caused by a blocked airway—blocked by the tongue or by soft tissue in the rear of the throat that collapses and closes during sleep.

ImThera CEO Marcelo Lima.

^{Courtesy photo}

According to the American Sleep Apnea Association, those affected stop breathing repeatedly during the night, sometimes hundreds of times and often for longer than a minute. Scary stuff, and up until now, the standard treatment for severe apnea has been a bulky, noisy device. Continuous positive airway pressure or CPAP is by far the most effective method of treatment right now. It is a machine about the size of a shoebox with a flexible tube that connects to a mask worn over the mouth and/or nose. The biggest problem with the CPAP is compliance—it’s a big mask with tubes and noisy respirators, which can, ironically, make it hard to sleep.

Enter ImThera Medical, an early stage Carmel Valley medical device company with a treatment for obstructive sleep apnea that involves neurostimulation: stimulating the motor nerve that controls the muscles of the tongue. The treatment is called Targeted Hypoglossal Neurostimulation or THN Sleep Therapy. It uses a very small electrode implanted under the skin, near the lower jaw and attached to the nerve. That is connected to a pulse generator—measuring 11.5 cubic centimeters—implanted in the patient’s chest, over the pectoral muscle.

“It’s very thin and small, so the patient can touch it but it’s not noticeable to the eye,” says ImThera’s CEO Marcelo Lima.

Neurostimulation is used to treat a variety of medical conditions that involve motor or sensory nerves. ImThera’s device targets specific muscles in the tongue because not every tongue muscle is involved in opening the airway. Lima says once the nerve is stimulated, the back of the tongue flattens, the sides stiffen and the tip moves forward, which keeps the tongue from blocking the airway. A patient turns the device on by remote control before going to sleep.

Unlike the CPAP, this device “can be used everywhere—on an airplane, while taking a nap on the beach,” says Lima.

The sticking point in all of this is getting insurance to cover the device, especially when the CPAP is already covered. But Lima says the problem is patients that don’t use the CPAP even though they have it.

“Right now, insurance tends to reimburse for the CPAP, and for the next ten years, it will continue to be less expensive than our device,” he says.

That is likely to change, when the cost of ImThera’s THN comes down. For the immediate future though, THN is aimed squarely at the non-compliant patient.

“If you don’t wear the CPAP, you can have some very serious health consequences—like heart failure, stroke, type II diabetes, hypertension, even decreased libido,” says Lima.

THN is currently being tested in a pilot study in Europe, largely because it’s less expensive to do it there, says Lima. Ultimately, 12 patients will be involved. Lima says the company wants to collect that human data before starting the approvals process with the FDA here in the U.S.

Patients in the European study will be followed for a total of two years, but once six months of data is collected and published, ImThera will apply for a CE Marking—essentially, the device approval in Europe. Lima says that will give the company rights to commercialize in Europe. They also hope to begin clinical trials in the U.S. in December of 2010 or January 2011.