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Carmel Valley Startup Unveiling Device to Treat Sleep Apnea

Keeping on top of the nighttime routine can prove daunting for the millions of people who wear pressurized air masks to manage obstructive sleep apnea, which causes the upper airways to collapse, often repeatedly, during sleep.

Major device makers such as San Diego’s ResMed have been attacking the issue through design improvements and monitoring techniques, but compliance remains one of the biggest challenges in treating the condition, which is estimated to affect more than 12 million Americans.

ImThera Medical, which has five full-time employees, has raised nearly $5 million from private investors to come up with an alternative to continuous positive airway pressure, or CPAP, masks. Last week, the privately held Carmel Valley-based startup announced it received European regulatory clearance to begin testing a new device in a Belgium study of 12 patients early next year.

The device, which it plans to exhibit Oct. 5 at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery at the San Diego Convention Center, could one day be offered as an alternative to traditional treatments or major surgeries.

For ImThera CEO Marcelo Lima, whose brother-in-law suffers from sleep apnea, the cause is both personal and professional.

“I looked at the markets and saw there’s a real problem there,” Lima said. “It’s estimated there’s 1.5 million CPAP patients in North America and, I think, 10 times that in the world that do not comply with the therapy.”

The size of the U.S. market for sleep breathing equipment is $2 billion.


Surgical Implants

ImThera’s sleep therapy system, known as aura6000, was developed as a surgical option for patients who have tried CPAP without success. Rather than forcing air down a patient’s throat through a mask, the ImThera system relies on implantable electrodes that deliver a charge to muscles of the tongue to prevent it from collapsing into the upper airway. Patients turn the rechargeable device on or off.

The technique, known as hypoglossal neurostimulation, requires patients to undergo surgery to implant the device, something analysts see as a potential deterrent for some patients.

Edward Grandi, executive director of the Washington, D.C.-based American Sleep Apnea Association, cautions that the treatment isn’t a “silver bullet” for all sufferers.

“Obstructive sleep apnea is a condition that affects all ages, all genders, all body types,” he said. “I think it’s appropriate for there to be alternate treatment modalities to be able to address the condition.”

Sleep apnea is a major concern among medical researchers who suspect that the condition plays a bigger role in chronic disease. In 2003, the National Institutes of Health pinpointed sleep apnea as a major cause of hypertension, which affects one in four American adults.

More recent studies by researchers at the Yale School of Medicine have shown that people with sleep apnea are three times more likely to suffer a stroke or die compared with people in a similar state of health without the condition.

A small study published by Johns Hopkins University researchers in 1997 suggested that neurostimulation can have positive benefits in managing obstructive sleep apnea. Efforts to fine-tune the work simmered after one of its lead researchers died.

“The idea was there, but nobody had gone any further than the Johns Hopkins work,” said Dr. Terence Davidson, ImThera’s chief medical officer and a head and neck surgery professor at UC San Diego.


Growing Industry

Since then, Davidson says knowledge surrounding sleep apnea has advanced. Interest in developing alternative treatments has fueled at least two other startups in the industry, including Medtronic-backed Inspire Medical Systems and Apnex Medical, both of St. Paul, Minn.

ImThera is aiming its device at moderate to severe obstructive sleep apnea patients, a market Lima estimates could attract 500,000 people in Europe alone. Unlike its competitors, the device employs an open-looped system, which Lima says requires a simpler surgery than closed-loop devices, which employ sensors to monitor breathing.

Preliminary results of its Belgium-based trial are expected in the first half of next year. If the study goes as planned, Lima says the device could apply for European regulatory approval next year.

“The concept is 100 percent correct,” Davidson said. “It is the tongue that falls back at night. Awake people don’t snore and they seem to be able to breathe just fine.”

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