ImThera Medical, the San Diego medical device startup developing an alternative to respirator-type treatments for sleep apnea, has disclosed what it calls “promising” results from a very small group of patients in a European study.
Even though the test involved just 10 patients, ImThera chairman and CEO Marcelo Lima anticipated the results would be a key indicator for the early stage startup when I talked to him in March. ImThera has been developing an electronic device that is surgically implanted and transmits neurostimulation to the hypoglossal nerve, which controls multiple muscles of the tongue. The steady electric current emitted by the device causes the tongue to tighten and pull back so it doesn’t block the upper airway.
The six-year-old company hopes to eventually gain approval for its technology in Europe—and ImThera is not currently targeting the U.S. market. But ImThera says more than 800,000 patients in the United States are diagnosed each year with “obstructive” sleep apnea, in which the tongue relaxes so much during sleep that it physically obstructs much of the upper airway. The condition can cause repeated interruptions of sleep, and can lead to increased blood pressure and other problems. A standard treatment nowadays is a respirator-type mask that maintains “continuous positive airway pressure” during sleep.
Some patients, though, are non-compliant because they don’t like the mask or don’t feel comfortable while they’re wearing it. ImThera is betting they’ll feel more comfortable getting a steady, low-power jolt of electricity to their tongue.
In the European clinical trials, a team led by Daniel Rodenstein of Belgium’s Université Catholique de Louvain implanted ImThera’s aura6000 device in 10 obstructive sleep apnea patients. In six of those patients, ImThera reports that neurostimulation from its device reduced their apnea hypoponea index (a measure of reduced air intake) by an average of 73 percent, and improved their oxygen desaturation index (a measure of low blood-oxygen) by 77 percent. The overall effect was that patients reduced their sleep interruptions (which the investigators termed “arousals”) by 50 percent.
Doctors implanted ImThera’s devices in four other patients in September, and the company says that data will be reported at a later date.
