Apnex Medical has pulled in another $10 million from New Enterprise Associates, money it will use to advance clinical trials for its sleep apnea device and, eventually, seek FDA approval.
Apnex is in the midst of evaluating the Hypoglossal Nerve Stimulation (HGNS) system for obstructive sleep apnea, an implantable device that stimulates the muscles in the upper airway to ensure it stays open during sleep.
With this $10 million in hand, Apnex can carry out its FDA-OKed randomized clinical trial, gathering data to support a premarket approval application for the device, CEO Robert Atkinson said in a statement.
About 100 million people around the world suffer from obstructive sleep apnea, according to the World Health Organization, and Apnex says its device is more effective than CPAP machines and other treatments in providing relief. HGNS kicks in while patients are sleeping, detecting breathing rates and delivering mild stimulation to the hypoglossal nerve when the pattern is interrupted, Apnex says. The stimulation triggers the muscles in the airway to resume normal function, and the result is a restful night's sleep, according to the company.
Apnex has closed about $50 million in total since its founding in 2006, and the company will face two principle competitors once it gets HGNS to market, as MedCity News notes. Inspire Medical, a Medtronic ($MDT) spin out, has a similar neurostimulation device and snagged $14.5 million in the spring to support a planned 2013 PMA application. San Diego's ImThera Medical is in the midst of clinical study for its hypoglossal neurostimulation device, the Aura6000, which got a CE mark in March.
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