ImThera Medical Inc. said its tongue stimulation device for sleep apnea can improve patients’ snooze time.
The San Diego-based device maker concluded a European pilot study of its aura6000, an implanted neurostimulation device for treating obstructive sleep apnea (OSA) that delivers electrical pulses to the tongue during sleep.
The therapy uses a multi-contact electrode and programmable pulse generator, and provides treatment by producing muscle tone in certain tongue muscles to help control upper airway flow and reduce or eliminate sleep apnea, according to the company’s website.
The trial took patients who had varying levels of failure undergoing continuous positive airway pressure (CPAP) therapy for their OSA and gave them daily treatments with the aura6000. The company estimates that 38 million Americans have OSA and only 20 percent receive treatment for the condition, which involves pauses in breathing during sleep because of a narrowed or closed airway.
"We are very happy with the results of our pilot study showing significant improvements of OSA patients when using our aura6000 system. Especially with the very positive comments received from our patients," ImThera CEO Marcelo Lima said in prepared remarks.
The company is preparing for an investigational device exemption (IDE) application with the FDA as well as U.S. clinical trials, he said.
ImThera recently raised $1.8 million in a Series B funding round, according to a regulatory filing.
The company is planning to present the results from the study at the American Thoracic Society conference in Denver on May 16.
Here’s a roundup of recent clinical trial and scientific study news:
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