Rhinomed's Mute approved by TGA, FDA, EMA
Melbourne’s Rhinomed (ASX:RNO) has secured regulatory approval from the TGA, the US FDA and the EMA for its snoring and sleep-quality medical device Mute.
The product has been registered with the US FDA as a medical device and received a CE Mark, while the TGA has cleared the company to begin selling the product in Australia.
“The testing process and steps we put in place for our first product - the Turbine - ensured that our second technology Mute was right from the start designed, tested and manufactured to fully comply with the most rigorous of regulatory requirements,” Rhinomed CEO Michael Johnson said.
Mute is an internal nasal dilator that increases airflow to improve sleep breathing and reduce snoring.
During a recent independent home trial in snorers and partners sharing a bed, Mute was found to reduce snoring in 75% of the 118 patients enrolled and improve sleep breathing for 78%.
Partners of the patients also reported a reduction in snoring severity (73%), volume (67%), frequency (63%) and duration (65%).
Both groups also reported improved sleep quality. The snorer group reporting good or excellent sleep quality increased from 21% before the trial to 57% with treatment. In the partner group, the improvement was even more significant, growing from 14 to 57%.
“The trial clearly and unequivocally shows that the Mute technology can improve the breathing of the snorer and that it may alleviate snoring,” Johnson said. “This is genuinely exciting news for millions of couples who are awoken each night by snoring.”
Rhinomed (ASX:RNO) shares were trading 14.29% higher at $0.032 as of around 12 pm on Wednesday.
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