Australian company Somnomed set to crack the U.S market with new FDA approval

Sydney-based sleep company Somnomed was today granted approval to market and sell their snoring and sleep apnoea product in the US.

The U.S Food and Drug Administration (FDA) has given the company approval to expand into the US market with a device that helps snorers and sleep apnoea sufferers. The company has already established itself as a future market leader in the Australian dental and sleep medicine fields.

Somnomed Ltd anticipates that the approval will not only increase the commercial interest in their product, but also create awareness of snoring and obstructive sleep apnoea among the general public.

Somnomed Chairman Mr Robert Stovold said: “This is great news for us. We have worked hard for months to get this approval and it’s a real achievement. This is the key milestone for growing the company internationally.”

Snoring is often linked to the more serious condition of obstructive sleep apnoea, a condition that can result in heart attacks and strokes because of the increase in blood pressure. People who suffer from obstructive sleep apnoea wake up many times in the night, though they are often unaware of it, meaning they are constantly tired. This can lead to accidents at work or while driving and can have a significant impact on relationships. Somnomed Ltd makes a custom-made splint, similar to a mouthguard, that the sufferer wears while sleeping. The device opens up the airway and reduces or even eliminates snoring and sleep apnoea. The Company has its state-of-the-art dental laboratory in Sydney.

http://www.somnomed.com