BALA CYNWYD, Pa., March 10, 2015 /PRNewswire/ -- Sleep Specialists, LLC, a medical device company specializing in sleep therapy, announced today that the Therapeutic Goods Administration (TGA) in Australia has approved the Zzoma® sleep apnea device for listing on the Australian Register of Therapeutic Goods (ARTG). This regulatory approval will allow the device to be sold in Australia.
"Various resources estimate that approximately one million Australians are affected by sleep apnea," says Sila Yesilsoy, COO of Sleep Specialists, LLC. "Our research and collaboration with healthcare professionals in the country shows that positional obstructive sleep apnea is prevalent among these individuals, and that many additional cases may be undiagnosed. We are excited to reach this regulatory milestone as it will enable thousands of Australians to benefit from using our Zzoma device."
Positional Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for short periods of time while asleep in a supine or "on-the-back" position due to the narrowing or collapsing of the upper airway during sleep. Zzoma is a medical device worn around the upper torso that keeps patients asleep on their sides by preventing supine sleeping.
Clinicians may recommend Zzoma as a first line therapy or as an alternative for patients who cannot tolerate oral appliances or Continuous Positive Airway Pressure (CPAP) therapy. A study in the Journal of Clinical Sleep Medicine found that Zzoma was equivalent to CPAP therapy in treating patients with positional OSA.
About Sleep Specialists, LLC
Sleep Specialists, LLC (www.ZzomaOsa.com) is a medical device company that specializes in sleep therapy. Our team of board-certified physicians designed the Zzoma®, an FDA-cleared Class II (prescription only) medical device for the treatment of sleep apnea. The company is headquartered in Bala Cynwyd, Pennsylvania, and works with various distributors.
SOURCE Sleep Specialists, LLC