04 March 2024

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FDA Clears AIOMEGA’s AIO Breathe for Treatment of Obstructive Sleep Apnea

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AIOMEGA, a Texas biomedical company, announced that AIO BREATHE, their medical device that treats Obstructive Sleep Apnea, has been cleared by the Food and Drug Administration.

AIO BREATHE is a “new mandibular repositioning device” designed by Tyler, Texas-based Board Certified Sleep Physician Dr. Raghavendra V. Ghuge, MD, MBA, DABSM, FAASM. Ghuge is the founder and CEO of AIOMEGA.

“I designed AIO BREATHE, supported by multiple patents, to overcome several shortcomings of conventional oral appliances used for the treatment of OSA,” said Dr. Ghuge.

AIO Breathe Summary

AIO Breathe acts by increasing the patient’s airway during sleep, improving the ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.

AIO Breathe features right and left protrusive flanges that engage with corresponding right and left vertical flanges. This engagement repositions the jaw to reflect the dentist’s prescribed anterior mandibular advancement and is maintained while the mouth is open or closed.

Additionally, mandibular plateaus guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw and work together to maintain advancement in open and closed mouth positions.

Indications for Use

AIO Breathe is intended to reduce or alleviate snoring and mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.

The unique features of this Mandibular Repositioning Device along with lightweight and small form factor provide an attractive option for those who seek treatment of OSA.

OSA, a chronic medical sleep disorder affecting about 30% of the world’s population, is associated with lifelong oxygen deprivation and snoring during sleep. This may result in many cardiovascular and neurological complications such as Hypertension, Atrial Fibrillation, stroke, congestive heart failure and metabolic complications such as obesity and Diabetes. The conventional treatment of OSA is a CPAP device although a significant number of patients refuse or fail such therapy, and many are reluctant to seek help on account of hearing negative reports about CPAP. AIOMEGA’s AIO Breathe could provide a comfortable, convenient method of treatment to people around the world.

Source: www.sleeptyler.com