AIOMEGA AIO BREATHE FDA CLEARANCE FOR OSA AND SNORING
February 23, 2024, Tyler, Texas, USA. Today, The United States Food and Drug Administration (US FDA) cleared a new medical device, AIO BREATHE, for treatment of Obstructive Sleep Apnea. AIOMEGA, LLC is a Tyler, Texas, based Biotechnology Startup.
AIO BREATHE is a “new mandibular repositioning device” that uniquely combines flanges and plateaus that interact while in use to provide On-Demand-Airflow effectively treating Obstructive Sleep Apnea.
Dr. Raghavendra Ghuge, MD, DABSM, FAASM, MBA who is the founder of AIOMEGA, is a Board-Certified physician and is President and CEO of Sleep Medicine Institute of Texas, a Tyler Texas based Adult and Pediatric Sleep Disorders Center founded in 2011. He is a Diplomate of the American Academy of Sleep Medicine since 2005 and a Fellow of the AASM. With two decades of experience as an adult and pediatric sleep physician, Dr. Ghuge designed the unique characteristics of AIO BREATHE using six patents granted to him by the US Patent Office. The design overcomes several shortcomings seen with the use of legacy devices.
AIO Breathe Summary
Device Description: AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the teeth during sleep to reduce snoring and alleviate signs of Obstructive Sleep Apnea. The device is manufactured at AIOMEGA facilities from intraoral scans using additive manufacturing with FDA cleared SLA 3D printing technology from FDA approved biocompatible resins. 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 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. These design features create room and traction for the tongue to migrate forward and increase the
patient’s pharyngeal space, improving ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.
Operating Principle
AIO Breathe is a traction-based mandibular repositioning device that permits anterior, vertical, and lateral jaw movements and is designed to maintain an open airway intended to increase air exchange:
• by anterior advancement of the tongue.
• throughout opening and closing movements of the mouth.
• throughout lateral movements of the mandible.
Indications for Use
AIO Breathe is intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
General Information:
The unique features of this Mandibular Repositioning Device along with light weight and small formfactor combined with the use of biomedical materials provides an attractive option for those who seek treatment of OSA. OSA is a chronic medical sleep disorder which is associated with lifelong oxygen deprivation and snoring during sleep resulting in many cardiovascular and neurological complications such as Hypertension, Atrial Fibrillation, stroke, congestive heart failure and metabolic complications such as obesity and Diabetes. It is considered a silent killer by many experts in the field. The conventional treatment of OSA is a CPAP device although a significant number refuse 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.