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FDA clears AIO BREATHE for moderate/ mild Obstructive Sleep Apnea & snoring
AIO BREATHE: A US custom-built Mandibular-Lingual Repositioning Medical Device received clearance from US FDA on 02/23/2024.
AIΩMEGA™
MISSION STATEMENT
Mission: Invention, innovation and market execution of health & fitness products aimed at fulfilling unmet needs focused on reducing costs and complications in biotechnology & healthcare.
OUR GOAL
Bring innovation and disruptive technology to the world of healthcare and fitness. AIO devices have unique patented flange technology that utilizes its CONNECTED -ARC-OF MOTION™ to create ON-DEMAND AIRFLOW™ and REVIVE AIRFLOW PROTECTION SYSTEM™ packed in a simple, small, lightweight (5 grams) device.
OUR STRATEGY
Synergistic simplification of strategic operational diversity aimed at agility and global reach to fulfill rapidly changing unmet needs in fitness and health. AI driven robotic digital workflow for AIO BREATHE™ delivers superior performance every time.
AIO BREATHE NOW AVAILABLE
February 23, 2024, Tyler, Texas, USA. Today, The United States Food and Drug Administration (US FDA) cleared AIOMEGA’s 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 plateau to treat 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.
The device is manufactured at AIOMEGA facilities here in Tyler, Texas.
The unique features of this Mandibular Repositioning Device are its light weight and small formfactor combined with the use of biomedical materials thus providing 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.
How to get an AIO BREATHE
AIO BREATHE is now available at www.thepapstore.com and www.sleeptyler.com for Obstructive Sleep Apnea and Snoring.
AIOMEGA app now displays Sleep Graph
Quality sleep is essential for physical and psychological health. It strengthens your immune system and protects against athletic injury. AIO's unique sleep tracking can help you get good sleep for a great tomorrow! Try our free download on the App Store and the Google Play Store.
AIOMEGA app NOW AVAILABLE
AIOMEGA™ app is now available on the APP store and the Google Play Store. The AIOMEGA APP is unique in its applications for body composition, nutrition, sleep, weight loss or weight gain, hydration, monitoring of your HR/BP/RR and many more parameters.
Smart Dynamic Widgets provide insight into how your body works. You can adjust every parameter and share it with your doctor or fitness coach.
Ask your doctor to contact us. We will set them up with our amazing interface that helps them give precise advice and maximize your efforts.
We can set up your fitness coach with amazing tools and help you succeed.
NOW AVAILABLE
AIΩMEGA™ product line, AIΩ™ series include AIΩ™ REVIVE™, AIΩ™ SWIFT™, AIΩ™, GRIT™, AIΩ™ BRUT™ and AIΩ™ UNIVERSE™. SWIFT™, GRIT™, and BRUT™ use patented and patent pending technology to target improvement in specific fields of sports & athletic performance (speed, stamina/endurance, strength/power & impact management), body-composition, weight management sciences and aerospace.
AIΩ™ SWIFT™ (AIΩ™ γρή™) is designed for accelerating short bursts of speed best for short distance running, cycling, swimming, high jump, long jump and other sports. It increases delivery of oxygen at a cellular level and maximizes circulatory efficiency (increases capillary flow and decreases vascular resistance) while optimizing athlete-specific target cardio-pulmonary performance.
AIΩ™ GRIT™ (AIΩ™ τρί™) is designed to suit needs of endurance sports. It conserves cardio-pulmonary reserve reducing muscle exhaustion and dehydration experienced in endurance sports such as long-distance swimming, running, cycling, Baseball, Soccer and even in sports like Golf and racing. Focused on body composition and weight management sciences, AIΩ™ GRIT™ influences molecular and sub-cellular metabolism through cardio-pulmonary coupling to accelerate capillary growth, reducing cellular injury and accelerating cellular recovery.
AIΩ™ BRUT™ (AIΩ™ ζώο™) is designed specifically for contact sports. It provides sustained cellular oxygenation at moments critical to the athlete pushing limits of athletic performance further out. It provides critical airflow and oxygenation to vital organs following impact in contact sports thus reducing the after-effects of concussion. It best serves needs of contact sport athletes in Football, Rugby, Boxing, Ice Hockey to name a few.
AIΩ™ REVIVE™ (AIΩ™ συν™) is a fully customized oral device to be used over teeth. Individually crafted from specific digital or physical dental impressions, it uses FDA ISO 10993 rated bio-compatible material that is safe for perpetual use inside the oral cavity.
REVIVE reduces sleep disruptions. Sleep better, wake up feeling better. REVIVE facilitates easy airflow and breathing and uses patented and patent pending designs and predictive algorithms embedded in AIOMEGA™ BSGT™ (Better Sleep Greater Tomorrow) program. The improvement can be tracked on any wearable biometric devices that offer sleep biometrics.
Is your Oura Ring or Fitbit or Apple Watch picking up unusually disrupted sleep and heart rate variability? Do you wake up feeling tired? AIΩ REVIVE is your refreshing solution delivering a unique custom-built oral appliance just for you. Measurable results through your Fitbit/Apple Watch/Oura Ring or any other non-medical biometric tracking device.
AIΩ REVIVE consists of two easy to wear dental coverings that look and fit like retainers over your upper (mandibular) and lower (maxillary) teeth. It has unique intrusion-free non-restrictive flange technology that makes breathing effortless.
AIΩ™ UNIVERSE™ (AIΩ™ σύμ™) combines properties of REVIVE™ with one of the active lifestyle fitness or athletic products (SWIFT™, GRIT™ or BRUT™) into a unique 2-in-1 design. AIΩ™ UNIVERSE™ is an amazing single device that delivers the enhanced athletic performance you desire with the refreshing sleep you dream about.
Some professional athletic needs demand perfection and require rigorous standards in the device made for performance improvements. Such devices are built individually for professional or athletic needs at the highest levels of competition. Such athletes would need a separate REVIVE™ for refreshing sleep. AIΩ™ is designed for protection from impact in contact sports and protection from immediate subsequent brain hypoxia. It absorbs G forces and maintains critical flow of oxygen to vital organs while conserving cardio-pulmonary reserve. This combination reduces tissue hypoxia, lactic acidosis and cellular injury. Benefits include immediate protection from devastating effects of concussion and long-term protection from consequent TBI (Traumatic Brain Injury), CTE (Chronic Traumatic Encephalopathy) and hypoxic brain and heart damage. AIΩ™ custom complimentary predictive algorithms target up to 27 different biometric parameters. Customize unique targets for individual athletic, fitness, weight loss and sleep needs.
AI driven Robotic LANETEA (Laser Assisted Nanotech Endovascular Trans-Endothelial Atherolysis) Soon to come. AIOMEGA brings an array of designs of balloon catheters, nanotechnology catheters and Laser catheters. We bring innovation of technology and process to restore a narrow artery's lumen to normal through a fusion of human skill, robotics and machine learning. LANETEA promises to be the first of its kind to fully remove lipids from sub-endothelial plaque in an artery using 'Microvascular Atherolysis' without fear of plaque-rupture, acute thrombosis, widespread damage to endothelium or vascular recoil. Preventing vascular recoil eliminates need for stents. Stent-related complications include re-endothelization, neo-intimal hyperplasia, early and late stenosis or arterial thrombosis. LANETEA restores normal elasticity of arteries, eliminating stent-related arterial wall stiffness or lumen cross-sectional limitation. Recipients are likely to experience greater improvement in physical performance.
We embody innovations in Science and Technology. We tailor uniquely customized Advanced Wearable Biometrics, therapeutics and continuous AI and robotically adaptable physiologic monitoring and intervention systems. We provide Performance Athlete Protection and Hypoxic Damage Prevention and anti-concussion strategy. We customize AI driven robotics & 3-D 5G enhanced Neural and Cardiac Injury Prevention and Restoration algorithms and intervention. We specialize in AI-Enhanced Blockchain Technology based secure remote wireless wake & sleep physiology management strategies. Applications include high performance sports, early fatigue and performance degradation detection, early warning and injury prevention in space, aviation, defense and healthcare. Robotic AI driven restoration of cardiac and neurological functions and pre-emptive drug delivery system powered by Blockchain.
We provide integrated customized solutions to restore health, enhance athletic performance and maximize opportunities through innovation to make the Universe a better place for you.
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