SLEEP APNEA TREATMENT DEVICES

The American Academy of Sleep Medicine (AADSM) defines Obstructive sleep apnea (OSA) as: “A sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe. It occurs when the muscles relax during sleep, causing soft tissue in the back of the throat to collapse and block the upper airway.

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There are 80-84 million Sleep Apnea Sufferers in the USA, and 936 million adults worldwide, and 80% are Undiagnosed. Frost & Sullivan calculated that the annual economic burden of undiagnosed sleep apnea among U.S. adults is approximately $149.6 billion. The estimated costs include $86.9 billion in lost productivity, $26.2 billion in motor vehicle accidents, and $6.5 billion in workplace accidents.

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Untreated sleep apnea also increases the risk of costly health complications such as hypertension, heart disease, diabetes, and depression. The report estimates that undiagnosed sleep apnea also costs $30 billion annually in increased health care utilization and medication costs related to these comorbid health risks. Reference

CURRENT SOLUTIONS

• Large CPAP Machines: Continuous Positive Airway Pressure (CPAP) therapy accounts for 85% of diagnosed sleep apnea patients, yet nearly half don't comply with the therapy. CPAP devices are cumbersome, loud, uncomfortable and overall intrusive. Some patients have difficulty tolerating the forced air, can feel claustrophobic, and have a leaky mask or skin irritation.

• Oral Appliances: Oral Appliances moves the lower jaw forward to open the airway. Excessive movement can cause bite changes, TMJ pain, or pain in the jaws and teeth.

• Surgery/Implants: Surgery is invasive, non-reversible, cost-prohibitive, and can have serious complications.

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Patients need a better option

OUR SOLUTION

With over 8 years of research, we have developed a Patented first-of-its-kind oral-airflow sleep apnea treatment device called "Apnea Tek ” Nightguard. The Apnea Tek comfortably provides therapeutically controlled atmospheric airflow without requiring air pressure or significant or no repositioning of the lower jaw. This device operates without a hose, mask, or nasal pillows, which results in unobstructed, comfortable sleep. The Apnea Tek's compact, detachable control unit houses a micro-fan, sensors, and a battery. It is attached to an adjustable oral mouthpiece for minimal or no repositioning, if combination therapy is desired, and is capable of Bluetooth, Wi-Fi, or cellular connectivity.  A small-scale NSR Clinical Study (air stimulation) has been completed, and a 510(k) is pending.

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​The current Apnea Tek Device draws in room air at atmospheric pressure and has an adjustable flow rate – the air moves from the front of the mouth to the back of the throat, completely bypassing the teeth, palate, and tongue. The consistent airflow increases oxygen levels during sleep and stimulates and stabilizes the tongue and oral airway. Stimulation at the base of the tongue and pharyngeal walls helps to prevent throat tissues from collapsing during sleep.

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The Apnea Tek is a patient-specific 3D-printed device made from FDA-accepted medical-grade material. It has high tensile strength and is resistant to cracking and abrasion. It is also resistant to bruxism. The material is biocompatible and ensures the rarest levels of allergy and intolerance.​​

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Current and Future developments in our Intellectual Property Portfolio include the following concepts: 

• Air-stimulation Apnea-Tek Device (No implant) - The device has already been developed (after 76 design iterations), and a small-scale NSR clinical study has been completed (USA Granted Patent)

• US patents have been granted for, and the EU Nations Patents and Indian patents are under review (Concept Devices are available to share)

  • A Device with Electrical Neuromuscular Stimulation of the tongue - (No implant, No Surgery) - A Smart Nightguard (Only Lower Teeth Tray with sensors, electrode, and a microprocessor having Bluetooth)

  • Hybrid  Device with Air/Electric Neuromuscular stimulation (No Implant, No Surgery)

  • Nasal Apnea Tek Device

  • Patient's Sleep Position Control Apnea Tek Device

  •  “Dual Purpose Electric Stimulation Apnea Tek Device” - Sleep Apnea Treatment and Straightening of the teeth at the same time (nighttime device)