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 100 million Sleep Apnea Sufferers 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

• 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

With over 6 years of research, we have developed a first-of-its-kind, oral airflow sleep apnea treatment device called "Apnea Tek”. The Apnea Tek comfortably provides therapeutically-controlled atmospheric air flow, without the need for air pressure or significant 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 battery. It is attached to an adjustable oral mouthpiece for minimal repositioning, if combination therapy is desired, and capable of Bluetooth, Wi-Fi, or cellular connectivity. We are in preparation of filing with the FDA for approval in the USA. Our 510(k) status is pending. The NSR Clinical study is underway.

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​The Apnea Tek brings in room-air at atmospheric levels and has an adjustable flow rate – the air moves from the front of the mouth to rear 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 intolerances.​​

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

 

• Air-stimulation Apnea-Tek Device (No implant) - Device is already developed and clinical study underway

• Minimal electric current Stimulation of Tongue Device- (No implant, No Surgery) - "Proof of Concept" underway

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

• Nasal Apnea Tek Device - "Proof of Concept" underway

• Patient's Sleep Position Control Apnea Tek Device -"Proof of Concept" underway

• “Dual Purpose Electric Stimulation Apnea Tek Device” - No Implant, No Surgery (Sleep Apnea Treatment with Nightguard to avoid Bruxism or teeth Grinding). No External housing. It is just a mouthguard with sensors and electronics