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. The excessive movement can cause bite changes, TMJ pain, or pain in the jaws and teeth.

• Surgery/Implants: Surgery can have complications and is cost-prohibitive.

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Patients need a better option

Over 6 years of research, we have developed first-of-its-kind miniature sleep apnea treatment device called  CPAF® (Controlled Positive Air Flow) having No air pressure. This device operates without a hose, mask, or nasal pillow, which results in comfortable sleep. CPAF®’s detachable miniature unit houses sensors, a micro-fan, and electronics, and is attached to the mouthpiece and capable of Bluetooth, Wi-Fi, or cellular connectivity. We are in preparation of filing with the FDA for approval in USA. The Clinical trial is underway.

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​The device brings air in at atmospheric pressure with the desired controlled flow rate – the air moves from the front of the mouth to rear of the throat, completely bypassing the tongue. It stabilizes the lower jaw and tongue, keeping airways open and free from obstruction during sleep. The device has capability of air stimulation of tongue and soft tissues which may not allow soft tissues to relax, keeping air passageway in throat area open during the sleep.

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The customized 3D-printed device is made from FDA-approved medical grade material. It has high tensile strength and resistance 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 CPAF® (No implant) 

• Minimal electric current Stimulation of Tongue - CPAF® (No implant)

• Hybrid Air/Electric simulation Device (No Implant)

• Patient's Sleep Position Control CPAF® Device

• Nasal CPAF®  Device

• “Dual Purpose” (Sleep Apnea Treatment with directly 3D printed Aligner to straighten the teeth)