Obstructive Sleep Apnea
People with Obstructive Sleep Apnea (OSA) suffer from recurring collapses of the upper airway during sleep, causing complete occlusion of the airway. The individual’s breathing stops for a period that can last between 10 seconds and several minutes, followed by stressful arousals during which the patient gasps for air. As a result, up to hundreds of oxygen desaturation events occur per night, leading to long-term cardiovascular and endocrine co-morbidities, such as drug-resistant hypertension, congestive heart failure, diabetes, and stroke. It is estimated that 46 million people in the US suffer from OSA, of which more than 18 million exhibit moderate to severe disease and are thus prime candidates for OSA treatment.
The gold standard, and by far the most prescribed therapy for OSA, is Continuous Positive Airway Pressure (CPAP) – a device that generates a flow of air pressure to keep the airway passages open. A standard CPAP device consists of a table-top blower unit that applies airflow through a flexible hose to a sealed face mask. CPAP side effects include a sensation of suffocation, nasal and/or oral dryness, nasal congestion, nosebleeds, and skin irritation. Once diagnosed, the patient has to continue using CPAP every night for the rest of her life; however, because of the inconvenience and side effects associated with CPAP, compliance with the therapy in the US is less than 50%.
The Market Opportunity
The OSA treatment market is an under-penetrated high-growth market valued at $4 billion globally, with anticipated substantial
growth for the foreseeable future. The major market growth drivers are incessantly rising obesity and increased adoption of home sleep testing devices. Studies suggest that about 100 million people worldwide are suspected to have obstructive sleep apnea, of which more than 80% remain undiagnosed.
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The keePAP™ is an investigational device and is limited by U.S. law to investigational use. This product is not currently available for sale or distribution and has not been approved by the U.S. FDA or by any other country’s regulatory authority.
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