INAP

Somnics Health is a medical device company that develops and markets solutions for Obstructive Sleep Apnea (OSA). The company was founded in Taiwan in 2011 by Dr. Chung-Chu Chen, who, after struggling with OSA and unsatisfactory treatments for over 25 years, leveraged his expertise and a Stanford Biomedical fellowship to create a new therapy alternative. Somnics established its U.S. presence after receiving FDA clearance for its flagship product in May 2020.

The company's primary product is the iNAP Sleep Therapy System, a CPAP-alternative device that treats OSA for all severity levels. Unlike CPAP machines that use positive pressure to keep the airway open, the iNAP system uses intraoral negative pressure. It employs a soft oral interface, thin tubing, and a quiet, smartphone-sized, battery-powered console to create a gentle vacuum in the mouth. This suction stabilizes the tongue and soft tissues, preventing airway obstruction and allowing the user to breathe naturally through their nose during sleep. The device is designed to be comfortable, portable, and quiet, addressing common complaints associated with traditional CPAP therapy.

The iNAP system is accompanied by the iNAP Lab+ mobile app, which allows users to track their treatment data, such as seal time and usage hours. This data can be shared with healthcare providers through a secure online portal, enabling remote monitoring and personalized adjustments to the device's pressure settings for optimal efficacy. In June 2023, the FDA cleared a significant update allowing physicians to remotely adjust the device's negative pressure settings.

Somnics operates on a direct-to-consumer and business-to-business model, making the iNAP system available by prescription through partnerships with physicians, sleep centers, and durable medical equipment (DME) providers. The company offers several ways for patients to acquire the device, including outright purchase, financing options through Affirm, and a monthly subscription/membership program (iNAP Essentials) that includes the device and regular resupply of consumables. The system is currently a private-pay therapy but is eligible for HSA/FSA reimbursement.

Keywords: obstructive sleep apnea, OSA treatment, negative pressure therapy, CPAP alternative, sleep therapy system, medical device, sleep-disordered breathing, oral appliance, iNAP, Somnics Health, mask-free sleep apnea, digital health, remote patient monitoring, telemedicine, sleep medicine, portable medical device, FDA cleared, intraoral vacuum, sleep tech, tongue stabilization