ProSomnus Sleep Technologies has obtained a $38m in funding to advance the global expansion of its oral appliance therapy (OAT) devices for obstructive sleep apnoea (OSA).

ProSomnus also intends to use the investment by Catalio Capital Management to initiate further comparative clinical studies for its devices and scale its infrastructure.

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The California-based company’s OAT devices include its EVO range. The mouthguard-like devices for OSA treatment are worn by users while they sleep to hold the lower jaw forward to alleviate OSA symptoms.

OSA causes the airways to narrow or close during sleep, resulting in short periods of not breathing (apnoeas). A common condition, approximately 30 million individuals in the US are living with OSA, as per the American Lung Association (ALA).

In the FLOSAT study (NCT05393531), conducted at Belgium’s University Hospital, Antwerp, EVO was non-inferior to continuous positive airway pressure (CPAP) therapy – the gold standard treatment for the condition. In 136 OSA patients, oral appliance therapy (OAT) was found to be effective among 90% of moderate and 85% of severe OSA patients, with 98% continuing therapy at three months versus 22% discontinuing CPAP therapy over the same time period.

CPAP therapy is typically the first-line treatment for moderate- to severe OSA. It is a machine or mask that is worn over the mouth to deliver a steady stream of pressurised air to keep the airways open during sleep.

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Another of ProSomnus’s devices is ProSomnus HWO2. Worn like a retainer during sleep, the OAT device addresses OSA in a similar way to the company’s EVO device, but also includes an intraoral oximeter that tracks metrics including blood oxygen saturation and pulse rate, with data viewable via a companion smartphone app.

The most recent device in ProSomnus’s EVO line, the ProSomnus EVO [PH] Sleep and Snore Device, was US Food and Drug Administration (FDA) cleared in November 2022, while ProSomnus HWO2 was FDA-registered in August 2025.

“This partnership [with Catalio] enables ProSomnus to expand access to care while advancing and scientifically validating our next-generation sensor‑enabled medical devices,” said ProSomnus CEO Lin Liptak.

“Catalio’s investment affirms our mission to address the global public health burden of obstructive sleep apnoea with precision, data‑driven medical solutions that create meaningful value loops for patients, clinicians, and payers,” Liptak continued.