ProSomnus

ProSomnus developed the first FDA-cleared precision oral appliance therapy device as a non-invasive alternative to CPAP machines for obstructive sleep apnea. Their devices are mass-customized using digital manufacturing to fit each patient’s anatomy and have been prescribed over 175,000 times by more than 4,000 providers. Clinical data show a ~75% success rate in treating sleep apnea with higher compliance than CPAP. The company has ongoing landmark studies including the Severe OSA Study (SOS) and Frontline OSA Treatment study (FLOSAT). As of May 2024, the company filed for Chapter 11 bankruptcy but had previously established itself as a market leader in precision oral appliances with broad reimbursement coverage.