ProSomnus, Inc. announced results of its pilot study for the Company?s Next Generation Remote Patient Monitoring (RPM) device for Obstructive Sleep Apnea (OSA). Data from the pilot study demonstrated that an oximeter embedded in a precision medical device can accurately, safely, and continuously monitor SpO2. An intraoral medical device capable of performing RPM of physiologic parameters relevant to OSA such as arterial oxygen saturation and pulse rate would be beneficial, as it would enable healthcare providers to monitor the residual risks associated with any OSA treatment.

Few treatments for OSA offer the healthcare provider real-time information about treatment status. Even fewer, if any, offer the healthcare provider access to metrics predictive of cardiovascular morbidity and mortality such as sleep apnea-specific hypoxic burden (SASHB) or sleep apnea specific-pulse rate response. The calculation of such predictive metrics requires, at minimum, full night pulse oximetry.

Healthy adult volunteers were fitted with a ProSomnus RPMO2 OSA Device and an FDA-cleared reference oximeter. Each volunteer then underwent a standard controlled desaturation protocol in accordance with FDA and medically accepted parameters to achieve six desaturation plateaus between 70% and 100% SaO2. Five matched data pairs between the ProSomnus RPMO2 and FDA-cleared reference oximeter from each desaturation plateau were pooled to determine the accuracy of the ProSomnus RPMO2 Device.

Based on the FDA?s requirements for accuracy, a performance goal of root mean square error (?RMSE?) less than 3.5% was selected. Eighty-five matched data pairs were included in the analysis. The RMSE for the ProSomnus RPMO2 OSA Device was 2.32%.

The minimum and maximum SpO2 values recorded by the ProSomnus RPMO2 OSA Device were 71.8% and 100%, respectively. Bland-Altman analysis showed a bias of 0.24 and lower and upper 95% limits of agreement of -4.31 and 4.79, respectively.