ProSomnus has revealed promising results from its pilot study of a next-generation Remote Patient Monitoring (RPM) device for obstructive sleep apnoea (OSA), ProSomnus RPMO₂ OSA Device.
The study’s data confirmed that an oximeter integrated into a precision medical device can monitor SpO₂ levels accurately, safely, and continuously.
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ProSomnus said that an intraoral medical device can perform RPM of physiological parameters relevant to OSA, such as arterial oxygen saturation and pulse rate.
It would allow healthcare providers to monitor residual risks associated with OSA treatments.
During the study, healthy adult volunteers were equipped with a ProSomnus RPMO₂ OSA Device, and reference oximeter cleared by the Food and Drug Administration (FDA).
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They underwent a standard controlled desaturation protocol to achieve six desaturation plateaus ranging from 70% to 100% SaO₂.
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By GlobalDataThe accuracy of the ProSomnus RPMO₂ Device was assessed by pooling five matched data pairs from each desaturation plateau.
The analysis included 85 matched data pairs, with the ProSomnus RPMO2 OSA Device demonstrating a root mean square error (RMSE) of 2.32%, well below the FDA’s accuracy requirement of an RMSE less than 3.5%.
Furthermore, the device recorded minimum and maximum SpO₂ values of 71.8% and 100%, respectively.
A Bland-Altman analysis indicated a bias of 0.24, with lower and upper 95% limits of agreement of -4.31 and 4.79, respectively.
ProSomnus Sleep Technologies CEO Len Liptak said: “This pilot study validation represents a step toward bringing sleep medicine into the P4 medicine era. The ProSomnus RPMO₂ OSA Device enables sleep medicine to be more personalised, predictive, preventative, and participatory.
“Although we have more work to do in terms of FDA clearances, market access and commercialisation, I am very proud that team ProSomnus is in the process of bringing this potentially life-changing innovation to the millions of people suffering from OSA.”
Last month, ProSomnus’ EVO precision medical device, designed for the treatment of patients with severe OSA, was accepted by the US Food and Drug Administration and is in the process of reviewing.
