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ProSomnus, Inc. (NASDAQ:OSA) (the "Company"), the leading non-CPAP Obstructive Sleep Apnea (OSA) therapy™, 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.
"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 personalized, predictive, preventative, and participatory," commented Len Liptak, Chief Executive Officer for ProSomnus Sleep Technologies. "Although we have more work to do in terms of FDA clearances, market access and commercialization, 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."
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.
"The results of our pilot studies are impressive and demonstrate that ProSomnus has the capability to implement an intraoral oximeter," stated Dr. John E. Remmers, MD, Chief Scientist for ProSomnus Sleep Technologies. "We believe that this technology, following further validation testing and obtaining the necessary regulatory approvals, has the potential to meaningfully advance the role of oral appliances in treating OSA; oxygen monitoring provides ongoing assessment of the efficacy of oral appliance therapy."
"Pilot testing was a crucial step in the development and preliminary validation of the ProSomnus RPMO2 OSA Device," commented Dr. Erin Mosca, PhD, Director of Scientific and Medical Affairs for ProSomnus Sleep Technologies. "The results of the pilot testing hold tremendous promise for the formal validation testing, in which the ProSomnus RPMO2 OSA Device will be compared against a gold standard."
Posted In: OSA
