ProSomnus, Inc. announced that the United States Food and Drug Administration (the ?FDA?) has accepted, and is in the process of reviewing, the Company?s premarket notification for its ProSomnus® EVO® precision medical device for the treatment of patients with severe obstructive sleep apnea. The Company?s premarket notification 510(k) submission included a robust clinical data dossier demonstrating the safety and efficacy of its ProSomnus EVO precision medical device relative to the performance goals indicated in pre-submission meetings and reference devices. The clinical data submitted by the Company in support of its 510(k) submission included data on 92 patients with severe OSA from two prospective clinical studies.

The mean age of patients was 52 (26-77); Mean body mass index (?BMI?) was 31.4 (19.8-45.9); Baseline mean apnea-hypopnea index (?AHI?) was 47.5 (30.1-106.9); and Mean baseline oxygen desaturation index (?ODI?) was 47.1 (16.7-107.9). 75% of patients successfully achieved the AHI target of AHI < 20 and a 50% reduction from baseline; 91% of patients successfully achieved the ODI target of 25% improvement from the baseline; 82% of patients achieved the sleep apnea specific hypoxic burden target of < 60 % min /hr.; and 89% of patients achieved a 45% improvement in AHI or improved their OSA severity by at least one strata. With ProSomnus treatment, compared to baseline, patients experienced: a mean AHI improvement of 66%; a mean ODI improvement of 60%; and a mean improvement in sleep apnea specific hypoxic burden of 69%.

These results were achieved without patient preselection or excluding patients with concentric collapse airway profiles.