ProSomnus Severe Indication 510(k) Submission Accepted for Review by the FDA

Core Viewpoint - ProSomnus, Inc. announced that the FDA has accepted its premarket notification for the ProSomnus® EVO® precision medical device aimed at treating severe obstructive sleep apnea (OSA), marking a significant step towards providing a non-invasive treatment alternative to CPAP [1][3]. Group 1: FDA Submission and Review Process - The FDA is currently reviewing the Company's 510(k) submission, which includes a comprehensive clinical data dossier demonstrating the safety and efficacy of the ProSomnus EVO device [1][3]. - The FDA aims to complete its review of 510(k) submissions within 90 calendar days, excluding the time needed for the Company to respond to any additional information requests [3]. Group 2: Clinical Data and Patient Outcomes - The clinical data supporting the 510(k) submission involved 92 patients with severe OSA, showing significant improvements in key metrics: - 75% of patients achieved an apnea-hypopnea index (AHI) target of AHI < 20 and a 50% reduction from baseline - 91% achieved a 25% improvement in the oxygen desaturation index (ODI) - 82% met the hypoxic burden target of < 60% min/hr - 89% improved their OSA severity by at least one strata [2]. - Patients experienced a mean AHI improvement of 66%, a mean ODI improvement of 60%, and a mean improvement in hypoxic burden of 69% compared to baseline [2][3]. Group 3: Company Overview and Market Position - ProSomnus is recognized as the leading non-CPAP therapy for OSA, a condition affecting over 1 billion people globally and associated with serious comorbidities [4][5]. - The Company's intraoral medical devices are designed to be non-invasive, patient-preferred, and easy to use, demonstrating excellent efficacy and safety in clinical investigations [4][5].