Inspire Medical ((INSP)) announced an update on their ongoing clinical study.
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Inspire Medical Systems, Inc. is conducting a significant clinical study titled ‘Inspire UAS High AHI/High BMI Post-Approval Study.’ The study aims to evaluate the long-term safety and effectiveness of the Inspire® UAS System in patients with obstructive sleep apnea (OSA) who have a higher Apnea Hypopnea Index (AHI) and Body Mass Index (BMI). This research is crucial as it expands the patient population for this treatment, potentially offering new hope for those with severe OSA conditions.
The intervention being tested is the Inspire® UAS System, a device designed to treat OSA by stimulating the airway muscles to prevent collapse during sleep. Patients will use a remote to initiate therapy each night, aiming to improve sleep quality and reduce apnea events.
The study is observational with a case-control model, focusing on a prospective time perspective. It does not involve random allocation or masking, as it primarily seeks to observe outcomes in a real-world setting. The primary purpose is to assess the device’s performance over an extended period.
The study began on May 7, 2025, with its primary completion and estimated overall completion dates yet to be announced. The latest update was submitted on August 4, 2025, indicating ongoing recruitment and progress.
This study update could positively impact Inspire Medical’s stock performance by demonstrating the device’s effectiveness in a broader patient group, potentially increasing market share. Investors may view this expansion as a strategic move to outpace competitors in the OSA treatment market.
The study is currently recruiting, with further details available on the ClinicalTrials portal.