Inspire Medical Publishes Inspire V Clinical Outcomes Data From Singapore Clinical Study And Limited Market Release In US Including Single Site Experience At Two Leading Centers; Data To Be Presented At AAO-HNS And ISSS Meetings

Author: Benzinga Newsdesk | October 10, 2025 06:59am

Inspire Medical Systems, Inc. (NYSE:INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), today published Inspire V clinical outcomes data from its Singapore clinical study as well as the Company's limited market release in the United States including single site experience at two leading centers. These data will be presented at the American Otolaryngology-Head and Neck Surgery (AAO-HNS) and International Surgical Sleep Society (ISSS) meetings being conducted in Indianapolis between October 9 and October 14.

The Inspire V system trial conducted in Singapore at two centers was the initial experience with the new device. The study included 44 patients who received the Inspire V system and are being followed for six months post implant. The surgeons demonstrated a 20% reduction in surgical times as compared to their Inspire IV case times and 100% of the procedures were completed successfully. A key feature of the Inspire V system is that the respiratory sensing is internal to the neurostimulator, eliminating the need for the pressure sensing lead required with prior generations. The Inspire design provides for closed-loop stimulation to optimize therapy outcomes, and the primary endpoint of this Inspire V study was to measure the inspiratory phase overlap percentage (IPOP), which measures how well inspiration is covered by stimulation. The results showed the Inspire V device to be superior to the Inspire IV device (Inspire V IPOP of 87.1% vs 79.4% for Inspire IV with a non-inferiority margin of 4.6%). Important secondary measures included patient adherence to therapy of all 44 patients averaged 5.5±1.7 hours/night at a mean of 246 days post-implant, as well as the median reduction in the Apnea Hypopnea Index (AHI), as measured by overnight polysomnography (PSG), to be 34.4 events/hour at baseline to 8.3 events/hour at month six for the 37 patients who have completed this clinical visit to date. The safety profile was equally strong with only two patients requiring post-operative antibiotics for wound care that resolved within two weeks following the procedure. Once the remaining patients complete their six-month visit, these data will be submitted for publication.

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