Company: INSP
Filing Date: 2025-02-10
Form Type: 10-K
Source: 0001609550-25-000011
Chunk: 29

Company: Inspire Medical Systems, Inc.
Filing Date: 2025-02-10
Form: 10-K
Item: Item 1
Chunk 29
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 90%, with 92% of patients reporting that they would choose the procedure again. In addition, 91% of patients reported a better experience than CPAP. This same study demonstrated comparable outcomes across five disease severity groups.

Select Recent Clinical Results and Studies

Meta-analysis showed Inspire therapy has been effective over time

Dr. Do Hyun Kim and colleagues published a meta-analysis of hypoglossal nerve stimulation therapy effectiveness in 2024 in Otolaryngology–Head and Neck Surgery. Meta-analysis is a statistical method to estimate effect size across data from high quality publications, i.e. a “study of studies”, and can identify potential trends and consistency across a body of data. They identified 44 studies (total of 8,670 patients) of sufficient quality for inclusion. For 12 month follow up, they found that 82% of patients evaluated in this publication had an AHI<15 and a success rate of 80%, where success was defined as the patient’s residual AHI is no greater than half of the baseline AHI, and is also no greater than 20. A similar trend was reported for three year follow up at which 74% of patients had an AHI<15 and a success rate of 73%. The authors concluded that hypoglossal nerve stimulation is an effective treatment for obstructive sleep apnea that can significantly improve clinical outcomes over long-term 

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(three year) follow up. We note that this meta-analysis included publications using other devices, but most of the data was from Inspire therapy patients. 

Meta-analysis showed Inspire therapy is an effective alternative to other airway surgeries

Dr. Kim and colleagues published another meta-analysis in the Journal of Sleep Research in 2024 of papers that compared hypoglossal nerve stimulation outcomes to outcomes either from no treatment or from other airway surgeries (e.g., uvulopalatopharyngoplasty). They identified ten papers (nine of which included only Inspire therapy patients) that met inclusion criteria for a total of 2,209 patients in the analysis. Among their findings: compared to airway surgeries and to PAP therapy, hypoglossal nerve stimulation therapy had higher rate of patients achieving AHI<15. Analysis also showed that the hypoglossal nerve stimulation therapy success rate was higher than the success rate from all other evaluated airway surgeries. Success was defined as residual AHI no greater than 20 and no greater than half of the baseline AHI. The results of this