secwatch.observer — SEC 8-K summary
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Issuer:     Inspire Medical Systems, Inc. (INSP)
CIK:        0001609550
Form:       8-K
Filed at:   2025-10-10T23:59:59+00:00
Accession:  0001609550-25-000046
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Inspire V clinical data shows superior efficacy, adherence, and reduced surgical times; AHI cut from 34.4 to 8.3
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- Singapore study (44 patients): Inspire V IPOP 87.1% vs Inspire IV 79.4%, exceeding non-inferiority margin of 4.6%.
- Median AHI reduced from 34.4 to 8.3 events/hour at 6 months for 37 Singapore patients.
- US limited market release (101 patients): no serious adverse events; 100% therapy usage at 60 days; average adherence 6.8 hrs/night.
- AHI for first 34 US patients dropped from 30 to 4.5 events/hour; average stimulation amplitude 1.7V.
- 20% reduction in surgical times; average implant time 34.5 minutes at one site; new internal respiratory sensing eliminates pressure lead.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1609550/000160955025000046/0001609550-25-000046-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1609550/000160955025000046/insp-20251010.htm
  HTML page:      https://secwatch.observer/filing/0001609550-25-000046

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer