secwatch.observer — SEC 8-K summary
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Issuer:     LivaNova PLC (LIVN)
CIK:        0001639691
Form:       8-K
Filed at:   2023-01-19T23:59:59+00:00
Accession:  0001639691-23-000003
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

LivaNova RECOVER depression trial enrollment to continue to 450 patients per DSMB advice
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- Independent Statistical Analysis Committee advised enrollment continue from 425 to 450 unipolar patients.
- Trial remains on track; interim analyses every 25 patients assess predictive probability of success.
- If successful, results could support peer-reviewed article and CMS reimbursement reconsideration for VNS Therapy.
- No efficacy or safety signal disclosed; trial continues per protocol.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1639691/000163969123000003/0001639691-23-000003-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1639691/000163969123000003/livn-20230118.htm
  HTML page:      https://secwatch.observer/filing/0001639691-23-000003

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