LivaNova Announces a Positive Predictive Outcome of Trial Success in its OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea [Yahoo! Finance]
LivaNova PLC - Ordinary Shares (LIVN)
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Source: Yahoo! Finance
study, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation , has achieved a positive predictive outcome and will conclude enrollment earlier than anticipated. This means there is a greater than 97.5% probability that the OSPREY trial will successfully meet its primary endpoint. OSPREY is a prospective, multi-center, randomized controlled open-label trial demonstrating the safety and effectiveness of the aura6000™ Hypoglossal Nerve Stimulator System versus a no stimulation control in subjects with moderate to severe obstructive sleep apnea (OSA) who have failed or are unwilling to use positive airway pressure treatment. LivaNova notified the U.S. Food and Drug Administration (FDA) and its partner trial sites of this significant milestone for the OSPREY study. "A planned interim analysis, per the approved protocol, was conducted for the first 90 patients enrolled in OSPREY. We are now able to estimate a high chance of success for achieving the primary endpoin
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LIVN
Earnings
- 5/1/24 - Beat
LIVN
Sec Filings
- 5/1/24 - Form 8-K
- 4/26/24 - Form ARS
- 4/26/24 - Form DEF
- LIVN's page on the SEC website