LivaNova’s LIVN OSPREY trial, evaluating the aura6000 nerve stimulation system for obstructive sleep apnea (OSA), has delivered promising results. By meeting primary safety and efficacy endpoints, the study marks a significant step forward for targeted hypoglossal nerve stimulation as a viable treatment for moderate to severe OSA.
The trial’s primary endpoint focused on responder rates, defined as patients achieving at least a 50% reduction in apnea-hypopnea index (AHI), resulting in an AHI below 20. The treatment group showed significantly higher responder rates than the sham group, meeting the pre-specified statistical threshold of p<0.025. This achievement not only underscores the therapy’s clinical relevance but also strengthens the case for FDA premarket approval.
The company’s shares have risen 0.7% so far this year compared with the industry’s growth of 2.7%. The S&P 500 Index has gained 23.4% during the same period.
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Study Data in Details
The OSPREY trial focused on measuring AHI and oxygen desaturation index (ODI) as secondary endpoints, both critical metrics in assessing OSA severity. The data from the trial showed that using aura6000 led to a 66.2% reduction in AHI, with the median falling from 34.3 at baseline to 11.6 at six months. ODI reduced 63.3%, with the median dropping from 34.9 at baseline to 12.8 at six months. These reductions represent statistically significant improvements, highlighting the efficacy of the aura6000 system in managing OSA.
The OSPREY trial reported no serious adverse device-related or procedure-related events, emphasizing the aura6000 system’s favorable safety profile. This result bolsters confidence in the device's potential for widespread clinical use.
The OSPREY trial will continue to collect 12-month data, with results expected in early 2025. These findings will offer valuable insights into the therapy's sustained efficacy and safety. A favorable long-term profile could further solidify the device’s role in the OSA treatment landscape.
FDA Submission and Path to Approval
LivaNova plans to submit the OSPREY trial data to the FDA as part of its premarket approval application following the completion of the six-month data assessment. The robust safety and efficacy data provide a strong foundation for regulatory review. Approval of the aura6000 system would position it as a novel option for patients who struggle with conventional OSA treatments such as positive airway pressure (PAP).
OSA affects millions of adults worldwide, with significant implications for cardiovascular health, cognitive function and quality of life. The aura6000 system provides an alternative for patients who cannot tolerate or benefit from PAP. With significant reductions in AHI and ODI demonstrated in just six months, the device holds promise for improving long-term outcomes and adherence.
Favorable Industry Prospects for LIVN
Per a report by Markets and Markets, the global sleep apnea device market was valued at approximately$6.5 billion in 2023 and is anticipated to reach $9.3 billion by 2029 at a CAGR of 7.3%.
Factors like the expansion of reimbursement coverage and the growing adoption of telemedicine and artificial intelligence are likely to be the key drivers for sleep apnea device demand.
Given the market potential, an approval for Auro6000 next year is likely to boost LIVN’s business prospects.
LivaNova PLC Price
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LIVN’s Zacks Rank & Other Stocks to Consider
LivaNova currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the medical industry are Masimo MASI, AngioDynamics ANGO and Globus Medical GMED.
Masimo, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated growth rate of 10.4% for 2025. You can seethe complete list of today’s Zacks #1 Rank stocks here.
MASI’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 17.10%. Masimo’s shares have risen 37.2% year to date compared with the industry’s 6.7% growth.
AngioDynamics, carrying a Zacks Rank #2 at present, has an estimated growth rate of 38.2% for 2025. ANGO’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 31.71%.
AngioDynamics’ shares have lost 8.9% year to date against the industry’s 6.7% growth.
Globus Medical, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 12.7%. GMED’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 12.1%. Its shares have risen 56.5% year to date compared with the industry’s 6.7% growth.
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