LONDON - LivaNova PLC (NASDAQ:LIVN), a prominent medical technology company, today announced successful primary endpoint results for its OSPREY trial, which assesses the efficacy of the aura6000™ System, an implantable device designed to treat obstructive sleep apnea (OSA) in adults. The randomized controlled trial (RCT) demonstrated a statistically significant difference in responder rates between the treatment group and the sham control group.
The trial's secondary endpoints included the median reduction in apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), two critical measures of OSA severity. Results showed a 66.2% reduction in AHI and a 63.3% reduction in ODI at the six-month mark, compared to baseline figures. These outcomes are based on a comparison of median values from baseline to six months of therapy, which are assessed at a seven-month follow-up visit.
Dr. Atul (NS:ATLP) Malhotra, the lead investigator for the OSPREY study and a noted sleep medicine specialist at the University of California San Diego Health, highlighted the significant clinical impact of these reductions for patients after just six months of therapy.
The OSPREY trial will continue to gather long-term data, with full results expected after all subjects have completed 12 months of therapy. This data is anticipated to be available in the first half of 2025. The study's progress is being closely monitored, and upon completion of the six-month results analysis, LivaNova plans to submit the clinical data to the U.S. Food and Drug Administration (FDA) for premarket approval of the aura6000 System.
LivaNova's CEO, Vladimir Makatsaria, expressed confidence in the technology, citing the considerable reductions in AHI and ODI as strong evidence of the potential benefits of targeted hypoglossal nerve stimulation for OSA patients. The company emphasized the absence of serious adverse device-related or procedure-related events reported during the primary endpoint visits of the OSPREY trial.
The aura6000 System is currently classified as an investigational device and is limited by U.S. federal law to investigational use. This announcement is based on a press release statement from LivaNova PLC.
In other recent news, LivaNova PLC reported a robust 11% revenue growth in its third quarter, marking the seventh consecutive quarter of double-digit growth. The company has also raised its revenue guidance for 2024 to 8.5%-9.5% and anticipates adjusted diluted earnings per share to be between $3.30 and $3.40. The U.S. Centers for Medicare and Medicaid Services (CMS) will maintain the current payment level for LivaNova's VNS Therapy™ for drug-resistant epilepsy (DRE) in 2025, according to recent developments. Despite the company's hopes for a higher reimbursement tier, LivaNova expressed that it does not foresee a negative impact on its business due to this decision. The company's cash balance reached $346 million, with total debt at $626 million as of September 30, 2024. Despite an anticipated increase in R&D and SG&A expenses in Q4 2024, LivaNova remains optimistic about maintaining momentum into 2025, focusing on operational performance, market share gains, and increased investment in innovation. These are the latest developments in the company's operations.
InvestingPro Insights
LivaNova's positive OSPREY trial results align with the company's strong financial performance and market position. According to InvestingPro data, LivaNova has shown impressive revenue growth of 11.04% over the last twelve months, with quarterly revenue growth of 11.19% in Q3 2024. This growth trajectory supports the company's ability to invest in innovative technologies like the aura6000 System.
InvestingPro Tips highlight that LivaNova is expected to grow its net income this year, which could be partly attributed to the potential success of new products like the aura6000 System. The company's strong return over the last three months, with a 17.47% price total return, suggests that investors are optimistic about LivaNova's future prospects, including the potential FDA approval of the aura6000 System.
Additionally, LivaNova operates with a moderate level of debt and has liquid assets exceeding short-term obligations, indicating financial stability to support ongoing research and development efforts. The company's P/E ratio (adjusted) of 14.66 for the last twelve months as of Q3 2024 suggests it may be undervalued relative to its earnings potential, especially considering the positive trial results and potential market expansion.
For investors seeking more comprehensive analysis, InvestingPro offers 11 additional tips for LivaNova, providing deeper insights into the company's financial health and market position.
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