LivaNova Announces a Positive Predictive Outcome of Trial Success in its OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea

Rhea-AI Summary

LivaNova PLC (Nasdaq: LIVN) announces positive results from OSPREY clinical study on treating obstructive sleep apnea using targeted hypoglossal nerve stimulation. The study achieved a predictive outcome with over 97.5% probability of meeting primary endpoint, concluding enrollment earlier than expected. The aura6000™ Hypoglossal Nerve Stimulator System showed safety and effectiveness in subjects with moderate to severe OSA.

Insights

Medical Research Analyst

The positive predictive outcome of LivaNova's OSPREY clinical study is a significant development in the field of sleep apnea treatment. The aura6000 Hypoglossal Nerve Stimulator System represents a potential alternative for patients with moderate to severe obstructive sleep apnea (OSA) who do not respond well to the standard positive airway pressure treatment. The early conclusion of enrollment based on a high probability of meeting the primary endpoint suggests strong efficacy of the device.

From a medical research perspective, the primary efficacy endpoint—the apnea-hypopnea index (AHI) responder rate—serves as a critical measure of success in OSA treatment. AHI is a common metric used to quantify the severity of sleep apnea, with a lower score indicating fewer breathing interruptions during sleep. The responder rate reflects the proportion of patients experiencing at least a 50% improvement from their baseline AHI, which is a substantial clinical improvement for those suffering from OSA.

The long-term follow-up is equally important as it provides data on the durability of the treatment's effectiveness and its impact on patient quality of life. Factors like daytime sleepiness are essential quality of life indicators that can directly affect a patient's daily functioning and overall health.

Market Research Analyst

LivaNova's announcement regarding the OSPREY study potentially positions the company as a prominent player in the OSA treatment market. The early success indicated by the interim analysis could lead to a competitive advantage in a market that is currently dominated by CPAP (Continuous Positive Airway Pressure) devices. The ability to offer an alternative treatment modality could expand LivaNova's market share and appeal to a subset of patients who are non-compliant or intolerant to CPAP therapy.

Investors should monitor the progress of the OSPREY study's final analysis and subsequent FDA submission, as these are key milestones that could influence the company's stock performance. The market for sleep apnea devices is growing due to rising awareness and diagnosis rates and LivaNova's entry with a novel device could disrupt the current market dynamics. However, it's important to consider regulatory hurdles and the time it may take for the aura6000 System to gain market acceptance, even after a successful trial outcome.

Financial Analyst

The financial implications of the OSPREY study for LivaNova are substantial. The early termination of patient enrollment suggests cost savings in trial operations, which could positively affect the company's short-term financials. In the long run, if the aura6000 System is approved by the FDA, it could lead to a new revenue stream for LivaNova, especially considering the high prevalence of OSA and the number of patients seeking alternatives to CPAP therapy.

It is important for investors to consider the potential market size and the pricing strategy LivaNova might employ for the aura6000 System. The adoption rate by healthcare providers and reimbursement by insurance companies will also play a important role in the financial success of the product. A favorable outcome could lead to a bullish outlook for LivaNova's stock, but it is important to remain cautious until the FDA's decision and the market's reception of the new treatment are clear.

LONDON--(BUSINESS WIRE)-- LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced its OSPREY clinical 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 endpoint in this unique randomized controlled trial without further patient enrollment,” said Dr. Atul Malhotra, Professor of Medicine at University of California, San Diego and Principal Investigator for OSPREY. “While this milestone shows we are on a positive trajectory, long-term follow-up visits will continue for each patient through the primary endpoint and beyond.”

The OSPREY study’s primary efficacy endpoint is the demonstration that the apnea-hypopnea index (AHI) responder rate of subjects with device stimulation activated is statistically significantly higher than the rate of subjects without stimulation after seven months of follow-up. For OSPREY, response is defined as at least a 50% improvement from the baseline AHI, leading to an AHI value below 20. After the full cohort completes the seven-month follow-up visit and the results are compiled, LivaNova will submit OSPREY’s final clinical module to the FDA.

“We are pleased to have achieved this positive milestone for the OSPREY study,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “In accordance with the study protocol, once the last patient implanted completes their final follow-up visit, we will conduct the final analysis for the study. Until then, we will continue to actively work with the clinical sites to manage the study patients.”

The OSPREY study also assesses the safety of the aura6000 System and measures patient quality of life through indicators such as daytime sleepiness. For more information on the therapy and the treatment of OSA, visit the LivaNova website.

About Obstructive Sleep Apnea

OSA affects almost one billion people worldwide, of which 75% are undiagnosed. If left untreated, OSA can have serious implications, including increased cardiovascular disease, stroke, metabolic disease, excessive daytime sleepiness and a higher risk for traffic accidents.

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. For more information, please visit www.livanova.com.

Safe Harbor Statement

This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding progress relating to the OSPREY study and the aura6000 system. Actual events may differ materially from those indicated in forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

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LivaNova Investor Relations and Media Contacts

+1 281-895-2382



Briana Gotlin

Director, Investor Relations

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Deanna Wilke

VP, Corporate Communications

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Source: LivaNova PLC

FAQ

What is the ticker symbol for LivaNova PLC?

The ticker symbol for LivaNova PLC is LIVN.

What is the primary endpoint of the OSPREY clinical study?

The primary endpoint of the OSPREY study is to demonstrate that the apnea-hypopnea index (AHI) responder rate of subjects with device stimulation activated is statistically significantly higher than the rate of subjects without stimulation after seven months of follow-up.

Who is the Principal Investigator for the OSPREY study?

Dr. Atul Malhotra, Professor of Medicine at University of California, San Diego, is the Principal Investigator for the OSPREY study.

What is the significance of achieving a positive predictive outcome in the OSPREY study?

Achieving a positive predictive outcome indicates a high chance of success for meeting the primary endpoint in the OSPREY study without further patient enrollment.

What is the response definition for the OSPREY study?

Response in the OSPREY study is defined as at least a 50% improvement from the baseline apnea-hypopnea index (AHI), leading to an AHI value below 20.