LivaNova Announces OSPREY Clinical Study Meets Primary Safety and Efficacy Endpoints
LivaNova announced successful results from its OSPREY randomized controlled trial for the aura6000 System, an implantable device treating moderate to severe obstructive sleep apnea. The study met its primary safety and efficacy endpoints with statistically significant responder rates between treatment and sham arms. Key secondary endpoints showed impressive results at six months: 66.2% reduction in median apnea-hypopnea index (from 34.3 to 11.6) and 63.3% reduction in oxygen desaturation index (from 34.9 to 12.8). No serious adverse device or procedure-related events were reported. LivaNova plans to submit the data to FDA for premarket approval, with 12-month data expected in first half of 2025.
LivaNova ha annunciato risultati positivi dal suo studio clinico controllato randomizzato OSPREY per il sistema aura6000, un dispositivo impiantabile per il trattamento dell'apnea ostruttiva del sonno da moderata a grave. Lo studio ha raggiunto i principali obiettivi di sicurezza ed efficacia con tassi di risposta statisticamente significativi tra i gruppi di trattamento e controllo. I principali endpoint secondari hanno mostrato risultati impressionanti a sei mesi: riduzione del 66.2% nell'indice di apnea-ipopnea mediano (da 34.3 a 11.6) e riduzione del 63.3% nell'indice di desaturazione dell'ossigeno (da 34.9 a 12.8). Non sono stati riportati eventi avversi gravi legati al dispositivo o alla procedura. LivaNova prevede di presentare i dati alla FDA per l'approvazione pre-commercializzazione, con i dati a 12 mesi attesi nella prima metà del 2025.
LivaNova anunció resultados exitosos de su ensayo clínico controlado aleatorio OSPREY para el sistema aura6000, un dispositivo implantable para tratar la apnea obstructiva del sueño de moderada a severa. El estudio cumplió con sus principales objetivos de seguridad y eficacia, mostrando tasas de respuesta estadísticamente significativas entre los grupos de tratamiento y control. Los principales puntos finales secundarios mostraron resultados impresionantes a los seis meses: reducción del 66.2% en el índice de apnea-hipopnea mediano (de 34.3 a 11.6) y reducción del 63.3% en el índice de desaturación de oxígeno (de 34.9 a 12.8). No se informaron eventos adversos graves relacionados con el dispositivo o el procedimiento. LivaNova planea presentar los datos a la FDA para la aprobación previa al mercado, con datos a 12 meses esperados en la primera mitad de 2025.
LivaNova는 중증 폐쇄성 수면무호흡증 치료를 위한 이식형 장치인 aura6000 시스템에 대한 OSPREY 무작위 대조 시험의 성공적인 결과를 발표했습니다. 이 연구는 치료군과 위약군 간의 통계적으로 유의미한 반응률을 통해 주요 안전성 및 효능 목표를 달성했습니다. 주요 2차 목표는 6개월 시점에서 인상적인 결과를 보여주었습니다: 중간 수면 무호흡-저호흡 지수 66.2% 감소 (34.3에서 11.6으로) 및 산소 저산소 지수 63.3% 감소 (34.9에서 12.8로). 장치나 절차와 관련된 심각한 부작용은 보고되지 않았습니다. LivaNova는 2025년 상반기 중에 12개월 데이터를 예상하고 FDA에 사전 시장 승인을 위한 데이터를 제출할 계획입니다.
LivaNova a annoncé des résultats positifs de son essai contrôlé randomisé OSPREY pour le système aura6000, un dispositif implantable traitant l'apnée obstructive du sommeil modérée à sévère. L'étude a atteint ses principaux objectifs de sécurité et d'efficacité, avec des taux de réponse statistiquement significatifs entre les groupes de traitement et de contrôle. Les principaux points secondaires ont montré des résultats impressionnants à six mois : réduction de 66,2% de l'indice médian d'apnée-hypopnée (de 34,3 à 11,6) et réduction de 63,3% de l'indice de désaturation en oxygène (de 34,9 à 12,8). Aucun événement indésirable grave lié au dispositif ou à la procédure n'a été signalé. LivaNova prévoit de soumettre les données à la FDA pour une approbation préalable à la mise sur le marché, avec les données de 12 mois attendues au premier semestre 2025.
LivaNova hat erfolgreiche Ergebnisse aus seiner randomisierten kontrollierten Studie OSPREY für das aura6000-System bekannt gegeben, ein implantierbares Gerät zur Behandlung von moderater bis schwerer obstruktiver Schlafapnoe. Die Studie erreichte ihre primären Sicherheits- und Wirksamkeitsziele mit statistisch signifikanten Ansprechquoten zwischen den Behandlungs- und Placebogruppen. Die wichtigsten sekundären Endpunkte zeigten beeindruckende Ergebnisse nach sechs Monaten: 66.2% Reduktion des medianen Apnoe-Hypopnoe-Index (von 34.3 auf 11.6) und 63.3% Reduktion des Sauerstoffdesaturationsindex (von 34.9 auf 12.8). Es wurden keine schwerwiegenden geräte- oder verfahrensbezogenen unerwünschten Ereignisse berichtet. LivaNova plant, die Daten zur Vorabgenehmigung bei der FDA einzureichen, wobei Daten nach 12 Monaten in der ersten Hälfte von 2025 erwartet werden.
- Met primary safety and efficacy endpoints in OSPREY trial
- 66.2% reduction in apnea-hypopnea index at 6 months
- 63.3% reduction in oxygen desaturation index at 6 months
- No serious adverse events reported
- Advancing towards FDA premarket approval submission
- Full 12-month data not yet available until 2025
Insights
The successful completion of the OSPREY clinical trial marks a significant milestone for LivaNova's aura6000 System. The trial demonstrated remarkable efficacy with a
The absence of serious adverse events and achievement of primary endpoints positions the aura6000 System favorably for FDA approval. The sleep apnea device market, currently dominated by CPAP machines, presents a substantial opportunity. With approximately 30 million Americans affected by OSA and many struggling with CPAP compliance, an implantable alternative could capture significant market share.
The planned FDA submission following the completed analysis could lead to market entry in late 2025 or early 2026, potentially driving significant revenue growth for LivaNova in this expanding market segment.
Top-line results compared to baseline at six months:
Median apnea-hypopnea index reduction of
Median oxygen desaturation index reduction of
In the OSPREY study, apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) reductions are analyzed as part of the study’s secondary endpoints. Comparing median values from baseline to six months with therapy (assessed at the seven-month follow-up visit), OSPREY subjects in the device stimulation group experienced significant reductions in these endpoints as follows:
-
AHI reduced by
66.2% when the median at baseline of 34.3 is compared to the median of 11.6 at six months. -
ODI reduced by
63.3% when the median at baseline of 34.9 is compared to the median of 12.8 at six months.
Once the six-month results analysis is completed, LivaNova will submit the OSPREY clinical data to the
“The study results reinforce our belief that targeted hypoglossal nerve stimulation provides a compelling alternative for patients with obstructive sleep apnea. The significant reductions in AHI and ODI achieved after only six months of therapy gives us strong evidence of this technology’s potential at 12 months and beyond,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “I would like to thank the patients and physicians who have participated in OSPREY to date. We look forward to evaluating the full results as patients complete 12 months of therapy.”
Beyond the primary endpoints, the OSPREY trial will continue to collect long-term data. After all subjects have completed 12 months with therapy (assessed at the 13-month follow-up visit), LivaNova expects the data to be available in the first half of 2025.
"In addition to meeting the primary safety and efficacy outcomes, the reductions in AHI and ODI after only six months of therapy demonstrate a significant clinical impact for the patients,” said Dr. Atul Malhotra, lead investigator for the study, who is also a professor of medicine at University of California San Diego School of Medicine and sleep medicine specialist at University of California San Diego Health.
There were no serious adverse device-related or procedure-related events reported in OSPREY throughout the primary endpoint visits.
For more information on the aura6000 System and the treatment of OSA, visit the LivaNova website.
1 |
The primary efficacy endpoint measured the difference in apnea-hypopnea index (AHI) responder rates between active and no stimulation targeted hypoglossal nerve stimulation (THNS) therapy after seven months of follow-up with a predetermined p-value of p<0.025. |
2 |
Per trial protocol, a responder is defined to have realized at least a |
About OSPREY
OSPREY is a prospective, multi-center, randomized controlled open-label trial demonstrating the safety and efficacy of the aura6000™ Hypoglossal Nerve Stimulator System versus a no stimulation control in subjects with moderate to severe OSA who have failed or are unwilling to use positive airway pressure treatment. CAUTION—the aura6000 System is an investigational device. Limited by Federal (or
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 solutions in select neurological and cardiac conditions. Headquartered in
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 the OSPREY study and the aura6000™ System. Actual events may differ materially from those indicated in our 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241111606578/en/
LivaNova Investor Relations and Media Contacts
+1 281-895-2382
Briana Gotlin
VP, Investor Relations
InvestorRelations@livanova.com
Deanna Wilke
VP, Corporate Communications
Corporate.Communications@livanova.com
Source: LivaNova PLC
FAQ
What were the main results of LivaNova's OSPREY trial for the aura6000 System (LIVN)?
When will LivaNova (LIVN) release the 12-month data for the OSPREY trial?
What is the next regulatory step for LivaNova's aura6000 System (LIVN)?
