Company studies continue to show durability and retention of benefits for patients receiving proximal hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea
LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced its participation in the International Surgical Sleep Society (ISSS) 2025 Annual Meeting in Indianapolis. The Company will present a five-year analysis of the THN-3 randomized control trial (RCT), which studied the use of its aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA). LivaNova will also deliver an oral presentation and feature a scientific poster to support a deeper understanding of the use of proximal hypoglossal nerve stimulation (p-HGNS) for OSA, including 12-month, top-line data from its follow-on RCT, OSPREY.
"Nearly 2 million patients with moderate to severe OSA have failed first-line therapies. These patients have a high need for an effective solution, and that is the problem LivaNova is working to solve," said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. "At ISSS, we will have two oral presentations and a poster showcasing the continued durability and retention of benefits we are seeing when p-HGNS therapy is used to treat OSA. We're eager to share these positive outcomes and continue our efforts to bring this innovative treatment to market."
The oral and scientific poster presentations feature the research of independent investigators:
Thurs., Oct. 9, from 11 a.m.-12 p.m. EDT during Research Abstracts
- Phenotypical Trajectories of Subjects Receiving Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: A 5-Year Analysis of the THN-3 Randomized, Controlled Trial Oral presentation by Alan Schwartz, M.D., Adjunct Professor of Otorhinolaryngology, Perelman School of Medicine at the University of Pennsylvania, from 11:00-11:08 a.m. EDT.
Fri. Oct. 10, from 1-2 p.m. EDT during Research Abstracts
- Proximal Hypoglossal Nerve Stimulation Improves Sleep-Disordered Breathing, Oxygenation, and Quality of Life at One Year in Moderate to Severe Obstructive Sleep Apnea in the OSPREY Trial Presented by Ofer Jacobowitz, M.D., Ph.D., Otolaryngologist at ENT and Allergy Associates and Clinical Professor of Otolaryngology, Zucker School of Medicine at Hofstra University/Northwell Health, from 1:48-1:56 p.m. EDT.
Fri., Oct. 10, from 5-7 p.m. EDT during the ISSS Welcome Reception
- Hypoglossal Nerve Stimulation Response Rates: Caveat Medicus (poster 31) Presented by Dr. Schwartz.
LivaNova will also host a breakfast symposium at ISSS on Thurs., Oct. 9, from 7-8 a.m. EDT, where three renowned sleep experts will discuss OSPREY results and describe their firsthand experiences with p-HGNS therapy.
The symposium is titled, "The Next Generation for OSA: Proximal HGNS," and will feature talks by Dr. Schwartz, Dr. Jacobowitz, and Atul Malhotra, M.D., lead investigator for the OSPREY study, professor of medicine at University of California San Diego School of Medicine, and sleep medicine specialist at UC San Diego Health.
Attendees will have the opportunity to learn more about p-HGNS, a differentiated neurostimulation modality utilizing six electrodes placed on the proximal trunk of the hypoglossal nerve, offering broad access to the muscles controlling the airway through customized titration.
As announced in May of this year, the treatment arm responder rate in the OSPREY study, featuring p-HGNS, was 65% at 12 months of therapy. Responders are defined as those who realized at least a 50% improvement from the baseline apnea-hypopnea index (AHI) and an AHI value below 20.
In November 2024, the company announced that OSPREY met its primary and secondary endpoints following six months of therapy.
About THN-3 and OSPREY
Following the conclusion of LivaNova's THN-3 clinical study (THN-3: A Randomized, Controlled Trial of Targeted Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea) evaluating the aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA, the Company launched a second RCT, entitled OSPREY. Both studies evaluated a differentiated neurostimulation modality called proximal hypoglossal nerve stimulation (p-HGNS), which utilizes six electrodes placed on the proximal trunk of the hypoglossal nerve, offering broad access to the muscles controlling the airway and providing customized titration. OSPREY is a prospective, multi-center, randomized controlled open-label trial evaluating the safety and efficacy of the aura6000 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 United States) law to investigational use.
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 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 the THN-3 study, the OSPREY study, the aura6000 System, p-HGNS, and presentations at upcoming conferences. 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.
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