LivaNova Demonstrates 84.5% Cumulative Response Rate with PolySync Programming in OSPREY Study for Obstructive Sleep Apnea

Key Terms

apnea-hypopnea index medical

A measure of how often a person has pauses or shallow breaths during sleep, calculated as the average number of these events per hour. Investors care because this single number is used by doctors and insurers to diagnose sleep-disordered breathing and decide on treatments and device coverage, so higher or lower values can affect demand for diagnostic tools, therapies, and related healthcare spending—think of it as counting traffic jams per hour to judge road congestion.

obstructive sleep apnea medical

Obstructive sleep apnea is a common medical condition where the throat repeatedly narrows or closes during sleep, causing short pauses in breathing, drops in blood oxygen and fragmented rest. It matters to investors because it creates ongoing demand for medical devices, diagnostics, treatments and sleep-monitoring services, and it can affect population health, workforce productivity and healthcare spending—like a recurring leak in a system that requires continual repair and monitoring.

oxygen desaturation index medical

Oxygen desaturation index (ODI) is a measure of how often a person’s blood oxygen level drops by a set amount during sleep, reported as events per hour. Investors care because ODI is a common clinical and regulatory measure used to diagnose and track sleep-disordered breathing and to judge the effectiveness of devices or drugs; changes in ODI can directly affect product approvals, reimbursement, market demand and clinical trial outcomes. Think of it like counting how many times an alarm goes off at night—more alarms signal a bigger problem.

hypoglossal nerve stimulation medical

Hypoglossal nerve stimulation is a medical-device therapy that uses a small implanted pulse generator to gently activate the nerve controlling the tongue, keeping the airway open during sleep to reduce obstructive sleep apnea. For investors it matters because it is a regulated implantable technology whose clinical effectiveness, safety profile, approval status and reimbursement determine patient adoption, sales growth and long-term revenue potential—similar to how a pacemaker’s performance drives demand in heart care.

neuromodulation medical

Neuromodulation is the use of devices or targeted treatments to change how nerves or brain circuits send signals, much like adjusting the volume or tuning on an audio system to alter what you hear. For investors, it matters because these therapies can treat chronic conditions (pain, movement disorders, depression) where existing medicines fall short, creating potential markets, regulatory milestones, and durable revenue streams if technologies prove safe and effective.

glp-1 receptor agonists medical

GLP-1 receptor agonists are medicines that mimic a natural gut hormone to lower blood sugar and reduce appetite, often used to treat diabetes and obesity. Investors care because these drugs can drive large prescription sales, face strict regulatory approval and patent timelines, and their safety, pricing, or label changes can meaningfully affect a drug maker’s revenue much like a bestselling product or a recalled item would impact any company’s financial outlook.

pdufa regulatory

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

magnetic resonance imaging medical

Magnetic resonance imaging (MRI) is a medical scan that uses strong magnets and radio waves to make detailed pictures of the inside of the body without X-rays or surgery. For investors, MRI matters because the machines, software, maintenance, and scan services represent steady capital spending and revenue streams for equipment makers, hospitals and imaging centers; advances or wider adoption can change market size, pricing power and competitive dynamics much like a camera upgrade transforms picture quality and demand.

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– Presentation at SLEEP 2026 illustrates ability to convert non-responders into responders using personalized programming

LONDON--(BUSINESS WIRE)-- LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced new data showing that use of its PolySync™ programming algorithm increased the cumulative apnea-hypopnea index (AHI) response rate to 84.5% in patients with moderate to severe Obstructive Sleep Apnea (OSA) when treated with proximal hypoglossal nerve stimulation (pHGNS). The findings were presented at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), by lead author Alan R. Schwartz, M.D., adjunct professor of otorhinolaryngology in the Perelman School of Medicine at the University of Pennsylvania and research professor of otolaryngology for Vanderbilt Health.

The results build on LivaNova’s previously reported outcomes from the OSPREY randomized controlled trial (RCT), which reported a 65% responder rate in the treatment arm after 12 months of pHGNS therapy delivered by the Company’s aura6000™ System. In the PolySync substudy, patients who did not meet responder criteria after one year of individual-contact stimulation in OSPREY underwent reprogramming using simultaneous-contact stimulation. This approach converted the majority of these patients into responders, significantly improving both AHI and oxygen desaturation index (ODI) outcomes and increasing the cumulative response rate to 84.5%. LivaNova previously announced that PolySync will be available with its commercial pHGNS product, enabling the integration of advanced, patient-specific titration at the onset of therapy.

“These results underscore the strength of our underlying therapy and the opportunity to further enhance outcomes through innovation,” said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. “OSPREY demonstrated rapid and durable clinical benefit, and PolySync shows that we can meaningfully build on that foundation by improving response rates and expanding the impact of pHGNS therapy. This reflects our ongoing commitment to advancing personalized neuromodulation for patients with Obstructive Sleep Apnea.”

The PolySync findings extend the strong clinical foundation established by LivaNova’s OSPREY and THN3 RCTs, the first RCTs in hypoglossal nerve stimulation (HGNS). As previously reported, OSPREY met its primary safety and efficacy endpoints at six months, demonstrating significant reductions in AHI and ODI, with continued improvements through 12 months of therapy. The full dataset, published in Annals of Internal Medicine, confirmed clinically meaningful and sustained improvements across both objective measures and patient-reported outcomes, including daytime sleepiness and functional quality of life.

PolySync builds on LivaNova’s differentiated pHGNS platform, which utilizes a six-contact electrode positioned on the proximal hypoglossal nerve, prior to any nerve branching, to enable broader access to airway muscles and flexible therapy optimization. By enabling simultaneous-contact stimulation, PolySync expands the variety and number of possible stimulation fields, allowing for broader and more flexible activation of lingual muscles and improved treatment responsiveness across a heterogeneous patient population.

“These data are particularly meaningful because they demonstrate that this novel stimulation paradigm can further improve outcomes beyond that achieved with the initial response to therapy,” Schwartz said. “The ability to convert non-responders into responders through optimized programming represents an important advancement in treating Obstructive Sleep Apnea.”

PolySync programming was well tolerated, with no serious treatment-emergent adverse events and no stimulation- or device-related adverse events reported in the substudy.

“The progression from strong 12-month response rates to even higher cumulative outcomes highlights the clinical potential of this platform and its ability to address a broader patient population,” said Lucile Blaise, Global Head of Commercialization, OSA, at LivaNova.

In addition to the PolySync substudy, LivaNova presented a second scientific poster Tuesday at SLEEP 2026 relating to PolySync. Rex Chin-Hao Chen, Ph.D., a LivaNova research scientist, presented computational modeling supporting the dosing rationale for the simultaneous-contact stimulation used in PolySync.

On Wednesday at 10 a.m. EDT, 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, will present a poster at SLEEP 2026 examining the integration of GLP-1 receptor agonists into treatment protocols for OSA.

The poster presentations by Schwartz and Chen can be viewed here. Malhotra’s poster will be available at the same site upon conclusion of his presentation on June 17.

Together, these data and presentations highlight LivaNova’s continued investment in advancing neuromodulation science and expanding treatment options for the large and growing population of patients with OSA.

pHGNS is an FDA-approved therapy designed to improve airway patency during sleep by stimulating tongue muscles to prevent upper airway collapse. LivaNova’s multi-contact architecture enables a broad range of programmable configurations, supporting more precise, individualized therapy. The addition of PolySync programming demonstrates how advanced algorithms can further enhance outcomes and extend the benefits of therapy to more patients.

Building upon the FDA premarket approval received in March for aura6000, LivaNova is continuing to prepare its next-generation OSA device for a PMA supplement application to the FDA in the second half of 2026. This device is being designed for compatibility with magnetic resonance imaging (MRI), remote and secure configuration management capabilities, and long-lasting, rechargeable battery technology (up to 15 years).

Please visit our new OSA website to learn more.

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a vision to change the trajectory of lives for a new day. Through ingenious medical solutions in select neurological and cardiac conditions, LivaNova strives to ignite patient turnarounds. Headquartered in London, with approximately 3,300 employees and a presence in more than 100 countries, LivaNova serves 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 data presented at scientific meetings, the interpretation and potential clinical impact of such data, the performance and capabilities of the aura6000, and anticipated regulatory submissions, approvals, and commercialization of the Company’s next-generation OSA device. 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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Source: LivaNova PLC