LivaNova submits nerve stim for sleep apnea to FDA, raises 2025 guidance

 LivaNova (Nasdaq: LIVN)

 today announced 12-month data from its OSPREY study supporting an FDA submission of the aura6000 system.

The London-based medtech company recently completed its submission based on meeting OSPREY’s primary safety and efficacy endpoints. It submitted six-month data and provided 12-month interim results with plans to share the full 12-month dataset during the review.

aura6000 is an investigational implantable proximal hypoglossal neurostimulator. LivaNova hopes to bring it to market to treat adult patients with moderate to severe obstructive sleep apnea (OSA). If successful, the implant could rival Inspire Medical’s neurostimulator as an alternative to traditional CPAP sleep respiratory systems.

Year-long data shared today by LivaNova highlighted a 65% responder rate in the treatment arm, with responders defined as those who realized at least a 50% improvement from the baseline apnea-hypopnea index (AHI) and an AHI value below 20. The study features a differentiated neurostimulation modality called proximal hypoglossal nerve stimulation (p-HGNS). It utilizes six electrodes placed on the proximal trunk of the hypoglossal nerve for broad access to the muscles controlling the airway.

“OSPREY is the first major multi-center randomized, controlled pivotal trial of hypoglossal nerve stimulation. Patients in the device stimulation group experienced a rapid onset of therapy with continued improvement over time,” 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 UC San Diego Health. “Responder rates in the treatment group were strong throughout the first year with one in four patients responding on day one, 50% responding by month three, and 65% responding by the 12-month mark. In addition, patient-reported outcomes for daytime sleepiness and functional outcomes of sleep quality demonstrated meaningful improvement over the course of 12 months.”

More on the data shared by LivaNova

When comparing baseline median values to six and 12 months of therapy (assessed at the seven- and 13-month follow-up visits, respectively), OSPREY subjects showed significant reductions in AHI and oxygen desaturation index (ODI) over time.

AHI and ODI reduced by 68%, LivaNova said. After 12 months of treatment, OSPREY subjects in the device stimulation group experienced clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ).

LivaNova also reported no serious adverse device-related or procedure-related events during OSPREY.

“The OSPREY trial demonstrated rapid and sustained improvement for patients who received active proximal hypoglossal nerve stimulation, including those with severe obstructive sleep apnea, elevated body mass index, and high risk of complete concentric collapse,” said Ahmet Tezel, chief innovation officer of LivaNova. “The OSPREY 12-month results further validate the potential of this therapy as a treatment alternative for the large and growing OSA population. With the strength of our clinical data, expertise of our neuromodulation team, and strategic growth opportunity ahead, we are eager to bring this innovation to patients.”

First-quarter results and raised guidance

In addition to the OSPREY results, LivaNova shared first-quarter financial results today that topped Wall Street estimates.

Shares of LIVN rose 8.5% to $38.13 apiece before the market opened today.

The company reported losses of $327.3 million. That equals $6.01 per share on sales of $316.9 million for the three months ended March 31, 2025.

LivaNova reported a massive bottom-line slide of nearly $300 million on a sales increase of 7.5%. It attributed the losses to an Italian Supreme Court Decision determining that LivaNova can be held liable for the established environmental liabilities of SNIA (a former parent of Sorin). It said the SNIA environmental liability accounted for €333.3 million ($360.4 million).

Adjusted to exclude one-time items, earnings per share came in at 88¢. That landed 12¢ ahead of expectations on Wall Street. Sales also topped projections as experts forecast $302.4 million in revenue.

“In the first quarter, LivaNova delivered solid revenue growth, driven by the ongoing success of the Essenz rollout, demand for Cardiopulmonary consumables, and strong Neuromodulation performance in the Europe and Rest of World regions,” said Vladimir Makatsaria, CEO of LivaNova. “This top-line result, coupled with operational efficiencies, contributed to meaningful operating income growth and cash generation. Importantly, we also achieved significant regulatory and clinical milestones in our obstructive sleep apnea program, including our PMA submission and 12-month data from the OSPREY trial. These achievements reflect effective execution across the organization and reinforce our focus on talent, innovation, growth, and operational excellence.”

LivaNova now expects full-year revenue growth between 6% and 7%, raising its previous range from between 5% and 6%. It expects adjusted EPS, however, to land between $3.60 and $3.70, dropping 5¢ at each end of the range. That now incorporates the impact of the SNIA decision and currently applicable tariffs.

https://www.massdevice.com/livanova-submits-nerve-stim-sleep-apnea-fda/