The system utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality. It aims to treat obstructive sleep apnea (OSA) in patients with an apnea-hypopnea index (AHI) between 15 and 65 who have failed, do not tolerate, or are ineligible for first-line therapies, such as positive airway pressure (PAP).
London-based LivaNova’s system could rival on-the-market neurostimulators from Inspire Medical and Nyxoah. They all offer an alternative to traditional CPAP sleep respiratory systems. LivaNova submitted the technology to the FDA in May 2025.
The company supported its approval with data from the OSPREY clinical trial, which met 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.
Next, LivaNova plans to build on its PMA with a next-generation OSA device, set for a PMA supplement application to the FDA. It said it designed the updated device for compatibility with MRI, remote and secure configuration management capabilities and long-lasting, rechargeable battery technology (up to 15 years). The company has also previously outlined its hopes for CMS to reconsider coverage for difficult-to-treat depression after submitting a request last year.
CEO Vladimir Makatsaria outlined plans for the technology in an interview with MassDevice last year.
Commentary from LivaNova officials
Ahmet Tezel, chief innovation officer for LivaNova, said:
“FDA approval of the aura6000 marks a transformative moment for LivaNova and represents a major step forward for patients struggling with inadequately treated OSA. Our p-HGNS therapy underwent a rigorous evaluation for safety and efficacy in the OSPREY randomized controlled trial and delivered clinically significant responses and sustained improvements over time. Now, with FDA approval secured, we are advancing the device toward an even more sophisticated, next-generation system for patients and, ultimately, commercialization. We are proud to bring the option of p-HGNS to more patients, as the first and only HGNS device FDA-approved without a contraindication or warning related to CCC and no requirement for a pre-implantation DISE (drug-induced sleep endoscopy).”
Lucile Blaise, LivaNova’s global head of commercialization for OSA, said:
“FDA approval of the aura6000 System validates our innovative solution that will soon provide a much‑needed alternative for OSA patients who are unsuccessful with PAP and are seeking effective therapy, regardless of complete concentric collapse. The system has also been validated with a pivotal study in more severe patients than any other approved HGNS therapy, and we look forward to bringing our next-generation technology to market next year.”
The analysts’ take
Needham analyst Mike Matson maintains a “Buy” rating for LivaNova on the back of this announcement.
Matson explains that LivaNova expects to capture a “substantial portion” of the HGNS market. He also pointed to the fact that the OSPREY trial was a large, randomized, controlled trial with CCC inclusion and diverse patient demographics.
According to the analyst, LivaNova estimates a $1 billion market for OSA, with a total addressable market that’s less than 5% penetrated. The company expects between $200 million and $400 million in OSA revenue by 2030.
“We expect the OSA device to be a meaningful growth driver in 2027+ and reiterate our Buy rating,” Matson concluded.
