April 2026 issue, BioElectRx Business Report
April 30, 2026 | Following the recent FDA PMA approval of its aura6000 device, LivaNova joined two other OSA firms in the U.S. market: Inspire Medical with its Inspire V device and Nyxoah with the Genio device.
Earlier this month, LivaNova published the 12-month results from its pivotal OSPREY study, which supports the efficacy of its proximal hypoglossal nerve stimulation approach. The study included 104 adult patients, with 67 receiving treatment and 37 serving as unblinded controls. Results showed that 65% of patients in the pHGNS group were responders—achieving at least a 50% improvement in the apnea-hypopnea index and an AHI score below 20—compared with 14% responder rate in the control group. These figures are comparable to the responder rates seen in pivotal studies for Inspire (66%) and Nyxoah (64%).
While demonstrating similar efficacy to its competitors, LivaNova’s study included a broader patient population, including individuals with a higher body mass index (35 kg/m2) and those with complete concentric collapse. These subpopulations have historically been considered poor candidates for HGNS therapy. Including CCC patients is particularly significant because the condition affects 20-30% of the OSA population. By validating therapy for these patients, LivaNova can skip the drug-induced sleep endoscopy screening typically required for HGNS, potentially reducing patient wait times by several weeks. Recognizing this advantage, Nyxoah is also conducting a clinical trial in CCC patients to expand its own therapy coverage.
The three competing HGNS therapies are further distinguished by their anatomical targets and electrode designs. Inspire’s system requires muscle dissection to reach the distal medial branch of the nerve, while LivaNova targets the proximal nerve trunk before it branches. According to LivaNova’s vice president of R&D Holly Grammer, “Our cuff has six electrodes, so we’re able to tailor how we change the tongue and airway to improve sleep apnea. Our competitors [Inspire] are on one of the branches. We’re on the proximal, so we have the ability to impact the entire airway and tongue.”
In contrast to unilateral placement of cuffs on the nerve by LivaNova and Inspire, Nyxoah uses a single-component implant featuring an externally powered pulse generator and two electrodes placed bilaterally on the distal nerve branches near the genioglossus muscle.
Interestingly, LivaNova has opted to develop a next-generation version of the system rather than immediately launching the approved aura6000, likely to further differentiate its therapy. According to, LivaNova’s chief innovation officer, Ahmet Tezel: “We are advancing the device toward an even more sophisticated, next-generation system for patients. We will launch a next-generation version in 2027. First half of the year will be a limited market release followed by full market release in H2 2027. Aura6000 will not be our launch product.”
With an estimated 23 million people in the U.S. suffering from OSA, the availability of these diverse HGNS therapies is expected to significantly benefit the market growth.
