Neuromod Vendors Close in on Inspire in OSA Market

by James Cavuoto, editor

March 2024 issue, BioElectRx Business Report

The bioelectronic medicine market for treating sleep disorders using hypoglossal nerve stimulation is rapidly becoming more competitive as new vendors emerge and existing players report progress. While Inspire Medical currently has the U.S. market to itself, Nyxoah has begun to compete in Europe and expects to gain FDA approval soon.

Earlier this month, Nyxoah announced that its DREAM pivotal study in the U.S. achieved a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and ODI responder rate, both on an ITT basis. The DREAM pivotal trial of the Genio hypoglossal nerve stimulation system enrolled 115 patients required subjects to sleep supine for at least 60 minutes at their 12-month polysomnography test. Study participants entered the DREAM study with a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5. At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria, resulting in an ITT AHI responder rate of 63.5%, and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3%. The safety results for the investigational treatment were favorable, with 11 serious adverse events in 10 subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device related and there were three explants.

“DREAM is a pivotal, multicenter, international study of Genio, a next generation HGNS technology offering patients bi-lateral stimulation with a non-implanted battery solution powered and controlled by a wearable. With the DREAM data, Genio has demonstrated positive efficacy results that OSA patients, having failed traditional medical therapies, have come to expect. Notably, Genio’s unique bilateral stimulation provides the potential for improved outcomes for a wider spectrum of OSA patients. I am excited that Nyxoah and Genio are working towards expanding options and advancing HGNS therapy for OSA, and I look forward to offering it to my patients upon FDA approval,” said B. Tucker Woodson, of the Medical College of Wisconsin and principal investigator of the DREAM study.”

“I am excited to report the positive DREAM results, as they pave the way for Genio to shift the OSA treatment paradigm in the U.S. With Genio’s patient centric design, strong clinical data and commercial learnings from Europe, we are confident Nyxoah can become a leading OSA company.” commented Olivier Taelman, Nyxoah’s CEO. “We are finalizing the fourth and final module submission in the PMA application and I look forward to launching Genio in the U.S., pending FDA approval.”

Nyxoah also announced that the company has signed a strategic partnership to become a corporate champion at the ENTerprise Circle level with the American Association of Otolaryngology – Head & Neck Surgery Foundation. Nyxoah is the first medical device company to partner with the AAO-HNSF at this level.

The AAO-HNSF is committed to identifying and combating harmful coverage policies that threaten access to quality otolaryngology-head and neck services. The Academy’s Advocacy team, in collaboration with its dedicated members and strategic industry partners like Nyxoah, actively engage with payers to achieve this goal. They are currently advocating for reducing the hurdles to new, bilateral HGNS therapy with clinical guidelines to be used by CMS and commercial insurance payers.

Meanwhile, LivaNova plc, the London, U.K. manufacturer of neuromodulation systems, announced that its OSPREY clinical study, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation, has achieved a positive predictive outcome and will conclude enrollment earlier than anticipated. This means there is a greater than 97.5% probability that the OSPREY trial will successfully meet its primary endpoint.

OSPREY is a prospective, multi-center, randomized controlled open-label trial demonstrating the safety and effectiveness of LivaNova’s aura6000 HGNS 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. LivaNova notified the FDA and its partner trial sites of this significant milestone for the OSPREY study.

“A planned interim analysis, per the approved protocol, was conducted for the first 90 patients enrolled in OSPREY. We are now able to estimate a high chance of success for achieving the primary endpoint in this unique randomized controlled trial without further patient enrollment,” said Atul Malhotra, professor of medicine at University of California, San Diego and principal investigator for OSPREY. “While this milestone shows we are on a positive trajectory, long-term follow-up visits will continue for each patient through the primary endpoint and beyond.”

The OSPREY study’s primary efficacy endpoint is the demonstration that the AHI responder rate of subjects with device stimulation activated is statistically significantly higher than the rate of subjects without stimulation after seven months of follow-up. For OSPREY, response is defined as at least a 50% improvement from the baseline AHI, leading to an AHI value below 20. After the full cohort completes the seven-month follow-up visit and the results are compiled, LivaNova will submit OSPREY’s final clinical module to the FDA.

“We are pleased to have achieved this positive milestone for the OSPREY study,” said Vladimir Makatsaria, CEO of LivaNova. “In accordance with the study protocol, once the last patient implanted completes their final follow-up visit, we will conduct the final analysis for the study. Until then, we will continue to actively work with the clinical sites to manage the study patients.”

The OSPREY study also assesses the safety of the aura6000 System and measures patient quality of life through indicators such as daytime sleepiness. For more information on the therapy and the treatment of OSA, visit the LivaNova website.

Another new entrant in the OSA market is a startup firm called LunOSA. The firm, founded by Micro-Leads CEO Bryan McLaughlin and former StimWave executive Chad Andresen, will exploit the capabilities of Micro-Leads’ injectable paddle-lead technology for peripheral nerve stimulation. Andresen said the company is developing both a battery and batteryless version of its device, which will be injected percutaneously with a 14-gauge introducer.

Yet another new player is Invicta Medical in Santa Clara, CA. That company has raised $29.5 million in funding since 2020 and is backed by leading investors including Forepont Capital, Aphelion Capital, Greatpoint, and Shangbay Capital. Invicta CEO Rick O’Conner is a former VP of engineering at Spinal Modulation, now part of Abbott.

Another firm, XII Medical in Union City, CA, raised a $30 million Series A round in 2022.