Signifier Medical Technologies Announces Publication of Peer-Reviewed Analysis Demonstrating Improvement in Obstructive Sleep Apnea Severity with Neuromuscular Electrical Stimulation
Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announced that a peer-reviewed paper has recently been published in Sleep and Breathing. The analysis, published by University of California San Diego investigators Dr. Brandon Nokes, Professor Atul Malhotra, and other collaborators, is based on a post-hoc analysis of 65 participants with mild obstructive sleep apnea (OSA) who completed sleep testing before and after six weeks of genioglossus (tongue muscle) neuromuscular electrical stimulation (NMES) with eXciteOSA.
The first of its kind, eXciteOSA is an FDA-authorized, non-invasive daytime treatment for snoring and mild OSA. Unlike other treatment options, this does not require a nighttime wearable, which allows patients to conveniently fit therapy into their daily routine. The therapy works by using NMES to build endurance of the genioglossus muscle so that the tongue doesn’t collapse into the airway during sleep. The eXciteOSA device is used for only 20 minutes per day for six weeks and then a minimum of twice per week thereafter for maintenance.
Based on the data from the peer-reviewed analysis, the researchers observed a significant improvement in the average apnea-hypopnea index (AHI) from 10.2 to 6.8 events/hour (33%) among all participants, and from 10.4 to 5.0 events/hour (52%) in the responder subgroup which represented 78% of the study sample (51 of 65). Statistically-significant improvements in self-reported sleepiness, sleep quality, objectively measured snoring, and bed partner reported snoring were observed. Average adherence to eXciteOSA therapy was 85%.
The Sleep and Breathing article can be found here:
https://link.springer.com/article/10.1007/s11325-022-02644-9
eXciteOSA has the benefit of being a daytime-only treatment modality which confers a high level of tolerability and patient acceptance. It alleviates the need for an in situ device during sleep and is associated with improvements in OSA severity, snoring, sleepiness, and sleep quality. Further studies are needed to define which individuals may benefit most from the device across the wider spectrum of OSA severity and assess long-term therapeutic outcomes. Signifier Medical Technologies is supporting four clinical trials on these topics, currently underway.
Signifier is a pioneer in addressing a key root cause of sleep disordered breathing. We are focused on the development and commercialization of innovative and non-invasive solutions that help people breathe normally and naturally all night – entirely on their own. The publication of this study in conjunction with ongoing clinical trials represents Signifier Medical’s commitment to research of therapies that improve population health, increase the quality of patients’ experience, and generate healthcare savings.