Signifier Medical Technologies’ eXciteOSA®, the Only FDA-Authorized Daytime Therapy for Primary Snoring and Mild Obstructive Sleep Apnea, Demonstrates Real-World Adherence to Treatment of Over 80%

Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announced today the results of an analysis of real-world patient adherence data for its lead product, eXciteOSA. The data demonstrated that real-world patients in the US prescribed eXciteOSA, the first daytime therapy indicated to treat primary snoring and mild obstructive sleep apnea (OSA), exhibited strong adherence to the treatment by using therapy on over 80% of days over the first six weeks of treatment. The current standard of care for treating mild OSA, positive airway pressure (PAP), has long been plagued with low adherence and low patient satisfaction. Clinical trials and observational studies indicate 25-46% of patients are not adherent to PAP.^1-3 There is also evidence those with mild OSA are 34% less likely to be adherent to PAP than those with moderate/severe OSA.⁴

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In the white paper, A descriptive analysis of objectively monitored real-world adherence to eXciteOSA, Signifier analyzed real-world data from 3,561 individual patients in the US up until June 2022. The results demonstrate that patients have used eXciteOSA therapy on over 80% of days during the first six weeks of treatment. Signifier reported that real-world patients use therapy for an average of 680 minutes (11:20 hh:mm) within the first six weeks, representing over 80% of the total duration prescribed (840 minutes). The dataset represents the entire population of US-based patients who started therapy on eXciteOSA over the 15-month period from April 2021 to June 2022.

“The real-world data released today suggests eXciteOSA patients adhere strongly to the therapy. Sleep apnea is a serious condition, and adherence to treatment is both a challenge and a requirement. We’re delighted that eXciteOSA appears to become a part of a patient’s daily routine, and we’re thrilled to provide a treatment that is easy-to-use and allows patients to get a good night’s rest without hoses and masks. We understand patients’ desire for effective treatments that fit their lifestyle,” said Dr. Jessie Bakker, Executive Vice President of Medical Affairs at Signifier.

Signifier will hold a webinar, What's New with eXciteOSA®, on September 28, 2022 at 7 PM ET, which will be available after the live event on-demand. The webinar will provide an update on the results published in the white paper as well as reimbursement updates for easier patient access, progress on clinical trials, and app developments for an improved patient experience.

Recent estimates indicate 54 million adults in the United States suffer from OSA, with more than half falling into the mild range. Patients with mild OSA are more likely to report poor quality of life compared to controls, after adjusting for confounders including age, gender, ethnicity, marital status, smoking, education, and co-morbidities.⁵ In addition, epidemiological analyses have found compared with controls, patients with mild OSA have a 224% increased risk of developing hypertension⁶,are 83% more likely to be diagnosed with diabetes⁶, and 59% more likely to have abnormal fasting glucose.⁸

Past studies have shown eXciteOSA is associated with reductions in both objectively-measured and bed-partner reported snoring, along with significant improvements in disease severity, the Epworth Sleepiness Scale, and Pittsburgh Sleep Quality Index.^9-11 Clinical trial participants experienced an average 33% reduction in their AHI overall, with a 52% reduction evident in the responder subset.¹¹ Following a successful FDA submission through the de novo pathway, eXciteOSA was launched in the United States in early 2021 as the first daytime therapy product indicated for treatment of primary snoring and mild OSA.

“The body of evidence regarding the efficacy and adherence of eXciteOSA is growing and we continue to evaluate and learn about the utility and impact this therapy can have on the lives of those patients living with sleep apnea and their partners. We’re looking forward to the results of our ongoing clinical trials including a study of patients with moderate OSA,” said Phil Hess, Chief Operating Officer of Signifier.

Signifier is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. Randomized trials are in progress to understand the potential placebo effect (NCT04974515), the impact of therapy relative to usual care without treatment (NCT05183009; NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

About Signifier Medical Technologies

Signifier is a pioneer in addressing the root causes of sleep disordered breathing. The Company is focused on the development and commercialization of innovative and non-invasive solutions to help people breathe normally and naturally all night – without needing to use a wearable medical device or a surgical implant. Founded in 2015, Signifier is at the forefront of sleep therapy, with a mission to develop therapies improving population health, increase the quality of patients’ experience, and generate healthcare savings. Signifier has offices in London (UK) and Needham (Massachusetts, USA).

About eXciteOSA

eXciteOSA is a revolutionary daytime therapy device for sleep disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA improves daytime sleepiness and sleep quality. Nearly one billion adults aged 30 to 69 years globally are estimated to suffer from OSA, which is a serious medical condition associated with health problems such as high blood pressure and increased risks of heart attack, stroke, or death.

A major underlying cause of OSA is the upper airway muscles lack endurance during sleep and the tongue falls back, blocking the upper airway. By using neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, eXciteOSA works the intrinsic and extrinsic tongue muscles to improve endurance and prevent airway collapse during sleep.

Unlike other devices which are used while patients sleep, eXciteOSA is the first commercially available device used while awake. The full benefits of the daytime therapy are realized without patient use during sleep.

For more information, please visit www.signifiermedical.com or www.exciteosa.com.

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