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%

In the first 6 weeks of treatment, US patients used eXciteOSA 81% of the days –

Signifier Medical Technologies Releases White Paper and Announces Upcoming Webinar –

BOSTON & LONDON–(BUSINESS WIRE)–Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, today announced the results of an analysis of real-world patient adherence data for its flagship product, eXciteOSA . The data showed that real patients in the US who were prescribed eXciteOSA, the first day therapy to treat primary snoring and mild obstructive sleep apnea (OSA), demonstrated strong therapy adherence, comparing therapy on over 80% of days for the first used six weeks of treatment. The current standard of care for treating mild OSA, positive airway pressure (PAP), has long been plagued by poor adherence and low patient satisfaction. Clinical and observational studies show that 25-46% of patients do not comply with PAP.1-3 There is also evidence that people with mild OSA are 34% less likely to persist with PAP than those with moderate/severe OSA.4

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

“The real-world data released today suggest that eXciteOSA patients are strictly on therapy. Sleep apnea is a serious condition and maintaining treatment is both a challenge and a requirement. We are excited that eXciteOSA appears to be becoming part of a patient’s daily routine and we are excited to offer a treatment that is easy to use and allows patients to sleep well without tubes 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.

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Signifier will hold a webinar What’s new in eXciteOSA®, on September 28, 2022 at 7:00 p.m. ET, which will be available on-demand after the live event. The webinar will provide an update on the results published in the whitepaper, as well as reimbursement updates for easier patient access, clinical trial advances, and app developments for an improved patient experience.

Recent estimates show that 54 million adults in the United States have OSA, with more than half falling in the mild range. Patients with mild OSA are more likely than controls to report poor quality of life after adjusting for confounders such as age, gender, race, marital status, smoking, education, and comorbidities.5 In addition, epidemiological analyzes have found that patients with mild OSA have a 224% increased risk of developing hypertension compared to controls6, are 83% more likely to be diagnosed with diabetes6and 59% more likely to have abnormal fasting glucose.8th

Previous studies have shown that eXciteOSA is associated with a reduction in both objectively measured and bed partner reported snoring, along with significant improvements in condition severity, the Epworth Sleepiness Scale and the Pittsburgh Sleep Quality Index.9-11 Overall, participants in the clinical study experienced an average reduction in their AHI of 33%, with a 52% reduction evident in the responder subgroup.11 After a successful FDA submission by the New Pathway launched eXciteOSA in the US in early 2021 as the first day therapy product indicated to treat primary snoring and mild OSA.

“Evidence of the efficacy and adherence of eXciteOSA is accumulating, and we continue to investigate and learn about the benefits and impact this therapy can have on the lives of patients with sleep apnea and their partners. We look forward to the results of our ongoing clinical trials, including a trial in patients with moderate OSA,” said Phil Hess, Signifier’s Chief Operating Officer.

Signifier is committed to collaborating with the sleep research community to provide high quality evidence from rigorous clinical studies. Randomized trials are underway to understand the potential placebo effect (NCT04974515), the effect of therapy compared to usual care without treatment (NCT05183009; NCT05252156), and the effect of therapy in patients with moderate OSA (NCT05252156).

About Signifier Medical Technologies

Signifier is a pioneer in tackling the root causes of disrupted breathing during sleep. The Company is focused on developing and commercializing innovative and non-invasive solutions that help people breathe normally and naturally throughout the night – without the use of a wearable medical device or surgical implant. Founded in 2015, Signifier is a leader in sleep therapy with a mission to create therapies that improve population health, improve the quality of patient experience and deliver healthcare savings. Signifier has offices in London (UK) and Needham (Massachusetts, USA).

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About eXciteOSA

eXciteOSA is a revolutionary daytime sleep breathing device. Clinically proven to target a common cause of OSA, eXciteOSA improves daytime sleepiness and sleep quality. It is estimated that almost a billion adults aged 30 to 69 worldwide have OSA, a serious condition associated with health problems such as high blood pressure and increased risks of heart attack, stroke or death.

One of the main causes of OSA is that the upper airway muscles suffer from insufficient endurance during sleep and the tongue falls back and blocks the upper airway. Using neuromuscular electrical stimulation (NMES) to “train” the upper airway muscles, eXciteOSA targets the intrinsic and extrinsic muscles of the tongue to improve endurance and prevent airway collapse during sleep.

Unlike other devices that are used while you are asleep, eXciteOSA is the first commercially available device that is used while you are awake. The full benefits of daytime therapy are realized without patient application during sleep.

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