BOSTON & LONDON–(BUSINESS WIRE)–Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announces the FDA approval to remove dental contraindications for eXciteOSA. This opens the door for doctors and other providers to prescribe eXciteOSA on a more widespread basis.
Based on an observational study conducted by Signifier Medical, the data demonstrated no significant difference in the occurrence of eXciteOSA side effects amongst those with intraoral metal and those without intraoral metal dental work. As a result of these findings, the FDA has approved the removal of temporary or permanent metal implants, dental braces, and intraoral metal prosthesis, restorations, and appliances from contraindications. This meaningfully expands the number of patients who can benefit from a daytime therapy, with no nighttime wearable, for mild obstructive sleep apnea and snoring.
“It’s a good thing when the FDA removes a barrier that didn’t make sense to us as clinicians. The exclusion because of metal restorations made it more difficult to talk to non-dentist medical colleagues. Now, with the restriction lifted, we can go about finding the best therapy for the individual patient,” said Steve Carstensen, DDS, Co-founder of Premier Sleep Associates, the Director of Education for Airway Technologies, and Chief Dental Editor for Dental Sleep Practice Magazine.
In the study, Signifier gathered therapy experience data from 499 real-world users of eXciteOSA, including both civilian and Veteran patients. The focus of the study was primarily on the occurrence of side effects amongst patients with and without intraoral metal dental work and/or jewelry. Participants were asked to report the frequency, level of discomfort, and duration of eXciteOSA side effects. A thorough intraoral/dental history was obtained, focused on the presence of intraoral metal.
“A large number of Veterans were previously deemed ineligible for eXciteOSA for mild OSA/simple snoring because of the dental contraindications. This latest development is going to be well-received by VA clinics and patients across the country,” said Dr. Brandon Nokes, Director of Hypoglossal Nerve Stimulation at VA San Diego.
This study demonstrates the low-risk profile of eXciteOSA — a novel medical therapy that was authorized in the FDA De Novo process. This important milestone moves eXciteOSA, which treats one of the root causes of OSA, one step closer to being a first-line therapy for millions of people suffering with mild sleep apnea and snoring.
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 to improve population health, increase the quality of patients’ healthcare experience, and generate healthcare savings. Signifier has offices in London (UK) and Needham (Massachusetts, USA).
eXciteOSA is a revolutionary daytime therapy 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 reduced endurance of the upper airway muscles, allowing the tongue to fall back and block 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.
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).
For more information on the dental study, please email [email protected].
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