Boston-based Signifier Medical Technologies LLC received US Food and Drug Administration (FDA) approval to remove dental contraindications for eXciteOSA, its daytime sleep apnea therapy device, an approval it says will allow greater patient reach.
Based on an observational study conducted by Signifier, the data demonstrated no significant difference in the occurrence of eXciteOSA side effects among those with intraoral metal and those without intraoral metal dental work.
As a result of these findings, the FDA OKed the removal of temporary or permanent metal implants, dental braces, and intraoral metal prosthesis, restorations, and appliances from contraindications. According to a press release by Signifier, this “meaningfully” expands the number of patients who can benefit from the daytime therapy, with no nighttime wearable, for mild obstructive sleep apnea (OSA) and snoring.
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 among 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,” says Brandon Nokes, MD, director of hypoglossal nerve stimulation at VA San Diego, in a press release.
The study demonstrates the low-risk profile of eXciteOSA, which 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,” according to the press release by Signifier.