Boston-based Signifier designed eXciteOSA as a daytime therapy for sleep-disordered breathing. The company says it’s the only such treatment with FDA authorization.
The 20-minute daytime therapy allows patients to restore their nighttime breathing naturally. It comes through a wireless, smart device.
Nasdaq recognized this milestone by congratulating the company on the Nasdaq Tower in Times Square, New York.
“This is a proud moment knowing that our therapy has made a positive impact on the lives of so many patients,” said Signifier co-founder and CEO Akhil Tripathi. “It’s been a great team effort among our employees, clinicians, distributors, and most of all, our patients.”
This kind of treatment could open up new avenues for patients with sleep apnea. Philips remains out of the market due to a massive recall surrounding its sleep therapy devices.
ResMed at first struggled to cope with increased orders and supply chain shortages as that recall unfolded. However, earlier this year, the company said it boosted production to alleviate the CPAP shortage. Inspire Medical, which develops an implantable sleep apnea therapy, saw a massive sales bump this year, too.
More about Signifier Medical and the eXciteOSA
The FDA authorized marketing for eXciteOSA in February 2021. Signifier’s prescription-only device is used while awake to improve tongue muscle function. Its targeted neuromuscular electrical stimulation can help prevent the tongue from collapsing backward and obstructing the airway during sleep. It represents the first device of this kind for use while awake.
The smart, wireless device pairs with an intuitive app and a dedicated sleep advocate for one-on-one coaching and support.
Past studies associate the device with reductions in both objectively measured and bed-partner-reported snoring, the Signifier said. It also demonstrated significant improvements in disease severity, measured by the Epworth Sleepiness Scale, and Pittsburgh Sleep Quality Index. Clinical trial participants experienced a significant reduction in apnea-hypopnea index (AHI).
“eXciteOSA is a new and novel daytime treatment for sleep apnea. Burden of use is as low as 20 minutes.” Evidence is mounting about the positive effects of eXciteOSA in improving disease severity and daytime sleepiness. Patients now have an alternative approach that is easy to use and well accepted,” said Dr. Naresh M. Punjabi, chief of the division of pulmonary, critical care, and sleep medicine at the University of Miami.