Signifier Medical Technologies Limited (Signifier) has gained EU MDR certification for eXciteOSA, its daytime therapy for obstructive sleep apnea (OSA).

“Achieving EU MDR certification is a significant milestone for Signifier Medical Technologies and a testament to the hard work and dedication of our entire team,” Signifier Director/Head of Finance Mujtaba Chohan said. “This certification underscores our commitment to providing safe, effective, and cutting-edge solutions that improve the lives of patients with obstructive sleep apnea worldwide.”

The EU MDR certification will facilitate eXciteOSA’s broader adoption in European markets, enhancing accessibility to a non-invasive and effective treatment option for millions of patients living with OSA. With adherence rates exceeding 80%, eXciteOSA has demonstrated its ability to improve sleep quality, increase energy levels, and enhance overall well-being, according to the company.

“eXciteOSA is reshaping the treatment landscape for obstructive sleep apnea,” Signifier Commercial, Clinical, and Compliance Head Yasser Zayni stated. “The EU MDR certification ensures that more individuals in need can access this treatment, showcasing its potential to positively impact public health across Europe and beyond. This certification validates the clinical efficacy of the treatment, and I am delighted that many more people struggling with obstructive sleep apnea will now have the opportunity to benefit from it.”

Signifier Medical Technologies aims to advance sleep medicine through innovation, research, and a focus on patient outcomes. The company is actively working to expand the availability of eXciteOSA globally.

eXciteOSA is a daytime therapy for sleep-disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA uses neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, working the intrinsic and extrinsic tongue muscles to improve endurance and prevent airway collapse during sleep. Unlike other devices that are used while patients sleep, eXciteOSA is the first commercially available device used while awake.

Signifier is engaging with the sleep research community to produce evidence from clinical trials.

Signifier is developing and commercializing 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 is headquartered in London.