Signifier Medical Technologies Secures European Union Medical Device Regulation (EU MDR) Certification for eXciteOSA®

LONDON--(BUSINESS WIRE)--Signifier Medical Technologies Limited (“Signifier”), a global leader in medical technology for sleep-disordered breathing, announces that it has achieved the EU MDR certification for eXciteOSA^®, its groundbreaking daytime therapy for obstructive sleep apnea (OSA). This certification demonstrates Signifier’s commitment to meeting the highest standards of safety, performance, and efficacy required by the European Union for medical devices.

The EU MDR certification is recognized globally for ensuring that medical devices meet stringent requirements for quality, safety, and clinical evaluation. The EU MDR certification paves the way for broader adoption of eXciteOSA^® across 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.

“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,” said Mujtaba Chohan, Head of Finance and Director at Signifier. “This certification underscores our commitment to providing safe, effective, and cutting-edge solutions that improve the lives of patients with obstructive sleep apnea worldwide.”

“eXciteOSA^® is reshaping the treatment landscape for obstructive sleep apnea,” said Yasser Zayni, Head of Commercial, Clinical and Compliance at Signifier. “The EU MDR certification ensures that more individuals in need can access this transformative 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 is committed to advancing the field of sleep medicine through innovation, research, and a focus on patient outcomes. The company is actively working to expand the availability of eXciteOSA^® globally while maintaining quality and compliance with the highest regulatory standards.

About Signifier Medical Technologies

Signifier is a pioneer in addressing the root causes of sleep-disordered breathing. The Company is focused on 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’s headquarters are in London (UK).

About eXciteOSA^®

eXciteOSA^® is a revolutionary 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 dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials.

To learn more about eXciteOSA^®, please visit www.signifiermedical.com or www.exciteosa.com.