CMS Sets Pricing with New HCPCS Codes for eXciteOSA Therapy, Expanding Access to Innovative Daytime Sleep Apnea Treatment

Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, welcomes the recent announcement by the Centers for Medicare & Medicaid Services (CMS) regarding the establishment of final HCPCS coding, benefit category determination, and payment determination for eXciteOSA therapy. This milestone decision represents a significant step toward expanding access to innovative and effective treatment options for individuals with sleep apnea, especially those covered by Medicare.

The recent CMS HCPCS Level II coding decision became effective on October 1, 2023. Here is the complete list of available codes for eXciteOSA.

HCPCS Codes and Descriptions

• E0490: Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by hardware remote to describe eXciteOSA® with a remote.
• K1028: Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by phone application.
• E0491: Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by hardware remote, 90-day supply.
• K1029: Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by phone application, 90-day supply.

Sleep apnea affects 55 million adults in the US, and if left untreated, it can lead to serious costly comorbidities, including cardiovascular disease, respiratory diseases, and metabolic disorders, resulting in increased hospital visits and healthcare costs. While continuous positive airway pressure (CPAP) therapy has been the standard treatment for moderate to severe OSA, it has long been plagued with low adherence and low patient satisfaction. eXciteOSA has shown greater than 80% adherence through the simplicity and convenience of a non-invasive daytime therapy that empowers patients to restore their nighttime breathing naturally.

These decisions made by CMS demonstrate their recognition of the clinical value and potential impact of eXciteOSA therapy. By providing a defined pricing structure, CMS is facilitating broader access to this innovative treatment, ensuring that eligible individuals covered by Medicare can benefit from its effects.

“This milestone accelerates our mission to improve patients’ lives by offering innovative and effective treatment options,” stated Director and Co-founder, Akhil Tripathi. “Demand is growing, with over 12,000 patients who have sought our therapy, and reimbursement will now help even more patients who suffer from OSA.”

As Signifier Medical continues to work closely with CMS, the company remains dedicated to supporting the adoption and implementation of eXciteOSA therapy across various healthcare settings. Through ongoing research, education, and collaboration, Signifier Medical strives to maximize the positive impact of its therapy and improve the quality of life for individuals living with sleep apnea.

About Signifier Medical Technologies

Signifier Medical 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 has offices in London (UK) and Needham (Massachusetts, USA).

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 which are used while patients sleep, eXciteOSA is the first commercially available device used while awake.

Signifier Medical 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.

Contacts

Media:
Jay Cranston
Signifier Medical Technologies LLC
jay.c@signifiermedical.com

Investors and Partners:
Mujtaba Chohan
Signifier Medical Technologies LLC
mujtaba.c@signifiermedical.com