Signifier Medical Technologies is Granted HCPCS Codes for eXciteOSA to Help Patients Access Innovative Technology

Boston – (BUSINESS WIRE) – Signifier Medical Technologies LLC, a Boston-based medical technology company, announced today that the Centers for Health Services and Health Services (CMS) have created two new codes for the General Health Coding System (HCPCS) to describe eXcite.OSA, the first-ever FDA-approved de-novo device for the day-to-day treatment of mild obstructive sleep apnea (SLA) and primary snoring. The CMS coding decision was published on February 16, 2022, and the following codes will take effect on April 1, 2022:

HCPCS Code

Description

K1028

Power supply and electronics control unit for oral-muscle electrical stimulation of the tongue muscles to reduce snoring and obstructive sleep apnea, controlled by a telephone program.

K1029

The oral / neuromuscular electrical stimulation device of the tongue muscle, used in conjunction with a power supply and control electronics unit, is controlled by a telephone program, 90-day supply.

“We welcome CMS’s decision to create two new codes to describe eXciteOSA device, ”said Achilles Tripati, CEO of Signifier. “With more than 3,000 patients treated ExciteOSA, we have seen great demand for our therapy. The creation of the codes marks an important milestone for physicians, health systems, DME providers, payers and patients, and will allow Signifier to further demonstrate the real benefits of improved outcomes, cost savings and significant improvements in the quality of patient care. Compensation will help patients in the U.S. who suffer from sleep-disordered breathing be able to receive new, effective daytime treatments. ”

AAS is a progressive disease that often begins with primary snoring, affecting nearly 1 billion adults between the ages of 30 and 69 worldwide.1 Used only 20 minutes a day during the initiation period and then twice a week thereafter for maintenance, eXciteOSA targets the underlying cause of mild SLA by providing neuromuscular electrical stimulation to increase tongue muscle endurance.

“HPCCS codes play an important role in giving patients access to new medical devices, often improving payment options and healthcare solutions,” said Dr. Mark Benton, a pulmonologist and sleep medicine specialist from New Jersey. “The eXciteOSA it is a non-invasive, easy-to-use therapy that does not require patients to wear any devices overnight. Once the payment is set, eXciteOSA it will be easier to access for a wider and more diverse group of sleep apnea patients, and I’m excited to share the good news with all of them. ”

The CMS solution can be viewed at: https://www.cms.gov/files/document/2021-hcpcs-application-summary-biannual-2-2021-non-drug-and-non-biological-items-and- services .pdf

About Signifier Medical Technologies

Signifier is a pioneer in combating the root causes of sleep apnea. We focus on developing and commercializing innovative and non-invasive solutions for patients with conditions such as obstructive sleep apnea and primary snoring. Founded in 2015, Signifier is at the forefront of sleep therapy with a mission to develop treatments that improve the health of the population, improve the quality of patient experience and save money on health care. Signifier has offices in London (UK), Needham (Massachusetts, USA) and Berlin (Germany).

About eXciteOSA®

ExciteOSA is a revolutionary day therapy device for sleep apnea. It is clinically proven that eXcite targets the common root cause of OSAOSA improves sleep quality, improves health and improves quality of life. Nearly a billion adults between the ages of 30 and 69 worldwide suffer from AAS, which is a serious disease associated with health problems such as high blood pressure and an increased risk of heart attack, stroke or death.1-10

The main reason for SAS is that the muscles of the upper airways lack endurance during sleep, and the tongue dips back, blocking the upper airways. Using neuromuscular electrical stimulation (NMES) to “exercise” the upper respiratory tract muscles, eXciteOSA works on the internal and external muscles of the tongue to improve endurance and prevent airway collapse during sleep.

Unlike other devices used during patients ’sleep, eXciteOSA it is the first commercially available device used while awake. All the benefits of day therapy are realized without the use of patients during sleep.

About snoring and obstructive sleep apnea

It is estimated that about one billion adults between the ages of 30 and 69 worldwide suffer from OSA.1 AAS and snoring are problems for many people whose tongue muscles relax during sleep, causing airway collapse and reduced oxygen consumption, causing the sleeper to stop and breathe again during sleep, often pushing them to wake up.15-16

OSA is a serious condition associated with health problems such as high blood pressure and an increased risk of heart attack, stroke or death.2-9 AAS and snoring also affect patients ’partners and family members, thus creating a strain on the relationship.15-16

For more information, visit www.signifiermedical.com or www.exciteosa.com

Literature

  1. Benjafield, AV, Ayas NT, Eastwood PR et al. Estimation of global prevalence and severity of obstructive sleep apnea: a literature analysis. Lancet Respir Med 2019; 7: 687-698.

  2. Peppard PE, Young T, Palta M et al. A promising study of the relationship between sleep apnea and hypertension. N Engl J Med. 2000; 342: 1378–1384. [PubMed: 10805822]

  3. Gottlieb DJ, Yenokyan G, Newman AB et al. A promising study of obstructive sleep apnea and coronary heart disease and heart failure: a study of sleep heart health. Circulation. 2010; 122: 352– 360. [PubMed: 20625114]

  4. Yaggi HK, Concato J, Kernan WN et al. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005; 353: 2034–2041. [PubMed: 16282178]

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  6. Peker Y, Hedner J, Norum J et al. Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnea: 7-year follow-up. Am J Respir Crit Care Med. 2002; 166: 159–165. [PubMed: 12119227]

  7. Marin JM, Carrizo SJ, Vicente E et al. Long-term cardiovascular outcomes in men with obstructive sleep apnea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005; 365: 1046–1053. [PubMed: 15781100]

  8. Peppard PE, Szklo-Coxe M, Hla KM et al. Longitudinal association of respiratory disorders and sleep-related depression. Arch Intern Med. 2006; 166: 1709–1715. [PubMed: 16983048]

  9. Kendzerska T, Gershon AS, Hawker G et al. Obstructive sleep apnea and diabetes: a historical cohort study. Am J Respir Crit Care Med. 2014; 190: 218–225. [PubMed: 24897551]

  10. Johnson KG and Johnson DC. Incidence of sleep apnea in stroke patients and tia: a meta-analysis. J of Clinical Sleep Med 2010; 6 (2): 131-7

  11. Baptist et al. Daytime neuromuscular electrotherapy of the tongue muscles in improving snoring. 2021

  12. Kotsecha. et al. A new device for intraoral neuromuscular stimulation to treat sleep-disordered breathing. Sleep breathing. 2021

  13. Data in the file. Signifier Medical Technologies

  14. Davey, MJ. An epidemiological study of snoring as a result of a random survey of 1,075 participants. British Association of Snoring and Sleep Apnea. 2002; Available at: https://britishsnoring.co.uk/pdf/epidem.pdf

  15. Levy P, Kohler M, McNicholas WT et al. Obstructive sleep apnea syndrome. Nat Rev Dis Primers 2015; 1: 15015.

  16. Lewister FS. Effects of obstructive sleep apnea and its treatment on partners: a review of the literature. J Clin Sleep Med. 2017; 13 (3): 467-477.

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