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
[email protected]

Investors and Partners:
Mujtaba Chohan
Signifier Medical Technologies LLC
[email protected]

Signifier Medical Technologies Announces Upcoming Publication of Randomized Controlled Trial Results Examining High-Intensity (Active) Vs. Low-Intensity (Sham) Neuromuscular Electrical Stimulation in Patients for 6 Weeks

Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, is pleased to announce that the publication of AEGIS clinical trial results is in press at the ERJ Open Research. The objective of the trial was to determine whether patients with mild obstructive sleep apnea (OSA) would adhere to eXciteOSA, a daytime neuromuscular electrical stimulation (NMES) therapy. Results showed high adherence, with approximately 90% of participants in each arm adherent to NMES. This trial demonstrates the potential of Signifier Medical’s innovative medical technology to significantly improve the lives of individuals suffering from obstructive sleep apnea (OSA).

“The encouraging results from our first randomized controlled trial further validate the data from our previous studies, and we’re thrilled to see how well patients accept the therapy,” says Co-founder and Director, Akhil Tripathi.

The current standard of care for treating mild OSA, positive airway pressure (PAP), has long been plagued with low adherence and low patient satisfaction. Clinical trials and observational studies indicate 25-46% of patients are not adherent to PAP.1-3 There is also evidence that those with mild OSA are 34% less likely to adhere to PAP than those with moderate/severe OSA.4 Given that adherence to positive airway pressure (PAP) therapy in OSA is suboptimal, alternative strategies are needed, particularly for patients with mild OSA.

The AEGIS clinical trial was a randomized, double-masked, sham-controlled study to assess the adherence and overall impact of Signifier Medical’s innovative medical device, eXciteOSA, in managing and treating obstructive sleep apnea. Using NMES to “exercise” the upper airway muscles, eXciteOSA improves tongue muscle endurance and reduces the occurrence of airway collapse during sleep. The trial involved 40 patients and was conducted in collaboration with a network of renowned medical institutions and healthcare professionals.

Key findings of the AEGIS trial include:

High adherence: eXciteOSA for 20 minutes a day for 6-weeks in mild OSA was well accepted, with approximately 90% of the participants adhering to the required days of use.

Improvement in OSA severity: eXciteOSA was associated with approximately a 33% improvement in OSA severity after accounting for patient-related factors such as age, sex, race, body mass index, and the time in the supine position. In contrast, OSA severity remained unchanged in participants who received the sham device.

Improvement in Daytime Sleepiness: Participants in the active arm experienced improvements in daytime sleepiness, whereas no such change was noted in the sham arm.

“We are immensely pleased with the positive outcomes observed in the AEGIS clinical trial,” said Dr. Naresh Punjabi, the trial’s principal investigator. “This publication underscores our commitment to advancing healthcare and developing solutions that can make a meaningful difference in the lives of patients.”

Signifier Medical Technologies remains dedicated to further research, development, and collaboration with healthcare professionals to continue advancing medical technology and improving patient outcomes.

For further information about the AEGIS clinical trial please visit:

Neuromuscular Electrical Stimulation for Obstructive Sleep Apnea: Comparing Adherence to Active and Sham Therapy | European Respiratory Society (ersjournals.com)

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 is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. Randomized trials are in progress to understand the impact of therapy relative to usual care without treatment (NCT05183009NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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


Contacts

Media:
Jay Cranston
Signifier Medical Technologies LLC
[email protected]

Investors and Partners:
Mujtaba Chohan
Signifier Medical Technologies LLC
[email protected]

 

References:

  1. Hwang D, Chang JW, Benjafield AV, Crocker ME, Kelly C, Becker KA, Kim JB, Woodrum RR, Liang J, Derose SF. Effect of Telemedicine Education and Telemonitoring on Continuous Positive Airway Pressure Adherence. The Tele-OSA Randomized Trial. Am J Respir Crit Care Med 2018;197(1):117-126.
  2. Cistulli PA, Armitstead J, Pepin JL, Woehrle H, Nunez CM, Benjafield A, Malhotra A. Short-term CPAP adherence in obstructive sleep apnea: a big data analysis using real world data. Sleep Med 2019;59(114-116.
  3. Patel SR, Bakker JP, Stitt CJ, Aloia MS, Nouraie SM. Age and Sex Disparities in Adherence to CPAP. Chest 2021;159(1):382-389.
  4. Jacobsen AR, Eriksen F, Hansen RW, Erlandsen M, Thorup L, Damgard MB, Kirkegaard MG, Hansen KW. Determinants for adherence to continuous positive airway pressure therapy in obstructive sleep apnea. PLoS One 2017;12(12): e0189614.

Neuromuscular Electrical Stimulation as a treatment for obstructive sleep apnea gains traction with a recently announced World Sleep 2023 Congress symposium

BOSTON and LONDON – September 26, 2023, Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston- and London-based medical technology company, is excited to announce that the presentation “Neuromuscular Electrical Stimulation: A Novel Approach for Treatment of Obstructive Sleep Apnea” will be included in the prestigious World Sleep 2023 Congress. Since its FDA De Novo authorization in 2021, Signifier Medical has been a leader in applying neuromuscular electrical stimulation (NMES) to obstructive sleep apnea (OSA).

The NMES-for-OSA World Sleep presentation will be led by doctors Alexandre Abreu, Atul Malhotra, Adrian Williams, Marina Carrasco, and Naresh Punjabi. These leaders in sleep medicine will dive into the innovative research and clinical findings that demonstrate the efficacy and unique benefits of NMES in treating OSA. At this session, attendees can expect to gain an understanding of the therapy’s mechanism of action, clinical trial results, and its benefits on patient quality of life.

“We look forward to sharing our research and engaging with sleep medicine professionals from around the world at the World Sleep 2023 Congress,” added Dr. Naresh Punjabi. “By collaborating and exchanging ideas, we can collectively work towards improving the lives of individuals affected by sleep disorders.”

The inclusion of NMES in the World Sleep presentation reinforces the importance of expanding the portfolio of treatment options to treat OSA patients. Over 12,000 patients have started Signifier Medical’s eXciteOSA® innovative NMES therapy. They achieve over 80% therapy adherence. This high adherence is enabled by the simplicity and low burden of an NMES-based therapy, coupled with a digital platform and Sleep Advocate coaching.

“We are thrilled that the importance of NMES to meet the unmet needs of OSA patients is being recognized in a World Sleep session“, said Akhil Tripathi, Director, and Co-founder. “This recognition affirms the significance of our research and the potential of neuromuscular electrical stimulation as a novel and effective approach in treating obstructive sleep apnea.”

The World Sleep 2023 Congress is scheduled for October 20-25, 2023, in Rio de Janeiro, Brazil. The NMES presentation will take place on Tuesday, October 24th, from 10:45 a.m. to 12:15 p.m. Attendees can also visit the Signifier Medical booth #196 to speak with device experts and learn more about eXciteOSA®.  throughout the conference. For more information on the presentation at the World Sleep 2023 Congress, please visit:

https://ws2023.abstractserver.com/program/#/details/sessions/316

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 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, for just 20 minutes a day.

Signifier is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. Randomized trials are in progress to understand the potential placebo effect (NCT04974515), the impact of therapy relative to usual care without treatment (NCT05183009NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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

Contacts

Media:
Jay Cranston
Signifier Medical Technologies Inc
[email protected]

Investors and Partners:
Mujtaba Chohan
Signifier Medical Technologies Inc
[email protected]

Appointment of new Board

BOSTON and LONDON – Aug 25, 2023

Signifier Medical Technologies Limited is delighted to announce the successful appointment of its new Board members: Shahzada Ahmed, John Bentley, Mujtaba Chohan, Rupert Connell, Rupert Reid, Andrew Schumer and Yasser Zayni.

 

John Bentley, Board Member, said “Signifier is in a really exciting period. The Board is looking forward to working with co-Founder Akhil Tripathi to drive the company as a leader in the sleep therapy sector”.