Author: Signifier Medical Technologies

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Signifier Medical Technologies Announces Participation In Piper Sandler Healthcare Conference

December 1, 2022 – Signifier Medical Technologies, a medical technology company developing innovative sleep-disordered breathing products for use in the homecare setting, will be presenting at the Piper Sandler Healthcare Conference today.

Signifier Medical Technologies is scheduled to present at 9 a.m. at the 34th annual healthcare conference at Piper Sandler

Conference Theme: Delivering a thoughtful perspective on tomorrow’s trends
The goal of each conference is to bring together key industry executives, investors and our own professionals to provide multiple perspectives, investigate critical trends and identify the leaders in the markets that are driving our economy.

About Signifier Medical Technologies

Signifier is a pioneer in addressing the root causes of sleep disordered breathing. The Company is focused on the development and commercialization of 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 improving population health, increase the quality of patients’ experience, and generate healthcare savings. Signifier has offices in London (UK) and Needham (Massachusetts, USA).

About eXciteOSA®

eXciteOSA is a revolutionary daytime therapy device for sleep disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA improves daytime sleepiness and sleep quality. Nearly one billion adults aged 30 to 69 years globally are estimated to suffer from OSA, which is a serious medical condition associated with health problems such as high blood pressure and increased risks of heart attack, stroke, or death.

A major underlying cause of OSA is the upper airway muscles lack endurance during sleep and the tongue falls back, blocking the upper airway. By using neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, eXciteOSA works 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. The full benefits of the daytime therapy are realized without patient use during sleep.

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

Contacts

Marketing:
marketing@signifiermedical.com
+1 (844) 645 3672

Investors and Partners:
Alastair Maxwell
Signifier Medical Technologies Inc
alastair.m@signifiermedical.com 

Home / Archives for Signifier Medical Technologies / Page 2

Signifier Medical Technologies’ eXciteOSA®, the only FDA-authorized daytime therapy for primary snoring and mild obstructive sleep apnea, demonstrates real-world adherence to treatment of over 80%

Signifier Medical Technologies’ eXciteOSA®, the only FDA-authorized daytime therapy for primary snoring and mild obstructive sleep apnea, demonstrates real-world adherence to treatment of over 80%

– In the first six weeks of treatment, US patients used eXciteOSA on 81% of days –

– Signifier Medical Technologies releases white paper and announces upcoming webinar –

BOSTON and LONDON – September 21, 2022 Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announced today the results of an analysis of real-world patient adherence data for its lead product, eXciteOSA. The data demonstrated that real-world patients in the US prescribed eXciteOSA, the first daytime therapy indicated to treat primary snoring and mild obstructive sleep apnea (OSA), exhibited strong adherence to the treatment by using therapy on over 80% of days over the first six weeks of treatment. 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 those with mild OSA are 34% less likely to be adherent to PAP than those with moderate/severe OSA.4

In the white paper, A descriptive analysis of objectively monitored real-world adherence to eXciteOSA, Signifier analyzed real-world data from 3,561 individual patients in the US up until June 2022. The results demonstrate that patients have used eXciteOSA therapy on over 80% of days during the first six weeks of treatment. Signifier reported that real-world patients use therapy for an average of 680 minutes (11:20 hh:mm) within the first six weeks, representing over 80% of the total duration prescribed (840 minutes). The dataset represents the entire population of US-based patients who started therapy on eXciteOSA over the 15-month period from April 2021 to June 2022.

“The real-world data released today suggests eXciteOSA patients adhere strongly to the therapy. Sleep apnea is a serious condition, and adherence to treatment is both a challenge and a requirement. We’re delighted that eXciteOSA appears to become a part of a patient’s daily routine, and we’re thrilled to provide a treatment that is easy-to-use and allows patients to get a good night’s rest without hoses and masks. We understand patients’ desire for effective treatments that fit their lifestyle,” said Dr. Jessie Bakker, Executive Vice President of Medical Affairs at Signifier.

Signifier will hold a webinar, What’s New with eXciteOSA®, on September 28, 2022 at 7 PM ET, which will be available after the live event on-demand. The webinar will provide an update on the results published in the white paper as well as reimbursement updates for easier patient access, progress on clinical trials, and app developments for an improved patient experience.

Recent estimates indicate 55 million adults in the United States suffer from OSA, with more than half falling into the mild range. Patients with mild OSA are more likely to report poor quality of life compared to controls, after adjusting for confounders including age, gender, ethnicity, marital status, smoking, education, and co-morbidities.5 In addition, epidemiological analyses have found compared with controls, patients with mild OSA have a 224% increased risk of developing hypertension6, are 83% more likely to be diagnosed with diabetes7, and 59% more likely to have abnormal fasting glucose.8

Past studies have shown eXciteOSA is associated with reductions in both objectively-measured and bed-partner reported snoring, along with significant improvements in disease severity, the Epworth Sleepiness Scale, and Pittsburgh Sleep Quality Index.9-11 Clinical trial participants experienced an average 33% reduction in their AHI overall, with a 52% reduction evident in the responder subset.11 Following a successful FDA submission through the de novo pathway, eXciteOSA was launched in the United States in early 2021 as the first daytime therapy product indicated for treatment of primary snoring and mild OSA.

“The body of evidence regarding the efficacy and adherence of eXciteOSA is growing and we continue to evaluate and learn about the utility and impact this therapy can have on the lives of those patients living with sleep apnea and their partners. We’re looking forward to the results of our ongoing clinical trials including a study of patients with moderate OSA,” said Phil Hess, Chief Operating Officer of Signifier.

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 (NCT05183009; NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

About Signifier Medical Technologies

Signifier is a pioneer in addressing the root causes of sleep disordered breathing. The Company is focused on the development and commercialization of 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 improving population health, increase the quality of patients’ experience, and generate healthcare savings. Signifier has offices in London (UK) and Needham (Massachusetts, USA).

About eXciteOSA®

eXciteOSA is a revolutionary daytime therapy device for sleep disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA improves daytime sleepiness and sleep quality. Nearly one billion adults aged 30 to 69 years globally are estimated to suffer from OSA, which is a serious medical condition associated with health problems such as high blood pressure and increased risks of heart attack, stroke, or death.

A major underlying cause of OSA is the upper airway muscles lack endurance during sleep and the tongue falls back, blocking the upper airway. By using neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, eXciteOSA works 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. The full benefits of the daytime therapy are realized without patient use during sleep.

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

Contacts

Media:

Shani Lewis
LaVoieHealthScience
signifier@lavoiehealthscience.com
+1 (844) 645 3672

Investors and Partners:

Alastair Maxwell
Signifier Medical Technologies Inc
alastair.m@signifiermedical.com 

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.
  5. Baldwin CM, Griffith KA, Nieto FJ, O’Connor GT, Walsleben JA, Redline S. The association of sleep-disordered breathing and sleep symptoms with quality of life in the Sleep Heart Health Study. Sleep 2001;24(1):96-105.
  6. Vgontzas AN, Li Y, He F, Fernandez-Mendoza J, Gaines J, Liao D, Basta M, Bixler EO. Mild-to-moderate sleep apnea is associated with incident hypertension: age effect. Sleep 2019;42(4): zsy265.
  7. Reichmuth KJ, Austin D, Skatrud JB, Young T. Association of sleep apnea and type II diabetes: a population-based study. American Journal of Respiratory & Critical Care Medicine 2005;172(12):1590-1595.
  8. Bakker JP, Weng J, Wang R, Redline S, Punjabi NM, Patel SR. Associations between Obstructive Sleep Apnea, Sleep Duration, and Abnormal Fasting Glucose. The Multi-Ethnic Study of Atherosclerosis. American Journal of Respiratory & Critical Care Medicine 2015;192(6):745-753.
  9. Baptista PM, Martinez Ruiz de Apodaca P, Carrasco M, Fernandez S, Wong PY, Zhang H, Hassaan A, Kotecha B. Daytime neuromuscular electrical therapy of tongue muscles in improving snoring in individuals with primary snoring and mild obstructive sleep apnea. Journal of Clinical Medicine 2021;10(9):1-11.
  10. Wessolleck E, Bernd E, Dockter S, Lang S, Sama A, Stuck BA. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie 2018;22(2):47-52.
  11. Nokes B, Baptista PM, de Apodaca PMR, Carrasco-Llatas M, Fernandez S, Kotecha B, Wong PY, Zhang H, Hassaan A, Malhotra A. Transoral awake state neuromuscular electrical stimulation therapy for mild obstructive sleep apnea. Sleep & Breathing 2022
Home / Archives for Signifier Medical Technologies / Page 2

Signifier Medical Technologies Announces Publication of Peer-Reviewed Analysis Demonstrating Improvement in Obstructive Sleep Apnea Severity with Neuromuscular Electrical Stimulation

Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announced that a peer-reviewed paper has recently been accepted for publication in Sleep and Breathing. The analysis, published by University of California San Diego investigators Dr. Brandon Nokes, Professor Atul Malhotra, and other collaborators, is based on a post-hoc analysis of 65 participants with mild obstructive sleep apnea (OSA) who completed sleep testing before and after six weeks of genioglossus (tongue muscle) neuromuscular electrical stimulation (NMES) with eXciteOSA.

The first of its kind, eXciteOSA is an FDA-authorized, non-invasive daytime treatment for snoring and mild OSA. Unlike other treatment options, this does not require a nighttime wearable, which allows patients to conveniently fit therapy into their daily routine. The therapy works by using NMES to build the endurance of the genioglossus muscle so that the tongue doesn’t collapse into the airway during sleep. The eXciteOSA device is used for only 20 minutes per day for six weeks and then a minimum of twice per week thereafter for maintenance.

Based on the data from the peer-reviewed analysis, the researchers observed a significant improvement in the apnea-hypopnea index (AHI) from 10.2 to 6.8 events/hour (33%) among all participants, and from 10.4 to 5.0 events/hour (52%) in the responder subgroup which represented 78% of the study sample (51 of 65). Statistically-significant improvements in self-reported sleepiness, sleep quality, objectively measured snoring, and bed partner-reported snoring were observed. Average adherence to eXciteOSA therapy was 85%.

The Sleep and Breathing article can be found here:
https://pubmed.ncbi.nlm.nih.gov/35624401/

eXciteOSA has the benefit of being a daytime-only treatment modality which confers a high level of tolerability and patient acceptance. It alleviates the need for an in situ device during sleep and is associated with improvements in OSA severity, snoring, sleepiness, and sleep quality. Further studies are needed to define which individuals may benefit most from the device across the wider spectrum of OSA severity and assess long-term therapeutic outcomes. Signifier Medical Technologies is supporting four clinical trials on these topics, currently underway.

Signifier is a pioneer in addressing a key root cause of sleep disordered breathing. We are focused on the development and commercialization of innovative and non-invasive solutions that help people breathe normally and naturally all night – entirely on their own. The publication of this study in conjunction with ongoing clinical trials represents Signifier Medical’s commitment to research of therapies that improve population health, increase the quality of patients’ experience, and generate healthcare savings.

About Signifier Medical Technologies

Signifier is a pioneer in addressing the root causes of sleep disordered breathing. We are focused on the development and commercialization of innovative and non-invasive solutions that help people breathe normally and naturally all night – entirely on their own. Founded in 2015, Signifier is at the forefront of sleep therapy, with a mission to develop therapies that improve population health, increase the quality of patients’ experience and generate healthcare savings. Signifier has offices in London (UK), Needham (Massachusetts, USA) and Berlin (Germany).

About eXciteOSA®

eXciteOSA is a revolutionary daytime therapy device for sleep disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA improves sleep quality, health and quality of life. Nearly one billion adults aged 30 to 69 years globally are estimated to suffer from OSA, which is a serious medical condition associated with health problems such as high blood pressure and increased risks of heart attack, stroke or death.1-10

A major underlying cause of OSA is that the upper airway muscles lack endurance during sleep and the tongue falls back, blocking the upper airway. By using neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, eXciteOSA works 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. The full benefits of the daytime therapy are realized without patient use during sleep.

About Snoring and Obstructive Sleep Apnea

Nearly one billion adults aged 30 to 69 years are estimated to have OSA globally.1 OSA and snoring are problems for many people whose tongue muscles relax during sleep, causing airway collapse and decreased oxygen intake, which causes the sleeper to stop and restart breathing during sleep, often jolting them awake.15-16

OSA is a serious medical condition associated with health problems like high blood pressure and increased risks of heart attack, stroke, or death.2-9 OSA and snoring also affect patients’ partners and family members, consequently putting strain on relationships.15-16

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

Contacts

marketing@signifiermedical.com
+1 (844) 645 3672

References

  1. Benjafield, A. V., Ayas N T, Eastwood P R et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med 2019; 7: 687-698.
  2. Peppard PE, Young T, Palta M, et al. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000; 342:1378–1384. [PubMed: 10805822]
  3. Gottlieb DJ, Yenokyan G, Newman AB, et al. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010;122:352– 360. [PubMed: 20625114]
  4. Yaggi HK, Concato J, Kernan WN, et al. Obstructive sleep apnoea as a risk factor for stroke and death. N Engl J Med. 2005; 353:2034–2041. [PubMed: 16282178]
  5. Redline S, Yenokyan G, Gottlieb DJ, et al. Obstructive sleep apnea- hypopnea and incident stroke: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2010; 182:269–277. [PubMed: 20339144]
  6. Peker Y, Hedner J, Norum J, et al. Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnoea: a 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 apnoea-hypopnoea 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 sleep-related breathing disorder and depression. Arch Intern Med. 2006; 166:1709–1715. [PubMed: 16983048]
  9. Kendzerska T, Gershon AS, Hawker G, et al. Obstructive sleep apnoea and incident diabetes: a historical cohort study. Am J Respir Crit Care Med. 2014; 190:218–225. [PubMed: 24897551]
  10. Johnson KG and Johnson DC. Frequency of sleep apnea in stroke and TIA patients: a meta-analysis. J of Clinical Sleep Med 2010;6(2):131-7
  11. Baptista et al. Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring. 2021
  12. Kotecha. et al. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021.
  13. Data on File. Signifier Medical Technologies
  14. Davey, M. J. Epidemiological study of snoring from a random survey of 1075 participant. British Snoring and Sleep Apnoea Association. 2002; Available at: https://britishsnoring.co.uk/pdf/epidem.pdf
  15. Levy P, Kohler M, McNicholas WT, et al. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers 2015; 1: 15015.
  16. Luyster FS. Impact of Obstructive Sleep Apnea and Its Treatments on Partners: A Literature Review. J Clin Sleep Med. 2017;13(3):467-477.
Home / Archives for Signifier Medical Technologies / Page 2

Signifier Medical Technologies Announces $49MM Purchase of Existing Shares by Waha Capital, Angelus Sano Ventures and Segulah Medical Acceleration

BOSTON, U.S.A., March 22, 2022 (BUSINESS WIRE) – Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announced that Waha Capital PJSC (“Waha Capital”), Angelus Sano Fund L.P. (“Angelus”), Segulah Medical Acceleration AB (“Segulah Medical”) and certain other individual investors have collectively invested approximately $49 million in the purchase of existing shares in the Company from shareholders unrelated to the Board and Management.

Signifier is the developer of the revolutionary eXciteOSA® medical device for the treatment of sleep disordered breathing, which has now been launched in key markets including the United States of America, Canada, the United Kingdom and Germany. Nearly one billion adults aged 30 to 69 years globally are estimated to suffer from OSA (Obstructive Sleep Apnea), which is a serious medical condition associated with health problems such as high blood pressure and increased risks of heart attack, stroke or death.1-10

Waha Capital is an Abu Dhabi listed investment management company and is one of the United Arab Emirates’ leading private sector investors, which also counts Mubadala Investment Company as an anchor shareholder. Waha Capital has a long-established track record of investing in public and private markets, deploying capital across diverse sectors and geographies.

Angelus is a medical technology fund that specializes in identifying start up opportunities that bring a truly disruptive and innovative approach in the areas of technology, services, and infrastructure. Angelus is managed by Angelus Partners, L.L.C. and offered within its family of funds.

Segulah Medical seeks to invest in and develop game changing businesses within medical technologies and related value chain solutions. These companies use cutting edge research in real-world applications such as medical devices, diagnostics and life science tools. Segulah Medical seeks to bridge the gap between innovation and commercial validation to bring advanced research to global markets.

Akhil Tripathi, Chief Executive Officer and Co-Founder of Signifier, said: “On behalf of the Board and management of Signifier, I am delighted to welcome Waha Capital as a significant new investor in the Company. I am also extremely grateful to Angelus and Segulah Medical for their longstanding support for Signifier in our previous fund raises as well as through this purchase. We are honored by their confidence in our business following the successful commercial launch of eXciteOSA in our core target markets of the USA, Canada, the UK and Germany and we look forward to working closely with Waha Capital, Angelus and Segulah Medical as we continue to execute on our strategy and move to secure the funding required to finance our future growth.”

Hitesh Gupta, Managing Director, Waha Capital, said: “Signifier has made a tremendous amount of progress since receipt of FDA approval for eXciteOSA. We are pleased with the successful commercial launch and are impressed by the positive patient outcomes and growth potential of this innovative technology. We are thrilled to be investing alongside domain experts in the medical technology space.”

David Jarvis, Managing Partner of Angelus Partners, L.L.C., said: “Over three years ago we identified eXciteOSA as a viable, non-invasive treatment for those suffering from OSA. As we monitored both the internal and external growth of the company, we realized we had a special investment opportunity emerging, and for that reason we were more than eager to acquire a greater ownership interest in Signifier Medical Technologies.”

Roger Gunnarsson, Managing Partner of Segulah Medical, said: “We are highly impressed with the significant progress that has been achieved by Signifier in the short period since we invested and which is ahead of the original plan. Despite the fact that we would normally not buy secondary shares, when given the opportunity we were keen to deploy more capital.”

About Signifier Medical Technologies

Signifier is a pioneer in addressing the root causes of sleep disordered breathing. We are focused on the development and commercialization of 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 therapies that improve population health, increase the quality of patients’ experience and generate healthcare savings. Signifier has offices in London (UK), Needham (Massachusetts, USA) and Berlin (Germany).

About eXciteOSA®

eXciteOSA is a revolutionary daytime therapy device for sleep disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA improves sleep quality, health and quality of life. Nearly one billion adults aged 30 to 69 years globally are estimated to suffer from OSA, which is a serious medical condition associated with health problems such as high blood pressure and increased risks of heart attack, stroke or death.1-10

A major underlying cause of OSA is that the upper airway muscles lack endurance during sleep and the tongue falls back, blocking the upper airway. By using neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, eXciteOSA works 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. The full benefits of the daytime therapy are realized without patient use during sleep.

About Snoring and Obstructive Sleep Apnea

Nearly one billion adults aged 30 to 69 years are estimated to have OSA globally.1 OSA and snoring are problems for many people whose tongue muscles relax during sleep, causing airway collapse and decreased oxygen intake, which causes the sleeper to stop and restart breathing during sleep, often jolting them awake.15-16

OSA is a serious medical condition associated with health problems like high blood pressure and increased risks of heart attack, stroke, or death.2-9 OSA and snoring also affect patients’ partners and family members, consequently putting strain on relationships.15-16

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

Contacts

marketing@signifiermedical.com
+1 (844) 645 3672

References

  1. Benjafield, A. V., Ayas N T, Eastwood P R et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med 2019; 7: 687-698.
  2. Peppard PE, Young T, Palta M, et al. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000; 342:1378–1384. [PubMed: 10805822]
  3. Gottlieb DJ, Yenokyan G, Newman AB, et al. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010;122:352– 360. [PubMed: 20625114]
  4. Yaggi HK, Concato J, Kernan WN, et al. Obstructive sleep apnoea as a risk factor for stroke and death. N Engl J Med. 2005; 353:2034–2041. [PubMed: 16282178]
  5. Redline S, Yenokyan G, Gottlieb DJ, et al. Obstructive sleep apnea- hypopnea and incident stroke: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2010; 182:269–277. [PubMed: 20339144]
  6. Peker Y, Hedner J, Norum J, et al. Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnoea: a 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 apnoea-hypopnoea 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 sleep-related breathing disorder and depression. Arch Intern Med. 2006; 166:1709–1715. [PubMed: 16983048]
  9. Kendzerska T, Gershon AS, Hawker G, et al. Obstructive sleep apnoea and incident diabetes: a historical cohort study. Am J Respir Crit Care Med. 2014; 190:218–225. [PubMed: 24897551]
  10. Johnson KG and Johnson DC. Frequency of sleep apnea in stroke and TIA patients: a meta-analysis. J of Clinical Sleep Med 2010;6(2):131-7
  11. Baptista et al. Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring. 2021
  12. Kotecha. et al. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021.
  13. Data on File. Signifier Medical Technologies
  14. Davey, M. J. Epidemiological study of snoring from a random survey of 1075 participant. British Snoring and Sleep Apnoea Association. 2002; Available at: https://britishsnoring.co.uk/pdf/epidem.pdf
  15. Levy P, Kohler M, McNicholas WT, et al. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers 2015; 1: 15015.
  16. Luyster FS. Impact of Obstructive Sleep Apnea and Its Treatments on Partners: A Literature Review. J Clin Sleep Med. 2017;13(3):467-477.
Home / Archives for Signifier Medical Technologies / Page 2

Signifier Medical Technologies is granted HCPCS Codes for eXciteOSA to help patients access innovative technology

CMS establishes new Level II HCPCS codes to describe eXciteOSA, the first-ever daytime treatment for obstructive sleep apnea

BOSTON, U.S.A., February 22, 2022 (BUSINESS WIRE) — Signifier Medical Technologies LLC, a Boston-based medical technology company, announced today that the Centers for Medicare & Medicaid Services (CMS) established two new Level II Healthcare Common Procedure Coding System (HCPCS) codes to describe eXciteOSA, the first-ever FDA authorized de-novo device for daytime treatment of mild obstructive sleep apnea (OSA) and primary snoring. The CMS coding decision was published on February 16, 2022 and the following codes will become effective on April 1, 2022:

 

HCPCS Code Description
K1028 Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle for the reduction of snoring and obstructive sleep apnea, controlled by phone application.
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.

 

“We welcome CMS’ decision to establish two new codes to describe the eXciteOSA device”, said Akhil Tripathi, Chief Executive Officer at Signifier. “With over 3,000 patients treated with eXciteOSA, we have seen strong demand for our therapy. Establishing codes marks an important milestone for physicians, health systems, DME suppliers, payers and patients alike, and will enable Signifier to demonstrate further the real world benefits of improved outcomes, cost savings and significantly improved quality of care for patients. Reimbursement will help patients in the US who suffer from sleep disordered breathing with an option to obtain a new, effective daytime treatment.”

OSA is a progressive disease, often starting with primary snoring, affecting nearly 1 billion adults aged 30 to 69 globally.1   Used for only 20 minutes per day during the initiation period, and then twice per week thereafter for maintenance, eXciteOSA targets a primary root cause of mild OSA by delivering neuromuscular electric stimulation to increase tongue muscle endurance.

“HCPCS codes play a critical role in providing patients with access to new medical devices, often improving payment options and healthcare decisions,” said Dr. Marc Benton, a New Jersey-based pulmonologist and sleep medicine specialist. “The eXciteOSA is a non-invasive, easy to use therapy that does not require patients to wear any sort of device during the night. Once reimbursement is established, eXciteOSA will be easier to access for a broader and more diverse population of patients suffering from sleep apnea, and I’m excited to share the good news with all of them.”

The CMS decision 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 addressing the root causes of sleep disordered breathing. We are focused on the development and commercialization of 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 therapies that improve population health, increase the quality of patients’ experience and generate healthcare savings. Signifier has offices in London (UK), Needham (Massachusetts, USA) and Berlin (Germany).

 

About eXciteOSAâ

eXciteOSA is a revolutionary daytime therapy device for sleep disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA improves sleep quality, improves health and increases quality of life. Nearly one billion adults aged 30 to 69 years globally are estimated to suffer from OSA, which is a serious medical condition associated with health problems such as high blood pressure and increased risks of heart attack, stroke or death.1-10

A major underlying cause of OSA is that the upper airway muscles lack endurance during sleep and the tongue falls back, blocking the upper airway. By using neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, eXciteOSA works 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 awake. The full benefits of the daytime therapy are realized without patient use during sleep.

 

About Snoring and Obstructive Sleep Apnea

Nearly one billion adults aged 30 to 69 years are estimated to have OSA globally.1 OSA and snoring are problems for many people whose tongue muscles relax during sleep, causing airway collapse and decreased oxygen intake, which causes the sleeper to stop and restart breathing during sleep, often jolting them awake.15-16

OSA is a serious medical condition associated with health problems like high blood pressure and increased risks of heart attack, stroke, or death.2-9 OSA and snoring also affect patients’ partners and family members, consequently putting strain on relationships.15-16

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

 

Contacts

marketing@signifiermedical.com

+1 (844) 645 3672

 

References

  1. Benjafield, A. V., Ayas N T, Eastwood P R et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med 2019; 7: 687-698.
  2. Peppard PE, Young T, Palta M, et al. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000; 342:1378–1384. [PubMed: 10805822]
  3. Gottlieb DJ, Yenokyan G, Newman AB, et al. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010;122:352– 360. [PubMed: 20625114]
  4. Yaggi HK, Concato J, Kernan WN, et al. Obstructive sleep apnoea as a risk factor for stroke and death. N Engl J Med. 2005; 353:2034–2041. [PubMed: 16282178]
  5. Redline S, Yenokyan G, Gottlieb DJ, et al. Obstructive sleep apnea- hypopnea and incident stroke: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2010; 182:269–277. [PubMed: 20339144]
  6. Peker Y, Hedner J, Norum J, et al. Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnoea: a 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 apnoea-hypopnoea 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 sleep-related breathing disorder and depression. Arch Intern Med. 2006; 166:1709–1715. [PubMed: 16983048]
  9. Kendzerska T, Gershon AS, Hawker G, et al. Obstructive sleep apnoea and incident diabetes: a historical cohort study. Am J Respir Crit Care Med. 2014; 190:218–225. [PubMed: 24897551]
  10. Johnson KG and Johnson DC. Frequency of sleep apnea in stroke and TIA patients: a meta-analysis. J of Clinical Sleep Med 2010;6(2):131-7
  11. Baptista et al. Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring. 2021
  12. et al. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021.
  13. Data on File. Signifier Medical Technologies
  14. Davey, M. J. Epidemiological study of snoring from a random survey of 1075 participant. British Snoring and Sleep Apnoea Association. 2002; Available at: https://britishsnoring.co.uk/pdf/epidem.pdf
  15. Levy P, Kohler M, McNicholas WT, et al. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers 2015; 1: 15015.
  16. Luyster FS. Impact of Obstructive Sleep Apnea and Its Treatments on Partners: A Literature Review. J Clin Sleep Med. 2017;13(3):467-477.

 

Home / Archives for Signifier Medical Technologies / Page 2

eXciteOSA® Daytime Sleep Apnea Therapy Device Surpasses 50,000 Patient Session Milestone

Driving comfort and relief for patients with snoring and mild obstructive sleep apnea

BOSTON, U.S.A. and LONDON, U.K., October 12, 2021 (BUSINESS WIRE) — Signifier Medical Technologies Ltd, an innovator in the sleep-disordered breathing market, announced today that it has hit the 50,000 therapy session milestone with its innovative eXciteOSA® sleep device.

Following FDA authorization and clearance for marketing in February 2021, eXciteOSA has been quickly adopted by physicians and patients alike. The first of its kind, eXciteOSA is a daytime treatment for snoring and mild obstructive sleep apnea (OSA). Used for only 20 minutes per day for six weeks and then twice per week thereafter for maintenance, the eXciteOSA therapy is clinically proven to improve quality of sleep by significantly reducing mild OSA and snoring1,2.

“We are thrilled with what this milestone represents for the improvement of patient care,” said Akhil Tripathi, CEO, and co-founder of Signifier Medical Technologies. “Being a comfortable and effective treatment has helped patients stay adherent to their therapy and feel the difference. 50,000 sessions is only the beginning, and we look forward to supporting the millions of people who suffer from mild OSA and snoring.”

Unlike devices used while patients are asleep, eXciteOSA is the first marketed device designed to be used while awake. It works by applying neuromuscular electrical stimulation (NMES) on the genioglossus muscle – the major muscle that forms the tongue mass. NMES creates contractions of the tongue muscle, enhancing function and endurance so that after 6 weeks of therapy, the tongue stays in an ideal position for optimal airflow.

“eXciteOSA has been a life-saver for me and my family. The device has significantly reduced my snoring after just 2 weeks of use,” said Jessie Cadet-Legros, an eXciteOSA patient. “It was easy to find 20 minutes during the day to use it and the results have paid off. My husband now sleeps better without my snoring, and so do I.”

OSA affects one in three adults – as many as 54 million Americans. Left untreated, obstructive sleep apnea can lead to serious complications such as hypertension, heart attack, cancer, and cognitive disorders. To learn more about eXciteOSA, please visit www.eXciteosa.com

-END-

About Signifier Medical Technologies

Signifier Medical Technologies is a medical technology company focused on the development and commercialization of innovative and non-invasive solutions for patients with sleep-disordered breathing conditions and snoring.

Signifier’s proprietary therapy, eXciteOSA®, is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology authorized in the US for mild obstructive sleep apnea and primary snoring and is supported by clinical data from prestigious and well-recognized universities and academic institutions, that provides a safe and effective treatment for its patients.1,2

References

  1. Wessolleck E, Bernd E, Dockter S, Lang S, Sama A, Stuck BA. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie 2018;22(Suppl 2):47-52.
  2. Baptista PM, Martinez Ruiz de Apodaca P, Carrasco M, et al. Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring in Individuals with Primary Snoring and Mild Obstructive Sleep Apnea. J Clin Med 2021;10(9):1-11.
Home / Archives for Signifier Medical Technologies / Page 2

Signifier Medical Technologies Raises $35M in Series D Funding Round to Accelerate Commercialization of eXciteOSA Therapy

Rapidly commercializing eXciteOSA to treat millions of patients around the world suffering from primary snoring and mild obstructive sleep apnea (OSA).

Boston, MA, USA, and London, United Kingdom

July 27, 2021

Signifier Medical Technologies Ltd, a pioneer in patient-friendly therapies for sleep disordered breathing, announced that it has successfully raised $35 million in its Series D capital raise. This financing will underpin the commercialization of Signifier’s FDA-approved De Novo device and therapy, eXciteOSA®, to treat millions of patients around the world suffering from primary snoring and mild obstructive sleep apnea (OSA).

connected technology snoozeal

“Our Series D fund raise will enable Signifier to bring our novel therapy to millions of patients suffering from sleep disordered breathing for whom there is today no effective treatment”

The lead investors in the financing were Segulah Medical Acceleration, Angelus Venture Fund I L.P., Alan Howard (co-founder of Brevan Howard Asset Management) and Pioneer Healthcare Partners LP.

The proceeds of the financing will be directed towards commercialization of eXciteOSA in Signifier’s core target markets, continued development of Signifier’s proprietary digital patient and physician interface platforms, the generation of additional clinical data to reinforce the therapeutic efficacy of eXciteOSA, and progressing reimbursement.

OSA affects an estimated one billion adults aged 30 to 69 globally, with 60% having mild OSA.1 The disease is linked to a number of comorbidities, such as hypertension, stroke, heart failure, diabetes, depression, and an increased risk of road traffic accidents.2-9 In contrast to complex night-time wearables commonly used to treat OSA, eXciteOSA provides a low-burden, patient-friendly option of daytime therapy. Patients are guided by an intuitive Smartphone App, monitored remotely by their physician, and supported by Signifier’s world-class Patient Advocate support team. Extensive clinical trials and real-world usage indicate high (>80%) adherence to therapy, as confirmed by over 25,000 successfully completed daily therapies which have been recorded through our App.

Dr Asim Roy, a leading pulmonologist and the medical director of the Ohio Sleep Medicine Institute, commented: “My patients’ experience with eXciteOSA has been truly remarkable. The therapy has proven to be transformational in terms of its clinical efficacy and its impact on patients’ health and their quality of life. With the current challenges facing the sleep market, there could not be a better time for a viable, effective and easily accessible alternative to CPAP for mild OSA patients.”

Roger Gunnarsson, Managing Partner of Segulah Medical Acceleration, a fund which seeks to invest in and develop game changing businesses within medical technologies, said: “Segulah Medical is delighted to be co-leading Signifier Medical’s Series D financing. We are very excited about the prospects for eXciteOSA as a revolutionary daytime therapy to treat OSA. With an estimated 25% of the global adult population suffering from sleep disordered breathing, we believe that eXciteOSA will become the first line therapy for these patients.”

David Jarvis, Managing Partner of Angelus Partners, LLC, said: “We believe that Signifier Medical Technologies has created the most disruptive, non-invasive treatment for OSA that the market has seen in the past 20 years.”

“Our Series D fund raise will enable Signifier to bring our novel therapy to millions of patients suffering from sleep disordered breathing for whom there is today no effective treatment,” said Akhil Tripathi, the Chief Executive Officer of Signifier. “We are truly grateful for the strong support the Company has received from both our existing shareholders and new investors which provides strong validation of our technology, team and commercial strategy.”

About Signifier Medical Technologies

Signifier Medical Technologies is a pioneer in understanding and addressing the root causes of sleep disordered breathing. We are focused on the development and commercialization of innovative and non-invasive solutions for patients with conditions such as OSA and primary snoring. Founded in 2015, Signifier Medical Technologies is at the forefront of sleep therapy, focused on developing therapies that put patient experience and comfort first. Signifier has offices in London (UK), Needham (Massachusetts, USA) and Berlin (Germany).

About eXciteOSA

eXciteOSA is a revolutionary daytime therapy device for sleep disordered breathing. Clinically proven to target a common root cause of OSA and snoring, eXciteOSA helps to improve sleep quality and give patients better health and a better quality of life.10, 11

A major underlying cause of snoring and OSA is that patients have abnormalities in upper airway muscle function, or the tongue lacks endurance during sleep and falls back, blocking the upper airway. eXciteOSA works by using neuromuscular electrical stimulation (NMES) to exercise those muscles, using safe, low-intensity impulses to stimulate the intrinsic and extrinsic pharyngeal and tongue muscles directly to improve muscle tone, strength, and endurance.

Unlike other devices which are used while patients sleep, eXciteOSA is the first device which is used exclusively while awake. The device rests on the tongue and stimulates the pharyngeal and tongue muscles directly to improve their endurance, much like going to the gym would improve any other muscle. The device has been designed to target a wide range of patients with mild OSA, in addition to primary snoring, by building endurance of the weak tongue and surrounding muscles. This then prevents the muscles from collapsing in the first place, tackling a root cause of mild OSA and snoring.

About Obstructive Sleep Apnea and Snoring

Snoring is the most common cause of sleep deprivation, affecting around 42% of people.12 Nearly one billion adults aged 30 to 69 years are estimated to have obstructive sleep apnea (OSA) globally.3 OSA and snoring are problems for many people whose tongue muscles relax during sleep, causing partial airway collapse and a decreasing oxygen intake, which causes the sleeper to stop and restart breathing during sleep, often jolting them awake.14

OSA is a serious medical condition associated with health problems like high blood pressure and increased risks of heart attack, stroke, or death.13 OSA and snoring do not just affect those suffering from them, but also their partners and family members, consequently putting strain on relationships.14, 15

References

  1. Benjafield, A. V., Ayas N T, Eastwood P R et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med 2019; 7: 687-698.
  2. Peppard PE, Young T, Palta M, et al. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000; 342:1378–1384. [PubMed: 10805822]
  3. Gottlieb DJ, Yenokyan G, Newman AB, et al. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. 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]
  5. Redline S, Yenokyan G, Gottlieb DJ, et al. Obstructive sleep apnea- hypopnea and incident stroke: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2010; 182:269–277. [PubMed: 20339144]
  6. Peker Y, Hedner J, Norum J, et al. Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnea: a 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 apnoea-hypopnoea 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 sleep-related breathing disorder and depression. Arch Intern Med. 2006; 166:1709–1715. [PubMed: 16983048]
  9. Kendzerska T, Gershon AS, Hawker G, et al. Obstructive sleep apnea and incident diabetes: a historical cohort study. Am J Respir Crit Care Med. 2014; 190:218–225. [PubMed: 24897551]
  10. Baptista et al. Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring. 2021
  11. Kotecha. et al. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021.
  12. Davey, M. J. Epidemiological study of snoring from a random survey of 1075 participant. British Snoring and Sleep Apnoea Association. 2002; Available at: https://britishsnoring.co.uk/pdf/epidem.pdf
  13. Levy P, Kohler M, McNicholas WT, et al. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers 2015; 1: 15015.
  14. Johnson KG and Johnson DC. Frequency of sleep apnea in stroke and TIA patients: a meta-analysis. J of Clinical Sleep Med 2010;6(2):131-7
  15. Luyster FS. Impact of Obstructive Sleep Apnea and Its Treatments on Partners: A Literature Review. J Clin Sleep Med. 2017;13(3):467-477.

For media enquiries:
info@signifiermedical.com
+1 (844) 645-3672
+44 (0) 20 7096 0586

Home / Archives for Signifier Medical Technologies / Page 2

Signifier Medical Receives Prestigious 2020 GOOD DESIGN Award for Superior Design Excellence

eXciteOSA® is the World’s First Daytime Therapy Targeting the Root Cause of Mild Obstructive Sleep Apnea and Snoring

Boston, MA, USA, and London, United Kingdom

March 01, 2021

Signifier Medical Technologies, an innovator in the sleep disordered breathing market, today announced that eXciteOSA®, the first and only daytime intraoral neuromuscular stimulation device for treating mild obstructive sleep apnea and snoring, has received the prestigious GOOD DESIGN® Award in the Medical category. The device was recently approved by the U.S. Food and Drug Administration (FDA), giving millions of sufferers in the U.S. access to this innovative therapy.

“We are honored to accept this recognition for eXciteOSA, which provides people who suffer from sleep disordered breathing a new treatment option – the first major innovation for the treatment of sleep apnea since the invention of the continuous positive airway pressure machine nearly 40 years ago,” said Akhil Tripathi, CEO and co-founder of Signifier Medical Technologies. “As a daytime treatment, the device was specifically designed to be compact and mobile. Paired with the eXciteOSA smartphone or tablet application, the device allows patients to use it freely while tracking progress and results wherever they go. This award further demonstrates the value of eXciteOSA as a proven, transformative treatment for patients with a design optimized for ease of use and high functionality.”

eXciteOSAThe GOOD DESIGN award is presented by The Chicago Athenaeum Museum of Architecture and Design and The European Centre for Architecture Art Design and Urban Studies. Each year since 1950, The Chicago Athenaeum presents the award to the most innovative and cutting-edge industrial, product, and graphic designs produced around the world. With 30 distinguished award categories across various industries, the GOOD DESIGN Award was founded to create an awareness of contemporary design and to honor both products and industry leaders in design and manufacturing that have chartered new directions for innovation and pushed the envelope for competitive products in the world marketplace.

Unlike devices used while patients sleep, eXciteOSA is the first device used while awake that is intended to improve tongue muscle function, targeting the root causes of these conditions. Used for only 20 minutes per day for a period of six weeks and then twice per week, the therapy is clinically proven to improve the quality of sleep by significantly reducing obstructive sleep apnea and snoring.

Signifier Medical Technologies has developed a digital OSA therapy interface for patients and clinicians, which includes an intuitive app for use alongside the eXciteOSA device. The app is designed to give personalized care and motivate patients to achieve high therapy adherence. A “light touch design” with no fitting required, the eXciteOSA system includes digital connectivity between patient, bed partner and provider to enable virtual setup, remote monitoring, and an overall exceptional patient experience.

For more information on eXciteOSA visit www.eXciteOSA.com

About Obstructive Sleep Apnea and Snoring

Nearly 1 billion adults aged 30 to 69 years are estimated to have obstructive sleep apnea (OSA) globally. There is a strong, clinically proven link between OSA and co-morbidities like diabetes, hypertension, and strokes. Mild OSA affects over 110 million people in the US and 100 million people in Europe.

Obstructive sleep apnea is marked by the recurring collapse of the upper airways during sleep. The most common symptoms are restless sleep, snoring, tiredness during the day, decreased intellectual alertness, and personality alterations. Higher risks of cardiovascular diseases and increased mortality rates have been associated with OSA.

Standard therapy of all advanced levels of sleep apnea is with a continuous positive airway pressure (CPAP) device. Many patients find this therapy invasive, and the long-term compliance of CPAP therapy is limited, so there is a clear demand for new forms of treatment.

About Signifier Medical Technologies

Signifier Medical Technologies is a medical technology company focused on the development and commercialization of innovative and non-invasive solutions for patients with sleep disordered breathing conditions and snoring.

Signifier’s proprietary therapy eXciteOSA® is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the US for mild obstructive sleep apnea and snoring, and is supported by clinical data from prestigious and well-recognized universities and academic institutions, that provides a safe and effective treatment for its patients.

References

  1. White DP. Sleep-related breathing disorder: 2—pathophysiology of obstructive sleep apnoea. Thorax. 1995; 50:797–804. [PubMed: 7570420]
  2. Wessolleck E, Bernd E, Dockter S, et al. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie (Berl). 2018; 22 (Suppl 2): 47–52.
  3. Sama A, et al. Daytime Intraoral Neurostimulation with eXciteOSA® for Treatment of Snoring and Mild Sleep Apnea. CHEST Annual Meeting Notes. 2018.
  4. Clinical study of 115 patients with snoring or mild OSA (Apnea-Hypopnea Index (AHI <15 n=65)). Objective snoring and respiratory parameters were recorded with 2 consecutive WatchPAT® night sleep studies before and after the use of the device. An intra-oral tongue stimulator (eXciteOSA®) device was used for 20 mins, once a day for a 6-week period.

For media enquiries:
info@signifiermedical.com
+44 (0) 207 096 0586

Home / Archives for Signifier Medical Technologies / Page 2

Signifier® Medical Ushers In New Era of Treatment for Sleep Apnea and Snoring with FDA Approval of eXciteOSA® Device

Revolutionary first-ever daytime treatment for mild obstructive sleep apnea and snoring will now be available in the United States

Boston, MA, USA, and London, United Kingdom

February 09, 2021

The FDA has approved eXciteOSA, the revolutionary first-ever daytime treatment for mild obstructive sleep apnea and snoring. Used for only 20 minutes per day for a period of six weeks and then twice per week, the therapy is clinically proven to improve the quality of sleep by significantly reducing obstructive sleep apnea and snoring.

Signifier Medical Technologies, an innovator in the sleep disordered breathing market, today announced that eXciteOSA®, the first and only daytime intraoral neuromuscular stimulation device for treating mild obstructive sleep apnea and snoring, has been cleared by the U.S. Food and Drug Administration (FDA), giving millions of sufferers in the U.S. access to this innovative therapy.

Unlike devices used while patients sleep, eXciteOSA is the first device used while awake that is intended to improve tongue muscle function, targeting the root causes of these conditions. Used for only 20 minutes per day for a period of six weeks and then twice per week, the therapy is clinically proven to improve the quality of sleep by significantly reducing obstructive sleep apnea and snoring.1-4

eXciteOSAIn a study of 65 mild obstructive sleep apnea patients, 79% of patients responded to therapy with a mean reduction of 52% in AHI (Apnea Hypopnea Index), a 50% reduction in ODI (Oxygen Desaturation Index), and a 3.9 point reduction in ESS (Epworth Sleepiness Scale). In the pivotal study of the device, eXciteOSA exceeded the targeted endpoint of a 20% mean reduction in snoring time, achieving nearly a 40% mean reduction in snoring time across 115 patients.

“We are thrilled that this groundbreaking treatment will soon be available in the U.S., offering an entirely unique, simple, and comfortable solution that has the potential to improve the lives of millions of people,” said Akhil Tripathi, CEO, and co-founder of Signifier Medical Technologies. “Restful sleep is critically important, yet for too many it is out of grasp because they or their partner suffer from a sleep disorder. We look forward to launching this revolutionary new option to select markets in the coming weeks.”

Obstructive sleep apnea and snoring affect one in three people – as many as 110 million Americans. Left untreated, obstructive sleep apnea can lead to serious complications such as hypertension, heart attack, glaucoma, diabetes, cancer, and cognitive and behavioral disorders.

“Treatment of sleep apnea has been shown to be highly effective for patients as there is growing evidence that it improves symptoms, reduces blood pressure, improves glucose control, and reduces the risk of motor vehicle accidents, among other benefits. A strong argument can be made that early treatment may be beneficial since the consequences of the condition may become irreversible,” said Atul Malhotra, M.D. Research Chief, Pulmonary, Critical Care and Sleep Medicine at UC San Diego Health, who served as a clinical trial investigator for the eXciteOSA device. “I believe that eXciteOSA will be an important treatment approach for patients with snoring and mild sleep apnea and look forward to offering it to my patients.”

Signifier Medical has developed a digital OSA therapy interface for patients and clinicians, which includes an intuitive app for use alongside the eXciteOSA device. The app is designed to give personalized care and motivate patients to achieve high therapy adherence. A “light touch design” with no fitting required, the eXciteOSA system includes digital connectivity between patient, bed partner, and provider to enable virtual setup, remote monitoring, and an overall exceptional patient experience.

“The FDA approval for eXciteOSA is great news for OSA patients. This novel device will bring benefit to a neglected cohort of the sleep disordered breathing condition, namely those with mild obstructive sleep apnea,” said Peter Cistulli, M.D., Professor of Respiratory Medicine and Head of the Discipline of Sleep Medicine at the University of Sydney, and Head of the Department of Respiratory and Sleep Medicine at Royal North Shore Hospital.

About Obstructive Sleep Apnea and Snoring

Nearly 1 billion adults aged 30 to 69 years are estimated to have obstructive sleep apnea (OSA) globally. There is a strong, clinically proven link between OSA and co-morbidities like diabetes, hypertension, and strokes. Mild OSA affects over 110 million people in the US and 100 million people in Europe.

Obstructive sleep apnea is marked by the recurring collapse of the upper airways during sleep. The most common symptoms are restless sleep, snoring, tiredness during the day, decreased intellectual alertness, and personality alterations. Higher risks of cardiovascular diseases and increased mortality rates have been associated with OSA.

Standard therapy of all advanced levels of sleep apnea is with a continuous positive airway pressure (CPAP) device. Many patients find this therapy invasive, and the long-term compliance of CPAP therapy is limited, so there is a clear demand for new forms of treatment.

About Signifier Medical Technologies

Signifier Medical Technologies is a medical technology company focused on the development and commercialization of innovative and non-invasive solutions for patients with sleep disordered breathing conditions and snoring.

Signifier’s proprietary therapy eXciteOSA® is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the US for mild obstructive sleep apnea and snoring and is supported by clinical data from prestigious and well-recognized universities and academic institutions, that provides a safe and effective treatment for its patients.1-3

References

  1. White DP. Sleep-related breathing disorder: 2—pathophysiology of obstructive sleep apnoea. Thorax. 1995; 50:797–804. [PubMed: 7570420]
  2. Wessolleck E, Bernd E, Dockter S, et al. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie (Berl). 2018; 22 (Suppl 2): 47–52.
  3. Sama A, et al. Daytime Intraoral Neurostimulation with eXciteOSA® for Treatment of Snoring and Mild Sleep Apnea. CHEST Annual Meeting Notes. 2018.
  4. Clinical study of 115 patients with snoring or mild OSA (Apnea-Hypopnea Index (AHI <15 n=65)). Objective snoring and respiratory parameters were recorded with 2 consecutive WatchPAT® night sleep studies before and after the use of the device. An intra-oral tongue stimulator (eXciteOSA®) device was used for 20 mins, once a day for a 6-week period.

For media enquiries:
info@signifiermedical.com
+44 (0) 207 096 0586

Home / Archives for Signifier Medical Technologies / Page 2

Signifier® Medical Technologies Announces Award of UK NHS Supply Chain Tender

Contract award will position Signifier as an approved NHS supplier
Contract will launch in May 2021, expected to drive UK sales of eXciteOSA® for sleep disordered breathing

Boston, MA, USA, and London, United Kingdom

December 22, 2020

Signifier Medical Technologies (“Signifier” or “the Company”), an innovator in the sleep disordered breathing market, is pleased to announce the successful award of the UK Non-invasive Ventilation, Sleep Therapy and Sleep Monitoring Tender, which will confirm Signifier as an approved supplier to the UK’s National Health Service (NHS).

This contract award gives Signifier direct access to the NHS supply chain, including the relevant coding, inventory and ordering systems, to enter the important UK NHS market. Yasser Zayni, Signifier’s Regulatory & Quality Director, was instrumental in the process and commented that “this award will help to accelerate patient access to our innovative technology across the UK.”

eXciteOSAeXciteOSA® is the only clinically proven daytime intraoral neuromuscular stimulation device to improve the quality of sleep by reducing sleep apnea and snoring significantly when used for 20 minutes once a day for six weeks1-4. The device has been designed to treat a wide range of patients with mild obstructive sleep apnea (OSA), in addition to primary snoring, by building endurance of the weak tongue and surrounding muscles known to be root causes of these conditions.

Signifier has also focused on digital OSA therapy interfaces for patients and clinicians. An intuitive app for use alongside the eXciteOSA device motivates a patient to achieve high treatment compliance and to monitor progress. In addition, therapy data is available on Signifier’s clinician portal, enabling the medical community to monitor and track results.

With European CE Mark approval, the Company is planning for wider expansion to support the commercialization and reimbursement of eXciteOSA in the UK, Germany and other major European markets. The Company has also established its US office in Boston and is building commercial operations there ahead of the anticipated approval and launch of eXciteOSA in the important US market.

Akhil Tripathi, CEO of Signifier, commented: “The light touch nature of eXciteOSA and its digital user interface and companion app means that it is a product ideally suited to current times. The award of this NHS contract reflects the hard work and commitment of our employees and is an important pillar of our commercial launch strategy, which will focus on HCPs (Health Care Professionals). We have a unique product backed by excellent clinical data, which we believe can make a significant difference to the lives of many patients suffering from sleep disordered breathing conditions and we look forward to bringing this product to patients more widely.”

For more information, please contact:

Signifier Medical Technologies
Email: info@signifiermedical.com
Tel: +44 (0)20 7096 0586

About Signifier Medical Technologies

Signifier Medical Technologies is a medical technology company focused on the development and commercialization of innovative and non-invasive solutions for patients with sleep-disordered breathing conditions and snoring.

Signifier’s proprietary therapy eXciteOSA® is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology for mild obstructive sleep apnea and snoring, supported by clinical data from prestigious and well-recognized universities and academic institutions, that provides a safe and effective treatment for its patients.1-3

About OSA and Snoring

Nearly 1 billion adults aged 30 to 69 years are estimated to have obstructive sleep apnea (OSA) globally. There is a strong, clinically proven link between OSA and co-morbidities like diabetes, hypertension, and strokes. Mild OSA affects over 110 million people in the US and 100 million people in Europe.

Obstructive sleep apnea is marked by the recurring collapse of the upper airways during sleep. The most common symptoms are restless sleep, snoring, tiredness during the day, decreased intellectual alertness, and personality alterations. Higher risks of cardiovascular diseases and increased mortality rates have been associated with OSA.

Standard therapy of all advanced levels of sleep apnea is with a continuous positive airway pressure (CPAP) device. Many patients find this therapy invasive, and the long-term compliance of CPAP therapy is limited, so there is a clear demand for new forms of treatment.

References

  1. White DP. Sleep-related breathing disorder: 2—pathophysiology of obstructive sleep apnoea. Thorax. 1995; 50:797–804. [PubMed: 7570420]
  2. Wessolleck E, Bernd E, Dockter S, et al. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie (Berl). 2018; 22 (Suppl 2): 47–52.
  3. Sama A, et al. Daytime Intraoral Neurostimulation with Snoozeal® for Treatment of Snoring and Mild Sleep Apnea. CHEST Annual Meeting Notes. 2018.
  4. Clinical study of 115 patients with snoring or mild OSA (Apnea- Hypopnea Index (AHI <15 n=65). Objective snoring and respiratory parameters were recorded with 2 consecutive WatchPat night sleep studies before and after the use of the device. An intra-oral tongue stimulator (Snoozeal®) device was used for 20mins, once a day for 6-week period