Author: Signifier Medical Technologies

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Signifier Medical Technologies Announces Partnership with Sunrise, the company revolutionizing home sleep testing for sleep apnea diagnosis

BOSTON and LONDON – May 9, 2023, Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, is proud to announce its partnership with Sunrise, a health tech company that offers a quick and easy way to help in the diagnosis of sleep apnea from home. This collaboration combines Sunrise’s cutting-edge artificial intelligence solutions and the innovative technologies of daytime sleep apnea therapy, eXciteOSA, to improve patient care through more efficient diagnostics and treatments.

Founded in 2015, Sunrise aims to democratize access to care for sleep apnea syndrome by bringing clinical quality directly into the patient’s home. Its artificial intelligence-powered technology analyses a new signal on the human body, mandibular jaw movements, and other standard apnea signals, from a single sensor simply placed on the chin.

“We are excited to partner with Signifier Medical Technologies, starting with the UK market, and offer our innovative home sleep test to more patients suffering from OSA,” said Laurent Martinot, CEO of Sunrise.

The integrated solutions of Sunrise’s customized personal home sleep testing and Signifier Medical’s patient management portal will enable healthcare providers to gather comprehensive data on their patients’ day-to-day clinical experiences while providing tools for them to understand the unique needs of each individual better and optimize patient outcomes. With a common goal of improving patients’ lives through better sleep, Signifier Medical and Sunrise hope to create a future where better healthcare is available for all.

Akhil Tripathi, Signifier’s co-founder, and CEO, said, “We look forward to offering this innovative home sleep test to provide millions of patients suffering from OSA with easier access to diagnostics and personalized treatment.”

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.

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).

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

Contacts

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

Investors and Partners:
Ekin Sezgen
Signifier Medical Technologies Inc
ekin.s@signifiermedical.com

Home / Archives for Signifier Medical Technologies / Page 2

Signifier Medical Technologies Wins Edison Award for Innovative Sleep Apnea Treatment

BOSTON and LONDON – April 20, 2023, Signifier Medical Technologies, a leading medical device company, has been honored with a prestigious Edison Award for its innovative sleep apnea treatment, eXciteOSA®. The Edison Awards, named after Thomas Alva Edison, recognize the most innovative and game-changing products, services, and business leaders across the globe.

eXciteOSA® is the world’s first and only FDA-authorized, clinically proven daytime therapy for mild obstructive sleep apnea (OSA). It is a non-invasive, easy-to-use, and portable solution to help people breathe normally and naturally all night without needing a wearable medical device or a surgical implant. The therapy uses neuromuscular electrical stimulation (NMES) to improve the endurance of the tongue muscles and reduce airway collapse during sleep. This results in a significant reduction in the number of apnea and hypopnea events, and improvements in sleep quality and daytime function.

“We are thrilled to be recognized by the Edison Awards for our groundbreaking work in sleep apnea treatment,” said Akhil Tripathi, CEO of Signifier Medical Technologies. “eXciteOSA® provides a new therapy option for millions of people worldwide who suffer from sleep apnea. Our device offers a non-invasive, effective, and comfortable alternative to traditional sleep apnea treatments.”

The Edison Award is a testament to Signifier Medical Technologies’ commitment to revolutionizing healthcare through innovative solutions that meet the needs of both patients and healthcare professionals alike.

About Signifier Medical Technologies

Signifier is a pioneer in addressing the root causes of sleep-disordered breathing. The Company focuses on developing and commercializing innovative and non-invasive solutions to help restore nighttime breathing – naturally. 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 (NCT05183009; NCT05252156), 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
jay.c@signifiermedical.com

Investors and Partners:
Ekin Sezgen
Signifier Medical Technologies Inc
ekin.s@signifiermedical.com

Home / Archives for Signifier Medical Technologies / Page 2

Nasdaq congratulates Signifier Medical Technologies for treating 10,000 patients with eXciteOSA, a daytime therapy for sleep apnea

BOSTON and LONDON – March 29, 2023 Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announces that eXciteOSA, the only FDA-authorized daytime therapy for sleep-disordered breathing, has treated over 10,000 patients since the commercial launch in 2021. Nasdaq recognized this milestone by congratulating Signifier Medical on the Nasdaq Tower in the heart of Times Square, New York.

Akhil Tripathi, Signifier’s co-founder and CEO said, “This is a proud moment knowing that our therapy has made a positive impact on the lives of so many patients. It’s been a great team effort among our employees, clinicians, distributors, and most of all, our patients.” Signifier Medical is simplifying the complex standard of care for obstructive sleep apnea with eXciteOSA by tackling a root cause – empowering patients to restore their nighttime breathing naturally – with a novel 20-minute daytime therapy.

Past studies have shown that eXciteOSA is associated with reductions in both objectively measured and bed-partner-reported snoring, along with significant improvements in disease severity, measured by the Epworth Sleepiness Scale, and Pittsburgh Sleep Quality Index.1-3 Clinical trial participants experienced a significant reduction in their AHI overall.3

“eXciteOSA is a new and novel daytime treatment for sleep apnea. Burden of use is as low as 20 minutes. Evidence is mounting about the positive effects of eXciteOSA in improving disease severity and daytime sleepiness. Patients now have an alternative approach that is easy to use and well accepted,” said Dr. Naresh M. Punjabi, Ph.D. – Chief, Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Miami.

eXciteOSA is a smart wireless device used for 20 minutes per day paired with an intuitive app and a dedicated Sleep Advocate for one-on-one coaching and support. Joel Hanlon, Manager of Patient Experience, said, “We’re thrilled with how well patients are responding to therapy, and we’re here to support them every step of the way throughout their therapy journey.”

The current standard of care for treating OSA, positive airway pressure (PAP), has long been plagued with low adherence and low patient satisfaction. Based on a recent study, eXciteOSA therapy demonstrates real-world adherence of more than 80%, which is exceptional in this space.

Effective treatment of OSA, which leads to better sleep, unlocks the potential for each of us to do more of what we love in life. We have a good reminder of that this month — March – which is Sleep Awareness Month. It’s a good time to learn about sleep health and seek a diagnosis and treatment for sleep-related conditions. Signifier Medical would like to be a part of that — transforming the standard of care for sleep apnea to help the millions of those suffering from the condition.

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 to improve population health, increase the quality of patient’s 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 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).

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

Contacts

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

Investors and Partners:
Ekin Sezgen
Signifier Medical Technologies Inc
ekin.s@signifiermedical.com

References

  1. 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.
  2. 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.
  3. 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 Breath 2022;
Home / Archives for Signifier Medical Technologies / Page 2

Signifier Medical Technologies Reaches a Wider Patient Population with FDA Approval to Remove Dental Contraindications for eXciteOSA

February 22, 2023 02:03 PM Eastern Standard Time

BOSTON & LONDON–(BUSINESS WIRE)–Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announces the FDA approval to remove dental contraindications for eXciteOSA. This opens the door for doctors and other providers to prescribe eXciteOSA on a more widespread basis.

Based on an observational study conducted by Signifier Medical, the data demonstrated no significant difference in the occurrence of eXciteOSA side effects amongst those with intraoral metal and those without intraoral metal dental work. As a result of these findings, the FDA has approved the removal of temporary or permanent metal implants, dental braces, and intraoral metal prosthesis, restorations, and appliances from contraindications. This meaningfully expands the number of patients who can benefit from a daytime therapy, with no nighttime wearable, for mild obstructive sleep apnea and snoring.

“It’s a good thing when the FDA removes a barrier that didn’t make sense to us as clinicians. The exclusion because of metal restorations made it more difficult to talk to non-dentist medical colleagues. Now, with the restriction lifted, we can go about finding the best therapy for the individual patient,” said Steve Carstensen, DDS, Co-founder of Premier Sleep Associates, the Director of Education for Airway Technologies, and Chief Dental Editor for Dental Sleep Practice Magazine.

In the study, Signifier gathered therapy experience data from 499 real-world users of eXciteOSA, including both civilian and Veteran patients. The focus of the study was primarily on the occurrence of side effects amongst patients with and without intraoral metal dental work and/or jewelry. Participants were asked to report the frequency, level of discomfort, and duration of eXciteOSA side effects. A thorough intraoral/dental history was obtained, focused on the presence of intraoral metal.

“A large number of Veterans were previously deemed ineligible for eXciteOSA for mild OSA/simple snoring because of the dental contraindications. This latest development is going to be well-received by VA clinics and patients across the country,” said Dr. Brandon Nokes, Director of Hypoglossal Nerve Stimulation at VA San Diego.

This study demonstrates the low-risk profile of eXciteOSA — a novel medical therapy that was authorized in the FDA De Novo process. This important milestone moves eXciteOSA, which treats one of the root causes of OSA, one step closer to being a first-line therapy for millions of people suffering with mild sleep apnea and snoring.

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 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 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 reduced endurance of the upper airway muscles, allowing the tongue to fall back and block 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.

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).

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

For more information on the dental study, please email clinicaltrial@signifiermedical.com.

Contacts

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

Investors and Partners:

Ekin Sezgen
Signifier Medical Technologies Inc
ekin.s@signifiermedical.com

Home / Archives for Signifier Medical Technologies / Page 2

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.