Signifier Medical Technologies’ eXciteOSA Now Covered by Medicaid in South Carolina: Reaching a Wider Patient Population with Daytime Sleep Apnea Therapy

BOSTON, MA –Signifier Medical Technologies Limited (“Signifier”), a leader in medical technology for sleep-disordered breathing, is thrilled to announce that eXciteOSA therapy is now covered by South Carolina’s Healthy Connections Medicaid program. This significant milestone further broadens access to eXciteOSA’s revolutionary daytime therapy for obstructive sleep apnea, ensuring that more individuals can benefit from this innovative and effective treatment.

Sleep apnea affects millions of Americans, and if left untreated, can lead to severe health issues. eXciteOSA’s non-invasive daytime therapy has shown greater than 80% adherence, demonstrating the positive impact on the lives of those suffering from obstructive sleep apnea by offering an alternative to traditional night-time devices.

“We are thrilled that eXciteOSA is now covered by Medicaid in South Carolina,” states Akhil Tripathi, Director and Co-founder of Signifier. “This achievement represents a significant milestone in our mission to make high-quality sleep apnea care accessible to all individuals. We look forward to continuing to collaborate with Medicaid and healthcare providers to improve sleep health outcomes for patients across the state and the country.”

The decision by the South Carolina Department of Health and Human Services to cover eXciteOSA therapy through its Medicaid program underscores the importance of accessible, effective treatment options for sleep-disordered breathing. This coverage opens new doors for patients 18 and older who have previously had limited access to advanced treatments for obstructive sleep apnea. Recognizing the therapy’s potential to improve health outcomes and reduce overall healthcare costs, this decision marks a pivotal step towards inclusive healthcare.

Dr. Joshua Lennon states, “As a physician prescribing eXciteOSA, I’ve witnessed firsthand the transformative impact this therapy has had on my patients struggling with obstructive sleep apnea. With Medicaid coverage now available in South Carolina, I’m thrilled to see more individuals gaining access to this innovative solution.”

“Adding coverage of this new therapy aligns well with our agency’s mission to be boldly innovative in improving health and quality of life for South Carolinians,” states Robby Kerr, Director of Human and Health Services in South Carolina.

Signifier extends its gratitude to the South Carolina Department of Health and Human Services for their partnership in expanding access to obstructive sleep apnea therapy for Medicaid beneficiaries. The company continues to work closely with healthcare providers, payers, and patients to support the adoption and implementation of eXciteOSA therapy, ensuring that more individuals can experience its life-changing benefits.

About eXciteOSA®

eXciteOSA is a revolutionary daytime therapy for sleep-disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA uses 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 that 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.

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

Contacts

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

Investors and Partners:
Investor Relations
Signifier Medical Technologies Limited
[email protected]

New Published Study Explores Cost-Effectiveness of Neuromuscular Electrical Stimulation for the Treatment of Mild Obstructive Sleep Apnea

Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announces that The International Journal of Technology Assessment in Health Care has recently published an exploratory analysis entitled “Cost-Effectiveness of Neuromuscular Electrical Stimulation for the Treatment of Mild Obstructive Sleep Apnea.” The study led by Drs. Shan Liu, Jan Pietzsch, and a collaborative research team explores the cost-effectiveness of using neuromuscular electrical stimulation (NMES) as a treatment option for patients with mild obstructive sleep apnea (OSA).

Recent estimates suggest that 55 million adults in the United States suffer from OSA, with over half falling into the mild range. Patients with mild OSA often experience a diminished quality of life compared to controls, and epidemiological analyses reveal increased risks of hypertension, diabetes, and abnormal fasting glucose among them. Despite the prevalence of OSA, the current standard of care, positive airway pressure (PAP) therapy, faces challenges such as low adherence and patient satisfaction, which creates a demand for alternative OSA treatment options.

The researchers in this study used a decision-analytic model to assess the incremental cost-effectiveness ratio (ICER) of neuromuscular electrical stimulation compared to no treatment and continuous positive airway pressure (CPAP) therapy. The analysis, conducted from the US healthcare system perspective, considered both direct medical costs and health outcomes measured in quality-adjusted life years (QALYs). The results of the exploratory analysis indicated that neuromuscular electrical stimulation may be a cost-effective treatment option for mild OSA compared to no treatment. Furthermore, it showed that neuromuscular electrical stimulation, depending on long-term adherence, may be preferred over CPAP therapy, suggesting that this alternative treatment approach could provide a valuable and more accessible option for individuals with mild OSA.

“We are excited to see the results of this study reinforce the potential of neuromuscular electrical stimulation as a revolutionary treatment option for individuals with mild obstructive sleep apnea,” states Mujtaba Chohan, Head of Finance & Chief of Staff at Signifier.

While CPAP therapy has been the standard treatment for moderate to severe OSA, it has long been plagued with low adherence and low patient satisfaction. With over 14,000 patients being prescribed eXciteOSA, and real-world data demonstrating strong adherence of patients using therapy over 80% of days, this simple, non-invasive NMES therapy allows patients to complete a session for just 20 minutes during the day, offering them the freedom to breathe naturally, all night long, on their own.

Senior author Dr. Jan B. Pietzsch, who directed the study, emphasized the significance of the findings, stating, “Our research provides important insights into the potential cost-effectiveness of using neuromuscular electrical stimulation for individuals with mild obstructive sleep apnea that are relevant for patients, clinicians, and healthcare payers.”

This study contributes to the ongoing efforts to improve the quality of life for individuals with sleep apnea by exploring innovative and more accessible treatment alternatives. As researchers continue to explore the cost-effectiveness of various treatments, patients and clinicians will benefit from a wider range of evidence-based options for managing obstructive sleep apnea.

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 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 that 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.

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


Contacts

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

Investors and Partners:
Investor Relations
Signifier Medical Technologies Limited
[email protected]

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

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

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

HCPCS Codes and Descriptions

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

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

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

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

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

About Signifier Medical Technologies

Signifier Medical is a pioneer in addressing the root causes of sleep-disordered breathing. The Company is focused on developing and commercializing innovative and non-invasive solutions to help people breathe normally and naturally all night – without needing to use a wearable medical device or a surgical implant. Founded in 2015, Signifier is at the forefront of sleep therapy, with a mission to develop therapies to improve population health, increase the quality of patients’ healthcare experience, and generate healthcare savings. Signifier has offices in London (UK) and Needham (Massachusetts, USA).

About eXciteOSA®

eXciteOSA is a revolutionary daytime therapy for sleep-disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA uses neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, working the intrinsic and extrinsic tongue muscles to improve endurance and prevent airway collapse during sleep. Unlike other devices which are used while patients sleep, eXciteOSA is the first commercially available device used while awake.

Signifier Medical is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. To learn more about eXciteOSA, please visit www.signifiermedical.com or www.exciteosa.com.


Contacts

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

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

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

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

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

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

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

Key findings of the AEGIS trial include:

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

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

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

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

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

For further information about the AEGIS clinical trial please visit:

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

About Signifier Medical Technologies

Signifier Medical is a pioneer in addressing the root causes of sleep-disordered breathing. The Company is focused on developing and commercializing innovative and non-invasive solutions to help people breathe normally and naturally all night – without needing to use a wearable medical device or a surgical implant. Founded in 2015, Signifier is at the forefront of sleep therapy, with a mission to develop therapies to improve population health, increase the quality of patients’ healthcare experience, and generate healthcare savings. Signifier has offices in London (UK) and Needham (Massachusetts, USA).

About eXciteOSA®

eXciteOSA is a revolutionary daytime therapy for sleep-disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA uses neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, working the intrinsic and extrinsic tongue muscles to improve endurance and prevent airway collapse during sleep. Unlike other devices which are used while patients sleep, eXciteOSA is the first commercially available device used while awake.

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

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


Contacts

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

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

 

References:

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

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

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

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

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

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

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

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

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

About Signifier Medical Technologies

Signifier is a pioneer in addressing the root causes of sleep-disordered breathing. The Company is focused on developing and commercializing innovative and non-invasive solutions to help people breathe normally and naturally all night – without needing to use a wearable medical device or a surgical implant. Founded in 2015, Signifier is at the forefront of sleep therapy, with a mission to develop therapies to improve population health, increase the quality of patients’ healthcare experience, and generate healthcare savings. Signifier has offices in London (UK) and Needham (Massachusetts, USA).

About eXciteOSA®

eXciteOSA® is a revolutionary daytime therapy for sleep-disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA® uses neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, working the intrinsic and extrinsic tongue muscles to improve endurance and prevent airway collapse during sleep. Unlike other devices which are used while patients sleep, eXciteOSA® is the first commercially available device used while awake, for just 20 minutes a day.

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

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

Contacts

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

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

Appointment of new Board

BOSTON and LONDON – Aug 25, 2023

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

 

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

 

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 (NCT05183009NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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

Contacts

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

Investors and Partners:
Ekin Sezgen
Signifier Medical Technologies Inc
[email protected]

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 (NCT05183009NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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

Contacts

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

Investors and Partners:
Ekin Sezgen
Signifier Medical Technologies Inc
[email protected]

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 (NCT05183009NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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

Contacts

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

Investors and Partners:
Ekin Sezgen
Signifier Medical Technologies Inc
[email protected]

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;

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 (NCT05183009NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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

For more information on the dental study, please email [email protected].

Contacts

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

Investors and Partners:

Ekin Sezgen
Signifier Medical Technologies Inc
[email protected]

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:
[email protected]
+1 (844) 645 3672

Investors and Partners:
Alastair Maxwell
Signifier Medical Technologies Inc
[email protected] 

Take your first steps towards a restful night’s sleep today

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
[email protected]
+1 (844) 645 3672

Investors and Partners:

Alastair Maxwell
Signifier Medical Technologies Inc
[email protected] 

References

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

Take your first steps towards a restful night’s sleep today

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

[email protected]
+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.

Take your first steps towards a restful night’s sleep today

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

[email protected]
+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.

Take your first steps towards a restful night’s sleep today

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

[email protected]

+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.

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.

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:
[email protected]
+1 (844) 645-3672
+44 (0) 20 7096 0586

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:
[email protected]
+44 (0) 207 096 0586

Signifier® Medical Ushers In New Era of Treatment for Sleep Apnea and Snoring with FDA Authorization 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 authorized 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.

connected technology snoozeal
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

In 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 authorization 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 authorized 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:
[email protected]
+44 (0) 207 096 0586

Take your first steps towards a restful night’s sleep today

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: [email protected]
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

Signifier® Medical Technologies appoints Alastair Maxwell as Chief Financial Officer

Brings significant capital markets and strategic development expertise to support Company growth 29 years of Investment Banking experience at Kleinwort Benson, Morgan Stanley and Goldman Sachs

Boston, MA, USA, and London, United Kingdom

November 24, 2020

Signifier Medical Technologies (“Signifier/the Company”), an innovator in the sleep-disordered breathing market, is pleased to announce the appointment of Alastair Maxwell as Chief Financial Officer with immediate effect. He will be based in Boston and London and will be responsible for all aspects of the Company’s financial strategy, management, and operations including ensuring that the Company is adequately financed to meet its ambitious growth plans.

Mr. Maxwell has enjoyed a long and successful career in the investment banking industry where he worked for almost 30 years. This was most recently with Goldman Sachs from 2010 to 2016 where he was a Partner and Global Industry Group Co-Head with responsibility for relationships with a wide range of corporate and other clients.

Previous to this, he was with Morgan Stanley, most recently as Managing Director and Industry Head in the EMEA region, and prior to that with Dresdner Kleinwort Benson.

Prior to joining Signifier, Mr. Maxwell was Chief Financial Officer at NYSE-listed companies GasLog Ltd and GasLog Partners LP where he worked closely with the Board and senior management team to facilitate the growth of the business and to secure the funding required to support this growth.

During his career, Mr. Maxwell has been involved in a wide range of strategic and financing transactions, including equity, equity-linked, bond and bank financings for a variety of private and public companies.

Akhil Tripathi, CEO of Signifier commented: “This latest key appointment further rounds out our world-class leadership team. Alastair brings significant expertise to the Company in capital markets, fundraising, and corporate strategy. His global and US experience will be crucial in supporting Signifier and ensuring that we have access to the appropriate financing as we seek to rapidly expand our business.”

Alastair Maxwell added: “I am excited to be joining Signifier at this important time in its development. With the anticipated launch of eXciteOSA®, the Company is poised for significant growth. I look forward to utilizing my skills and network to work with Akhil and the rest of the team to help the Company realize its tremendous potential.”

For more information, please contact:

Signifier Medical Technologies
Email: [email protected]
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

Signifier® Medical Technologies appoints Jim Hinrichs, former CFO and Director of CareFusion and Alere, to its Board

Boston, MA, USA, and London, United Kingdom

November 12, 2020

Signifier Medical Technologies (“Signifier” or the “Company”), an innovator in the sleep-disordered breathing market, is pleased to announce the appointment of Jim Hinrichs to the Board of the Company. He joins existing Directors Kieran Gallahue (Chairman), Akhil Tripathi (CEO), Steffen Kastner, and Robert Sullivan.

Jim has 30 years of financial leadership experience in large and small organizations within the healthcare industry. Prior to his current board roles, Jim served as Chief Financial Officer (CFO) of multiple companies. These included Alere Inc, a publicly-traded diagnostic company, until its sale to Abbott Labs for approximately $8 billion; CareFusion Corporation, a publicly-traded medical technology company, until its sale to Becton Dickinson for approximately $12 billion; Sangstat Medical, a publicly-traded biotechnology company; and Cibus, a startup gene-editing company focused on the agriculture markets.

He previously served at Cardinal Health in various financial leadership positions having joined the company following more than a decade of finance and marketing roles at Merck & Co.

Jim currently serves as a Director and Chair of the Audit Committee at Orthofix Inc. (OFIX), Director and Chair of the Compensation Committee at Integer Holdings (ITGR), Lead independent director and Chair of the Audit Committee at Acutus Medical (AFIB), and Director and Chair of the Audit Committee at Outset Medical (OM).

Akhil Tripathi, CEO of Signifier, commented: “I am delighted to welcome Jim to the Board of Signifier. He brings tremendous industry experience and well-proven financial leadership and governance skills that will be invaluable in supporting the senior management team as we move to commercialize eXciteOSA for mild sleep apnea and snoring.”

Jim Hinrichs added: “Signifier Medical is poised to begin a phase of rapid expansion and growth with the potential to revolutionize treatment for patients with sleep-disordered breathing. I am excited to be working with the company at this pivotal stage and look forward to bringing my skills and experience to complement those of the existing Board.”

Mr. Hinrichs’s appointment follows the recent expansion of Signifier’s senior management team. In September, Signifier announced the appointment of Philip Hess, former President and CEO of Bose Corporation, as Chief Operating Officer based in Boston, USA, where Signifier is establishing its US operations. In October, Travis Nieman was appointed as Managing Director International, joining the company from Stryker Corporation.

For more information, please contact:

Signifier Medical
Email: [email protected]
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

Signifier® Medical Technologies appoints Travis Nieman as Managing Director International

Boston, MA, USA and London, United Kingdom

October 08, 2020

Senior appointment in preparation for commercialization in markets outside the USA of eXciteOSA®, a novel, non-invasive, daytime therapy for sleep-disordered breathing conditions

Signifier Medical Technologies (“Signifier”), an innovator in the sleep-disordered breathing market, is pleased to announce the appointment of Travis Nieman as Managing Director International. Mr. Nieman joins the company from Stryker where he was Managing Director International & Global Reimbursement, Stryker Ear Nose & Throat. He will be responsible for the commercial development of eXciteOSA® in all markets outside the USA.

Travis Nieman, newly appointed Signifier Medical Managing Director International

Mr Nieman is a highly experienced commercial leader in healthcare with a proven track record in small and large organizations over more than 20 years. Prior to Stryker, he was a Director of International Marketing at Baxter and before that spent several years at Medtronic as Brand Manager Europe-Central Asia. Mr. Nieman began his career at The Coca-Cola Company.

Akhil Tripathi, CEO of Signifier commented: “We are very pleased to welcome Travis as the newest member of our senior management team. His skills and experience in healthcare device management, developing and launching new technologies, health economics outcomes research and market access, business development, and commercial leadership will be invaluable in driving the commercial strategy for eXciteOSA® in international markets outside of the US. His appointment represents another key building block in our mission to bring our novel technology to markets globally.”

Travis Nieman added: “eXciteOSA® is a highly innovative product and I believe represents a unique opportunity to improve the lives of many patients suffering from sleep-disordered breathing. We intend to build a seamless pathway for users including an integrated digital strategy that offers the potential to bring broader healthcare benefits to patients. I look forward to bringing my skills and experience to bear at Signifier Medical as we continue on this exciting phase of our journey over the next 12 months and beyond.”

Mr Nieman’s appointment further expands the senior management team. In September, Signifier announced the appointment of Philip Hess, former President and CEO of Bose Corporation, as Chief Operating Officer based in Boston, USA, where Signifier is establishing its US operations. In July, Signifier announced the appointment of Mr. Matt Sharris as Vice President of Sales for North America. We look forward to announcing further key appointments as we build out our world-class leadership team.

For more information, please contact:

Signifier Medical
Email: [email protected]
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 snoring and sleep-disordered breathing conditions.

Signifier’s proprietary therapy eXciteOSA® is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology for snoring and mild obstructive sleep apnea, 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 Snoring and OSA

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

Signifier® Medical Technologies Wins IDEA Design Award 2020 for eXciteOSA®, the World’s First, Daytime Treatment Device That Tackles the Root Cause of Sleep-Disordered Breathing

London, United Kingdom

September 17, 2020

Signifier® Medical Technologies, an innovator in the sleep-disordered breathing market is delighted to announce that it has been awarded a bronze IDEA award by the prestigious Industrial Designers Society of America (IDSA) in the “Medical & Health” category, for its novel medical device, eXciteOSA® – designed for patients with sleep-disordered breathing conditions.

Founded in 1965, Industrial Designers Society of America is one of the oldest and largest industrial design associations in existence, with 2020 marking the 40th anniversary of the International Design Excellence Awards (IDEA).

Originally founded to recognize exceptional achievement in industrial design, the program has since grown with thousands of entries submitted by design teams across the globe, making IDEA one of the largest and most widely anticipated annual awards programs in the world.

Professor Dr Anshul Sama (FRCS), Founder and Chief Medical Officer of Signifier Medical Technologies and Ear, Nose and Throat Surgeon at the University of Nottingham, was keenly aware of the fact that many of his patients were struggling with conventional treatment options for their sleep-disordered breathing (SDB) conditions. Based on an understanding of this significant unmet need and working with a talented multidisciplinary team, he created the world’s first, daytime treatment device that tackles the root cause of SDB.

eXciteOSA® works by improving tongue muscle endurance and responsiveness preventing upper airway collapse during sleep. Clinically significant results have been observed, when used for 20 minutes, once a day, for 6 weeks. 2-4

More information about the eXciteOSA IDSA award can be found here: https://www.idsa.org/awards/idea/medical-health/snoozeal

Images of the eXciteOSA® device are available upon request to [email protected]

About Snoring and OSA

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

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.

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 snoring and sleep-disordered breathing conditions. Signifier’s proprietary therapy is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology, with proven clinical data from prestigious and well-recognised universities and academic institutions, that provides a safe and effective therapy for patients.2-4

About International Designers Society of America

Founded in 1965, IDSA is one of the oldest and largest membership associations for industrial design professionals with thousands of members in Student Chapters, Professional Chapters and Special Interest Sections in the United States and internationally. IDSA sponsors IDEA®, the world’s most prestigious and rigorous design competition. The Society hosts events including an annual International Design Conference, five District Design Conferences and a Medical Design Conference, bringing together some of the biggest names and brightest minds in industrial design and related fields.

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). 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

For media enquiries:
[email protected]
+44 (0) 207 096 0586

Take your first steps towards a restful night’s sleep today

Signifier Medical Technologies Closes $10M Series C Funding Round

London, United Kingdom

September 16, 2020

Signifier Medical Technologies (“Signifier”), an innovator in the sleep-disordered breathing market, today announced it has closed a circa $10M Series C funding round led by Alan Howard, VC investor and co-founder of Brevan Howard. The proceeds from this latest successful fundraising will allow Signifier to invest further in its innovative and non-invasive solutions for patients with sleep-disordered breathing conditions.

The financing round also included participation from James Blair, a career healthcare venture capitalist and Partner/Co-founder of Domain Associates as an additional new investor in Signifier. Existing investors participating in the round included The Pritzker Organization and Signifier’s Chairman Kieran Gallahue, former CEO of both CareFusion, Inc. and Resmed Inc.

Alan Howard commented: “I look for companies that are addressing extensive market opportunities, are rapidly growing, and have experienced leadership teams. I strongly believe Signifier is one of those companies, and I am pleased to support its transformational innovation to address sleep and breathing disorders and chronic care management.”

Joseph Gleberman, Managing Director of The Pritzker Organization, added: “We are pleased to continue supporting Signifier’s breakthrough technology for treating both chronic snoring and obstructive sleep apnoea.”

James Blair noted: “I am delighted to become an investor in Signifier, which is combining the tools of information technology with the knowledge of leading physicians to improve the daily lives of millions of people suffering from sleep-disordered breathing both conveniently and inexpensively.”

Signifier is continuing to build its operations and infrastructure in preparation for global commercialization of its eXciteOSA® device for mild sleep apnoea, while expanding commercialization of its eXciteOSA® device for primary snoring.

Akhil Tripathi, CEO and co-founder of Signifier Medical added “I am delighted to have attracted such prominent and well-known investors in our latest financing round. Our non-invasive tongue muscle-neurostimulation devices are the first and only technologies being developed to solve the conditions of mild sleep apnoea and snoring and make a real impact on the lives of millions of people worldwide. We recently announced the appointments of Philip Hess, former President and CEO of Bose Corporation, as Chief Operating Officer based in Boston, US, as well as Matt Sharris as Vice President of Sales in the North American market and Steve Saunders as Head of Sales in EMEA. With the addition of this latest financing round we are well prepared to accelerate the commercial phase of our development.”

For more information, please contact:

Signifier Medical
Email: [email protected]
Tel: +44 (0)20 7096 0586

Citigate Dewe Rogerson
Frazer Hall/Mark Swallow
Email: [email protected]
Tel: +44 (0)20 7638 9571

Notes to Editors

About Signifier Medical Technologies

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

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

About Snoring and OSA

Nearly 1 billion adults aged 30 to 69 years are estimated to have obstructive sleep apnoea (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 apnoea 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 apnoea 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.

SOURCE Signifier Medical Technologies

Related Links
www.prnewswire.com

References

  1. 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.
  2. Sama A, et al. Daytime Intraoral Neurostimulation with Snoozeal® for Treatment of Snoring and Mild Sleep Apnoea. CHEST Annual Meeting Notes. 2018.
  3. Clinical study of 115 patients with snoring or mild OSA (Apnoea-Hypopnea Index (AHI <15)). 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.

Signifier® Medical Technologies Hosted a Global Webinar on: “Precision Medicine and Non-Invasive Therapies for Mild Obstructive Sleep Apnea”

sleep apnoea

LONDON, 3rd September 2020

Signifier Medical Technologies, an innovator in the sleep disordered breathing market, recently hosted a global webinar with leading world experts in the field of sleep disordered breathing (SDB).

The webinar was centred on “Precision Medicine and Non-Invasive Therapies for Mild Obstructive Sleep Apnea” and it was hosted by Prof. Dr. Adrian Williams (Professor of Sleep Medicine & Consultant Respiratory Physician, a founding member of the Sleep Section of the Royal Society of Medicine) and Prof. Dr. Atul Malhotra, (Research Chief in Pulmonary, Critical Care and Sleep Medicine at UC San Diego, USA).

Prof. Dr. Anshul Sama (Consultant ENT and Sleep Physician at Nottingham University Hospital, UK and inventor of the daytime intraoral neuromuscular electrical stimulation (NMES) technology1-2 for reduction of sleep disordered breathing) also participated in the webinar presenting the technology and the new therapy options provided by NMES.

The webinar shed light on the SDB space, current treatment modalities, and presented the mechanism of action and clinical data on the new NMES technology.

eXciteOSA® is a non-invasive daytime therapy for the tongue which delivers small contractions that improves muscle function and reduces the physiological collapse of the tongue during sleep. The device is a one size fits all and effective when used for 20 minutes a day for six weeks, with sustained improvement with minimal weekly maintenance.

Patients often find conventional night-time solutions for SDB ineffective or difficult to tolerate. With increasing public awareness of sleep related issues, and sleep therapy devices, it is increasingly likely that more patients will be consulting their healthcare professional on the therapy options available to them.

eXciteOSA® gives healthcare professionals and patients an effective therapy that is easy and convenient to use.

If you missed it live, visit www.exciteosa.com/past-webinars to view previous webinars on-demand and register for future webinars.

About Snoring and OSA

Nearly 1 billion adults aged 30 to 69 are estimated to have obstructive sleep apnea (OSA) globally. There is a strong, clinically proven link between obstructive sleep apnea 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 can be limited, so there is a demand for new and innovative approaches.

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 snoring and sleep disordered breathing conditions. Signifier’s proprietary therapy is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology, with proven clinical data from prestigious and well-recognised universities and academic institutions, that provides a safe and effective therapy for patients.1-3

References

  1. 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.
  2. Sama A, et al. Daytime Intraoral Neurostimulation with Snoozeal® for Treatment of Snoring and Mild Sleep Apnea. CHEST Annual Meeting Notes. 2018.
  3. Clinical study of 115 patients with snoring or mild OSA (Apnea- Hypopnea Index (AHI <15). 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

For media enquiries:
[email protected]
+44 (0) 207 096 0586

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Signifier Medical Technologies appoints Philip Hess, former President & CEO of Bose Corporation, as Chief Operating Officer

London, United Kingdom

September 02, 2020

Senior appointment in the US paves the way for the creation of USA operations in preparation for commercialisation of eXciteOSA®, a novel, non-invasive, daytime therapies for sleep-disordered breathing conditions.

Signifier Medical Technologies (“Signifier”), an innovator in the sleep-disordered breathing market, is pleased to announce the appointment of Philip Hess as Chief Operating Officer.

Mr. Hess is the former President & CEO of Bose Corporation, where he worked for 24 years across multiple leadership and operational roles. During his tenure, Mr. Hess was instrumental in Bose’s evolution from a speaker and DVD company to a leader in headsets and wireless products. Most recently, he was leading Bose into connected wearables and health products. He will be located in Boston, MA, where he will have responsibility for growing Signifier’s US infrastructure in preparation for the commercialisation of the company’s products.

Mr. Hess will additionally lead the formation of a new R&D function to identify and leverage innovative science to create new product opportunities for Signifier, aimed at improving the lives of the millions of people with sleep-disordered breathing conditions.

“With Signifier’s clinically-proven technology, we have the opportunity to treat several kinds of sleep disorders in a way never before possible” said Phil Hess. “Sleep is one of the core pillars of health. I’m incredibly excited to be part of a team that will improve the quality of life for millions of people.”

“I am delighted to welcome Phil to the company. He brings a valuable combination of skills and experience that we believe will benefit Signifier not only in the near-term, as we continue the global commercialisation of eXciteOSA®, but also in the future as we seek to build a global innovation-led healthcare company,” added Akhil Tripathi, CEO, and Co-Founder of Signifier Medical Technologies. “Phil is a key partner of this growth strategy. With other recent important appointments in the US and Europe, we are building a highly capable global team to deliver on our ambitions.”

In July, Signifier Medical Technologies announced the appointment of Mr. Matt Sharris as Vice President of Sales for North America. Matt brings strategic and commercial experience in respiratory and medical technologies and this follows the company strategy to drive and maximise the commercial footprint.

For more information, please contact:
Signifier Medical
Email: [email protected]
Tel: +44 (0)20 7096 0586
Citigate Dewe Rogerson

Frazer Hall/Mark Swallow
Email: [email protected]
Tel: +44 (0)20 7638 9571

Notes to Editors

About Signifier Medical Technologies

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

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

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

About Snoring and OSA

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.

SOURCE Signifier Medical Technologies

Related Links

www.signifiermedical.com
www.prnewswire.com

References

  1. 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.
  2. Sama A, et al. Daytime Intraoral Neurostimulation with Snoozeal® for Treatment of Snoring and Mild Sleep Apnea. CHEST Annual Meeting Notes. 2018.
  3. Clinical study of 115 patients with snoring or mild OSA (Apnea-Hypopnea Index (AHI <15)). 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.

Signifier® Medical Technologies to host webinar on Precision Medicine and Non-Invasive therapies for Mild Obstructive Sleep Apnea

Live Webinar: 1st September 7-8pm BST

sleep apnoea

LONDON, 30th July 2020

Signifier Medical Technologies today announced that it will host a live webinar on Monday 1st September 7-8pm BST to learn about the latest advances in the management of sleep disordered breathing and emerging new technologies in the field of sleep medicine.

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

The webinar will feature three experts on sleep disordered breathing, Prof. Dr. Adrian Williams, Professor of Sleep Medicine & Consultant Respiratory Physician, a founding member of the Sleep Section of the Royal Society of Medicine, as well as having been awarded the UK’s first Chair in Sleep Medicine, and Prof. Dr. Atul Malhotra – Research Chief in Pulmonary, critical care and sleep medicine at UC San Diego. He is Peter C. Farrell Presidential chair and Professor in Respiratory Medicine at UCSD. They will be joined by Prof. Dr. Anshul Sama Consultant Rhinologist, Dept. of Neurosurgery, Nottingham University Hospital and inventor of daytime NMES for OSA.

The speakers will cover the following topics in this free webinar:
• Mild Obstructive Sleep Apnea: burden of disease and the need for bespoke management
• Emerging technologies and future trends in management of OSA

The webinar will include a Q&A session with the speakers. Please register HERE.

About Signifier Medical Technologies

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

Signifier’s proprietary therapy is the first and only day time genioglossal muscle-neurostimulation technology, with proven clinical data from prestigious and well-recognised universities and academic institutions, that provides a safe and effective treatment for its patients. 1-3

References

  1. 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.
  2. Sama A, et al. Daytime Intraoral Neurostimulation with Snoozeal® for Treatment of Snoring and Mild Sleep Apnea. CHEST Annual Meeting Notes. 2018.
  3. Clinical study of 115 patients with snoring or mild OSA (Apnea- Hypopnea Index (AHI <15). 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

For media enquiries:
[email protected]
+44 (0) 207 096 0586

Take your first steps towards a restful night’s sleep today

Signifier® Medical Technologies Hosted a Global Webinar on: “Latest Advances in the Management of Sleep Disordered Breathing”

sleep apnoea

LONDON, 17th July 2020

Signifier Medical Technologies, an innovator in the sleep disordered breathing market, recently hosted a global webinar with leading world experts in the field of sleep disordered breathing (SDB).

The webinar was centred on “Precision medicine for obstructive sleep apnea and emerging technologies” and it was hosted by Prof. Dr. Peter Cistulli (ResMed Chair in Sleep Medicine at the University of Sydney, Australia) and Prof. Dr. Atul Malhotra, (Research Chief in Pulmonary, Critical Care and Sleep Medicine at UC San Diego, USA).

Prof. Dr. Anshul Sama (Consultant ENT and Sleep Physician at Nottingham University Hospital, UK and inventor of the daytime intraoral neuromuscular electrical stimulation (NMES) technology1-2 for reduction of sleep disordered breathing) also participated to the webinar presenting the eXciteOSA® technology and the new treatment proposed with the eXciteOSA® device.

The webinar shed new light on the SDB space and presented novel clinical data on the new NMES technology associated with eXciteOSA®.

This new data brought together results from a multi-centre clinical study held in tier-1 academic centres at London Teaching Hospital and Spain (University of Navarra) – with c. 115 participants.

The clinical results showed:

  • Significant clinical reductions in objective mild Obstructive Sleep Apnea (OSA) indexes, including AHI, ODI and RDI; and
  • Subjective questionnaires completed by bed partners that reported a substantial reduction in snoring.

This treatment resulted in an improved quality of sleep for both the patients and their partner3.

eXciteOSA® is a non-invasive daytime therapy for the tongue which delivers small contractions that improves muscle function and reduces the physiological collapse of the tongue during sleep. The device is a one size fits all and effective when used for 20 minutes a day for six weeks, with sustained improvement with minimal weekly maintenance.

Patients often find conventional night-time solutions ineffective or difficult to tolerate. With the increasing public and digital awareness of sleep and sleep devices, it is increasingly likely that more patients will be consulting their healthcare professionals on these issues.

eXciteOSA® gives healthcare professionals and patients an effective solution that is easy and convenient to use.

If you missed it live, visit www.exciteosa.com/past-webinars to view previous webinars on-demand and register for future webinars.

About Snoring and OSA

Nearly 1 billion adults aged 30 to 69 are estimated to have obstructive sleep apnea (OSA) globally. There is a strong, clinically proven link between obstructive sleep apnea 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 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 demand for new forms of treatment.

About Signifier Medical Technologies

Signifier Medical Technologies, previously known as Snoozeal, is a medical technology company focused on the development and commercialization of innovative and non-invasive solutions for patients with snoring and sleep disordered breathing conditions. Signifier’s proprietary therapy is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology, with proven clinical data from prestigious and well-recognised universities and academic institutions, that provides a safe and effective treatment for its patients.1-3

References

  1. 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.
  2. Sama A, et al. Daytime Intraoral Neurostimulation with Snoozeal® for Treatment of Snoring and Mild Sleep Apnea. CHEST Annual Meeting Notes. 2018.
  3. Clinical study of 115 patients with snoring or mild OSA (Apnea- Hypopnea Index (AHI <15). 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

For media enquiries:
[email protected]
+44 (0) 207 096 0586

Take your first steps towards a restful night’s sleep today

Signifier® Medical Technologies Appoints New Senior Member to the USA Organization

London, United Kingdom

July 17, 2020

Signifier Medical Technologies, an innovator in the sleep-disordered breathing market, is delighted to appoint Matt Sharris as Vice President of Sales in the North American market. Matt will further enhance and strengthen the organization with his wealth of experience and knowledge in the sleep market space.

This appointment follows the company strategy to drive and maximize commercial footprint later into the year in his geography.

Matt Sharris appointed Vice President of Sales – North America

Matt SharrisMr. Sharris appointed as Vice President of Sales for North America who will bring his strategic and commercial experience in respiratory and medical technologies to help guide Signifier Medical Technologies in the commercialization of its eXciteOSA® device in the region.

This will allow the company to generate interest and education within the health care professional community and managing the KOL platform across North America.

Mr. Sharris was most recently Director of Sales and Vice President of Payor Relations for Regional Home Care, with prior roles within account management and sales for ResMed.

Mr. Sharris is based in Boston.

“Today’s announcement further builds upon the Signifier team globally” said Anshul Sama, CMO and Co Founder of Signifier Medical Technologies. “Each person brings extensive medical technologies backgrounds to the business and will help Signifier strengthen channel partnerships, develop strategic alliances and expand our international sales presence.”

About Snoring and OSA

Nearly 1 billion adults aged 30 to 69 are estimated to have obstructive sleep apnea (OSA) globally. There is a strong, clinically proven link between obstructive sleep apnea 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 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 demand for new forms of treatment.

About Signifier Medical Technologies

Signifier Medical Technologies, previously known as eXciteOSA®, is a medical technology company focused on the development and commercialization of innovative and non-invasive solutions for patients with snoring and sleep-disordered breathing conditions. Signifier’s proprietary therapy is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology, with proven clinical data from prestigious and well-recognized universities and academic institutions, that provides a safe and effective treatment for its patients.1-3

For more information, please visit www.snoozeal.com

References

  1. 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.
  2. Sama A, et al. Daytime Intraoral Neurostimulation with Snoozeal® for Treatment of Snoring and Mild Sleep Apnea. CHEST Annual Meeting Notes. 2018.
  3. Clinical study of 115 patients with snoring or mild OSA (Apnea-Hypopnea Index (AHI <15)). 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.

For more information, please contact us at:
[email protected]
+44 (0) 207 096 0586