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
jay.c@signifiermedical.com

Investors and Partners:
Investor Relations
Signifier Medical Technologies Limited
investorrelations@signifiermedical.com

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®

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

Contacts

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

Investors and Partners:
Investor Relations
Signifier Medical Technologies Limited
investorrelations@signifiermedical.com

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
jay.c@signifiermedical.com

Investors and Partners:
Mujtaba Chohan
Signifier Medical Technologies LLC
mujtaba.c@signifiermedical.com

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.⁴Given 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

About eXciteOSA®

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

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

Contacts

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

Investors and Partners:
Mujtaba Chohan
Signifier Medical Technologies LLC
mujtaba.c@signifiermedical.com

References:

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.
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.
Patel SR, Bakker JP, Stitt CJ, Aloia MS, Nouraie SM. Age and Sex Disparities in Adherence to CPAP. Chest 2021;159(1):382-389.
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 eXcite^OSA® 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 24^th, 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 eXcite^OSA®. 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

About eXcite^OSA®

eXcite^OSA® is a revolutionary daytime therapy for sleep-disordered breathing. Clinically proven to target a common root cause of OSA, eXcite^OSA® 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, eXcite^OSA® is the first commercially available device used while awake, for just 20 minutes a day.

Signifier is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. Randomized trials are in progress to understand the potential placebo effect (NCT04974515), the impact of therapy relative to usual care without treatment (NCT05183009; NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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

Contacts

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

Investors and Partners:
Mujtaba Chohan
Signifier Medical Technologies Inc
mujtaba.c@signifiermedical.com

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, eXcite^OSA, 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

About eXcite^OSA®

eXcite^OSA is a revolutionary daytime therapy for sleep-disordered breathing. Clinically proven to target a common root cause of OSA, eXcite^OSA 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, eXcite^OSA is the first commercially available device used while awake.

Signifier is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. Randomized trials are in progress to understand the potential placebo effect (NCT04974515), the impact of therapy relative to usual care without treatment (NCT05183009; NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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

Contacts

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

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

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, eXcite^OSA®. The Edison Awards, named after Thomas Alva Edison, recognize the most innovative and game-changing products, services, and business leaders across the globe.

eXcite^OSA® 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. “eXcite^OSA® 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 eXcite^OSA®

Signifier is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. Randomized trials are in progress to understand the potential placebo effect (NCT04974515), the impact of therapy relative to usual care without treatment (NCT05183009; NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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

Contacts

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

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

Nasdaq congratulates Signifier Medical Technologies for treating 10,000 patients with eXcite^OSA, 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 eXcite^OSA, 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 eXcite^OSA 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 eXcite^OSA 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

“eXcite^OSA 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 eXcite^OSA 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.

eXcite^OSA 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, eXcite^OSA 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 eXcite^OSA®

Signifier is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. Randomized trials are in progress to understand the potential placebo effect (NCT04974515), the impact of therapy relative to usual care without treatment (NCT05183009; NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

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

Contacts

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

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

References

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.
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.
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 eXcite^OSA. This opens the door for doctors and other providers to prescribe eXcite^OSA on a more widespread basis.

Based on an observational study conducted by Signifier Medical, the data demonstrated no significant difference in the occurrence of eXcite^OSA 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 eXcite^OSA, 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 eXcite^OSA 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 eXcite^OSA 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 eXcite^OSA — a novel medical therapy that was authorized in the FDA De Novo process. This important milestone moves eXcite^OSA, 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 eXcite^OSA®

eXcite^OSA is a revolutionary daytime therapy for sleep disordered breathing. Clinically proven to target a common root cause of OSA, eXcite^OSA 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, eXcite^OSA 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, eXcite^OSA is the first commercially available device used while awake. The full benefits of the daytime therapy are realized without patient use during sleep.

Signifier is dedicated to engaging with the sleep research community to produce high-quality evidence from rigorous clinical trials. Randomized trials are in progress to understand the potential placebo effect (NCT04974515), the impact of therapy relative to usual care without treatment (NCT05183009; NCT05252156), and the impact of therapy amongst those with moderate OSA (NCT05252156).

To learn more about eXcite^OSA, please visit www.signifiermedical.com or www.exciteosa.com.

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

Contacts

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

Investors and Partners:

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

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