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

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

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

 

HCPCS Code Description
K1028 Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle for the reduction of snoring and obstructive sleep apnea, controlled by phone application.
K1029 Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by phone application, 90-day supply.

 

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

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

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

The CMS decision can be viewed at: https://www.cms.gov/files/document/2021-hcpcs-application-summary-biannual-2-2021-non-drug-and-non-biological-items-and-services.pdf

 

 

About Signifier Medical Technologies

Signifier is a pioneer in addressing the root causes of sleep disordered breathing. We are focused on the development and commercialization of innovative and non-invasive solutions for patients with conditions such as Obstructive Sleep Apnea and primary snoring. Founded in 2015, Signifier is at the forefront of sleep therapy, with a mission to develop therapies that improve population health, increase the quality of patients’ experience and generate healthcare savings. Signifier has offices in London (UK), Needham (Massachusetts, USA) and Berlin (Germany).

 

About eXciteOSAâ

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

A major underlying cause of OSA is that the upper airway muscles lack endurance during sleep and the tongue falls back, blocking the upper airway. By using neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, eXciteOSA works the intrinsic and extrinsic tongue muscles to improve endurance and prevent airway collapse during sleep.

Unlike other devices which are used while patients sleep, eXciteOSA is the first commercially available device used awake. The full benefits of the daytime therapy are realized without patient use during sleep.

 

About Snoring and Obstructive Sleep Apnea

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

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

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

 

Contacts

marketing@signifiermedical.com

+1 (844) 645 3672

 

References

  1. Benjafield, A. V., Ayas N T, Eastwood P R et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med 2019; 7: 687-698.
  2. Peppard PE, Young T, Palta M, et al. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000; 342:1378–1384. [PubMed: 10805822]
  3. Gottlieb DJ, Yenokyan G, Newman AB, et al. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010;122:352– 360. [PubMed: 20625114]
  4. Yaggi HK, Concato J, Kernan WN, et al. Obstructive sleep apnoea as a risk factor for stroke and death. N Engl J Med. 2005; 353:2034–2041. [PubMed: 16282178]
  5. Redline S, Yenokyan G, Gottlieb DJ, et al. Obstructive sleep apnea- hypopnea and incident stroke: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2010; 182:269–277. [PubMed: 20339144]
  6. Peker Y, Hedner J, Norum J, et al. Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnoea: a 7-year follow-up. Am J Respir Crit Care Med. 2002; 166:159– 165. [PubMed: 12119227]
  7. Marin JM, Carrizo SJ, Vicente E, et al. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005; 365:1046–1053. [PubMed: 15781100]
  8. Peppard PE, Szklo-Coxe M, Hla KM, et al. Longitudinal association of sleep-related breathing disorder and depression. Arch Intern Med. 2006; 166:1709–1715. [PubMed: 16983048]
  9. Kendzerska T, Gershon AS, Hawker G, et al. Obstructive sleep apnoea and incident diabetes: a historical cohort study. Am J Respir Crit Care Med. 2014; 190:218–225. [PubMed: 24897551]
  10. Johnson KG and Johnson DC. Frequency of sleep apnea in stroke and TIA patients: a meta-analysis. J of Clinical Sleep Med 2010;6(2):131-7
  11. Baptista et al. Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring. 2021
  12. et al. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021.
  13. Data on File. Signifier Medical Technologies
  14. Davey, M. J. Epidemiological study of snoring from a random survey of 1075 participant. British Snoring and Sleep Apnoea Association. 2002; Available at: https://britishsnoring.co.uk/pdf/epidem.pdf
  15. Levy P, Kohler M, McNicholas WT, et al. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers 2015; 1: 15015.
  16. Luyster FS. Impact of Obstructive Sleep Apnea and Its Treatments on Partners: A Literature Review. J Clin Sleep Med. 2017;13(3):467-477.

 

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 Receives Prestigious 2020 GOOD DESIGN Award for Superior Design Excellence

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

Boston, MA, USA, and London, United Kingdom

March 01, 2021

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

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

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

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

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

For more information on eXciteOSA visit www.eXciteOSA.com

About Obstructive Sleep Apnea and Snoring

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

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

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

About Signifier Medical Technologies

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

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

References

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

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

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

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

Boston, MA, USA, and London, United Kingdom

February 09, 2021

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

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

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

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

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

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

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

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

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

About Obstructive Sleep Apnea and Snoring

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

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

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

About Signifier Medical Technologies

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

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

References

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

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

Signifier® Medical Technologies appoints David Ritscher as Chief Engineer

David brings significant experience in medical devices and consumer wearables, having researched and commercialized products across several sectors, including sleep.

Boston, MA, USA, and London, United Kingdom

January 12, 2020

Signifier Medical Technologies (“Signifier/the Company”), an innovator in the sleep-disordered breathing market, is pleased to announce the appointment of David Ritscher as Chief Engineer with immediate effect. He will be based in Boston and will be responsible for the Company’s hardware and software development, as well as data science capability. David’s appointment ensures that the Company is prepared to meet its ambitious growth plans and continued innovation.

David is a highly effective R&D leader who has led numerous successful medical and consumer implantable and wearable devices. Most recently, David worked at Cambridge Consultants, where he developed systems ranging from physiology monitoring devices to robotic test systems.  He had a focus on predictive analytics applied to disease states.

David RitscherPrior to that, David was Director of Research & Development at Whoop. He led a team of world-class scientists and clinical specialists to develop the world’s most accurate wrist-worn health monitor, which became the official monitor of the NFL, helping athletes to train optimally.

Earlier in his career, David was a Senior Principal Scientist at Medtronic where he released products including an implantable cardiac monitor. He holds 12 patents and has published 26 book chapters and papers.

Akhil Tripathi, CEO of Signifier commented: “I’m excited that we’ve added David, a world-class R&D leader, to fuel our journey to treat patients with sleep-disordered breathing. Over the last six months, we’ve been building our management team so we can deliver on the incredible opportunities in front of us.”

David Ritscher added, “I see Signifier’s vision as potentially one of the greatest breakthroughs with the sleep pandemic we are now facing. I expect eXciteOSA® and the follow-on products to revolutionize how we treat sleep apnea and improve patient health.”

For more information, please contact:

Signifier Medical Technologies LLC
Email: info@signifiermedical.com
Tel: +1 844 645 3672

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 Announces Award of UK NHS Supply Chain Tender

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

Boston, MA, USA, and London, United Kingdom

December 22, 2020

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

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

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

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

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

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

For more information, please contact:

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

About Signifier Medical Technologies

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

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

About OSA and Snoring

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

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

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

References

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

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: info@signifiermedical.com
Tel: +44 (0)20 7096 0586

About Signifier Medical Technologies

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

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

About OSA and Snoring

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

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

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

References

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

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: info@signifiermedical.com
Tel: +44 (0)20 7096 0586

About Signifier Medical Technologies

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

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

About OSA and Snoring

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

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

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

References

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

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: info@signifiermedical.com
Tel: +44 (0)20 7096 0586

About Signifier Medical Technologies

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

Snoozeal in product boxOriginally 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. 1-3

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 info@signifiermedical.com

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 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

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