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

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

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

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

The Sleep and Breathing article can be found here:

https://link.springer.com/article/10.1007/s11325-022-02644-9

 

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

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

-END

 

About Signifier Medical Technologies

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

About eXciteOSA®

eXciteOSA is a revolutionary daytime therapy device for sleep disordered breathing. Clinically
proven to target a common root cause of OSA, eXciteOSA improves 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 that the upper airway muscles lack endurance during
sleep and the tongue falls back, blocking the upper airway. By using neuromuscular electrical
stimulation (NMES) to “exercise” the upper airway muscles, eXciteOSA works the intrinsic and
extrinsic tongue muscles to improve endurance and prevent airway collapse during sleep.

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

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

Contacts

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

References

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

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

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

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

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

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

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

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

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

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

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

About Signifier Medical Technologies

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

About eXciteOSA®

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

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

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

About Snoring and Obstructive Sleep Apnea

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

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

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

Contacts

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

References

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

Signifier® Medical Technologies Wins iF Design Award 2020 for Design Excellence for eXcite®, the World’s First, Daytime Treatment Device That Tackles the Root Cause of Sleep Apnoea and Snoring

snoozeal product controller and main product

February 25, 2020
– London, United Kingdom – Signifier Medical Technologies Limited, formerly known as eXciteOSA®, is delighted to announce that it has won the prestigious iF DESIGN AWARD for Design Excellence, in the “Product” category, for its novel medical device, eXciteOSA® for patients with sleep apnoea and snoring.

The iF DESIGN AWARD is the oldest independent quality design seal in the world and one of the most important design prizes when it comes to excellence in design. This award exemplifies Signifier Medical Technologies’ commitment to making outstanding, patient-centric design an integral component of the user experience, together with eXciteOSA’s® ergonomic styling, connected smart features and ease of use.

Professor 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 apnoea and snoring issues. 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 sleep apnoea – eXciteOSA®.

The eXciteOSA® treatment has been clinically proven with rigorous clinical trials conducted by prestigious institutions showing an objective improvement in sleep quality by reducing sleep apnoea and snoring significantly. 1, 2

Nearly 1 billion adults aged 30 to 69 are estimated to have obstructive sleep apnoea (OSA) globally. There is also a strong, clinically proven link between obstructive sleep apnoea and co-morbidities like diabetes, hypertension and strokes.

Professor Sama commented: “Our team is thrilled to have been awarded such a prestigious honour from iF International Forum Design. eXciteOSA® is a result of a devoted effort by many highly skilled professionals from sleep medicine, maxillofacial surgery, product development, medical engineering, software engineering and regulatory that led to an easy-to-use, effective product that will be readily available to all and workable through a phone app. We are looking forward to bringing eXciteOSA® to market and helping more people improve their quality of sleep with this easy-to-use and effective solution.”

Organized by iF International Forum Design GmbH, the iF Design Award contest started in Germany in 1953. Design submissions are subject to comprehensive evaluation for design, innovativeness, functionality and seven additional categories including product, packaging, communication and professional concepts.

iF Design Award 2020 winners are announced online through the iF Design Award website and iF Design app and winning designs will be presented at the iF Design Exhibition from 2-10 May during Berlin Design Week 2020.

More information about the eXciteOSA® iF DESIGN AWARD can be found in the “Design Excellence” section of the iF WORLD DESIGN GUIDE https://ifworlddesignguide.com

For the eXciteOSA® entry go to: https://ifworlddesignguide.com/search?search=snoozeal#/page/entry/285464-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 apnoea (OSA) globally. There is a strong, clinically proven link between obstructive sleep apnoea and co-morbidities like diabetes, hypertension and strokes. Mild OSA affects over 110 million people in the US and 100 million people in Europe.

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

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

About Signifier Medical Technologies

Signifier Medical Technologies, previously known as eXciteOSA®, is a medical technology company focused on the development and commercialisation of innovative and non-invasive solutions for patients with snoring and sleep-disordered breathing conditions. Signifier’s proprietary therapy is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology, with proven clinical data from prestigious and well-recognised universities and academic institutions, that provides a safe and effective treatment for its patients. 1, 2

For more information, please visit www.snoozeal.com

About the iF DESIGN AWARD

The iF DESIGN AWARD has been a globally recognized trademark when it comes to excellence in design for 67 years. The iF brand enjoys an international reputation as a symbol for outstanding design achievement. The iF DESIGN AWARD is one of the most important design prizes in the world. It honours design achievements in all disciplines: product, packaging, communication and service design, architecture and interior architecture as well as professional concepts. All the award-winning entries are presented in the iF WORLD DESIGN GUIDE, published in the iF design app and exhibited at the iF design exhibition in Berlin.

References

  1. 1. A.Sama et al. Daytime Intraoral Neuromuscular stimulation with Snoozeal® for treatment of Snoring and Mild Sleep Apnea. CHEST Annual Meeting Notes, 2018
  2. 2. E.Wessoleck et al. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie (Berl). 2018; 22(Suppl 2): 47–52.

For more information, please contact us at:
info@signifiermedical.com
+44 (0) 207 096 0586

Signifier Medical Technologies Announces Participation In JP Morgan 2020 Global Healthcare Conference

snoozeal product controller and main product

London, United Kingdom
October 10, 2019 – Signifier Medical Technologies, a medical technology company developing innovative sleep-disordered breathing products for use in the homecare setting, today announced that the Company’s management will be participating in the JP Morgan Global Healthcare conference 2020 Conference in San Francisco in January 2020.

About Signifier Medical Technologies

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

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

www.snoozeal.com

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

Signifier Medical Technologies Announces Participation In Jefferies 16th European Medtech Conference

snoozeal product controller and main product

London, United Kingdom
August 25, 2019 – Signifier Medical Technologies, a medical technology company developing innovative sleep-disordered breathing products for use in the homecare setting, today announced that the Company’s management will be participating in the Jefferies 16th European MedTech Conference in London in November 2019.

About Signifier Medical Technologies

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

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

www.snoozeal.com

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

Signifier Medical Technologies Announces Participation In Morgan Stanley 2019 Global Medtech Conference

snoozeal product controller and main product

London, United Kingdom

July 15, 2019 – Signifier Medical Technologies, a medical technology company developing innovative sleep-disordered breathing products for use in the homecare setting, today announced that the Company’s management will be participating in the 2019 Global MedTech conference in New York.

Signifier Medical’s Co-founder and CEO, Akhil Tripathi is scheduled to present on Monday, September 9, 2019 at 9:55 a.m. ET at the Morgan Stanley 2019 Global MedTech Conference.

About Signifier Medical Technologies

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

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

www.snoozeal.com

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

Signifier Medical Technologies Announces Participation In Goldman Sachs 2019 European Medtech Conference

snoozeal product controller and main product

London, United Kingdom
July 5, 2019 – Signifier Medical Technologies, a medical technology company developing innovative sleep disordered breathing products for use in the homecare setting, today announced that the Company’s management will be participating in the 16th Goldman Sachs European MedTech Conference in London in September 2019.

About Signifier Medical Technologies

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

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

www.snoozeal.com

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