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.

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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.

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

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

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

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

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

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

“The FDA 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

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