Signifier Medical heralds a brand new period within the remedy of sleep apnea and snoring with FDA approval of the eXciteOSA system

BOSTON & LONDON – (BUSINESS WIRE) – Signifier Medical Technologies, an innovator in the sleep-related breathing disorder market, today announced that eXciteOSA®, the first and only intraoral daytime neuromuscular stimulation device for the treatment of mild obstructive sleep apnea and snoring, has been launched by US-based Food and Drug Administration approved (FDA) providing access to this innovative therapy for millions of people in the United States.

Unlike devices that are used by patients while sleeping, the eXciteOSA is the first device to be used while awake and designed to improve the function of the tongue muscles, and it targets the root causes of these disorders. When used for just 20 minutes a day for six weeks and then twice a week, the therapy has been shown to improve sleep quality by significantly reducing obstructive sleep apnea and snoring.1-4

In a study of 65 patients with mild obstructive sleep apnea, 79% of patients responded to therapy, with an average reduction in AHI (apnea-hypopnea index) of 52%, a reduction in ODI (oxygen desaturation index) of 50% and a reduction of 3.9 points in ESS (Epworth Sleepiness Scale). In the pivotal study of the device, eXciteOSA exceeded the targeted endpoint of an average reduction in snoring time of 20% and achieved an average reduction in snoring time of almost 40% in 115 patients.

“We are excited that this breakthrough treatment will soon be available in the US, offering a completely unique, simple and convenient solution that has the potential to improve the lives of millions of people,” said Akhil Tripathi, CEO and Co-Founder of Signifier medical technology. “Restful sleep is vital, but for many it is out of reach because they or their partner have a sleep disorder. We look forward to introducing this revolutionary new option in selected markets in the coming weeks. ”

Obstructive sleep apnea and snoring affect one in three people – up to 110 million Americans. If left untreated, obstructive sleep apnea can lead to serious such as high blood pressure, heart attacks, glaucoma, diabetes, cancer, and cognitive and behavioral disorders.

“The treatment of sleep apnea has been shown to be very effective for patients as there is increasing evidence that it can improve symptoms, lower blood pressure, improve glucose control, and the risk of car accidents, among other things. It can be strongly argued that early treatment can be beneficial because the consequences of the disease can become irreversible, “said Atul Malhotra, MD Research Chief, Pulmonary, Critical Care and Sleep Medicine at UC San Diego Health, serving as a clinical trial served. Investigator for the eXciteOSA device. “I believe that eXciteOSA will be an important treatment approach for patients with snoring and mild sleep apnea and I look forward to offering it to my patients.”

Signifier Medical has developed a digital OSA therapy interface for patients and doctors that includes an intuitive app for use alongside the eXciteOSA device. The app should enable individual care and motivate patients to a high level of therapy adherence. The eXciteOSA system is a “light touch design” and does not require any adjustment. It 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 a neglected cohort of sleep-disordered breathing, namely those with mild obstructive sleep apnea, “said Peter Cistulli, MD, professor of respiratory medicine and head of sleep medicine at the University of Sydney. and Head of Breathing and Sleep Medicine at the Royal North Shore Hospital.

For more information on eXciteOSA, please visit: www.eXciteOSA.com.

About obstructive sleep apnea and snoring

It is estimated that around 1 billion adults between the ages of 30 and 69 worldwide have obstructive sleep apnea (OSA). There is a strong, clinically proven association between OSA and comorbidities such as diabetes, high blood pressure, and stroke. Mild OSA affects over 110 million people in the US and 100 million people in Europe.

Obstructive sleep apnea is characterized by the recurring collapse of the upper airways during sleep. The most common symptoms are restless sleep, snoring, daytime sleepiness, decreased intellectual alertness, and personality changes. A higher risk of cardiovascular disease and increased mortality rates have been linked to OSA.

Standard therapy for all advanced levels of sleep apnea is a CPAP (Continuous Positive Airway Pressure) device. Many patients find this therapy invasive and the long-term compliance of CPAP therapy is limited, so that there is a clear need for new forms of therapy.

About Signifier Medical Technologies

Signifier Medical Technologies is a medical technology company focused on developing and commercializing innovative and non-invasive solutions for patients with sleep-related breathing problems and snoring.

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

More information is available at www.signifiermedical.com.

For high resolution images from eXciteOSA, please contact signifiermedical@citigatedewerogerson.com.

References

  1. White DP. Sleep-Related Respiratory Disorder: 2 – Pathophysiology of Obstructive Sleep Apnea. 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. Somnology (Berl). 2018; 22 (Supplement 2): 47-52.

  3. SamaA, et al. Intraoral neurostimulation during the day with Snoozeal® for the treatment of snoring and mild sleep apnea. Notes on the CHEST annual meeting. 2018.

  4. Clinical study on 115 patients with snoring or mild OSA (apnea-hypopnea index (AHI <15 n = 65)). Objective snoring and breathing parameters were recorded with 2 consecutive WatchPAT® night sleep studies before and after using the device. An intraoral tongue stimulator (eXciteOSA®) was used once a day for 20 minutes for a period of 6 weeks.

Leave a comment

Your email address will not be published. Required fields are marked *