Signifier Medical Technologies, a company with headquarters in London, UK and Massachusetts, has created a new treatment for obstructive sleep apnea, and it is the first to be used during waking hours.
Unlike conventional sleep apnea devices, the eXciteOSA is designed to be used for short periods during the day and employs electrical stimulation to improve tongue muscle function, helping keep the airway open during sleep. It was recently authorized for sale by the FDA.
Sleep apnea involves airway obstruction during sleep and can have a variety of serious consequences, including cancer and cardiovascular disease. In many people the condition is undiagnosed, but for those who are aware of their condition there are effective treatments available.
Conventional treatments typically involve continuous pressure applied to the airway through a face mask. While this works well, some users find that this disrupts their sleep, and it isn’t a good fit for everyone. This inspired the eXciteOSA device, which is applied to the tongue for 20 minutes each day for a total of six weeks, and then twice per week thereafter.
See a video about the technology below:
Medgadget had the opportunity to speak with Akhil Tripathi, President and CEO of Signifier Medical Technologies about the technology.
Conn Hastings, Medgadget: Please give us an overview of obstructive sleep apnea and its consequences for patients.
Akhil Tripathi, Signifier Medical Technologies: Obstructive sleep apnea, or OSA, affects one in three people, reaching as many as 110 million people in the U.S. If untreated, it can lead to serious complications including hypertension, heart attack, glaucoma, diabetes and cancer, as well as cognitive and behavioral disorders. OSA occurs from the recurring collapse or narrowing of the upper airways during sleep. The most common symptoms are restless sleep, snoring, tiredness during the day, decreased intellectual alertness and personality alterations.
Medgadget: What treatments are currently used for obstructive sleep apnea, and what are their limitations?
Akhil Tripathi: The current standard of care for all advanced levels of sleep apnea is the routine use of a continuous positive airway pressure device, most often called a CPAP, during sleep. Unfortunately, there has not been much improvement in treatments for sleep apnea in about 40 years. Many patients find CPAP devices to be invasive and the long-term compliance of CPAP therapy is limited, so there is a clear demand for more treatment options – especially since a CPAP is not effective for everyone with sleep apnea.
Medgadget: Please give us an overview of the eXciteOSA device, and how it is used.
Akhil Tripathi: eXciteOSA is the first and only daytime genioglossal, or tongue, muscle-neurostimulation technology approved in the U.S. for mild OSA and snoring. Unlike devices used while patients sleep, eXciteOSA is the first device used while patients are awake. It’s used for 20 minutes a day for six weeks, then used twice per week following the sixth week.
Medgadget: What role does digital connectivity play in the system?
Akhil Tripathi: The eXciteOSA device is mobile and rechargeable through a USB port, and paired with the eXciteOSA smartphone or tablet application, allows patients to use it freely while tracking progress and results wherever they go. The app offers full remote-control functionality, and results can be shared directly with a physician.
Medgadget: What inspired the system? Why did you decide to develop a sleep apnea therapy for use during waking hours?
Akhil Tripathi: Our co-founder Professor Anshul Sama and I were deeply empathetic with sleep apnea patients who were struggling with lifelong conventional treatment options that had failed to change in the last two decades. Over the years, we had come across many devices, all of which had problems – they had to be worn during sleep and were only effective when in use, which only temporarily alleviates the problem; they only treated the symptoms and not the root cause of sleep apnea; many were invariably uncomfortable, and as nighttime wearables, they further disrupted the poor sleep quality patients were already experiencing.
We wanted to disrupt this dependence on products that had to be worn during sleep, so Professor Sama and I launched the initiative to develop the world’s first, unique daytime treatment for sleep-disordered breathing – eXciteOSA.
Over three years, the devoted effort from our assembled team of many highly skilled professionals from sleep medicine, maxillofacial surgery, product development, medical engineering, software engineering and regulatory has led to a simple, intuitive, non-intrusive and safe product that is clinically proven to treat the root cause of mild OSA. Our Signifier Medical Technologies team is excited to further transform the treatment landscape for people experiencing sleep-disordered breathing.
Medgadget: How does the system change the muscles of the tongue?
Akhil Tripathi: eXciteOSA is intended to improve tongue muscle function, targeting the root cause of obstructive sleep apnea. The device works by delivering small electric currents through the mouthpiece to the tongue, stimulating the tongue muscle and increasing its muscle endurance. The improved function of the tongue muscle will help keep the breathing passage open during sleep and reduce the vibration of the throat region.
In a study of 65 mild OSA patients, 79% of patients responded to eXciteOSA with a mean reduction of 52% in the Apnea Hypopnea Index, a 50% reduction in the Oxygen Desaturation Index and a 3.9-point reduction in the Epworth Sleepiness Scale. In a pivotal study of eXciteOSA, the device exceeded the targeted endpoint of a 20% mean reduction in snoring time, achieving nearly a 40% mean reduction in snoring time across 115 OSA patients.
Medgadget: When will the system be widely available?
Akhil Tripathi: eXciteOSA will be available to patients within the next 3-4 weeks through select physicians in the U.S. and we plan to launch more broadly later in 2021.