• Lev Mikulitski

The silent killer is going to get hit under the belt: A new hope for OSA patients.

Imagine a situation where a life-threatening illness affects 12% of adults worldwide goes untreated 80% of the time, and when it does, 50% of the patients associated with this illness do not tolerate the commonly used treatment, the CPAP. Well, this is the case of Obstructive Sleep Apnea (OSA), a "silent killer", affecting 936M people, double the size of Diabetes, an illness that has a crucial impact on life quality.



Sleep apnea is a sleeping disorder that results in breathing stopping and starting repeatedly. The risk factors associated with this disorder include obesity and age. Men are commonly affected by sleep apnea, where they exhibit symptoms such as loud snores and tiredness even after a long night's sleep. This condition happens due to blockage in your airways, which tends to collapse during the night. Whenever your breathing starts, it causes your throat to let out a loud snore that might wake both your partner and yourself.


Sleep apnea is linked to very many health conditions, including high blood pressure and obesity. When these conditions encounter lack of sleep, they can be very harmful to different systems of your body, such as the respiratory system, digestive system, and endocrine system.


Obstructive Sleep Apnea (OSA) is the most common type of sleep apnea, although there are various other types. It is a life-threatening illness, and Its prevalence is even more than diabetes, standing at 936M people. As for the US alone, and as estimated by the US academy of sleep medicine, a hidden annual economic cost of undiagnosed OSA is $150B a year. It is further estimated that OSA affects 12% of adults and goes untreated more than 80% of the time.


Think for a moment about these numbers. These numbers actually express the result of Lack of awareness, which often hurts humanity in quality of life without knowing what the cause really is.



So, how does OSA occur? OSA occurs when your airway is blocked by intermittently relaxing air muscles during sleep. OSA presents very many struggles for people suffering from the condition. Various OSA symptoms can potentially reduce the quality of your life if left untreated. For instance, it is believed that the effect of OSA on quality of life is directly equivalent to that of hypertension and diabetes.


Some of the struggles OSA patients undergo include sleepiness, memory issues, depression, societal, and family consequences. When suffering from OSA, you will find yourself excessively sleepy any time of the day. This makes it difficult for you to work, which may eventually lead to a job loss. Imagine falling asleep while driving your car, watching your favorite TV program, conversing on the telephone, or even having your meal. People suffering from this condition, yes, may not complain of sleepiness but just feel excessively tired more and more as they get older. If left untreated, OSA can lead to depression. In most cases, you end up spending too much treating depression only to realize later that OSA was the main cause of your depression. Besides depression, untreated OSA can lead you to suffer memory issues, difficulties concentrating, amnesia, and slow reaction to events.


Other than the body struggles, OSA can cause issues with your friends and family members. These are the reasons; while depression makes it hard for a person to maintain meaningful relationships; still, these people are less likely to engage in social activities, especially physical excessive, due to tiredness. Who would want to spend time with a snoring partner during bedtime? Because of the loud bothersome noise associated with the condition, partners may choose to spend their nights in separate rooms. OSA can still create problems to do with impotence, although this could be a motivational factor to seek medication.


The CPAP case:

For people with moderate to severe OSA condition, they are usually subjected to CPAP (Continuous Positive Airway Pressure Therapy) treatment where a machine is used to help the person breathe more easily anytime while sleeping. The CPAP machine works by increasing air pressure in the throat to prevent airways from collapsing whenever you’re breathing in. Despite the life-threatening issues associated with OSA, it still goes untreated most of the time. Reason? Most patients do not tolerate CPAP as a widely known treatment option. In fact, it is known that approximated that 50% of patients diagnosed with sleep apnea or rather OSA and prescribed the CPAP therapy would abandon the option within 6 months. Also, the market size targeting CPAP devices is estimated to be worth USD 6.5 B by 2023 representing 7.2% CAGR, The question comes, if CPAP is the golden treatment standard for OSA or sleep apnea, why then do people abandon the therapy upon prescription? Besides, where is there a promising market growth for sleep apnea devices?


It is known that approximated that 50% of patients diagnosed with sleep apnea or rather OSA and prescribed the CPAP therapy would abandon the option within 6 months.

The answer is that the use of CPAP therapy has many challenges. The main challenge has to do with selecting the best combinations that go in line with 3 CPAP components. These components include the heated humidifier, the CPAP device itself, and the Mask. Tweaking all the 3 CPAP components through a trial and error process is an uphill task. In the first place, the CPAP device itself has to be customized for each individual patient following the associated optional features. For the heated humidifier, yes, it guarantees much-needed comfort, but there is a challenge of finding the best working temperature. The most challenging component now is selecting the right mask choice. Without appropriate assistance, you may have to undergo various trial and error processes before arriving at the right choice. Other common challenges include skin irritation, mouth dryness, pressure intolerance, and gag reflex issues. Therefore, it is perhaps possible to understand a little why about 50% of those diagnosed with OSA cannot tolerate the solution of CPAP. At this point one has to ask the question, is it still possible to secure a future with a good quality of life for OSA patients who do not tolerate the CPAP treatment? The short answer is YES. There is a viable promise.


The Therapnea™ case:

Therapnea™, developed by the Israeli MedTech company "Thomas Medical" is an innovative device to treat OSA following an innovative approach that overcomes the CPAP compliance issues while guaranteeing effective healthcare performance. The device operates by providing mechanical support to the walls of the pharynx and at the back of the tongue, thereby preventing their collapse and eliminating airway obstruction during sleep. Additionally, the Therapnea™ device includes several sensors to monitor patients’ key parameters such as Pulse-Oximetry, Apnea events, Temperature, etc., sending them through the cloud and allowing detailed remote follow-up by health care providers.


The main novelty of Therapnea™ technology represents utilization of a well-known, but yet unused feature of the neural system called adaptation. The nerves in the body are mainly sensitive to change, but very quickly adapt to a steady state situation and stop sending signals, thus cancelling any sensation triggered by these nerves. In case of a very slow change, the same behavior applies: very slow changes are hardly felt, if at all. The problem thus far preventing use of stents in the upper airways in conscious patients is the gag reflex. Any contact with the very sensitive nerves at the back of the tongue normally triggers this reflex, leading to a violent gag, which may quickly develop to nausea and vomiting.


The Therapnea™ OSA therapy system makes use of neural habituation to circumvent gag reflex by inserting the stent extremely slowly into the upper airway, and only after the patient is in deep asleep. This allows Therapnea™ to place the needed support at this most sensitive location without waking the patient up, offering total relief of obstructive apnea.


Additionally, Thomas medical developed a unique stent design with minimal contact area with the tissue, and which is safe even if taken out quickly when fully extended because it does not include any closed loops. The system comprises a dental plate connected by a thin tube to a chest-worn unit. At bed-time, the Therapnea™ dental plate which carries multiple physiological, micro sensors is inserted into the patient’s mouth, and the chest unit worn on a chest belt. The stent is folded away in the tube, and is automatically deployed only after the patient is deep in sleep and respiratory disturbances are detected. Once the device detects awakening evidences, the stent is retracted into the tube, so it is again invisible when the patient awakes. The length of the stent is continuously adjusted to the minimal length which still prevents apenas.

Therapnea™ is not just a medical device per se. It's a novel smart IoT-base device and Data solution, enabling the practice of data-gathering from inside the patients’ mouth during the sleeptime. Therefore, it is not only a revolutionary therapeutic solution, but also a solution that enables outstanding diagnostics and the capacity to build unique Big Data set useful for health monitoring and research purposes.

To sum up, although there are a number challenges on the way to a commercial product, one can only say that currently preclinical trials of Therapnea™ have been successfully performed, and the outcomes demonstrate the outstanding results and market disruption potential of Thomas Medical Strategy, which directly responds to the main unmet needs and problems that patients, practitioners and healthcare systems are facing today. Further, patents have been obtained in various markets such as the US, China, Hong Kong, Japan, Russia, Israel and even Australia. Thomas Medical's vision is to give a significant health horizon to those suffering from one of the most horrible and less diagnosed symptoms and significantly reduce the burden on the health care system following the current situation.


Thus Therapnea™'s solution constitutes an exceptional invitation to all stakeholders including research institutions and investors to take up the challenge together with Thomas Meeical In order to enable tens of millions of sufferers around the world an innovative and high-quality solution.




#innovation #healthcare #medtech #sleepapnea

© 2016 by Mikulitski Critical Consulting. All rights reserved.

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