Session1-8 Paradigm changing curative treatment for sleep apnea.
Jean Michel Mauclaire ~Tongue Lab~
We would like to present you the first treatment that should provide a complete cure for the sleep apnea syndrome.
What is sleep apnea? Sleep apnea occurs when the tongue collapses on the pharynx.
Why does the tongue collapse? The tongue adopted a slightly backward position narrowing the pharynx, mainly due to mouth breathing. This will induce a stronger respiratory effort instead of a quiet inhaling during sleep, which is obtained by a stronger vacuum in the airways attracting the tongue further backwards. Because the tongue does not function (swallow) properly it lacks muscle tone enabling it to resist the backward attraction force during sleep. Inhaled air is thus accelerating, inducing snoring that maybe some of you know ... and quite often, the tongue collapses thus obstructing pharynx; this is sleep apnea.
Sleep apnea syndrome concerns about 30% of the Japanese population. You don't die from sleep deprivation and lack of oxygen caused by Sleep Apnea. But you have 6 times more risks of premature death due to its consequences. About half of cardiovascular diseases are caused by Sleep Apnea: we're talking hypertension, heart attacks and stroke... Also, to a lesser extent diabetes and other pathologies including neuro degenerative diseases. There are new findings every year: Sleep apnea is much degrading performance. When standing during sports physical performance is being reduced, when sitting cognitive performance, memory and concentration are impacted, which is bad for work and work productivity. I should add also for some people when lying down because sleep apnea has a negative impact on libido and probably erectile disorder. A study in the US has shown that the cost of untreated sleep apnea is three times higher because of treated apnea. Sleep Apnea has an overall cost amounting to 150 billion dollars per year for the country.
The CPAP mask is the main treatment. It is blowing pressurized air in your nose when possible or if not the mask covers the full face. CPAP has the biggest market share of Sleep Apnea treatments. For various reasons 30 to 50% patients drop out their treatment. The most widespread alternative is oral appliance. It pulls the mandible forward in order to attract the tongue forward and hence open the pharynx. The dropout rate is also quite high because it may be from uncomfortable to painful, with side effects.
The TRP device developed by Tongue Lab allows talking with it since it does not prevent the tongue to function properly; as you can see, it was inside my mouth. In fact it re-educates the tongue to function (swallowing) properly. We've been measuring improvement of patients' nasal patency and pharynx size. Improvements are lasting in average one year after TRP device has been removed. We've also measured effect of treatment with our device on a few patients with Sleep Apnea. 83% of the patient were cured which means their Sleep Apnea dropped below pathological level. Some patients even reported reduced cardiovascular trouble.
We have a well-tolerated device, so discreet that it is difficult to see it from far away. It has already generated great results on patients. Is there a market for our device?
The question is relevant because many patients are aware of their sleep apnea but do not go for a treatment, and many treated don't really tolerate their devices explaining the high dropout rate. Of course, patients need an efficient treatment. CPAP is the most efficient treatment. They also want a well-tolerated treatment, for a limited period. Key Opinion Leaders we met here in Japan confirmed that most people don't tolerate well the devices they're proposed today.
Preliminary results show that TRP is quite efficient, although we don't know yet if it is going to be 60, 80, or 90% efficient. But as far as tolerance is concerned, it's totally different story, once the adaptation period is over, no complaints. We have great reports from our European patients. And last, we believe that no more device is needed after one-year treatment, whereas other options are for life.
So, where are we today in Japan? We target a 10% share of the current annual market of a half million devices. This could generate a nice 6 billion-yen revenues. We target patients with moderate Sleep Apnea not eligible to CPAP and dropout patients because these have no solution and still have healthcare trouble. Our reputation is growing: for the first time during conferences at the sleep congress two professors talked about our device. We are now working on developing the 3-D manufacturing for our custom devices and we're testing this in Japan. We met with a few distributors during the sleep Congress who confirmed their interest in distributing our devices.
We are now looking to develop our business in Japan with strong business partners willing to contribute with us to make our business a great success and help many people in Japan.
1991 French Certified Public Accountant, Paris -France