Last September (2015), I recorded a video interview with Stephen Marsh, CEO of Airing, a company that is developing a hoseless, maskless micro-CPAP device. At that time, the company was running an Indiegogo campaign to raise money for product development. The campaign was wildly successful in exceeding its goal and, ultimately, raised $1.2 million.
I posted the video on YouTube and wrote an article about it that was posted on the site. The post was widely read and generated a lot of comments—many of which were from people who wanted to volunteer to be a tester of the product. Some, however, questioned whether the Airing would actually work.
Because of this interest, I thought it would be really fun to get an update on the Airing and also have Stephen respond to some of the issues that people have raised. What follows is a transcript (modified for readability) of the interview. Please watch the video for the full conversation.
Patricia Salber (PS) [0:50]: Stephen, if you are ready to go, the first question is when is the product going to be on the market?
Stephen Marsh (SM) [1:01]: We have been targeting 2017 from the beginning. It’s a pretty aggressive schedule, but I think that is still possible. When you’re doing product development, particularly for a breakthrough like this, you never really know. However, there are some things going on that are really going to help push us in the direction of still coming in at 2017.
PS [1:31]: Well, that’s not too far away now. This year is going by remarkably fast. Stephen, the last time we talked, you didn’t have a working prototype. Do you have one now?
SM [1:58]: If you are thinking of a working prototype of the microblowers, the answer is no. But, the good news is that it is not a linear process. We have parts and pieces of it working which are actually rapidly coming together now. So, the quick answer is no, we are still working on the proof of concept prototype, but I guess the good part of that is that we are making very good progress and it is speeding up.
PS [2:31]: When we talked about the product coming to market in 2017, I meant it actually being available to the public. I am assuming this device, because it is for a serious medical condition, is going to have to have FDA approval and that means you have to have clinical trials. Can you describe the timeline for us a little bit from where you are now (almost getting your working prototype going) to how you are going to get through the clinical trials? And when you are going to approach the FDA? And how all of this impacts when I can actually buy one of these things.
SM [3:05]: I think most people would say that the FDA process can be unpredictable. Often times, people say that can be a very long process. One of the things that we are that we are very hopeful of, but we can’t guarantee, of course, is that there is a precedent. There is a process. It’s called a fast-track. It’s a 510(k) program where the FDA looks for a predicate, something out there that they have already approved that is similar. What I like to point out to people is while this is a new device, it’s really a miniaturization of the bigger equipment that we are all familiar with. We haven’t invented CPAP treatment. If you think about it in a simple way, we are going to put the same amount of air in you from a little device under your nose as opposed to using a mask and a hose. But it will be the same flow at the same pressure and so, it should deliver the same treatment. So, we are not inventing a new treatment. We are not trying to get a new treatment approved, rather we are trying to get approval for the miniaturization of an existing system or device.
PS [4:19]: That is a nice segue to a comment I read on Quora from a respiratory therapist who said this is nasal CPAP. It is going to increase the resistance when you are breathing through your nose, leading you to automatically open your mouth—mouth breathing will bypass your device that is being used to hold open the airways. He was pretty adamant that he thought that meant your approach wouldn’t work. What do you have to say about that?
SM [4:53]: Well, I don’t know this gentleman or his background, but I can only tell you what I’ve been told by the doctors on our advisory board and many doctors I’ve spoken to including at the National Institute of Health (NIH). If your nose is working right, nature has a tendency to have you breathe through your nose and not out of your mouth. So if you put the device in your nose and if it is allowing you, as you breathe in, to get all the air your body needs even if you are building a slight bit of pressure (remember the pressure is in cm of water, not pounds per square inch), then you are not likely to open your mouth.
PS [5:55]: Well, when I walk down an airplane aisle, all the sleeping people I see have their mouths hanging open. But, I hope you are right about that one because I really want this device to work. There was another comment that was skeptical about whether your microblowers would be able to generate enough pressure to hold open the airway structures that are getting in the way when you are trying to breathe with OSA, obstructive sleep apnea.
SM [6:28]: It’s hard for a lot of people to believe that something so small could create enough flow rate of air to actually satisfy your inhalation and even a little bit more to actually elevate the pressure slightly for your treatment level. I understand that is difficult for people to see that but I have to tell you that that’s what a breakthrough is; the little microblowers are an invention, one that we are patenting as we speak. There are many, many of them. One of the things that is very unique about them is that they are very small. Not only that, but they can be built in a manufacturing paradigm that makes them extremely low cost. That is why they can be a one-time use device. If you have a little bit of air push from one blower and you need a lot of air push, then you have to have many blowers. We also have those little blowers running thousands of times each second so they are there huffing and puffing, sucking the air in and blowing it out. The typical tidal volume of an adult is about a half a liter. The capacity of the lung is bigger but the amount of the air you actually breathe in and out in a cycle of inhalation and exhalation is about a liter—that relates to about 333 mL per second. If you have enough little devices (our microblowers) that are running fast enough, you can produce 333 mL per second or more.
PS [8:17]: That sounds good, but you are blowing all this air against the mucous membranes inside the nose and throat, aren’t they going to end up dry as a bone? What is this going to do to the mucous membranes? The CPAP machines all have a humidifier component as a part of the device.
SM [8:44]: My answer is, after consulting the doctors that we talk to, I am told that nature has done a very good job in designing the nose. You may not know this, but when you exhale, the moisture in your breath is really high—that’s based on the water you have in your body, right? You have a sort of built-in humidification system. So, when things are right—forget about sleep apnea for the moment—you should be able to breathe just fine and not need a humidifier or anything. What I believe is true, and from an engineering perspective is kind of obvious, is that when you blow a tremendous amount of air out of your nose, say you are using nose pillows or something, and you blow like that continuously both as you inhale and as you exhale, I can absolutely believe that you would dry yourself out. What I think is when you have a smart device that will provide the air that you need when you inhale and not blow so hard when you exhale, you’re not going to dry out as much. Therefore, our design and our expectation that the device will not require a separate humidifier.
PS [10:18]: These concerns, of course, are theoretical and your device right now is also theoretical. We are really not going to know if it works until you are finished with it and you put it on some people and run some clinical trials. So, we still have a ways to go before we start saving our pennies to buy one. That leads me to the next question. You talk about this be a throw-away device because it is low cost, about $3 per device. And by the way, I had some comments from some people, environmental types, who worried that we were going end up with a lot of micro-CPAP’s in landfill. But my question is about the cost. In the past, you estimated the annual cost would be about the price of a traditional CPAP, is that still the case? Or have you learned that it will need to be more, or less?
SM [11:20]: $3 has been the target—the sales price for the end user. If you do the math, $3 times 365 comes out to $1095—that is if you pay the full price with no reimbursement from your insurance company. If you are reimbursed, say at a typical rate of 80%, then it will be much less—about 60 cents a night instead of $3.
PS [11:54]: You probably haven’t had any conversations with insurers yet about whether they would cover the device. Usually, commercial insurers follow Medicare’s lead so you are probably going to have to get it approved by Medicare in order to have the commercial insurers follow along.
SM [12:12]: The advice that I am getting is that insurance companies are getting to be a lot more results-oriented in terms of what they’re willing to pay for. The thing with CPAP therapy, which is known to be effective for OSA, is that it is hard for a lot of people to use. Long term, it is more effective to pay for effective treatment than pay for consequences later on. I think they’re going to be very excited about a device that could stave off some later problems. If we can prove that it’s effective and that people are willing to use it, then that is a winning combination. We won’t be surprised that they will be interested in supporting it.
PS [13:44]: There are some new devices coming out of Israel—there is one called the Zyppah Snoring Device that getting some hype on the Internet. And then, there is an another one that some people say is like yours (although, it is missing some important components) called the Provent. It is a little device that fits just under the nose. It looks even smaller than your device. Are you familiar with the Provent?
SM [14:11]: I am or have been. I don’t know if they just announced something new yesterday or last month. The Provent system that I am familiar with is a really very simple system that has adhesive-backed vents that let air breathe in easily, but blocks it by adding some resistance when you exhale. Most doctors that I have spoken to think it has a limited range of effectiveness, mainly for people with a slight degree of apnea. So, it is an adhesive thing that fits on the bottom of your nose. It is really not like our device at all. The Zyppah is a dental appliance as far as I can tell. Something you put in your mouth and bite down on. It has a member that orients your tongue in a certain way. Again, that is not like what we are doing at all. We get literally thousands, actually hundreds of thousands, of emails from people. One of the common responses that we get from people, who are praying we get this done as quickly as possible, is that they have they have tried CPAP but couldn’t tolerate it. And, they have tried some of the dental appliances but they just made their gums sore; it’s just hard for them. This is a good point for me to segue. It is important for me to say to your listeners and viewers. It is my position, Airing’s position, that until we can get there with the Airing device, which we hope will be a lot more tolerated and used by people, that if you think you have obstructive sleep apnea or a breathing disorder like that, please try to find something that you can use in the meantime until I can get our product there because it is really important for you not suffer from the long-term effects of oxygen deprivation. If you can tolerate, if you can use a Provent or a Zyppah or the standard equipment, god bless you, please try.
PS [16:58]: Thank you, a really good message for all of our listeners. If you are using a CPAP machine now, keep using it until the Airing is out, hopefully, next year. Don’t quit using it. And don’t delay starting on standard treatment until there is something more effective. Thank you, Stephen, for a great interview.
Please watch the video (above) to hear the unedited conversation and to watch parts of the video that were not transcribed due to length.