NIN: Let’s start at the start - Where'd this idea come from?
John: That's a good question. A few years ago, pretty much during the height of the war, the military approached the company to find a solution to severe battlefield hemorrhage. the gauzes they were using weren't quite getting it done, they were good but as the injuries got worse they needed something to quickly stop bleeding. So, we started working on different prototypes, gels, foams, and ended up on compressed sponges. It goes all the way back to -- a lot of people associate it with little sponges we’d drop in water as a kid and a dinosaur comes out -- We took that concept and went to a local store and bought compressed sponge, punched out a bunch of compressed discs and used them in a model. Sure enough it stopped bleeding effectively. So we took that concept from there to the device we have today, the XStat, which is a syringe the medic would carry – he comes up to a severe wound, puts the device in operation and injects all the sponge into the wound cavity. When the sponge makes contact with the fluid, in this case blood, it rapidly expands and creates internal pressure inside the wound that compresses the vessel and stops the bleeding very fast.
We've taken that from that stage there and also created another applicator for very, very narrow entrance wounds that are too small for the original device – such as a knife wound or small shrapnel wounds – to where the medic would inject it into the wound and then push the same sponges into the wound cavity.
We've also taken the technology, taken the same sponge that expands in the syringe and embedded it into a gauze material that the medics are very familiar with, and the gauze expands ten times its size and effectively stops bleeding without manual compression.
Amazing. What was the first time you used it on a person?
Andrew: So, the XStat device was actually just recently approved by the Food and Drug Administration in April. It was done based on preclinical data, there was no human clinical trial that was used to approve the device. We're not aware of any use on humans yet. The company is currently conducting its first production run of the device under contract from the United States Military. And we're gonna be delivering the first batch of devices to the United States Special Forces in October.
What kind of size an order is that?
Andrew: It's a small order, we're talking a few hundred devices in order for them to do additional testing and evaluation. And they may be fielding some of those devices.
And how did that feel the first time you got an actual order through for something that was conceptual?
Andrew: It's very exciting. This has been an absolute mission of ours. we signed up to do this work, our goal was to actually deliver these medical devices to the battlefield. Not just create a concept, not just create a prototype, so it's a big moment for the company when we actually do send those devices to the military. Because that's really been the goal.
And in terms of international attention and other countries interested in the XStat?
Andrew: Absolutely. We've had interest and inquiries and, frankly, flat out requests for the devices coming throughout the globe, as you can imagine. There's several areas in conflict and a lot of those governments, or people in those regions, have reached out to us. Unfortunately, we're trying to get it fielded to as many people as possible but, you know, there's a ramp-up involved and the first priority customer is the US Military given the fact that we collaborated with them to develop the technology. From there we're gonna do everything in our power to move out and make this thing a standard of care throughout the globe.
How hard is it when people ask for it from countries or groups you might not agree with politically?
Andrew: Well ... (laugh) It's a medical device. We try to be humane and agnostic to some of those issues but we're also cognizant of geopolitical issues. So, you know, frankly, at this point it really hasn't resulted in a conflicted situation given the fact that we just don't have enough of these to really even consummate those types of sales at this point but we're gonna be working with the US government to ensure that we certainly comply with any trade and export laws with regard to that, and we'll certainly have to cross that bridge when we come to it.
Has the success of this device inspired you to take on other projects – what other kind of devices or applications are there for this?
Andrew: Certainly our core marquee technology at this point is the Xstat and, as John described, its sort of cousin device is the Xgauze product based on this expanding sponge technology. But we've put together a great engineering team, and with that we've got some additional innovations that we've worked on. In fact, some of these devices have come to fruition already, and John can describe some of these.
John: Sure, so, one of the next products that will come out is what we call the Air Wrap. On the battlefield, when a medic packs a wound, the next thing medics are trained to do is dress the wound with an elastic bandage and then apply direct pressure to help stem the bleeding. So, we've taken an inflatable air bladder and sown it to an elastic bandage with a pressure indicator on it. So, after the medic packs the wound, he wraps it with the Air Wrap, then he's able to take a very small hand pump and inflate the bladder within the elastic bandage, which then applies direct pressure directly on top of the wound. This ensures that from the point of injury, all the way back to definitive care at the hospital, you're able to maintain direct pressure on top of the wound.
John: Very simple device. And it frees up a medic to do much more without having to wait around for several minutes holding pressure on a wound to make sure it stops bleeding. And another product that we're releasing soon is our tourniquet belt.
We've seen a trend, where, though everybody talks about tourniquets, nobody carries a tourniquet in their daily everyday life. But, everybody wears a belt. So, in light of things like the Boston Bombing and for people who work in hazardous industries, such as the logging industry, where you can easily slip with the chainsaw and cut yourself – and hunters, backpackers and everybody who's seen the prototypes of this is like, "That is a great idea" -- So this allows them to have a daily wear belt that is actually a tourniquet. So, if something horrible happens they can pull their belt off, put it around an extremity and have a military grade style tourniquet to stop the flow of blood.
The military contacted you to work on some of these programs. Are you from the military yourselves?
John: I have 25 years in the army as a special forces medic. I retired in the last couple years. And when I left the military, having a medical background, it was just a natural fit to stay in the medical industry. My last few years in the military I worked in medical research and development. I liked that type of work so I wanted to continue doing that when I got out of the military.
Cool. You're based out of where?
John: We're out of Oregon. Wilsonville, Oregon.
And you, Andrew?
Andrew: No, I don't have a military background. I became involved in doing medical device research both as a scientist and then managing that research. And a lot of it was funded by the Department of Defense, and so that's how I started building my relationship with the US Military.
Outside of this tech - if you could address any sort of issue, whether it's cancer or world peace or whatever else, what would you want to make not impossible?
Andrew: Well, I'll tell you about one project that is a bit outside of this but somewhat related to it is that we've actually received funding from the Saving Lives at Birth Global Grant Challenge to adapt the XStat sponge technology to stop postpartum hemorrhage. It's the number one cause of death for women giving birth worldwide. it's a major global health concern. It's one of those big issues and we're excited and proud to be working on that. And to be moving from pre-hospital trauma care and military medicine into women's health.
John: I think my personal passion is bringing the lifesaving technology that the military's developed through these dire years of warfare into the EMS community. There's no reason why every EMS ambulance service in the country should not be carrying the same type of gear that the medics on the battlefield are using in a pre-hospital setting. For example, hemostatic bandages and tourniquets and all that lifesaving gear that is every day use for a military medic, that most of the EMS agencies around the country aren't even aware of some of this technology, to me, is a travesty.
Recently recognized in the CNN 10 Inventions, you can find out more about the XStat and RevMedX's related devices at their site, here.