Russ: Hi, I’m Russ Capper coming to you from Alpha Conference. I’m very pleased to have as my guest now, John Simpson, founder of Avinger. John, welcome to the show.

John: Thank you.

Russ: You bet.  Also, a major innovator in resolving vascular problems. What led you down that path?

John: Well, vascular disease—Im trained as a cardiologist, I trained at Stanford. While I was at Stanford the physician that performed the very first balloon angioplasty, which is a balloon that goes in the arteries to open them up, that physician, Andreas Gruentzig, came to Stanford to give a talk. I went to hear his talk and I thought he’s going to really make things a lot better or he’s going to go to jail, because this is crazy putting balloons in people’s coronary arteries. In that era, no one had ever done it before, so it was just absolutely so bizarre. Now, it happens like a million times a year, it seems so routine. In that era, the criticisms of anybody who would ever consider doing that were legendary.

Russ: And so, you sort of followed him, and ultimately, made a major improvement to the process.

John: Well, my contribution was really, I simplified the balloon that he was using, and expanded the capabilities of the balloon, and sort of built a railroad system that we could put that balloon into the artery.  It’s called a guidewire, and we could track balloons over guidewires into places that you couldn’t get his balloon to go. It was something that a standard interventionist could use.

Russ: When you first started doing that, was that labelled as high risk taking?

John: Well, it was. People thought we were crazy, and the surgeons, because we were competing with the surgeons for patients in that era, and the surgeons just found us totally disgusting and they verbalized that pretty widely.

Russ: And eventually you sort of disrupted the whole process and took it over.

John: We prevailed and, still, you need, still there’s patients that can only have coronary artery bypass surgery, but the predominate therapy now for coronary artery disease is to use a balloon or a stent first, and then if that doesn’t work, then go to bypass surgery at some later stage.

Russ: Ok, but the whole process of clearing them out based on what I’ve seen that you’ve done has really advanced at the same time, as well, and you’ve been involved in quite a bit of that.

John: What I always try to do is to try to solve a really bad clunk of problem which usually means some problem I’ve created. The first balloon that I really wanted to get involved with, because I had induced a heart attack in a patient, and I thought if I had that balloon I could have pushed the material back to the side. Out of having induced that heart attack led me to really work hard and aggressively.  I don’t want to have another heart attack that I’ve caused, right? Then we had problems with bleeding, so I developed a device to help manage the bleeding, only because I couldn’t manage it any other way. So, it’s almost a matter of desperation has led me to how to make things better. But I’ve always thought that if we could, while work on an artery, if we could see what was going on in the artery the same time we’re working on it, that could be better.

Russ: And now a lot of times, based on what I heard you speak on, is that you go into them in the legs, and particularly, you can see right where you are and you’re essentially sort of cutting plaque out of the inside.

John: No, you shave it. So, you shave out slivers of plaque, and you may have to do three or four different orientations to get what you need. Sometimes, one wall is normal, so you can’t just go in and cut in four quadrants and expect to get all the bad stuff. One quadrant might be totally normal, so you’ll get normal artery if you do that. That’s where the Optical Coherence Tomography, the OCT imaging system, comes in.

Russ: Did it take some bad experiences to realize that could happen; that you could be cutting into good artery instead of a problem?

John: Let me just answer that really clearly, yes.

Russ: And so, that made it extra important to be able to have a camera, essentially, in there.

John: So, the camera is really important for below the knee vessels and for the heart. The camera is also important for the leg. The camera is important no matter where you are, but it’s really, because the consequences of a complication in the heart and below the knee can be devastating.

Russ: And the device that you use now that has the camera that you use below the leg a lot, really shaves them too, and it has the camera in it. That’s called the Pantheris?

John: The Pantheris, yes.

Russ: And that’s your most recent invention?

John: Correct.

Russ: And how frequently is that used today?

John: Well, not frequently enough, of course. It should be used in every intervention. It’s early in our experience with that device. They sell for around $3,000 a piece and sales are like $10 million, annual sales are like $10 million dollars, so whatever that turns out to be. I’m not sure what the exact frequency it is.

Russ: When you sell it, you reuse it?

John: No.

Russ: It’s one time.

John: It’s one time use, yes.

Russ: Does it stay in?

John: No. You put it in, shave your stuff, and collect it in the nosecone, and then take it out and empty it. You may put it back in and do some more shaving, then you take it out and then it’s–

Russ: That’s it.

John: Yeah. There’s no implant that goes along with it. The other implant that’s commonly used in arteries is a stent.  The stents are really, really widely used and we like to avoid stenting because when the stents break, or deteriorate, and restenose or re-narrow down, they’re really hard to treat. Whereas, if an artery just narrows down again, you go back in and shave it. You don’t have any metal stent in the way.

Russ: Ok. Alright, we kinda started with the balloon and then we went to the Pantheris, but you’ve have had quite a few success stories between those two, with starting companies and products that ultimately sold, I believe, in the vicinity of 1.8 billion. But the key thing that I gathered from watching you speak recently is, describe how all those were started and funded in the beginning.

John: As I mentioned to you, these were all angel investor funded.  Sometimes the angel investors would be my wife, a major angel, but sometimes it would be an official angel investor group. Ray Williams was my first, sort of, quote, angel investor with Gene Amdahl, Amdahl computers. That group, and a lot of the technology folks down around Stanford were some of our early. I always have said that if you do something really special for the patient, you can build a business around it.

Russ: Well, you apparently have been doing it very special, and John, I really appreciate you sharing your story with us.

John: Excellent. A pleasure for me, thanks.

Russ: You bet.  And that wraps up my discussion with John Simpson, the founder of Avinger. Coming to you today from Alpha Conference.