4/23/2007 -- Infrared Scientist GREG MATIS appears with Cardiac Surgery Appliance maker RAY BERTOLERO. SEGMENT 4 of 5
RAY BERTOLERO is the Vice President of ESTECH Cardiac Surgery Specialists of San Ramon, California. Estech makes dozens of products used daily by surgeons around the world. Take a listen as he tells us about their EXCITING new BREAKTHRU CURES for Stage 3 heart failure and Atrial Fibrilation!!! http://www.estech.com/
Wayne B. Norris: And we’re back on Business and Technology and that’s Dick Dale’s new album, by the way. I’m your host, Wayne B. Norris and we’re back again with Ray Bertolero, vice president of Estech Cardiac Surgery Specialists. As I always do during this time, I want to read my public service message here.
I learned at my veterinarian that dogs can develop glaucoma with no visible symptoms. If untreated, it can give them relentless splitting headaches. Often, a dog described simply as “grumpy” can actually be simply suffering from severe headaches. Medicines are available to alleviate the symptoms of glaucoma in dogs but you have to ask your vet if the dog needs them. So the next time you take your dog to the vet, ask about glaucoma. You and your dog will be glad you did.
Okay, now so Ray, you’re the actual – you and your brother are actually the idea spark plugs in the company, and you try the ideas out, and then – well, field the ideas. And then you get a consensus from the cardiac surgery community before you go out on a project, right?
Ray Bertolero: Exactly. And we have a number of great engineers that now work for us that are also a lot of spark plugs for the ideas and products that we bring to market.
Wayne B. Norris: Oh, I’ll bet. You know, now here’s the thing. Once you come out with an idea, don’t you have to go through a very difficult and long, extensive process of testing to get it certified?
Ray Bertolero: It depends all on the level of the product. If it’s a basic advancement in instrumentation, it’s a relatively simple approval process. So in other words, when we come up with instruments to go in through these small incisions, naturally, because those instruments are just used to do the procedure or facilitate the procedure, there’s a very short regulatory requirement on them. But if we make products that are implanted in the patient or that provide life support, handle the patient’s blood, then the testing and regulatory requirements are a little bit more stringent. You know, you go from – they have classifications. Class 1 would be the basic instrument. Class 2 would be the like life support system that’s just temporary and then Class 3 and 4 would be items that are actually left behind in the patient.
Wayne B. Norris: Oh, I imagine those are pretty horrific.
Ray Bertolero: Yeah, like, you know, heart valves or pacemakers, those kind of things, are very – have a very stringent regulatory pathway.
Wayne B. Norris: I mean I would assume that’s almost like years, isn’t it, to get one of those approved?
Ray Bertolero: Oh, yeah, and in fact, you know, now we’re seeing a big resurgence in coronary artery bypass surgery because even some of the stuff that’s approved like the drug-eluting stents, come to find out after they’ve been approved, they’re on the market for a couple of years, and patients are starting to have some various different complications and, all of a sudden, you know, it calls into a question of how these things were approved.
Wayne B. Norris: Wow, wow. Yeah, that’s crazy. You know, now do you have to get – I mean you have to get approval of just about everything even though, you know, for example, you know that maybe stainless steel is not gonna hurt somebody. Do you pretty much have to go through that again or –?
Ray Bertolero: No, not at all, and the FDA is actually pretty good on that stuff, you know. If it’s basic instrumentation, it’s very short regulatory filing.
Wayne B. Norris: Yeah, okay. So that – it’d be if you had to put in some brand new chemical or something, that’d be very different.
Ray Bertolero: Oh, yeah. If you’re introducing some new agent then that’s gonna be a very long regulatory process, and if you’re introducing something, like I say, that handles the patient’s blood then you have to do the testing that says, “Okay, this doesn’t cause any reaction with the patient’s blood.”
Wayne B. Norris: Now do you do those kinds of tests through universities?
Ray Bertolero: Well, actually, there’s testing laboratories that are specifically set up. You can imagine that. All of us companies small to medium size like Estech up to large companies that are developing these products, there’s a huge market for actually doing these, what we call “bio-compatibility” tests. So there’s then – and, you know, sterilization validation tests. There’s laboratories that are privately funded, that it’s a complete business in itself, dealing with the regulatory requirements.
Wayne B. Norris: Oh, I’ll bet.
Ray Bertolero: So there’s a whole industry around dealing with the regulatory requirements.
Wayne B. Norris: Well, now, are you a publicly traded company?
Ray Bertolero: No, we’re not. We’re still privately held.
Wayne B. Norris: Wow, so it’s all internally funded.
Ray Bertolero: We have investors, but it’s private investment.
Wayne B. Norris: Yeah, yeah, okay. No, that’s quite an interesting business model. I’m sure it’s – I would assume that everyone’s pretty happy with the way things are working.
Ray Bertolero: I would say that everyone – our investors are extremely happy with the growth that we’ve had over the last 11 years, and particularly over the last 2 to 3 years, when we’ve seen our sales revenues more than double every year.
Wayne B. Norris: Wow! I’ll bet they’re pretty happy about that. Well, there’s nothing like being able to turn a profit on your investment and save lives at the same time and make – and there’s just almost no bad hands in that.
Ray Bertolero: Yeah. The nice thing is for the people that work for us, and us, we have the reward that every day everybody who works here from the people that do administrative stuff to the guys that ship this product out, everybody’s involved in helping make the patients’ lives better.
Wayne B. Norris: Oh, it’s wonderful.
Ray Bertolero: So I mean not that everybody’s job in the world isn’t important to get something done but working for companies like Estech, you really kinda have a little bit more sense of purpose, knowing that when you ship something out the door, or when you build something, or whatever you do, that it’s going into the hands of a surgeon to help make a patient better.
Wayne B. Norris: How many people do you have working for you up there?
Ray Bertolero: We’re probably now up to about 60 people.
Wayne B. Norris: Wow! So you’re doing a lot of business.
Ray Bertolero: Yeah, we’re enjoying quite good growth.
Wayne B. Norris: Are you shipping all over the world or just to the U.S.?
Ray Bertolero: No. We ship to almost every country in the world.
Wayne B. Norris: Wow. Wow. Do you have any special kinds of stories, any really memorable thing that when you think of your company it comes to mind?
Ray Bertolero: Well, you know, when it comes to that treatment for heart failure, I could just mention this one patient, and we actually have had this patient go in front of some groups and in front of our sales group, and the gentleman’s name is Larry Lavery, and he’s one of these guys that had just – he’d had a heart attack, and he had just degenerated to the point where he worked at home and he just found that he would never go out anymore.
He would just get up, do some work, go back, go to sleep, and it turned out, after his heart attack, he had progressed into Stage 3 heart failure, and he went in, and he was lucky enough – ’cause this procedure we do is relatively new – and he was lucky enough to go in to a cardiologist who knew about the procedure and referred him to this surgeon who’s just outside Chicago. And I’ll tell you what. He had this procedure done, and if you could hear this guy talk and see him running around.
Over the course of his disease, he hadn’t been able to do any yard work, and his back yard had become like a jungle. And starting after about a month after his procedure, he felt good enough to go out. He completely re-landscaped his yard. He cut down all the trees. He rented a chipper. He actually put mulch from all the stuff around. And I mean, this night and day difference of somebody who’s so sick they can’t get up, they can’t leave their house, to somebody who now can go out and actually landscape their whole yard. It’s just – it’s a remarkable thing and this is a guy who’s just in his 60s.
Wayne B. Norris: Wow! A young guy!
Ray Bertolero: Well, yeah, a young guy.
Wayne B. Norris: I’m 60.
Ray Bertolero: Well, so that’s kind of one of the stories that I think – and if anybody wanted to actually see the story of this guy talking, they could actually go to heartfailure.com and –
Wayne B. Norris: That’s a good Web site.
Ray Bertolero: Yeah, heartfailure.com. And somewhere on there, they can click on a link and see an interview with Larry Lavery and kinda find out about it. And if any of the patients – like I say, this procedure is relatively unknown, so if anybody has heart failure, I would look at the alternatives. Because a lot of the family practitioners and cardiologists just don’t know that there’s this safe and effective treatment out there, this ventricular resizing.
And that’s the sad part, really, is that there’s literally millions of patients that could benefit from this, but that aren’t getting it, and being a small company, we can’t advertise like the Scherings of the world and put a “Try the purple pill” advertisement out on the evening news, so we’re trying the best we can to get the word out that there is a safe and effective treatment for heart failure.
Wayne B. Norris: You know what? Let’s talk about that in-depth right after these messages. This is Wayne B. Norris. The show is Business and Technology and we’re talking about cardiac surgery new treatments with Ray Bertolero, vice president of Estech Cardiac Surgery Specialists.