\n[Subscribe](https://boydbiomedical.com/design-build-launch)\n\n**FOLLOW US** \n[LinkedIn](https://www.linkedin.com/company/boyd-biomedical)\n","contentUrl":"https://embed-ssl.wistia.com/deliveries/64ca1d9b47432d050cc822ea602eb524d1b5a0ca.m3u8","transcript":"On today's episode of Boyd Biomedical Design Stories, we're joined by doctor Robert Chisena and Sean Gilligan from AVS. We'll be discussing AVS's approach to intravascular lithotripsy and their pulse IVL technology. And I'm joined by my co host Brian Johnson, president of MassMEDIC.\n\nThanks, Matt. Here's a bit about our guests. Robert Chisena is the cofounder and chief technology officer at AVS. He leads the research and product development team. Robert founded AVS in 2019 with doctor Hitinder Gurm at the University of Michigan.\n\nSean Gilligan is the chief operations officer at AVS. Before joining the company, Sean was the vice president of program management, r and d at Boston Scientific. He brings over thirty years of medical device experience to AVS.\n\nRobert, Sean, welcome to the roundtable. Thanks for joining us. Thanks for having us. Yeah. So let's jump in, Robert. Can you tell us about AVS?\n\nAVS or Amplitude Vascular Systems for short is a medical device company based here out of Boston.\n\nWe have the goal of of providing an additional tool for physicians to be able to treat a severe disease state in patients with peripheral artery disease, and coronary artery disease.\n\nAnd and we do so using a technology that we developed in house, called the pulse intravascular lithotripsy technology.\n\nSean, tell us about the products and technology. I mean, why would a physician choose to use this product? Sure.\n\nWell, first off, physicians like to have like to have multiple options on the table, but we've got a couple of unique features in our product versus the platform that's there today. So starting with, the first one being we don't actually don't have any emitters in our balloon. Those emitters and current technology add some bulk.\n\nOne of the things physicians have given us feedback on is sometimes it's difficult to track a balloon because, to try and get it through those tight tight lesions. So the fact that we don't have emitters on our balloon means we can get down to a lower profile. Hopefully that lends then to the lower need for adjunctive devices to basically create a hole to get access to deliver treatment.\n\nWe also deliver the treatment at fifteen times a second versus one or two, so that's that's an efficiency there. The energy is delivered uniformly, across the length of the balloon. And also we use a non compliant balloon, so once that lesion's opened, we can use that balloon to dilate dilate the vessel, you know, reducing the need for, adjunctive devices, keeping the cost and the time of the procedure low.\n\nOne of the biggest stories in medical device, and and certainly in the the IVL space, is J and J announced in in April their acquisition of Shockwave Medical, thirteen point one billion dollar deal. How does this affect you guys?\n\nI guess, first off, I mean, we're very very, very excited to, see something like that happen. I mean, a company like J and J, scale of that company and the success coming in to acquire a technology that's still relatively new, is very very exciting. I mean, Shockwave generated over seven hundred million dollars in revenue last year, has done a phenomenal job of growing the market and to get acquired for that premium is it says a lot about the space.\n\nWe're very excited because A, it tells you the space is big. Shockwave is, you know, the only player in the space right now. So, there's plenty of room, and we wanna we wanna occupy some of that space. So it's full on.\n\nI read the CFO of J and J said the space is, I think he described it, as severely underpenetrated, like, ten percent of the market penetration today. Is that correct?\n\nYep.\n\nIt's probably a little little more than ten percent, it's a rough estimate, but, yeah, I think the general, thought is that it is, underpenetrated.\n\nThey estimate that the I think in a their recent investor presentation, they highlighted that potential market is, almost, nine and a half billion dollars. So that tells you there's a lot of room to grow.\n\nYeah. Very exciting. Alright. So maybe can we take a a step back and just, you know, I guess thinking about the market, but maybe a little more centric on the patient, can you just tell us sort of what's the patient experience today and what's, you know, what's the unmet need that you guys are addressing?\n\nDoctor.\n\nSo the patient, it starts with the disease, so either peripheral artery disease or coronary artery disease.\n\nAnd, typically the patient is suffering from one symptom such as, lack of mobility or pain during mobility, and it can extend all the way to ulcerations or, or or, you know, various other diseases that may require amputation in the legs. In the heart, it can be more acute, such as myocardial infarction or heart attack, and and something that you need to treat right away.\n\nThe the the treatment itself, the patient doesn't necessarily feel. It's a percutaneous minimally invasive type of technology, where you go in through either the femoral artery, so the artery of the inner thigh or the artery of the wrist, and you track a small long catheter, tube up to the disease or affected vessel.\n\nAnd the physician is intending to expand, that vessel so that you restore normal blood flow. During the procedure, patient doesn't feel anything, but really what they feel is post treatment, they're going to feel the restoration of the normal blood flow that they used to have.\n\nAnd post that, they, you know, ambulate, more easily, less pain, especially in your heart if if you have that acute symptom. It's it's very helpful.\n\nI mean, this is maybe an obvious question, but what's the without your technology, what's the patient experience? I mean, what is this, what is their life like with this disease?\n\nYeah. So so you're you think about it, your your vessels, deliver, blood flow and essential nutrients and take away the waste.\n\nSo if if you don't necessarily have that, let's say, in your legs, you can get, all all sorts of issues, specifically around mobility. You know, patients have difficulty walking around, because you're not getting that blood flow to your distillates remedies.\n\nOnce once you go in with with our treatment, you can, you know, essentially expand that vessel.\n\nPhysicians, you know, are are targeting more and more difficult lesions to treat, expanding the patient population that they're able to treat. And when they do that, they experience, more difficult anatomy. So in other words, you know, you have this this vessel that's closed, and over time, you you get calcium forming over that vessel. And that calcium is very difficult to break up and restore the initial or the the original elasticity or compliance of that vessel.\n\nSo what we do is we go in and break up that piece piece of calcium, such that the initial elasticity or compliance of that vessel can be restored, and that allows blood flow to proceed normally. Doctor.\n\nYeah. A lot of the technologies that have been used up to date for patients that have had severe calcium treatment can range from surgery, which is not all desirable, or minimally invasive techniques are used, anything from high pressure balloons, scoring balloons, to atherectomy devices. They all have their they all have their risks and in many cases, the treatment isn't isn't isn't optimal.\n\nWhat's the, diagnosis path for discovering that you have these deposits?\n\nOne of the big ones is, you know, ultrasound. You can use diagnostic ultrasound to to visualize any stenosis or reduction in flow path.\n\nThey can use CT angiography, so, an X-ray that gives you a kind of a three-dimensional view of of the vessel, and then, you know, just patient symptoms really, so past medical history and and things like that.\n\nYeah. So what about the cholesterol testing? I mean, isn't the doctors first you you isn't that sort the first area you find out you have some issues going on, if your cholesterol is really high and there's a risk of clotting and then what kind of education are you do you have to do to does the market have to do to to patients to understand because doctors aren't immediately going to the imaging. Right?\n\nI I won't necessarily get into how how a physician kind of, triages the the disease. That's pretty well established. I mean, there's things like CAD scores, peripheral artery disease scores.\n\nSo so that that naturally has been established. We're kinda coming in, and if a physician expects a difficult treatment, and they can see that, you know, mid procedure under fluoroscopy under, you know, normal x-ray that that they do during a procedure, they expect difficulty in treatment, they they can use us as a first line of defense.\n\nAside from the I was gonna kinda go into your technology a little more specifically. Aside from the fact that this is a there's a large addressable market, it's maybe underpenetrated, What what are the specifics of the Pulse IVL technology that are better?\n\nOr or, you know, maybe just start with the specifics of your technology, but, what's the point of differentiation as well?\n\nYeah. So so so the AVS Pulse technology is a platform technology. So, what I mean by platform is we have, a piece of capital equipment that kinda sits in the cath lab, very mobile, sits on an IV pole. The cath lab is is wanting for room. Sean can tell you all about that. But, we we have, this this piece of capital equipment that is that can be used for multiple indications.\n\nAnd then on the second side, we have, that piece of, disposable technology that is inserted into the patient and is what does the treatment delivery or the therapy delivery.\n\nSo so, what what what differentiates us from from others is how we deliver this energy. So in order to fracture calcium and restore that blood flow I was talking about before, you wanna deliver these high intensity pressure waves.\n\nAnd when you deliver those pressure waves, you wanna do so in a safe manner that also cracks calcium.\n\nSo, you know, we we deliver this energy from outside the body and send it through the catheter shaft and into the the calcium that the balloon is in contact with, break up the calcium, and and we do so with these short bursts of high intensity pressure waves.\n\nWhat's the technology landscape here? Is there are are incumbents, are device makers trying to develop this type of technology? Is this we're gonna get into how you guys developed it and kind of the the path of the translational research. But what's go what's going on with technology development in this space?\n\nI guess, first off, you know, the technology is still relatively new, but Shopwave has done a phenomenal job of, of creating and growing growing that market, largely predicated on the technology. It's safe, it's efficacious, and it's very easy to use. So naturally in a space that's that big and that attractive, there are quite a few companies working on technologies to try and create a market entry position as well. Some of the strategics are also working on technologies, but I don't know that anybody out there has anything significant quite yet, so we're seeing quite a lot of interest of companies approaching us and wanted to understand more about our technology and and where we are in the space. But when you have a space that's that big and that attractive, it's it's not unexpected that you'll have other companies trying to, rapidly enter that market.\n\nHow is your I mean, how has your life changed since that Shockwave acquisition came out? I mean, our industry doesn't see thirteen billion dollar acquisitions every day. I mean, it's a big deal. So I would imagine that it it kinda changed some of the tenor of of the conversations you had. Perhaps you've got some more inbound, probably got a lot more, sort of vendor calls.\n\nBut I mean, what, what what Things are definitely more expensive. What's you know, what how has it changed the atmosphere in the market for you?\n\nLike you said, there's a lot of inbound interests. It it it's, it's been it's been good because we can really, differentiate ourselves. We can talk about the things that make us different, and nobody necessarily wants a me too. They you know, Shockwave is relatively established, and there's maybe, you know, a few players that are are sort of doing the same same thing.\n\nWhat what this has allowed us is to really differentiate ourselves and tell our own story. We wanna really add a tool to a physician's toolkit. We don't wanna, you know, either replace a tool or say we're better than another tool. We wanna add another tool tool to the toolkit.\n\nI mean, I would say, you know, for the last maybe in the last twelve months, in particular, or eighteen months, I mean, we've been heads down and just very focused on trying to get the job done.\n\nI would say, post the shockwave announcement in J and J, certainly we're getting a lot more people approaching us, whether it's physician community, industry community, want to know what we're doing, where we're at in our development cycle.\n\nOn practical terms, the number of vendors knocking on our door, recruiters, emails blowing up, junk emails off the charts, so there's a lot of intangibles that fill that space, but there are a lot more things that fill your day than it did historically, but it's all exciting.\n\nBut I mean, we're gonna go, as hard as we can and as fast as we can, but we but we're gonna do it right.\n\nYeah. I was really we're gonna see the walk and talk to where we took yesterday, a little later. But I was so impressed by the thoughtfulness you guys have given to kind of the the your systemic approach to everything in this kind of innovation loop from engineering and design and development, out into the production environment.\n\nWhen you talk about this as a platform technology, are you building those internal capabilities? Is is this about expansion of the technology to additional clinical applications? Is it about, you know, complimentary technologies?\n\nHow are you how do you think about that platform as you go, like, forward and, you know, maybe a little further out into the future?\n\nYeah. Sure. So so, first first and foremost, we wanna do things right from the beginning. It really saves you time.\n\nAnd and, you know, time is everything for us. We we we wanna be able to use this technology and patients. I think it's it's something that's going to benefit, people a lot that need it. You know, you talked about the system systemic, approach and strategy that we've taken up, and Sean has has this in his back pocket. I mean, you know, at Boston Scientific, this is really what they did, and I'm sure he'll get into that. But, you know, we we we wanna take a, you know, sort of a holistic approach where we have, our engineers communicating with our regulatory and quality and our operations and and and also, you know, our business development and, really merge all of those so that, you know, when we when we, launch this product, everything has been thought of, and, you know, user is gonna have the best experience.\n\nFrom a from a technology perspective, I guess the easiest way to describe it is, you know, we've got a console handle as a capital piece of equipment, and then you got an amplifier and a catheter.\n\nThat in all in essence, looks like it looks like a traditional catheter, but designed for this purpose. The The capital piece of the equipment and the amplifier will be agnostic to whatever clinical application we go in. So we have total leverage, whether it's vascular, peripheral vascular, coronary, crud, or whatever indication, all of those parts of the technology are already developed. The only parts that we need to develop for each of the different clinical indications is a new catheter.\n\nSo we've designed this in a way where we didn't wanna have to have a new system for every particular vascular part of the anatomy we were gonna go into. So we've got three quarters of the systems leverageable wherever we go, and then each clinical indication just needs a different catheter.\n\nYeah. I'm interested in the sort of difference in the balancing act that you guys must have to do internally between you know, the shockwave news probably adds an even higher layer of urgency and and and external pressure for speed. Right? Like, hey, this is momentum. Let's capture this momentum. Let's go faster.\n\nLet's let's push the this to the you know, as fast as we can. But then, obviously, you said it, you know, you have to do things the right way. You have to be really disciplined and incremental and and make sure you do things right the first time. How are you how are you balancing those two competing forces? Is there anything that you're leaning on from your Boston Scientific days? Or is there anything that you're kind of looking at to sort of keep you focused on the the small steps you have to take even though you know, like, basically, you know, it's almost like the time is now. Right?\n\nYou know, I was I was at Boston for over over twenty years, and I was fortunate to just have worked with a lot of lot of great talent and, you know, was able to bring a lot of products to market that are kind of standard of care today. I guess the way I look on product development is it's a constant learning process, and you've gotta be constantly learning and discovering along the way, because the more discovery you make on the front end, the less discovery you're gonna make when you get out into the field. But I think it's a very humbling process, but at the end of the day the backbone of success really comes back to the people that are on your team and how that team dynamic works. It's really all about the people at the end of the day, and we're very fortunate by the team that we have.\n\nI think you saw, as part of the tour you see people, everybody knows what they need to do, everybody's constantly asking themselves the question, am I leaving any opportunity on the table, is there something I should be doing that I'm not doing? It's a very open collaborative environment. The one thing that we don't do is we don't stand still, because when you're standing still you're not learning anything.\n\nAnd there's a spirit of engagement and transparency. Everybody's focused on the same goal. When everybody's focused on the same goal, everybody's thinking about how do I do it in the most effective way possible. From my experience historically, you can put systems and processes in place, but they really create just a framework of how you operate, But, you know, what takes you over the top is is the people. It really is. And the depth and breadth and talent and motivation.\n\nYeah. The goal is to wake up every day and make the best product you can, best, safest product that you can that the user is gonna have the best experience with.\n\nAnd and if you, you know, we have sort of a motto, check your ego out the door, because, you know, when you're you're quickly innovating, you don't always have the right solution. You don't marry you don't get married to a solution, because there's probably a better one that merges everybody's ideas, and and, that's what we try to try to accomplish at AVS every day.\n\nI'm always fascinated by the I mean, the teams enable these, devices and medical device. As we see it we're lucky to see it a fair amount, and certainly evident in the facility tour yesterday.\n\nThe these devices can appear sort of simple or or they're you know, the solution can appear simple, but there's all this technology packed into them. And that comes from these these diverse teams that that you guys are clearly putting together. What, what are the enabling technologies? I think you guys have referred to it as as sort of the mechanisms of of action of of the device itself that that are helping it do its job.\n\nWe definitely try to keep things simple, because the more complex you make it, the the more difficult the user is gonna be to experience it or gonna have to experience it.\n\nRegarding how how we operate our device and and the mechanism of action behind the device, so so we use a principle, in physics called, water hammer effect. You may have experienced it the last time you closed the sink off too quickly. Your the pipes in the wall, of your house may vibrate a little bit.\n\nAnd that's a that's a an effect that that's, it's pretty well known in physics, and we just applied it to, treatment of calcium. So, essentially, what we're doing is closing a valve on and off very quickly, and that's causing a very rapid pressurized, in the in the the balloon that's adjacent to the piece of calcium. And with that rapid pressure rise, we're able to fracture the piece of calcium, and then, like I said before, restore that blood flow.\n\nWe use a non compliant balloon. Physicians sort of have gravitated towards this non compliant balloon where when you pressurize it through a certain amount it grows to a certain diameter, and you tailor that diameter to the patient's anatomy. So we're merging, one new technology with an existing technology and with the fusion of those two pieces of technology, you get a really good end result.\n\nHas technology evolved to allow you to do what you're doing today, and it just simply wasn't here for incumbents or other innovators to to bring it this technology into the market? I think sometimes people look at the market and say, why hasn't there been any innovation in twenty years? And it's because these enabling technologies may not have arrived yet. So I think you just highlighted one. Is is is that really the the crux to pull this together for you guys, or are there other technologies that have come along?\n\nThere's definitely been, you know, other other technologies in the space. Like, you know, we're talking about Shockwave before. They've really disrupted the space, and and they've they've really created a new paradigm in terms of how do you treat this particular disease modality.\n\nWe just thought about it in a different way. And the way that we've thought about it, has really allowed us to have certain, key metrics that physicians will will will appreciate. And, you know, those things are everything from, you know, being able to deliver your catheter to, being able to go around, you know, torturous anatomy or difficult anatomy that's, you know, circular or, you know, things that that docs may may not be able to treat today. Yeah.\n\nBut but then you're right. The convergence of, different technologies is creating new enabling opportunities, you know, in in all aspects of society and and including including health care. I mean, our our device is a combination of of some new technologies.\n\nThere's also systems integrated electronic systems integrated into the device that at some point we hope to be able to make the device, smarter in terms of being able to give the physician feedback, not just to deliver treatment for a period of time, but deliver treatment and know when the treatment has been delivered, and then move on. So to drive, you know, more effective, more efficient procedure.\n\nAlright. I think I'm gonna pause this here. I think this is a good segue, to, we're gonna take a quick break, watch the facility tour we took yesterday. We had a great product demo in there.\n\nSo, we'll take a break now. And then on the other side of that, we'll come back and talk more. Boyd Biomedical is a growth partner for medical device and life sciences companies. Our growth platform provides a full suite of services to design, build, and launch regulated devices and liquid media solutions.\n\nWe approach our business with a long term mindset and believe in the virtue of doing great work. Every day, we focus on perfecting our capabilities and becoming stronger for our experience.\n\nWe deliver innovation, best to market.\n\nWe're here in the Seaport in Boston, Massachusetts at ABS's new headquarters facility. Sean, thanks so much for having us. Thanks, Matt, for being here. Yeah.\n\nSo I'm really excited. We're gonna take a facility tour and meet some of your team. Before we go inside and do that, tell me about this facility. What are you guys doing here?\n\nYeah. So we're a start up med device company developing a unique technology to treat Intravascular Calcium.\n\nWithin this facility itself, this is really the center of the enterprise in terms of the design. We control all aspects of the design from here and you'll obviously meet some of the team.\n\nBut one of the unique features is in this space we've got some manufacturing capability, lot of office space, and we're able to co locate our engineering teams and all the support functions around that. So it gives us a lot of lot of opportunity. We don't need a lot of structured meetings because everybody's working in the same space.\n\nYeah. And we're in the Seaport. I mean, I live in Boston. This is a really cool area for restaurants and cultural activities, why here for a medical device company?\n\nWell, let's start off let's start off with Boston. I mean, Boston is very fortunate in in the fact that there's a very rich talent pool here, huge ecosystems supporting med tech, biotech, so as a start up you obviously wanna tap into that. Why Seaport? I mean Seaport is a rapidly evolving cool part of town, it's very attractive to young professionals, very close to public transportation, to the airport, so we put it all together, why not here?\n\nYeah. It's all those things. Right? Yeah. That's great. I'm really excited to head inside and meet some of the team. Can we go take a look?\n\nYeah. Absolutely. Looking forward to it.\n\nGreat. Thanks.\n\nOkay. So, in this this area here, just past reception, we've got multiple conference rooms so we can have meetings when we need them, entertain, you know, any particular customers, guests, whatever. But we've got a pretty open plan set up, so it's it's very clean, it's very fresh, very modern looking, so peep people like that. Walking down along here, you probably know you'll see some of the display boards on the on the wall here. We use these as kind of visuals to explain, you know, the the procedure. Effectively, you know, you cross the lesion or just calcified area first.\n\nYep.\n\nAnd then we pulse the catheter, and the the rapid pulsation of the catheter then creates these cracks and micro cracks in the calcium, and then you expand the vessel to basically improve or restore blood flow.\n\nYeah. Keep that keep that tissue healthy. So this is our open plan office area.\n\nAs you can see, everybody's pretty close together. Don't need don't need to schedule a meeting. You just stand up with your cube or just walk over to your colleague and you just keep think keep things moving. But we're pretty self sufficient as you can see. We've got, got our own kitchen kitchen area over there.\n\nSo Great.\n\nYeah.\n\nSome people like to go out for lunch, some people bring bring lunch in, but it's another social area.\n\nThat area is bright. It's it's airy. It's pretty pretty fresh. That's great. But our engineering team are here all day, every day, so R and D, operations, and then we've got support from our regulatory quality and all the other all the other functions, so everybody's pretty co located, so this is the brain trust of the enterprise, this is where all the design elements are controlled. Our team is small, but when you add in all our suppliers and all our partners who help us on the design, the extended team is is quite large. So this is effectively our office space and then the space over there is the entryway to our lab space and production space.\n\nRight. This is fantastic. Thank you so much for showing us through here, and, I think we're gonna go check out a product demo with Damien.\n\nYep. Looking forward to it.\n\nThanks. Thank you.\n\nGreg, Damien. It's great to meet you guys. So we're gonna do a little product demo in here. Before we get to that, I would I wanna talk a little bit about both of your experiences, you know, what you do here at AVS now, and and kinda what led you into these these roles. So, Greg, maybe you could start with just what what's your role here today, day to day? And then I just want to follow-up with with, you know, what's led you to AVS.\n\nSure.\n\nSo I'm the principal product designer here at AVS. I'm generally responsible for the overall product design and function and making sure that, you know, mechanically everything is working well. And also guidance for the younger engineers and co ops and bringing them into our system. Basically allowing them to become a functional part of the team and kind of helping them find their place and role in in the the world of engineering for medical devices.\n\nGreat. And, you know, what what has your career path been to here? Has it always been start ups? Have you worked for big medical device companies? Has it always been medical device?\n\nIn the past twenty five years in Boston, I worked at five different start ups. I guess you could call them all start ups, but close enough.\n\nAnd every single one has been a medical device of some sort, whether it was heart or spine or various surgical equipment.\n\nAnd it's been a lot more fun to work in start ups on med tech versus being a small part of a corporate project where you're not sure if your work is actually ever gonna end up anywhere, as well as working with smaller teams that you have more influence on. And you're more able to connect to younger co ops engineers and create better engineers to join the team.\n\nAnd, Damien, what about you? What's your day to day role here?\n\nYes. So, I'm Damien Cross. I'm a senior R and D engineer at AVS. And initially, my role started off as more of a design engineer, I'd say, where I was working on designing our capital equipment.\n\nEventually, though, after we got that design sorted out, I geared towards becoming more of a testing engineer.\n\nSo when I say testing engineer, I mean, developing protocols and different verification validation activities to really ensure that all the user needs and the requirements that we've outlined and prescribed for our device are eff efficiently and effectively tested according to any confidence, reliability, and rules that, you know, the FDA or our internal quality team are calling out for. So in that regard, I've helped to develop over forty different, protocols to make sure that all of our requirements are are thoroughly tested to ensure that our device is safely, built and designed for for human use.\n\nAnd are you what's your career trajectory to AVS? Are you a a startup guy like Greg or have you had a mix of experience with corporate experience too? Has it always been medical device?\n\nWhat's that been for you?\n\nYeah. So, originally when I graduated, I started working for a big medical device company.\n\nAnd I think working for a big medical device company was instrumental in understanding how the medical device process and the life cycle of a medical device really works.\n\nI eventually transitioned more into a start up environment and eventually came to AVS. And what I really like about a startup is the fast paced nature of it and you really have a hand in every single subsystem that this device makes up. So, it makes you feel like you basically are an instrumental part of this team because you actually are.\n\nYeah. That's great. Alright. So we're gonna do a product demo. Before we turn it on here, Damien, can you give me just a quick explanation of what we're gonna see?\n\nYeah. So what we have here is, we have our balloon catheter that's sort of set up in between some calcium surrogates, which essentially is just gypsum or or plaster. And what we're trying to demonstrate here is that our device is able to transmit a uniform pulse wave throughout the length of the entire balloon.\n\nAnd, you're gonna see that we don't have any emitters, and that design artifact actually really helps with our crossing profile. So as our method of action is different, we're able to generate a uniform pressure wave throughout the entire length of the balloon and and crack calcium uniformly throughout the entire length of the lesion.\n\nOkay. Great. Let's do it.\n\nIf you're familiar with the water hammer effect in an old house, where you'll have, you know, a bubble in the boiler downstairs and knocking in the radiator upstairs. Yeah. Basically, we're using that pulsing through a water column to allow the balloon to expand it and pulse at high frequency in waves. While in the handle and in the amplifier, it acts like a speaker, which is why we call it the amplifier, to send those waves at high frequency with our electrical mechanical system.\n\nSo there's only saline and maybe contrast fluid in the balloon. And that's that pressure wave is what's breaking the calcium surrogates, whereas in the handle and in the, the console console, it's it's controlling the air pressure to allow that pulse to adapt to the pressure that's required. And so this demonstration is going to show us breaking the surrogates as if they were inside an artery or vein without doing any damage to the surrounding tissue.\n\nAnd we can do that demonstration now.\n\nAlright. Three, two, one. Treat.\n\nSo that's a pretty clean shatter.\n\nAnd generally what would happen in the intimal walls of the artery or vein is they would continue to treat this because here we see the calcium falling off of the balloon, where in the real world, the calcium would stay between the layers of the inner and outer wall of the vein or artery. And we wanna shatter that as much as possible and break it down into smallest pieces possible, which allows the vein and artery to stay flexible and to increase blood flow to the area, reducing any occlusions in your in your circulatory system.\n\nTed, great to meet you. We just had a really cool product demo with Greg and Damien. Talked a little bit about their roles in design and engineering, and now we're here in the r and d and manufacturing space that you guys have. Tell me about your role as a systems engineer and kinda how you bring all this together.\n\nThank you. So it really starts with the requirements and working with these guys up front, figuring out what they need, how the standards work, come together, working with the compliance team, and then letting them do their thing and jumping right back in and bringing it all together one piece at a time.\n\nI imagine, you know, you guys are pre commercial, right, as a start up medical device company.\n\nThere's still a fair amount of testing iteration that has to happen. Right? How important is the actual physical layout of this, space beneficial to you? You know, you have such close proximity to r and d and manufacturing. Does that benefit you guys?\n\nAbsolutely. So having the R and D team and the operations team in the same floor helps out a ton. We let the the guys come right over. The operations folks can just jump right in, tell us, hey, this is coming together great. This doesn't work too well. We can tweak things, change things just on the fly. So that iteration timeline just goes way faster and it helps us make a better product at the end of the day.\n\nTell me a little bit about your career path path up until this point. Have you been working in startups or or large companies? Have you have you always been in medical device?\n\nIt's been mostly medical device and makes a big and small. This is my first true startup and, it's been a great experience.\n\nWhat do you love most about the start up environment and and what and the EVS? It's the team.\n\nComing together, everyone has the same goal, the same ambition, everyone understands getting it done. That's great.\n\nWell, thank you so much for showing us your space today.\n\nLooking forward to seeing you guys succeed.\n\nAbsolutely. Thank you so much for coming in.\n\nThat concludes our tour of AVS. We're gonna take a quick break, and we'll head right back to the round table.\n\nFor more than a quarter of a century, Mass Medic has been the voice of the groundbreaking medical technology industry in New England, advocating for sound public policy that supports innovation and fostering a community built on a shared purpose, saving and improving the lives of patients everywhere through medical technology. Since the beginnings of New England's dominance in health tech, our members, the women and men who make up Massmedic, are researching, designing, developing, supplying, manufacturing, and deploying the next generation of medical innovations around the globe. The heart of health tech beats here in Massachusetts, and at MassMedic, we're proud to be part of that journey. Learn more about how you can join our community at mass medic dot com.\n\nI wanna kinda shift gears a little, I guess, but kind of exploring the path of this technology from university to AVS.\n\nCan you speak to that, Robert? Just how how did you come across this technology or develop it, and then maybe, you know, how did it move through this translational research process into now you guys are this growing, startup?\n\nIt's a good question. I appreciate you asking it. First first, I'll give, credit to, my cofounder, Hitinda Gurm, who's, now the chief medical officer at, University of Michigan Health System.\n\nAnd he he's got this brilliant innovative mind, and, you know, he's sort of trained in such a way that obviously all interventionists, all operators deal with intravascular calcium on a daily basis, and they all have challenges challenges treating it. And and his his mind is one that, you know, he doesn't just face the challenge, but he tries to overcome it and innovate on it. And that's where he kinda came up with the idea and the concept of trying to, create a pressure pulse in the in the balloon.\n\nAnd he had a prior relationship with the principal investigator of my lab. I was doing my doctorate at the time, and that's how I, met him and and came across the the technology and the concept.\n\nWe worked together together to build a first prototype, and then, so so the way that my lab operated is we would take a bottoms up approach and a top down approach. So in other words, bottom up is we study the disease state, the pathology, understanding the morphology of the calcium, and really why there is a clinical need.\n\nAnd then from a top down approach, we try to design a device that is, that's very user centric.\n\nAnd physicians are dealing with a lot of, you know, other competing interests in the cath lab, and you want them to focus on those things. Those are the most important things. So, you know, patient health is most important. And so you want to create as simple of a device and as familiar of a device as possible.\n\nSo we we kinda merge those two. They they met in the middle, and we came up with this concept for using, the water hammer effect and this physical principle of of creating a high pressure peak pressure pulse, that cracks the calcium but also doesn't damage the surrounding tissue and do so in a way that allows the device to be delivered to the, you know, very difficult, most difficult anatomy that you can, that you can imagine.\n\nWas this always your path for you personally? I mean or was there a point you know, like, did the was the technology so good that you said, I'm you know, I'm I just have to go for this, or did did you always intend to kind of try to go from a research environment into a commercial enterprise?\n\nI started research at my undergraduate, education at Penn State.\n\nAnd as soon as I started research, I sort of fell in love with it.\n\nAnd I, you know, recognized that, you know, I always wanted to sort of be in the medical device research space. So I chose Michigan, mostly because, of their great engineering program, but also the, proximity of the hospital to the engineering school. And the fusion of those two ideas and concepts really, you know, brings together the best and the greatest ideas.\n\nSo when when, Tinder brought this concept to me, you know, it was it was pretty much easy to choose. You see the impact it can have on patients' lives, and we we went from there. And it was it was, you know, as as hard and as fast as you could push.\n\nYou know, University of Michigan has this great translational program where you can you can, apply for funds, that are non dilutive. So I think we brought in about three hundred thousand in non dilutive funds prior to exiting the university, and that paid for everything from, you know, early device development to the basic science research that we were doing to, you know, solve solve this challenge.\n\nWell, while we're on it, Sean, what about you? Did did what was your path to AVS? I mean, were you itching to move from a corporate experience to a a start up, you know, or or did did they find you and it was just too good to to pass on?\n\nIt's kinda kind of an interesting journey too. You know I was with Boston for quite a long period of time and enjoyed my time there and I'm super happy for having worked there and all the experiences that the company gave me.\n\nYou know the healthcare environment is kind of like a small ecosystem in its own right but if you look at shockwave as an example there are many ex boss and scientific employees in that company but as it turns out there were two people in in in AVS that I had worked with in my, in my previous career, and and we'd had conversations on on and off over time, and I I knew what they were doing, and, they had reached a point, post raising Series B funding that they wanted to go to the next phase and they, they approached me just to take another look at the technology. We just sat down, started talking about it.\n\nI was super excited by what I'd heard. I knew I already knew enough about the space from having worked in Boston and, I also met Robert at the time, few of the other team members. The team was very small at that point and I'm like I'm like why not? Another opportunity to, get back to a more hands on role in a startup.\n\nIt's all hands on, which is kind of intimidating on one side, but it's super exciting because every decision you make every day just moves the ball forward. So I'm like I'm like, okay, I'm gonna give this give give this a run and have them look back.\n\nI'm interested in and what you talked what you said about Michigan and the proximity between engineering and the health system and sort of because that's a unique setup. I mean, I don't think many, university settings have that. And I just wanna gauge from you, like, what are some of the things that that really allows you to do to go from bench to the health care setting of the bed? Like, what how do you how does that help you speed up the innovation process?\n\nNot only speed it, but it's the birthplace.\n\nSo it's, you know, physicians are your end user. So, you know, a lot of times, technologies will come out of universities where, you've created this really cool thing and you're trying to find a place for it.\n\nIn Michigan or at least in our in our, you know, small lab space, we kinda did things in reverse. Physicians would come to us with their problems and challenges, and we would we would take that approach, that I mentioned before and start to develop a new product out of it, something that can really impact that particular space.\n\nAnd they just come to you unsolicited with those problems?\n\nSo it's based on relationships. So, you know, at Tendergirm, I had probably four or five projects with my, principal investigator prior to, prior to this particular one. In fact, you know, atherectomy was was a pretty big, topic in in in our lab environment. We we studied it from, you know, grinding, because it's a grinding burr. So we studied it from the basic science of how it grinds and shaves away calcium.\n\nSo there was a very deep understanding and relationship between the physicians and the engineers.\n\nThat's so fascinating. And and I think it's something that that that probably we'll see more of in the future, right, putting these biomedical engineering programs in health care settings. But it's something that I'm just really fascinated by because you said it right. You know, when the innovators are just sitting there working on problems and not engaging with the physicians, I it feels like you're just sort of doing one side of the coin. And it's just so fascinating because you don't you know, I'm just interested in how you guys were able to get this leg up from where you were sort of born.\n\nTell me a little bit more about the, the translational funding too and what that how that sort of gave you a head start.\n\nThere were two entities that really helped us out a lot.\n\nOne was called Fast Forward Medical Innovation, and it was it was a funding agency that was, I think initiated in Michigan legislature, but, you know, take my words of the grain of salt there.\n\nAnd there it was distributed amongst various universities.\n\nSo, you know, Michigan State had had a piece and and Michigan had a piece.\n\nAnd, we started with a Kickstart fund, which is a very small amount of you know, small pot of money, and then a larger, what's called the Amtrak fund. And that was that was the lion's share of the of the the fundraise that we did. And then we also went out to other institutions like, NIH, what was called NCAI at Cleveland Clinic.\n\nAnd all of these, all of these funding agencies require that you not only present a proposal, but sit in front of a board of, investors, that are really trying to understand your technology and whether it's, it it is suitable for a translational approach.\n\nCan we carry this forward a little to, like, the clinicians? And, I I think this is such an interesting area to talk about because you're talking about disruptive technologies in health care.\n\nYou know, the health care industry is really sort of inherently resistant to disruption, and sometimes we we encounter entrepreneurs who maybe come from outside of industry and say, I'm gonna change that entire standard of care because it doesn't work. That's really difficult to do. In your case, it what sort of can you characterize that for us? Is, is it about education and helping them use the technology?\n\nAVS?\n\nI think there's a I mean, there's a couple of things that, work in our favor here.\n\nSo the problem has been there for decades and there are just different tools that do it suboptimally. So when Shopwave came along, they put a lot of time and effort and investing into their product to show that it was safe and efficacious. I think the rapid adoption of the technology has really come down to the fact that it works and it's easy to use.\n\nAnd easy use is table stakes, docs are under pressure for time, hospitals are under pressure for money, so if you can hit those two buttons you're you're doing a really, really good job.\n\nSo physicians had rapid adoption, the second thing that Shockwave has done a really good job and it's where a lot of companies have good ideas unfortunately fall over is, you know, how do you get paid for your technology?\n\nSo, Shockwave put a lot of time and effort into, basically paving the way to get dedicated reimbursement codes for, for the technology. So now you've got a product that's easy to use, and the hospital get paid for it, the doctors get paid for it, so of course it's gonna it's gonna get rapidly adopted and if you're getting good clinical results ultimately that's the thing that's most important. What we're fortunate in that regard is they've paved the way in a lot of this and what we're coming behind is is trying to give them another option and to do treatment in a slightly different way.\n\nSo a lot of the commercial part has already been done because we've designed a product that's very easy to use, very small footprint, can be mobile between cath lab spaces always at a premium. The only thing the hospital needs to bring to the table is a size c c o two tank, which they typically have on hand. So we're trying to hit all the buttons that make the doc's job easy, the hospital's job easy, and not try and create any more any more, disruption in their workflow.\n\nI mean, so cool how elegantly this whole thing feels.\n\nAnd I don't know if you've gotten that talk to you. Everything from sort of coming out of university with a basically clean cap table, right, to sort of following somebody who's done a lot of the hard work on the reimbursement ad. I mean, those are those are two areas that just kill companies. Yep. And you guys have been able to, I think, very definitely navigate that. Do you you must have seen that, like, how when you when you took this job. Like, hey, this is this this this is all the earmarks of a successful company here.\n\nYeah. I mean, unfortunately, a lot of people get up in the good idea and no matter what happens, it's their it's their baby, it's their good idea, they're gonna make it successful no matter what happens. But I think in any enterprise, you have to be thinking about not just where you are now, but what does the future look like? And when you show up in the clinic, what have you got to bring to the table to make sure that the product is gonna get used or is gonna provide utility in that space? So, I think we're fortunate in that regard that we have people in the company, no charge of good ideas, but also we've got people in the company and through our board and through our advisors who have all this experience that we have that we can get access to. So when you bring bring all that together, it's what we have as a business, not just an objective.\n\nAnd you said, Robert, that that you you quickly gravitated a medical device.\n\nJust curious as to why. What what, what excited you about the space?\n\nMaybe since fifth grade. My my my my dad is an orthopedist.\n\nHe had he had his own, medical device enterprise, and I was along the ride along on the ride with, animal studies, early animal studies, and, never never really is still working on it, but it never really took off. But, it was that was the first entree in, into it. And then and then, you know, through undergraduate, I I, was very interested obviously in engineering, and then, you know, research it. And then it was it was really that that was it. That was that was my passion and my love for, you know, for for for all time.\n\nThat's great.\n\nIt's great to hear.\n\nI mean I wanna remove that part.\n\nNo. I would like passion. It's exciting to, it's exciting just to to always hear somebody's journey into this industry because it's a tough industry. Right?\n\nI mean, it's probably the hardest innovation you can do. I mean, considering there's a a lot of significant roadblocks. I mean, it's for sure. You know, dead decades of grinding.\n\nAnd this is your first company. Right? I mean, how how are you feeling few years in here in terms of, like, do you feel like, do you do you feel lucky? Do you already do you what's what's your headspace like?\n\nYeah.\n\nFor sure, blessed and lucky.\n\nYou know, you sort of wake up and every day and you're like, how did I how did I get here? Yeah.\n\nBut the the the company has shifted over time and and has grown.\n\nYou know, one of the one of the things that I think made us a little stronger or a lot stronger, was COVID. You know, a lot of a lot of companies, you know, you can look back to two thousand nine, you know, financial downturn. You know, some of the best companies grew up through that point. We grew up through COVID, just try running a clinical trial and developing a product, you know, when states and countries are shut down.\n\nAnd that that really hardened our resolve.\n\nYou know, we we got through that, and then we started building a a company around around our, you know, series b funding. And, you know, it went from a a company of three to a company of twenty three in in a short time frame. And and, you know, we've we've grown as, as the demand has has required us to to grow, not not anymore.\n\nI love that point. Brian's prior company grew up during the the financial crisis. I joined our business in two thousand eight.\n\nWe acquired a business that fall, I believe, and then the financial crisis hit. I think our revenue dropped by half within a quarter or so.\n\nAnd it was it's the foundational, part of our business that helped us get to where we are today. And I think that's get that gets lost a lot with entrepreneurs, you know, trying to think about this linear path, you know, from series a, b, c, exit, you know, yacht. And, I think it's it's great to hear you say that.\n\nWell, how difficult was it to raise that first round for you? Because you I I suspect you had to do that.\n\nSo it was it was, it was Gurm and I that we're raising that fund. Luckily, we had prior experiences with BioStar.\n\nYou know, we could probably talk about exiting the university for for another podcast. But, so so we, you know, I don't know if you guys are familiar with with Louie Kennan out of BioStar, but he had an intro into the company or the concept early on in the Michigan days.\n\nAnd he had been tracking along with the company for a while.\n\nGurman and I exited the company in twenty nineteen. We spent a year continuing to develop develop the concept and the idea, and and then COVID hit. Luckily, we had been spending that year doing our due diligence around the company and around the technology, and and, you know, it was it wasn't you weren't going to raise money because of COVID. You were, you're you're just going down the normal path of of a fundraise.\n\nWhen you think about where you guys are now, you know, and and your path forward, what are the what are the critical things you need for success? I mean, is it all execution?\n\nA few few key things. So, right right now, we're very we just got our ID approved, so now we're very heavily focused on, getting ready to start our first US pivotal peripheral trial, so that's number one priority. But we're now at a point where we're starting to focus on, heavily on the other disease states, coronary, carotids, etcetera, so the the demand on our resources now is suddenly gonna suddenly gonna increase, because our our workload is increasing. So we gotta we gotta spend a lot of thoughtful time thinking about those things that are most critical and the things that are least critical because the list of opportunities is endless, the list of things that we could do.\n\nSo you know that's, we're kind of at that inflection point now because as I talked about earlier, three quarters of the system now we can leverage into other disease states.\n\nSo now we gotta support the trial, but also rapidly innovate around those other platforms as well. So that's that's kind of top of mind right now.\n\nWhat's the end game? Is it is it a strategy for an acquisition?\n\nIs it to really build a platform of products out?\n\nOr you're not sure yet?\n\nWe're building the enterprise that we can we can do it either way.\n\nYou know, I think the technology would take off much more rapidly if a strategic were to acquire the technology because it's literally a product in the bag, that they already have a call point, so it could really make a big dent in the market very, very quickly.\n\nFor us to do it on our on our own, I'm sure we could do that, but it would take it would be a longer journey because we'd have to build a sales team, etcetera, etcetera.\n\nAnything to add? Yeah.\n\nI mean, just a lot of credit to Sean here.\n\nWe we built this this company such that, you you can go either way, and and it's easy to go either way. Right? So you can, continue to, grow the the technology and and grow the, you know, all of the, additional, components required to build out that company. So, you know, the appropriate levels of documentation, all of the quality features that you you need to be able to scale up production.\n\nAnd and if it goes down the other route of of an acquisition, it's literally a weekend, you know, pull and pull and play at, at the new at the new assembly facility.\n\nAnd that is really evident to being on-site yesterday that you guys I think that's what's feels just very impressive is that you're building, infrastructure in a company that, you know, it's built to last. It's it's built you know, if if the if the right partnership came along, it it's built to be able to fit into that.\n\nBut you really feel that being on sale.\n\nWe've we've we've purposely tried to, and I'll give Robert a lot of credit for this because he's, he's been with it the longest, and, and part of it was what was probably the time he spent working in his basement during COVID, but we try not to invent something that's already there. We try to tap into resources that, if somebody has skills and knowledge on a particular component, we try to tap into that because you can't do everything on your own.\n\nBut we've also tried to minimize the level of customization around the product because when you start building in a lot of complexities and uniqueness around parts of the technology itself, it gets to be really expensive, very fast, gets to be very complicated to build, gets to be very complicated to scale up or even transfer to a different location. If you need to do that, it might require, unique talent skills that are hard to acquire. So we've tried to keep common sense at the table on every aspect of this because, and maybe some of this is back to my experience, you know, in the Bostons of the world.\n\nThere's lots of cool technologies that have been acquired in many different spaces, including the med tech space. Very often, those cool technologies take a long time to actually scale up in the market because they're just really difficult to make in scale.\n\nBut does you have to kind of build a company for the long haul now? I mean, given where MedTech's at?\n\nI mean, I I I I feel like we're starting to move almost and I don't mean to take quibble with your question, Matt, but I think we're starting to I just don't see many instances now where you you can just sort of build the product and sell it to sell the company to a strategic like, you have to build for the the long term.\n\nYeah. And, you know, I I think you're doing exactly right there. Change for sure. I think that's right.\n\nI think, no offense taken.\n\nI think the I think the, you know, the casual entrepreneur or someone coming from outside of industry would that might be a surprise to them. I think that's what you see in a company like JBS when you're there is that, you guys are doing it the right way. And, it's going to be really exciting to watch the success from here.\n\nJoshua Foer: Yeah. We're excited.\n\nSo just quick, quick, quick, weird questions here. What's the worst advice you ever got on this journey?\n\nIt's gonna take a million dollars and you're gonna get sold.\n\nWhat's the best advice you have?\n\nYou know, it's a little cliche with the entrepreneur space, but fail fast and fail forward.\n\nThat's that's actually a pretty good one.\n\nYou you can learn learn a lot, and the quicker you learn it, the faster you realize that your original idea was not great.\n\nYeah. That was a first time entrepreneur who's who's helped you understand the business.\n\nYeah. So so hats off to, Mark Tolan, who's our chairman of the board.\n\nHe's, he's really, you know, guided not only myself, but I think the whole team, through the entire journey from start to finish. So, again, beginning was a little more hands off, you know, more more technical, but, you know, always always there as a resource on on how to overcome certain difficulties that we had.\n\nAnd then now, you know, definitely more more hands on and guiding the company and really being that, you know, pillar of of direction.\n\nYeah. And I don't know if you got to it, but you're in Boston.\n\nYou could have probably put this company anywhere. You came out of Michigan. You're a New York guy. Why'd you come here?\n\nYeah. I mean, there's a plethora of talent and resources and opportunities here.\n\nIt's a it's a great great space to grow the company, great space to grow up.\n\nAnd, you know, there's there's within maybe the first month or two, we had some of the brightest minds in all of Massachusetts applying for AVS, which is which is how you grow a real company.\n\nYeah. That's great to hear. That's right. I mean, that's the secret sauce of our ecosystem, right, is that you can get the right talent because you need the right people in those positions. Otherwise, we're not going anywhere. Yeah.\n\nI mean, you know, how med tech is is concentrated in, you know, multiple small pockets across the globe, Boston being one of them, but, I mean, there's a very rich med tech, biotech, footprint in in the Boston area. So, you know, we're fortunate we're able to tap into that. As a start up, you gotta tap into everything, all your resources, to try and best set yourself up for success. So we've been we've been we've been fortunate in that regard. It's worked out pretty well for us.\n\nYeah. I loved talking to Greg yesterday in your r and d group. I asked him, you know, about his startup experience. I think he said this was number five or six all in Boston. You know, he said he was looking for the next one, but I think that's a, you know, that's a great example of the ecosystem as you find people like that who you can plug in and and are passionate about, you know, pre commercial med device company.\n\nFor sure.\n\nNot every day you have an employee that skateboards to work.\n\nThat too.\n\nAlright. Well, thank you guys so much. It, it was really great to see the facility yesterday. Great to meet you. This is an incredible story. I know Brian and I are gonna be eagerly watching your success and, wish you guys the best. Thank you for sharing your story with us.\n\nThanks for having us on. Yeah.\n\nThank you.\n\nThanks thanks for coming to Boston. Thanks for being a part of Mass Medic, and thanks for everything you're gonna do for patients. It's really cool, and I hope, I know you left Boston Scientific. Hopefully, you're building the next Boston Scientific. That'd be pretty cool.\n\nThat would be. Definitely. We need it.\n\nThanks, guys. Thank you."}
Design Build Launch | Knowledge Center | Boyd Biomedical
FeaturedEpisode 12: Dr. Robert Chisena & Sean Gilligan from Amplitude Vascular Systems
On this episode of Design Build Launch. Matthew Boyd and Brian Johnson are joined by Dr. Robert Chisena and Sean Gilligan from Amplitude Vascular Systems. They discuss AVS’ approach to intravascular lithotripsy, their PULSE IVL technology, and more.