Medsider: Learn from Medtech and Healthtech Founders and CEOs - Knowing When to Pivot Without Starting Over: Interview with ABK Biomedical CEO Michael Mangano

Episode Date: August 25, 2026

In this episode of Medsider Radio, we sat down with Michael Mangano, President and CEO of ABK Biomedical. ABK’s Eye90 is an investigational Y90 radioembolization device for treating unresectable liver cancer.Michael brings over 30 years of medical device experience, including 15 years at Boston Scientific in commercial and international leadership roles. He previously served as CEO of ReShape Medical and as President of the Americas for Sirtex Medical, scaling regional revenues from $34 million to over $130 million.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you’re ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Michael Mangano, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:09) - Michael's journey from Boston Scientific and Sirtex to leading ABK Biomedical (04:54) - Why Michael pivoted ABK from embolization to radioembolization as soon as he joined as CEO (09:24) - How ABK reimagined Y-90 around physician control and patient-specific dosing (21:08) - What a functioning player-coach culture looks like inside a startup (27:26) - Lessons learned from a complex 120-person pivotal trial and how ABK remained the face of the study while partnering with a CRO (37:13) - How ABK is building advantages competitors can't easily replicate (42:50) - Michael's framework for choosing the right investors

So that pivot started immediately product design, building of the team in the first six months. You know, I started putting the senior team together, some engineers together, and we set off on a new adventure to take the existing technology. And look, the first technology they were developing wasn't bad, but it certainly was a 510K. It was not approved and it needed some revision. So we ended up changing that technology and still developing our EasyView product in parallel path. But a lot of that was done to help out more with the I-90 development. Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world.

Now, here's your host, Scott Nelson. Hey everyone, in this episode of Medsider, we sat down with Michael Mangano, CEO of ABK Biomedical. ABK's I-90 is an investigational Y90 radio embolization device for treating unresectable liver cancer. Michael brings over 30 years of medical device experience, including 15 years at Boston Scientific and Commercial and International Leadership roles. He previously served as CEO of Reshaped Medical and as president of the America's Four Surtex Medical, scaling regional revenues from $34 million to over $130 million. Here are a few topics we explored in this conversation. First, how do you pivot to a new market without abandoning your core technology? Second, how do you differentiate in a category with

entrenched competitors? Third, which parts of a clinical trial should your company own versus a clinical research organization? And last, what does a player coach culture look like at a MedTech startup? Before we dive into the full episode, if you're a MedTech founder or CEO preparing to raise capital, you should check out the MedSiter fundraising cohort. This four-week Live Workshop combines small group sessions with real-time feedback to help you sharpen your investor story, build a targeted investor pipeline, and run a focused fundraising sprint instead of a never-ending slog. Over the month, you'll walk away with an investor-ready narrative and deck, outreach scripts that actually get responses, a refreshed LinkedIn profile, a simple content

plan that keeps you on investors' radar, and a repeatable system for running your raise. You can join the waitlist at medsider.com forward slash fundraising cohort. Again, that's medsider.com forward slash fundraising cohort. All right, let's get to the interview. All right. Mike, welcome to MedSider Radio. Appreciate you coming on. Thanks, Scott. Thanks for having me. Yeah, very much looking forward to the discussion. I know you've been in the space for quite some times. Not only interested in learning about the category, but really your time over the past, gosh, almost, you know, closer to a decade now, right, building ABK.

Yeah, with this company specifically, yeah, but entering, I think in September, it'll be year 32 for me in MedTech. Wow. Wow. I am certainly starting to feel old. I can tell you that. You and me both. You and me both. So with that said, I recorded a very short bio at the outset of this episode, but let's start there. Give us like the one one to two minute kind of elevator pitch on your background before taking on the CEO role at ABK. Yeah, sure. No, appreciate it. Cut my teeth in the industry with the big strategics. It started out with Boston Scientific. I hate to say it back in 1995 and spent my first 15 years of my career there in various jobs, multiple jobs, mostly on the commercial side of the business, but spent a bunch of years overseas in different markets. had the opportunity to come back and work in corporate, do M&A work. So really learned the basics of MedTech there. And product development was a big part of it back then in the late 90s. We really did a lot of core team development and really learned a lot about the business.

But left Boston in late 2009 and took over a small startup, publicly traded smartup and a startup in Australia called Surtex Medical and ran that business in North American and that eventually expanded to South America for about six and a half years. I had a fantastic experience there, and then was able to get my first CEO role at Reshape Medical, spent a couple years there and joined a couple boards at that time. And one of them happened to be this small company called ABK Biomedical. We were able to exit Reshape, talked to the founder and the chairman of the board, and they convinced me to join ABK as a full-time CEO. Very good. And that was back in, I believe, 2018, correct?

2018, that is correct. So we're recording this in mid-26. So, you know, closer to a decade. Eight years, August 1st, yeah. Okay. Hard to believe. Yeah, very good. I mean, time, I'm sure. Overnight success. Exactly, exactly.

With that said, I'm looking at the website right now. We'll link to it in the full write-up, but it's ABK Biomedical, just as it sounds, abk biomedical.com. For those that are new to the company, new to the kind of your, you know, I guess two key products, gives the sense for kind of the space that you're operating in and maybe friend this up as if I'm a senior in high school and I know, I don't know a ton about the device space. You know, simplify it for me. The company is a great story. It's your very typical, you get a physician and some PhDs together,

and they want to solve the problem. So in 2012, they actually entered a contest. They won the contest. They won a small grant and formed this company. And really, over the next four to five years, they did a lot of what I'll call great R&D work. And the idea at the time was, you know, interventional radiologists do procedures under X-ray, so they see what they're doing. But they do one procedure called embolization that was not visible. So the idea back then was to build an embolization product that was visible under X-ray. Again, great, great concept, great R&D. And when I joined the board, you know, the markets had shifted, I'd say, in that first five-year period. And so the markets they were going after really weren't, I'll say, as attractive as they

were probably five to 10 years prior to that. That being said, I thought the technology was really interesting and really good. And having come from CERTex and worked in the Itrium 90 space and radio embolization, you know, in discussions with the board, you know, we decided to kind of pivot the company at that point. The board asked me to take over and we decided to go much bigger and much larger and go after what we call this radio embolization market, of which there were only two people, two really two players in the marketplace. Having worked for one of them for six and a half years, we had a lot of ideas of how we thought we could innovate the technology and that we could incorporate the R&D that was done at ABK and incorporate that into a new product design and go

after what we thought was a much larger opportunity. I want to drill into I-90 specifically because I think that's sort of the flagship product now. Was that pivot almost immediately? So like when you joined back in 2018, was that within kind of a year timeframe, you begin to like really pour more? Yeah, no, it was absolutely immediate the first meeting flying to Halifaxon. of Scotia where we were based and spun out of Dalhousie University. We sat down with the team and said, this is exactly what we want to do. I actually raised our first funds with the help of the chairman

of the board at that time. We raised $7 million immediately in the first two weeks of the company. Okay. Based on the analysis that we wrote in the pivot of the company. And then that ended up folding into what was a series B at the time at 30 million. So that pivot started immediately, product design, building of the team in the first six months. You know, I started putting the senior team together, some engineers together, and we set off on a new adventure to take the existing technology. And look, the first technology they were developing wasn't bad, but it certainly was a 510K. It was not approved, and it needed some revision. So we ended up changing that technology and still developing our EasyView product and parallel path. But a lot of that was done to help out

more with the I-90 development, because I-90 is a radioactive product and testing that can be much more challenging. So we used the bland product, we'll call it, to actually test a lot of things out that we're going to go into the I-90 development. But yeah, that was immediate. And within my first, I think, seven months, we had raised our 30 million dollar series B with the leads being F-prime and Varian at the time prior to being bought by Siemens. We were off to the races. Got it. Got it. That makes sense. And then Y-90 specifically, I'm sure a lot of folks that are listening to this or reading the summary of this conversation are maybe loosely familiar with kind of Y90 and interventional oncology. But, you know, for those that aren't, right, give us

like a high-level overview of this technology. Itrium 90. So Y-90 is actually the radioactive isotope that is either with one product, it's coated on the microsphere or with our product, it's embedded into a glass matrix in the microsphere. But the concept is for patients with liver cancer, and that can be typically hepatocular carcinoma, but also metastatic disease. It's very hard to irradiate the liver from the outside. And radiation is a treatment. in most liver cancers. So what this technology does is it delivers millions of microsphere, so a high dose of radiation by threading a catheter into the liver itself and injecting these millions of microspheres. They flow to the tumor bed and they get embedded into the tumor

itself, of which they deliver a high dose of radiation over about a two-week period. With the concept being we can irradiate or kill these tumors, it's a minimally invasive procedure. It's an outpatient procedure. It's not chemotherapy. It's not immunotherapy, although in some cases, it can be used in combination. So it really is a way to deliver a high dose of radiation to tumors without damaging any normal tissue around them. Okay. And I-90 specifically, how is it different versus the other kind of entrenched incumbents in the space?

So the concept we had, I'll go back through a little bit of the concept we had around designing this. What's unique about these products is they are technically a radio pharmaceutical. So they are a brachy therapy. They're typically, but it's a procedure done in the hospital, so they fall under med tech. But yet some of the clinical programs are more like a pharmaceutical clinical program. So, and it is an oncology, which is a little different from med tech. So it makes it a unique technology. And what happened with the other two technologies, the one I worked at and the one Therosphere and both Surtex,

a lot of clinical work was done early on. And these clinical trials showed mixed results. Some were really positive. And some of the results themselves weren't as great. So the oncology community, even though the products gained adoption, there really wasn't a great specific fit for all of them. It was usually used in late states, disease, patients that, you know, were more towards the end of their life. And so the concept we had and the thing I always had when I was with Surtex is to ask physicians, why doesn't it work? When does it work and when does it

not work? You know, and I really never got a good answer. But the only concept we could come up with at ABK was that if you deliver enough radiation to the right place, tumors will die. And that was the simple theory we had, which was we need to find a way to get doctors to be able to deliver this product better and to deliver a more lethal dose and then confirm that they had done a good job. And really what it turns out is those trials were designed in a way more around pharmaceutical endpoints. And what we learned, Scott, was that the patients that didn't do well on this treatment, either one, didn't get enough radiation to the tumor to kill the tumor, or two, which is really interesting, we missed. So we actually tried to deliver and thought we were delivering

to the tumor, but we only got part of it or we didn't really hit it at all. So with that concept, we set off to design a product where we wanted to give the physicians, we took a med tech perspective rather than a pharmaceutical perspective. And we said, is there a way that we can give the doctor more control, so the ability to deliver the product better, and then can we build a system around it where we customize these doses per patient, rather than just saying one patient, the activity is misered in something called gigabacorel. Rather than giving every patient two gigabacorel, we said we want to have the doctors do advanced calculations based on tumor sizes, tumor vascularity, that we can then do patient-specific doses for those patients. And that's not only

in the activity that we deliver to the tumor, but also in how many of these particles we use to deliver it. So a theory is if a centimeter is a tumor is two centimeters or a tumor is eight centimeters, those are going to need two completely different call-up prescriptions. So we build around our calculations, and then we build what we call as a very advanced delivery system, Rather than delivering most pharmaceuticals are delivered either intravenously or these products are delivered under pressure. We said if we can give the doctor control the ability to deliver this to start, to stop, and do more of a linear or consistent delivery, which we proved on the bench, he or she has the

opportunity then to deliver a greater amount of particles to the tumor and potentially to get a better result. So really about hemodynamics and vascular flow. So can we do that, incorporate that into the process? product. Then can we make it patient-specific? And then on top of that, we said now, looking at the patient perspective, most patients that receive these technologies, they're injected, and then they tell the patient, okay, procedure's done, go home, come back in three months. We'll do a scan, and we'll tell you how we did. We'll tell you if the tumor had a complete response, a partial response, or what is

going on with your liver. And we kind of felt from a patient perspective, that's tough. If you have cancer and somebody tells you, well, I just gave you a treatment, but I'm not sure if it works for two to three months, that's really hard on patients. So we said, is there any way a doctor can tell at the time of the procedure or closely after if he or she did a good job or not? So with that, we added, based on the original technology that was developed at ABK, we added radio opacity to this microsphere. So now we're able to deliver the particles, and the doctor doesn't have to send a patient down to nuclear medicine, pet or spec scan, they can put a patient right on a CT scanner, and they can look at that tumor, and they can really have the ideas to eventually be able to

correspond that image to what we call a complete or partial response. But the doctor can then tell almost immediately if they did a good job. Did the particles go to where we wanted them to go? And then they can use that image. We've built software along with our partners at MIMS slash GE. We built software to allow the doctor then to take that, that, that, radio opaque picture of the tumor itself and use that to calculate how much activity that we delivered to that tumor and did we deliver a lethal dose. So now you know where it went. You know exactly how much you delivered. And you have the ability then to look at that patient really and say, we did a good job. And you're going to come back in two and three months, we're going to consider

that tumor's probably going to be dead. Okay. And what we learned here in our first in man, which we did down with Dr. Andrew Holden in New Zealand, and this is what we submitted to the FDA, to, gain our breakthrough designation is in one of the patients. We did exactly that. It was a very difficult case. We delivered the product. We put the patient on the CT. And guess what, Scott? We actually missed the tumor. We got a very little bit of it, but we missed it. So we were able to tell right away and bring that patient back a couple weeks later to retreat that patient, right? Rather than bringing them back and what happened historically is we brought that patient back in three months and the doctors would look and say, see, it didn't work. Sorry, we're going to put you on

chemotherapy or immunotherapy or something else or do another local regional therapy. So those were the kind of the concepts behind the design of the I-90 product. Okay. Yeah. So just in summary, you're customizing the treatment. You're allowing physicians to deliver it in a more visual kind of user-friendly fashion, it sounds like. And then being able to kind of almost real time, right, be able to kind of offer up imaging that allows the physician to tell whether or not, you know, the effective dose was, you know, or an effective dose, you know, was delivered, uh, delivered to the, to the tumor. Okay. That's a much better summary than my long, uh, no, no, no, I'm loosely familiar with the space. So, uh, so, so just trying to just try to understand at a at a high level, right? Like how I-90 is, is differentiated versus, uh,

the entrenched players. So as of mid-26, um, you know, for those listening to this, maybe three or six months down the road, maybe a year down the road, potentially, where's the company at right now? It sounds like you've done this first demand feasibility study. You got breakthrough designation, you mentioned. We got breakthrough designation. We then submitted an IDE to the USFDA, which was approved a few years back, and we actually just completed that trial. Okay. So our pivotal trial is done.

Wow. It has a one-year follow-up period, and we're about halfway through that one-year follow-up period. Okay. So we're six months away from last patient, last visit, and then we'll put together, we've done a modular submission with the agency. We've already submitted half of the PMA. We're submitting another part this year, and then the final module that will go in will be the clinical data.

Okay, okay. Wow. So that's some heavy, heavy clinical lifting over the past several years. It was a big trial. It was 120 patients in the U.S. and cancer trials with a lot of imaging and a lot of follow-up are, yes, very, very expensive. So I appreciate if my investors do listen to this. Thank you very much for the funding to be able to complete this. Yeah, for the continued support. We'll get into fundraising because I know you've got a lot of experience, kind of attracting a capital to a startup like this, but also choosing the right investors, and you've got an impressive, like a really, really impressive list of investors that have infused capital into ABK. And then I guess just to circle back around to Easy View, are you actively

commercializing Easy View now? Or kind of where does that, where does that sit? We've done some patients clinically in the U.S. to, again, to continue to learn because our microspheres are a different composition than the normal bland and bollocks are out there. So we've learned a lot about the delivery. We do have side projects going on, changing some things to our delivery devices. And we actually have, we've pivoted that to a whole suite of imbolic products that we are developing. So we've got an R&D pipeline. We really are an embolic platform company, even though the flagship is I-90. So there's a trend today towards resorbable.

So we make a resorbable microsphere. We make a porous microsphere that can be loaded with different things, including contrast. We have the bland microspheres and we have multiple delivery devices. So right now, we didn't want to be a commercial company. We really wanted to spend that money in those. resources more towards I-90 and the flagship product, but we do have those. So when we do go commercial with I-90, we then can have follow-on products to also launch with it and fill out the bag. Makes sense. And if time permitting, we may be circle back around that strategy. So with that said,

again, abkbiomedical.com is the website, just as it sounds. We'll link to it in the full write-up on Medsider. But Mike, maybe for the next 20, 30 minutes, we'll get into some cross-functional topics, probably won't get into the entire list of questions that we sent over in advance. But first kind of topic I wanted to discuss with you is really kind of your experience going from, you know, senior operator to CEO, especially, you know, kind of focusing in on on the past eight years or so at ABK. Take us back to 2018. You kind of touched on this a little bit, but what sort of led you to kind of go all in on

ABK? I mean, did you see some of these differentiated features that you just kind of went, you just explained? Did you see those back then? And what did you see, I guess, at the company that caused you to say, you know what, this is where I want to spend maybe the next 10, 15 years of my career? Yeah, I mean, some of it has evolved, obviously, in that way. But, yeah, we saw the opportunity, again, having worked in the space very closely,

you know, the frustrations that I knew, and I think a lot of us have done this in our career, right? We work for big strategics. We see opportunities, and those can't be funded or they're not funded or they're secondary products, and we have experiences. So that's where a lot of these technologies are born from. And this was a similar story. in that Surtex really did not see it as a med tech. They did not innovate. Same with the other product, which has since been bought and sold three times by different companies and now sits with Boston

Scientific, but there was very little innovation. There was some interesting clinical work done, but not innovation. And I always thought if we could innovate in this space. So really, that's what it came from. It came from wanting to innovate in this space and wanting to improve things. Again, I saw a product that I saw cure patients of cancer, but it didn't do it as often as it should. And it wasn't accepted as well by the oncology community. So it was more of an afterthought a lot of times. And I always felt that if we could establish the right product and figure out the mechanism of action, how it works more effectively, that it could become more of a standard of care.

And since then, the market has moved in that direction, fortunately. And the two competitors have done a lot of great work since then. And the clinical data that is now coming out, it is really incredible clinical data from both companies and hopefully soon from us. Yeah, it's trying to leverage. It sounds like you're trying to leverage some of those. some of those tailwinds in the space. Yeah, for sure. When you think about the past, you know, eight years now, you know, especially against the backdrop of like a lot of leadership

experience at strategics at kind of, you know, let's call CERTX, kind of a midcap, you scale that significantly, right? And now with a couple of startups, what are, what are like a couple, like really key things that you're really trying to instill or that you maybe have instilled at ABK over the past, you know, seven, eight years now to lead, to ladder up to some of the, you know, the successes that you're now experiencing. Yeah. And I think it's the part that I love. about it that I learned early in my career. Look, it's all about the people, Scott. I mean, it is, you know, I build a network of people over the last 32 years. I was just telling someone the other day, I think I rarely use a recruiter because our network is so big. It's either somebody I know

or somebody who somebody I know knows. And, you know, we looked, I build out my leadership team was the first thing I'd done. And I'd say almost all those people I had either worked with in the past or knew someone who had worked with them. And so to me, if you hire great people, and that's what you can do in a startup. You get control of all that part of it, right? We can talk about managing a board later in the conversation, but if you hire the best people and let them do their job, to me, and set a culture that is a, you know, as I came into ABK, it certainly was not a California-based MedTech startup, right? So you had to instill that culture into everybody. You know, everybody's an owner in the company now. You get, you know,

you get your options, you get your shares. And everybody pointed in the right. direction. So for me, hire great people, let them do their job and create that culture. You know, the background I love is something that's similar to probably both of ours. You've spent time at a strategic. You learned the ropes. You've gone off and you've gone to a smaller company or a startup and you've had success, right? Those two attributes to me blend perfectly for the startup world. Because as you know, being a CEO yourself, sometimes it's a blank piece of paper you put in front of people and you say, go, go build it. Right. So people have to be comfortable with. with that. And I tell everybody when I hire them, look, we're all player coaches. There are no

coaches here. Everybody is a player coach. We're all doing all the heavy lifting ourselves. If you set that culture, it is amazing when you bring really good people into a company and say, wait a minute, you're not going to bog me down with bureaucracy, right? We're going to set our goals. We're going to set our goals every year. Everybody knows where we're headed. communicate as often as you can, it is amazing what you can get a startup to do. Really, you know, half the time of what a strategic can do to finish off some of these products. Yeah, yeah.

The pace that Strategics never ceases to amaze me, right? When you can pull something off at a smaller, more nimble company, that player coach kind of framework or analogy, I think makes so much sense for a startup because it's so true. Even if you bring in someone to lead a certain function, right, it's a clinical function or reg function, they may not be managing a lot of internal folks, right, early on, especially as they beat out of their team. It may be a lot of consultants, right? Or a mix of consultants. And so they still need to have that sort of coach mentality, even if they're not necessarily overseeing, you know, a large group of people. So I think that makes a time of sense to think about

it all. We create our own slides. We book our own travel. We do all those things, right? And it starts with me. And so I have to be the example all the way down. And then my leadership team. And when that blends together, then the rest of the company sees that we're all in and we're doing it and everybody joins in. And as you know, I just love coming. I'll pop into a meeting and just I'm shocked at the things that they've done. I'm like so impressed, whether it's a quality meeting or an R&D meeting or a clinical meeting. Just such an impressive team and what they can accomplish. Yeah.

Sounds like you've built out the right group of people. If you can pop in and sort of, you know, I assume that they've kind of taken the reins. But with that said, it sounds like you're able to pull in. or at least tap on the shoulder, right, a fair number of people, you know, based on your 30 plus years in the space. How important, I guess, circling back around to like the profile that you look for, right, someone that has maybe spent a fair amount of time at strategics and sort of gotten a lot of experience under the belt there, but it's also spent, you know, some time at startups too, so they understand kind of how a startup functions. Do you think the latter is almost equally as important, right?

So they're not, you know, totally shocked going from, you know, large corporate environment to a, you know, a small startup. You know, thinking about that, I probably lean still towards having that experience at a strategic. We have taken some people straight out of a strategic. And, you know, those are the people who are usually frustrated with the bureaucracy and want to leave because they want to do more. And I know we've both been there. So we have done that. But, you know, ideally, if you've already been to a startup, but I don't have to worry about, you know, because you don't have time to micromanage people, right, at a startup. You just can't. Everybody is so busy doing their things. You've got to trust that people are going to go in the right direction and do their things, right? So, and accomplish the goals that we've set for

them. You know, ideally both, but, you know, we have pulled people straight out of strategics who have great backgrounds and, you know, they've thrived in this environment. Yeah, I couldn't agree with you more. Sometimes like, I know there's a balance there, right? I mean, ideal scenarios that they, you know, someone's got experience at both in both, in both sort of environments. But to your point earlier, typically if they're if they're at a strategic and probably a little bit more of a comfortable role and they're actively looking to join a startup that those are usually some signals there, right? That maybe should tell you, you know, this person is, is maybe ready to make the leap and understands a little bit more about it. As you know,

there's nowhere, there's nowhere to hide in a startup. No doubt, no doubt. 100% true. I want to talk to you a little bit about this IDE pivotal, right, that you complete enrollment on. It sounds like you're, you know, roughly, roughly halfway through kind of that one-year follow-up at the route. Route 90 is what you call it, right? Route 90. Yes. Yeah. So significant pivotal, were there any like, you know, surprising lessons learned or, or maybe things that you went into this and you're like, look, you know, based on previous experience, we're going to do X, Y, and Z, and that ended up being correct, like the correct, the correct calls? Like, what are the, some of the, the key things that you maybe offer up to other CEOs, right, that are barking on a big pivotal?

Hey, everyone, let's take a quick break to catch you up on Medsider courses. These eight-week courses are designed to help you learn winning formulas from world-class CEOs. Medsider courses cover topics like fundraising, device design and development, clinical and regulatory strategy, commercialization, and M&A. Each course covers the hard-earned lessons shared by the MedTech founders and CEOs who join our program. MedSider courses can be purchased individually or they're included at no additional cost with the MedSider All Access Pass. You can explore Medsider courses at Medsider.com forward slash courses. Again, that's medsider.com forward slash courses. Okay, let's get back to the conversation. Right, and I'll give you the example that I've hired a fantastic

team. I have never run a phase three ID pivotal trial in my career, right? I've never been responsible for it, but hired an incredible group of clinical people who then brought in the people that they knew who had worked with in the past. And from a regulatory standpoint, obviously, to regulatory quality clinical altogether, all extremely important in this process. But we had some learnings along the way. I'm sure you're probably the same. I haven't heard one CEO that said that trial went faster than I thought. That was always a challenge. You know, I was just talking with my head of clinical today. about how we feel now that the enrollment is done. It's almost like a deep breath.

But, you know, it was a stressful time. But, yeah, look, what we learned there, you know, it takes longer. There's more bureaucracy. And every single site that you go to is going to be different, right? You think you've got a secret sauce and we can just go in. We know how to negotiate the contract. We know how to get the trial. And this happened to be a really complex trial in that you have nuclear medicine,

radiation safety, you have the nuclear regulatory commission. you have licensing in every account. So the complexity of it was to another scale for us. And that just took longer than we thought. And look, one of the challenges is, you know, this is probably the best and the worst thing. One of our sites actually got up and running very quickly and started to enroll very quickly, which was fantastic, except it set the expectations that everybody should be doing that. And when other sites lagged behind, it became a little bit of a tense experience with the board

directors because all of a sudden now enrollments behind and why can they do it? What's the secret sauce? What are you guys doing wrong? And the other thing I'll say is, you know, we did have help from a CRO, of course, running these massive trials. I don't know if it's possible to do it without a CRO, but the one thing, once we did get up and going and we had those eight to 10 sites up and running and enrollment started consistently going, the face of this trial was us and our team. It was not the CRO. We just didn't hand it to a CRO and said, do it. You know, I say the CRO was more in the background.

They were doing extremely important work. But our clinical team was the face of this trial and our senior management team. I think we had somebody at all 120 cases that ABK represented, except maybe a few at the end when sites were doing 15 and 20 patients. So that really, to me, was the key is, you know, I'm a little bit of a control-free going to be to that point. having ABK be the face of the trial was extremely important. Like I said, all of our team, whether it are R&D engineers, our clinical representation, you know, people are our chief

business officer, manufacturing people went to trials, they went to sites. I mean, we were all there for all the cases and we wanted to make sure people knew that this was known as an APK trial. So that, I think, you know, being a little patient, knowing that it's going to take longer than you think, and knowing that the site initiation process was. probably just so much longer than we thought it would be and the bureaucracy because most of our sites were huge institutions that were transplant sites. So that obviously the bureaucracy and those institutions tend to be a little bit more, take a little longer. Yeah. And it sounds like you and I think similarly in terms of embarking on any sort of clinical trial, right? Maybe it's an EFS or a feasibility,

an IDE, you know, feasibility study or a large pivotal like the, like Route 90. The ideal scenario is you're building out the team, the structure in a way where your company is front and center, right, with those touch points, right? Because obviously it's important from a brand perspective. You have more control, typically more control in that capacity. But it also, I mean, I'm not sure if you agree with this, but it kind of, it feels very much like, almost like an early commercialization phase a little bit, right? Because you're actually, you're obviously that you're executing against something very different, but you're shipping product, right? Your attending cases. You're coaching, you know, positions. You're training. You're training on the delivery device. You're

training on the procedure itself. Yeah, I mean, my chief medical officer was involved in looking at images, early images from every single patient, I think we went through. Even though we had central reviews for things, we're still involved in that. And we were very fortunate that it was an unblinded trial. So that also really helped us, you know, in communicating with the customers and understanding what early results were. Sharing, you know, we, of course, you have advisory. You have, you have meetings, you have clinical meetings and, and kickoff meetings. We had, you know, we ran the full program, but it was a lot of heavy lifting for the team. It was, say, a very stressful two and a half years or so for the organization, especially that first year when it, when it took a while to get

things going. Oh, yeah, no doubt. But I mean, that is the ideal scenario, right? If your team is managing all of those sort of end user touch points, it pays off. I mean, even though it's maybe a little bit more expensive, ideally, it's not something that you hand off completely. I mean, the amount of travel crisscrossing this country for all of us was, you know, commendable. But again, when you have a team full of great people who are really invested. We devised a product from ground up in a vertically integrated company that we are trying to cure patients from cancer. I mean, everybody rallies around that. And like I said, we have, we had great clinical sites who really worked closely with us. So, you know, those things were. But yeah, there was a there was a heck of a lot effort by the

team for sure. Yeah, yeah, no doubt. The breakthrough designation, how important was that to ABK? Yeah, I think it's been very helpful. We'll see at the end when the, when the, when the PMA finally goes in and what it goes through, but, you know, we certainly have been able to communicate, you know, directly with the agency. So an example, we had a first generation delivery device we used for our first in man. We started the trial with that device for the first 10 patients or so. And then we were able to submit a next generation delivery device that was much more advanced and integrate that into the trial. So I'd say, you know, communications with the agency, although if my regulatory person's lessons to this, hopefully she agrees with me.

But communications, you're able to go back and forth much quicker. I think the communication level, obviously they prioritize communication to break through technology. So I think that has helped us significantly when we had questions about things with the agency and then wanted to submit changes and everything. They were certainly recognized that and helped us in those areas. Did you see any advantages in other aspects of the business? Right. So when it comes to site selection or getting maybe a site up to speed faster, did you see any benefits and having it? sort of that breakthrough designation for those? I really don't think so because I'm not even sure the sites truly understand what that actually

means. But to understand what it means, I think it's more been in the communication with the agency. And we'll see what, you know, what have been then the groups end up doing on the back end of those when they're approved for reimbursement and different things like that. I know there's been a lot of talk and a lot of work on that. I think it's more communication and communication with more senior people at the agency too when there might be a controversy or an issue. We've been able to go directly to them, and they've helped us to resolve that. Got it. So it sounds like that's where the majority of sort of the benefits, right, to the

breakthrough designation that you've seen anyway. Let's segue into the broader market opportunity, how you're thinking about kind of differentiation versus the other two incumbents in the space. Obviously, we went through kind of like a couple, like, what's called two to three, like key areas that truly are different, right, from a device perspective. But give us a sense for kind of how you're thinking about, you know, eventual commercialization. And, you know, because even though I think we all know that even with a better technology, right, that's, that sounds like fairly, you know, reasonably straightforward to explain to someone why they maybe should consider this versus something else. That still is, it's difficult, right? When you're going up against kind of, you know, some big, some big competitors. And so walk us through kind of how you think about that. Yeah, so it's good and it's bad, right? We have two entrenched competitors who've been doing this for 25 years, right? So that's, that's the challenge. But then the good is they haven't had anything new in 25 years, right? So we are the third. product to market, you know, but it's been the other two been around since, you know,

2000 roughly. So I think that alone, you know, for us is an opportunity. Having done this and build out surretax, and that truly was early on at least was so much heavy lightning because it's market development, right? The market doesn't exist and you're trying to create a market. Fortunately, between us and now what's Boston Scientific's Theresterphere, there is an existing market and it's a pretty good market and it's a pretty good size and it's growing. And the clinical data that they're producing now and what we will hopefully produce continues to drive adoption in this area and continues to open up the opportunity to treat more and more patients. So with that, we hope to build our commercial team. We have another round of fundraising coming up of which we're going to look to

to build out a commercial organization for this. So I am super excited about that because I've done it in the past. I happen to know the space very well. I think I know particularly a lot of the positions and and main treating positions in this area. And so to a lot of people that I've worked with in the past. So they know we're coming, but it certainly will be a challenge, I'm sure, but we hope they at least give us the opportunity to try it and tell me, tell me if you like it or don't like it. Assuming that the clinical data is, you know, where we think it'll be and where the competitors are, let's look at, let's look at all the other options, right? Are we, you know, the visualization of it, the ease of use, the customization of it, all those different things, you know, we're,

really looking at trying to make it easier for the physicians, right? That to me is a key to continue the adoption to this technology. It's great if you're at a big cancer center and you've got everything all buttoned up, but you're treating patients out in the community. Is it more difficult to do with other technologies? So we've tried, we're trying very hard, whether it's building an ordering system, how we deliver the products, you know, how we train all those different things. We're certainly going to try and simplify things for the physicians to make it easier for the product to be used. You've mentioned the vertical sort of integration right at ABK. How important is that to the company moving forward?

Yeah, I'm hoping that the bet that we made is the right bet. So far, it seems to be what the challenge is with these technologies is they're radio pharmaceuticals. Doing development work, from a med tech perspective, you and I both know you launch a product in med tech, it's never perfect, right? There's always going to be tweaks you want to make to it. There's always a next generation. There's always new sizes you want to do, right? There's always iterations to that. When it's a radiopharmaceutical, that's hard to innovate.

And it's hard to do that. It's hard to do all the testing, by the way, that is required by the FDA now. If we want to tweak our product, right, that's a huge challenge. And we've tried to approach it in a way that, you know, we have control over everything. So other than irradiating our microspheres, which we have a long-term partnership to do that with Missouri University Research Reactor, we build our own delivery devices, we build our own microspheres, we do all our dispensing, shipping, packaging of the product ourselves, whereas our competition does a mix of some of that and they don't do some. So what that leads to is we

intimately understand the product. We understand the microsphere development. We understand the delivery devices. And as I told you earlier, we've already introduced a second generation delivery device. We have a third generation delivery device that wants PMA approval, will submit that also. So we're already continuing to innovate. We're looking at different microsphere configurations. We've got so much in the pipeline. So there's such an opportunity to me when you're vertically integrated and you control things in this type of environment, you can control R&D a lot better and manufacturing. And so the way we've and the way we've built the product. Our competitors have to worry about the product decay. We do not. We make custom doses per patient that we can deliver out

per patient because we build our manufacturing right next to the nuclear reactor, right? So a lot of little things that we tried to build into the company itself that we thought could give us advantages, not only when we launch, but in the future. So we have that core competency internally. It sounds like that was a pretty significant bet early on. Is that something that you saw, even during your days at CERTX that you thought if we, you know, if we were a little bit more vertically integrated, we could, you know, move faster, make changes quicker, etc. Yeah, for sure. And I think it's a culture too, right? It's a culture of wanting to do that. Surtex, they did have control over a lot of things, but there wasn't a med tech culture to innovate. And for us, that's sort of been the theme of what we

tried to do. We've tried to build so many advantages into our product, but then the ability to change if we need to and pivot, we have that competency and we could do that. So we've already shown some, some of our physician base, our next generation delivery device, and it's created a tremendous amount of excitement. So there's things we can do with our product. We feel because of the way, we designed it that our competition might not be able to do or it might take them a lot longer. I want to leave a little bit of time to talk about fundraising because you've, you know, you've raised significant capital for ABK, but you've got a lot of experience, you know, raising capital in general. Before we get there, you know, circling back around to kind of this

concept of, I don't want to say ABK is a fast follower, but to a certain extent, right, there's this developed market, right? Whereas, you know, compare that to your time at SERTEC, scaling a new market and the market development that activities and initiatives that you had to pour into that company just to sort of create this category, so to speak. When you're advising other startups, right, that come with that. Do you generally like kind of of the spot that you're in now, right? Where like, hey, there's a developed market here and we can just, we can be better. We can just develop better technology to serve, to serve that market versus the former, which is like, hey, like, there's something interesting here, but we've got to build

the whole thing for almost, almost from scratch. Yeah, I mean, there's advantages to both, right? And that's a whole different set of fundraising issues, as you know, also. You're going to create something market development is a lot of heavy lifting, right? And it's very difficult to do. you're in a similar situation, I think, right now and that a market was created by another company, and then you're going to come in and try and share take. So look, everybody always wants to talk about the Tam and how big is the addressable market. And it's great now that we've got one and we've got one globally that's approaching a billion. It wasn't there when we started eight years ago. I can tell you that. Right. So it's grown significantly and especially overseas. It's grown

tremendously. So yeah, having an existing market is great. I'd love to be a fast follow into there, especially at a space like this where there's huge barriers to entry. And you know, you deal with it, right? Whether it's IP barriers, technology barriers. For us, it's building a radio pharmaceutical, right? There's only so many reactors in the world. There's only so many ways to do this. So that's a huge barrier. And frankly, the agency now is much different than it was 15, 20 years ago. So that is another tremendous barrier to entry. you know, and rightfully so, they put us through the ringer on this, right? They made us do all the basic testing that wasn't required 20 years ago for some of these technologies. And again, in a

radiopharmaceutical that does not fit perfectly into all FDA regulations, you know, there was a lot of negotiation there on what testing we needed and what we had to do and not do. So, but back to your original question, I think, I think investors really love a huge total addressable market and a technology that's going to go in and take share. That being said, if you have something, that's going to create a whole new space, just be prepared that it's going to take a while. I just talked to another company that raised funds that's doing that in a similar adjacent space. And they're grinding it out.

It just takes a while. Even if the data is great, the technology is great, you still got to go gain adoption. Yeah. Almost feels like a bit of like a two-sided marketplace, right, where you're having to build the technology, but also have to build the market as well. So with that said, let's get the fundraising, right? Because like I said earlier, you've got a really, really impressive list of investors on the cap table, F prime, Sante.

even the most recently, I think your series D was led by J.P. Morgan. Yeah. So it's a really impressive list of investors. So talk to us a little bit about maybe how your approach to fundraising either has changed or evolved or maybe talk. And feel free to frame this up as if I'm a new CEO, right, about to raise my first, you know, institutional round of capital. You know, what are the top things that I should, I should kind of, you know, consider heading into this. Yeah, it's, you know, look, I got a little lucky because I had some connections in the space, I think, early on. But, you know, understand the pro.

the profile of your investor first, right? So F prime led our series B with a strategic at the time with variant. And I got term sheets from both of them and we were able to put the two together and raise this round and fill it out, which was which was fantastic. And F prime has been an incredible partner in that they are in it for the long term, right? They said, Mike, we're ready to go. We've got a big fund, plenty of money, right? We love the concept, love what you're doing. That really started us out. And what I'll say is, you know, your investor base, they know everybody and they network, right? So if you're a good investment and they're happy with the way the company is going, right, they will introduce you to all their friends and other other VCs and forms of capital

to continue the company. So that really is, was big for us as bringing an F prime to start. And then, you know, raising the series C, we have an undisclosed strategic on there also that people can probably figure out. So we brought in a second strategic as well as Sante, right? And Sante is a well-known name with a great reputation. Tend, tend to be slightly smaller funds than some of the some of the other investors that we have. But the networking has just been, you know, incredible through them also. So really that's, to me, that's what's really helped me is, you know, and you know, as a fellow CDU has got, you never stop fundraising, right? I mean, there are, you're just on calls every week with different, at least I am with different venture firms, updates, what's going on, what are you

thinking? What's the next round? Look, we've been knock on wood, very fortunate. We've had, you know, multiple, a lot of interest, a lot of turn down term sheets and been able to choose, really choose our investors and choose wisely. And the thing I think we were talking about a little bit before the call started, right? Your board of directors and your investors are one of the most important things for a CEO. They can easily help you or they can easily derail a company. And especially if they're all at different phases and someone's at the end of the fund and has no crossover and someone's got a bigger fund. And so having your investor base aligned and supportive of what you're doing and then being very particular about who you add to that investor base, I think is extremely important for any CEO out there. Oh, yeah.

I mean, I couldn't agree with you more. Obviously, it's a topic that's like I'm highly sensitive to, highly sensitive to at this point with Fastwave. But yeah, I mean, it's just like it's something that where I think my thinking has evolved pretty dramatically, right? Where in the earliest stages of a startup, you're pretty desperate typically. You're desperate. Yeah, for capital. And I would make the argument now, which is where I've kind of, you know, changed my thinking over the years is that if you did capital from the wrong party early on, right, that may feel okay, right? Hey, just get to the next phase, you know, work with that capital and just get to the next inflection point.

I think that's fair. That's fair to take that position. However, if you take capital for the wrong party, you could eventually end up wasting three, four, five years of your career only for, you know, those parties to effectively derail what you've, you know, what you've worked on. And so just people are listening to this, right? But I'm not like my head in agreement hearing your advice because it's so, so true. And I just, you know, for anyone that's in this in this boat, take, you know, think twice, right? It's kind of like. And the right. And the right terms, too. The other thing is understanding the terms, right? There's valuations. There's option polls. There's preferences. And understanding all. that. And I know as a first-time CEO, I didn't understand it as well as I probably should have and maybe would have rethought some of the things I did. But I spent the time learning it and understanding it and then, you know, negotiating that part of it is really important. So, yeah, I agree with you. You know, be very careful because it can set you back. Yeah, 100%. And to your point earlier about the right investors attracting sort of the right capital, right,

for future fundraise, that's that's so important because sometimes the, the terms may not on paper, you may have gotten maybe even a better term sheet on paper, right, from a different investor. But the one that maybe offered slightly less favorable economic terms, but has a really great reputation, a clear track record, could attract, you know, the right, the right, the right syndicate. They may pee off in spades, right, in those future rounds of capital. So, you know, we talk about this a lot in the program, right, that dilution is, is, does not mean, you know, you don't die by dilution. It's, it's really true, you know. It is. I agree. And as a CEO, know, if you end up in the wrong situation, as you know, you can spend all your time. Like, for me,

I like to spend my time running the company. And then fundraising is the necessary evil that comes along with it, right? It's your job. You got to do it. You know, they remind me all the time. It's part of your job, Mike. And I'm like, I understand that, but I'd rather be an operator and run the company. But, you know, the wrong board can really distract you away from that. And if you're spending all your time managing individual board members and their expectations and they're managing their partners and their LPs, right? And that just can weigh on you and you're going to be distracted from actually running the company, which is what you're hired to do. Yeah, 100%. I know we've only got a few minutes left. I want to leave time for the rapid fire

portion of this interview. But again, abkbiomedical.com is the website. We'll link to it the full write-up on Medsider. We'll also link to Mike's LinkedIn profile as well as you can check out his background a little bit more detail. But with that said, rapid fire portion of the interview, three hot questions. You can expound a little bit if you want. But take us out to mid, mid-20207, what's the most exciting milestone ahead for ABK? Yeah, I think filing that last module over PMA, right? Last patient, last visit is going to be a big milestone, but filing that last module, that's a big one because you're on your way to commercial,

assuming there's no issues. Yeah, I've got to feel good at this, at this stage, right? It's such a monster left getting through a pivotal trial like this. But what's one lesson every MedTech entrepreneur should understand? What's kind of the billboard message that you want to share? with other CEOs, other founders? I think I read an article that said the same exact thing the other day. It's all about the team. It is all about the team. You put the right team in place. You're going to be in great shape, you know, and the experience that we talked a lot about on the beginning of the call. To me,

that's the most important. As a CEO, you put the team in place, create the culture and let the team go do their jobs, what you hired them for. All right. Last question, you know, take us back to maybe your mid to late 20s. Your career started to take off. Any professional advice you'd whisper in the the years of the younger version of yourself. Yeah, that's probably a tough one. Look, we took a lot of risk, moved around it, a lot of, did a lot of different jobs. I'd say maybe be a little bit more patient in my life. You know, I tend to not be the most patient person.

My wife tells me that all the time. But I've mellowed a little bit as I've gotten older. You know, managing up was never a strength for me. I always wanted to get on to the next thing. And hence I ended up in the startup world, right? So, but yeah, now it's just been an incredible run. I've been extremely lucky of what I've. done so far and created some great friends and networks out there and love the industry we work in.

Yeah, a healthy bit of impatience mixed with maybe a healthy bit of patience, right? Yeah, when you're younger, it's a little different, but now that I'm a little, or hopefully I'm a little bit better. Oh, yeah, yeah. It's definitely one of the pieces of advice that I'd give my younger self as well, or I tell my yourself, too. So, Mike, thanks a ton for covering out some time to tell us a little bit more about your, your background, but also, you know, kind of the journey building ABK, you guys, be fun to watch kind of the next

the next year, a couple years ahead for you and your team. Greatly appreciate it. Thanks again for the conversation and best of luck to you with your adventures also. Yeah, I appreciate it. And I'll have you a hold on the line. But for everyone listening, you made it this far. Appreciate your attention as always until the next episode of MedSider goes live. Everyone, take care. Hey, it's Scott again. One quick thing before you go. You see, I love bringing you insightful conversations with the best founders and CEOs of medical device and health technology startups. But here's the thing. I'd be super grateful if you could help me reach even more ambitious doers who share our passion. So if you found value in this

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