Medsider: Learn from Medtech and Healthtech Founders and CEOs - Defying Boundaries in Medtech: Interview with Pixium Vision CEO Lloyd Diamond

Episode Date: July 25, 2023

In this episode of Medsider Radio, we sat down with Lloyd Diamond, CEO of Pixium Vision a company that is developing a groundbreaking retinal implant system for patients suffering from advanced dry age-related macular degeneration (dry AMD).Lloyd has a rich history of guiding medtech and biotech companies. His career spans decades, continents, and sectors, and he has been actively involved in both European and American markets. His experiences with large strategic firms and promising startups have equipped him with a unique entrepreneurial viewpoint. In this interview, Lloyd shares practical lessons on building a lean and adaptable team, navigating the intricacies of regulatory processes, and succeeding at strategic fundraising. His insights, drawn from hands-on experience, provide actionable advice for startups making their way in the challenging medtech landscape.Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's a link to the full interview with Lloyd if you prefer reading.

You can never underestimate the importance of really having conviction in your mission. Because people are going to tell you no all day long. That conviction that keeps you focused on the goals, gives you the strength to pull through when things are tough. And there are going to be many valleys. Unfortunately, probably in a startup world, more valleys than peace. So you've got to really believe in your mission. And you've got to get people, investors, employees, doctors, payers, you've got to get them to believe in it too. 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, it's Scott. In this episode of MedSider, I sat down with Lloyd Diamond, CEO of Pixium Vision. Lloyd's tenure in both European and American markets, as well as his experience. experiences with large strategics and promising startups have equipped him with a unique entrepreneurial viewpoint. His current company, Pixium, is developing a groundbreaking retinal implant system that brings hope to patients suffering from advanced, dry-aged macular degeneration.

Here for you the key insights that Lloyd shared in our conversation. First, in the unpredictable world of startups, an agile and lean team that can wear multiple hats is a priceless asset. Tapping into academic ecosystems is one way for cost-effective R&D and talent discovery. Second, to survive the stressful process of earning regulatory approval, acknowledge its complexity, anticipate delays, and consider the reimbursement landscape early on. Third, fundraising is more than just securing capital. It's about cultivating relationships with investors that align with your vision.

Treat capital raising as unique opportunity rather than a tedious necessity. Before we jump into this episode, I wanted to let you know that we just released the latest edition of Medsider Mentors, Volume 3, which summarizes the key learnings from the most popular Medsider interviews over the last several months with folks like Jim Persley, CEO of Hinge Health, Carol Burns, CEO of Cajun Vascular, and other leaders of some of the hottest startups of the space. Look, it's tough to listen or read every MedSider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors.

It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. If you're interested in learning more, head over to medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes. If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors,

you'll get full access to the entire library of interviews dating back to 2010. This includes conversations with experts like Nadine Yared, CEO of CVRX, Renee Ryan, CEO of Cala Health, and so many others. Learn more. by visiting MedsiderRadio.com forward slash mentors.

All right, Mr. Lloyd Diamond, welcome to Medsider Radio. Appreciate you coming on. Thanks, Scott. Thanks for having me. Yeah, yeah, really looking forward to the conversation. We had a little fun chat before hitting the record button. So this should be an engaging discussion to say the lead. So with that said, I recorded kind of a very brief bio on your background at the outset of this episode. Let's start there without, I guess, getting too far into the weeds, you know, going line by line,

I guess, you know, with all of your experiences, provide maybe, you know, a few minute kind of overview of your career leading up to your CEO role at Pixium. Sure. So, you know, when I graduated from grad school, it seems like a century ago, you probably hear that all the time. It wouldn't know my lack of gray air, but nonetheless, I moved out to Europe, actually. This was back in the early 90s when the European Union was just kind of starting to really form and come together. And I did some consulting work for non-European life science companies that were interested in in kind of penetrating the new European Union markets. So I kind of started there and I got to meet some really cool technology companies, some large life science companies as well.

And then, you know, over time I migrated back to the U.S. where I started working in for large med tech, biotech companies. I started my career early on with Bristol-Myers Squibb, and then I worked for Zimmer, the large ortho company, and then ConMed, Linvetech, and then eventually I migrated out west to Silicon Valley, where I got kind of my first taste of the real startup world, right? People, you know, coming from conservative East Coast and European kind of life science, heading out to the West Coast where people went to work in like Burkine Stocks and shorts, and they had purple air, and I'm not exaggerating, but... Quite the culture shock for this boy from New York.

And so, you know, I then started getting involved with really cool companies like Kaifan and Laserscope. And these were companies that were really disrupting the MedTech space with different types of technologies and got to commercialize those technologies and that eventually sell the companies to much larger consolidators like Medtronic and American medical systems, which eventually was acquired from Boston Scientific. So did that for a while. and then came back to Europe and worked for a pre-commercial startup that we took public on the Swedish Stock Exchange in the orthopedic space, and then eventually kind of made my way to Pixia, where I've been now the CEOs since 2019, totally different companies set up.

You know, we're a publicly listed company on the French Stock Exchange, so that's kind of been an interesting ride. But the technology itself is just awesome. Like it's worth every minute of banging your head against, the world trying to manage a small microcap publicly traded company in Europe. That's great. So tons of experiences along the way. I think that's a super helpful overview and I'm sure we'll get into some of these, you know, this journey a little bit more detail. But let's learn a little bit more about Pixium first, right? So you guys are working on some

pretty groundbreaking technology. Give us a kind of an overview of what you're doing and what you're building and maybe tell us a little bit about the origin story and you sort of have this technology came to be. Sure. So when you think about Pixium, I want you to kind of think about MedTech meets DeepTech, and I'll explain kind of why that is and what it is that we do. But basically, we have this retinal implant. It's like a solar panel that we surgically insert in the retinal space for patients that have lost vision due to advanced dry age-related macular degeneration, so dry AMD, not the wet form, but the dry form. And the reason I kind of say it's MedTech meets deep tech is because the implant itself is a neurostimulative device. So if you think about deep brain

stimulation, pain management, or Parkinson's, we apply a similar concept to the eye, right? And so, but the implant's only part of the story. So the implant needs a whole system for it to work. So the deep tech aspect of this is once we do the surgical implantation of this really small microchip, I mean, it's 2 millimeters by 2 millimeters. It's thinner than a human hair. Once we kind of insert it in the retina, we need to now make it work. So the way that we make it work is we have our patients where these intelligent or smart glasses, similar to like Google Glass, but our own.

And we use augmented reality to sort of create the visual experience for the patient. So we put these glasses on them. A camera on the glasses will capture the image. It will simplify the image and send it to this processor, pocket computer, that the patient has on them. The pocket computer will simplify that image and then convert it into light and it will then project

through the pupil onto the implant in the retina the image that we've created for the patient. And then so once the implant kind of captures that image, it will then convert the image into an electrical signal which is sent to the visual cortex of the brain where the patient will perceive the image that we've created for them. Wow.

So it's got it's it's I mean I know right it's people say oh it's like Star Trek or science fiction yes except it's here it's not I mean it's a reality right we've already implanted 50 patients between US and Europe we have published clinical data you know so so I mean it's not science fiction this is working yeah other point that I would mention um the listeners might find interesting is you asked about the origins right so so so the origins really um so um so so started back in 2011, but this is really kind of a collaboration between Stanford University and the Vision Institute in France. So it's really a multinational trans-border collaboration, right? But in 2011, the company was started out of the Vision Institute by Josie Allen Searle. And Jose Selle is a very well-known ophthalmologist. He's currently the chief of ophthalmology at University Pittsburgh Medical Center. But he also has academic appointments in France. He's French, originally. And he and a co-founder, a serial entrepreneur by the name of Bernalzschev, back in 2011, started Pixium. And the mission was to find a technology solution for blindness,

right? There's been a lot done in the drug space. There's been a lot of work done in gene therapies and optogenetics and all that. But in device solutions for vision restoration, there really There wasn't a lot done back then, and there still isn't a lot done now. They started the company, and then in 2014, the company went public on the French Stock Exchange. And just before that, they entered into an agreement with Stanford by where they in-licensed and acquired the retinal implant technology from Stanford. And so today, Apixium has the worldwide rights for the current generation and all future generations of the prima implant. Yeah, so really cool tech. Oh, amazing. Amazing. This is like one of the

things where it's like I, you know, sometimes you know, MedTech can be super complicated, right? And it's slow and, you know, the regulatory landscape can be difficult to navigate, etc. But like hearing like stories of technologies that are being developed, right, like Pixium, it just reminds you of like this is, this is why I stay in MedTech, right? I mean, this is like really, really cool stuff. It's not like you're developing some new, you know, cool gadget that, you know, helps, you know, someone look better. It's a fashion statement or whatever. I mean, this is like real stuff that is like really life-changing. So that's awesome.

And I'm looking at the website now, but for everyone listening, I highly, highly encourage you to check out Pixiam's site and learn a little bit more about this tech. It's really, really cool. It's Pixium-I-U-M-Hifon or dash vision.com. So Pixium-HifonVision.com. That's the site. And you can go learn a little bit more. super complex and pretty amazing, right? I mean, this implant, as you said, is like, you said it's two millimeters by two millimeters?

I mean, that's incredible. And the tech is like most of the R&D work done in France than I presume, correct? Yeah, so all the deep tech stuff. So the stuff outside the body, glasses, camera, algorithms, artificial intends, all the stuff that drives the system we develop in France. And then we still have a very close development collaboration with Stanford. So all of the research work is done at Stanford. on the implant, the preclinical work, and then we take it, we manage through all of the patent

processes, and then all the animal testing if needed, and then clinical trials, and then into commercial launched. Got it, got it. Okay, cool, cool. I want to leave enough time to kind of go back and get your thoughts on some different functional aspects of the world of MedTech startups, because you've got a ton of experiences. But before we do that, give us a kind of a high-level overview of kind of where the company's at in terms of its life cycle. You mentioned, I think you're in 50 patients by now, but you know, you can kind of wrap or give us an additional context to kind of where you guys are at now. Then be held. Sure. So our real clinical story in human clinical story started back in 2018. We have three ongoing trials right now. So we have one, which was our first

trial in Europe, which we're now coming up on five years post-implantation of those patients. That's what I mentioned earlier, sort of the publications. So we have five publications around various aspects of the outcomes associated with those patients around safety and efficacy and all of that. One cool, I will say, though, one cool fact, and this is the subject of one of the publications, which was the first ever, is, you know, we deal with older patients, right? So the average age of implantation might be around 72 years of age. And so one question that a lot of the clinicians and neurobiologists that experts had was, you know, in an older patient, would they be able to combine sort of the prosthetic vision, right? Because they lose their sensual vision in dry

AMV. That's the vision we restore. But they maintain peripheral vision. So most of these people can, like, walk around. They just can't see what's in front of them. They can't read. They can't see facial expression. So the question was, can they combine both? Can you create like a prosthetic vision and their sensual vision? And then have them combine it. with their peripheral vision. And we've demonstrated we can. Like that was the first ever, like the first ever of this kind. So, so I just kind of mentioned that as an aside. That's another cool aspect of the tech. But yeah, so that's one trial that's ongoing. And now, like I said, we're coming 60 months post-implantation of those patients. Then we have a feasibility study in the

U.S. that's ongoing as well. We've implanted patients all in Pittsburgh. And so we're following up with those patients. And then probably the bigger news is that we are now in the observational phase of our pubital study in Europe. So we call it the prima vera study. We have a lot of Italians working for us in France. So they named it the prima vera clinical trial. And that study is 38 patients and we've implanted all of them. And now we're just waiting for the data. So we're a late stage, late clinical stage company, I'd say. In Europe, we will not do any further trials. This will be our definitive trial for C-Mark approval. And then in the U.S., in addition to this early study, we have received breakthrough device designation from the FDA. And so now we're going to

accelerate to our final trial in Europe, excuse me just for it. I mean, in the U.S. Yeah, so a breakthrough device designation is, that was great that the company got that. And so now we're in diligence, you know, with the FDA to come to a conclusion on the final, final pivotal work we'll do in the U.S. Okay, cool, cool. So kind of on the, on the early stages of really, really seeing this, you know, technology sort of come to light in a form of pivotal trials and eventual, eventual commercialization. Yeah, that's great. That's great. That's awesome. If it's okay with you, and again, we'll link to the website, Pixie, fission.com in the full article write-up on MedSider. We'll also link to Lloyd's LinkedIn profile as

well. But let's use maybe the next 20 minutes or so to kind of, you know, go back in time and learn a little bit more about your experiences because you've got kind of both a deep and broad level of domain expertise across, you know, a lot of different MedTech startups. And so starting maybe, let's maybe start with like the earliest stages of a company, right, which can be extremely challenging. You're oftentimes trying to iterate quickly on alpha and beta prototypes, but you don't have a lot of capital. So, you know, when you think about that stage of a company, and I know you saw on the boards of a lot of startups as well, what's your typical advice, right, for other entrepreneurs that are in that stage, you know, trying to do a lot with, you know,

a little. Yeah. So I'm going to tell you, I'm going to say probably two things stand out, Scott. First is you got to remain lean. And I know that sounds. kind of cliche. I mean, everybody says do more with less. But when you're a startup early, early stage, you just got to remain lean, but it's demanding. So you need people that kind of can wear several hats. So what I found is useful is you got to find those talented people. There are a lot of smart people out there that are multidisciplinary that can do, you know, that understand the science but are able to communicate it in a distinct way. They're not afraid to clean the kitchen up. know, when you're having coffee. I mean, like, that's the kind of thing. I mean, that to keep it real,

that that's really the kind of type of people that you need, that roll their sleeves up. And, you know, what I find, and not to diverge much, but that's probably the one most important piece of advice. But what I find is the kind of younger generation now, I don't know where we are, Gen Z or Gen, whatever, Mal. I don't even know what we all. That's kind of harder. It's harder to find those people. You know, there's this, I want the instant gratification and I kind of want to do things the way I want to do it. And I don't want to do things I don't want to have to do. That's hard in a startup. You need people that are just multidisciplinary.

So that's the first thing. And in addition, the resource has to go far. So, you know, stay close to your universities. That's extra resource you can leverage. And that's a, that's good value for time investment, right? Universities have people. They're always looking to do research. you put PhDs to work, use the university setting to really hone and prove scientifically

what it is, you know, the tech that you're trying to bring forward. So I think that's the first piece of advice. Second piece of advice is find the one or two investors early on, friends, family, seed, I don't care what you call it, a group of investors, angels that really believe in your mission and whom you can count on when things get tough. And I don't even mean financially only. But some of these people are really smart. They have a lot of experience and investing in a lot of different

early stage companies and they have a lot of collective wisdom. Find the one or two and lean on them when times get tough. That's good advice. Your last comment, it reminds me of, I mean, it certainly resonates with me, right? I've got a couple people that sort of, the scars are very

real, right? And so whenever I call, whenever I call them, like, there's always, hey, this is real. This is normal, right, for, you know, what you're going through, right? Don't, you know, this is not an anomaly. These are real challenges. Everyone deals with them. You know what I mean? So it's, it's super, super helpful to have, to your point, to have, you know, those early stage investors or partners or people that you can call on it that truly, that truly get it, right? Vastly different than an angel investor that's just in it from a financial standpoint.

That could be tough. That could be tough. And, you know, I'm not sure if that, yeah, it sounds like that, that you've been there, done that. It's just, you know, working with with folks that they're only looking at it from a financial or an economics, economic framework. It's just, it can be, can create its own challenges, you know, when you've already got enough to deal with. But your other comment about just being close to, you know, surrounding yourselves just sort of generalists, right, in that early stage that could wear so many different hats. And then being close to kind of, you know, universities, right, and network of people. And that, sometimes that doesn't have to be physically located, right? It's just keeping in close contact with,

right, you know, academics, et cetera, that are in the space. Because I, I, I, I don't know. This has happened, you know, over and over again with me, is that just by keeping in touch, you know, I'll get a random email from, you know, a PhD at an academic center. It's like, hey, we just got some grant money, you know, just if you're working out of any projects or whatever, we'd love to get maybe corporate advice or whatever. And so that sort of, it feels serendipitous, but that's just sort of kind of the nature of being, you know, continuing to have, you know, being close communication with, you know, some of those, some of those centers. So, yeah, really, really good stuff. I can tell you've been, you've been around a lot of early

stage startups. The next topic. I wanted to kind of chat with you is regulatory, right? You mentioned you just got breakthrough device designation at Pixim. You guys are working on like some pretty sophisticated regulatory approaches, right? In the EU, in the U.S., etc. If you were to kind of coach up someone who's maybe not as early stage, right, but is beginning to really kind of formulate their reg approach, you know, how would you, how would you, you know, advise, you know, another MedTech founder or CEO?

Because it can be, it can get complicated super fast, right? And so how do you not, you know, get too overwhelmed, you know, as you approach this kind of gnarly topic? Yeah. I think there's, I think there's probably five points here that I want to mention, right? And I don't know if it's an order of importance, but I'm just going to say them, right? First of all, it always takes longer than you expect. I've been doing this for 30 years now. And I don't think, and maybe I'm just, maybe I'm just unlucky or bad or not smart enough or whatever.

but I don't think I've ever hit an anticipated regulatory timeline from the moment we set out, it always, always takes longer. Because so much is out of your control. That's the first point I want to mention. The second thing, the second point I want to mention, I thought all gloom or doom, you know, people like after this quit the med device world. But second point is regulations are getting tougher, not easier. I mean, I'll tell you, when I started years and years ago, it would take maybe 18 months and a couple of million bucks to bring a 510K product to market.

You know what I mean? Like if you had to start from paper, from napkin drawing all the way to market. You know, today it takes a class three implantable device, which I'm dealing with, 10 to 12 years and probably 1,000. 50 million to bring it to market. So. That sounds like a drug. It sounds like a drug process, right? Applied to the tech.

That, but that's where we were heading and that's kind of ours. So regulations are getting tough or not easier. Three, I'd say it always costs more than you anticipate. So this is again, goes back to my previous point. Surround yourself with financial people that believe in your mission because it's going to require more than you think. That's the third point. Hey there, it's Scott, and thanks for listening in so far.

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