Nick Talamantes 0:00
Mike, thank you so much for joining me here at LSI Europe.
Mike Karim 0:03
Great to meet you, Nick.
Nick Talamantes 0:04
Tell me a bit about Oxford Endovascular?
Mike Karim 0:06
Yeah, so Oxford Endovascular is a spin out from Oxford University. And we are developing origami engineering to treat brain aneurysms.
Nick Talamantes 0:16
What is origami engineering.
Mike Karim 0:18
Okay, so origami comes from the ancient art of paper folding. So what we've done is take that concept of how you fold metallic structures down into small spaces, and allow them to open up. So in this case, how it conforms to the blood vessels in the brain, and helps to seal off an aneurysm a weakness that can rupture. Now, aneurysms affect one in 50 people, they're extremely common. So our mission is to use origami engineering to cure brain aneurysms.
Nick Talamantes 0:49
What's sort of the unmet need in treating brain aneurysms today?
Mike Karim 0:53
Okay, so brain aneurysms are being treated and historically open surgery has been used, it actually works quite well. But it's got all the problems associated with an open procedure. Over the last 20 years or so doctors look for less invasive ways to access the blood vessels in the brain. So they developed a coiling procedure that became gold standard, but it doesn't work, as well as open surgery, and you're not healing the aneurysm. So in the last 10 years or so, people worked out a way to divert flow away from an aneurysm. And that's what a flow diverter is. Now, the problem with existing flow diverters is their fundamental design structure. They're made of a woven mesh of strands of metal, a bit like knitting, if you like, it doesn't have the radial force that is optimized to fit different shapes of blood vessels. And what that means is they often do not open, they often do not land in the right position, they often move out of position after they've been placed, and that results in adverse events for the patients.
Nick Talamantes 1:57
So Mike, what drives your desire to bring an innovative technology like this to market?
Mike Karim 2:03
Well, first of all, I think it's a privilege to work with something like this. You know, throughout my career, I've always worked with innovative technologies. So I'm very passionate about that. I think in this situation, what you're dealing with is a disease, which affects so many people, you know, one in 50, people have brain aneurysms, and they are frequently between the 40 to 60 year age group. So these are people who are working, bringing up families. Paying taxes, you know, are essential, you know, to society, it can also affect much younger people, this is a devastating disease, if you have a brain aneurysm and it ruptures, half of the people who suffer from that will die. And the ones who survive, over half of them will have permanent brain damage if this happens. So it's absolutely vital to be able to treat this condition with a better technology, reduce the risks to the patient, improve the outcomes for the patients, and the doctors. And ultimately, you can save healthcare systems, huge amounts of money and then make other treatments available for more patients. If you have a more effective cost effective technology.
Nick Talamantes 3:13
What is the market opportunity look like for treating aneurysms today?
Mike Karim 3:16
Okay, so one in 50 People have brain aneurysms, doctors have to work out which are the ones that are likely to rupture. There are over three quarters of a million that rupture every year. So it's somewhere in between that. And the way that translates monetarily is it's about a $3 billion market per year. So this is a fantastic opportunity. It's increasing year on year because of cardiovascular disease, better imaging, and more doctors who are getting into the space to actually treat this disease.
Nick Talamantes 3:47
What's your strategy to sort of disrupt the bigger strategics? who are providing coils today are selling flow diverters? Okay. Talk to me about that. Yeah.
Mike Karim 3:58
So disruption is an interesting term, we, we don't necessarily want to disrupt the big companies. We see ourselves as their solution, basically. Because, you know, a lot of the technologies, they have the acquired, they don't necessarily internally develop themselves. We know many of these companies are looking for a better flow diverter. They're all observing us. They're watching us, seeing how we're developing this technology. We know that some in other parts of the world that want to get into the neurovascular space, because it's so hot, are really looking at us. So we see us selves as a solution to that in some sort of partnering, licensing activity, or maybe even an acquisition later on. Who knows?
Nick Talamantes 4:42
Sure. Well, what stage is Oxford Endovascular at right now.
Mike Karim 4:48
Okay, so the original concept goes back about 10 years we spun the company out of the university six years ago. We have gone through extensive development of what the area general concept was, we've now essentially frozen the design. We've done extensive animal work, we're so confident with the technology. Now, we're going into all our verification and validation testing. And this allows us to pull out the data to submit to the authorities to gain approval for a first in human clinical study. And that study is about a year away now.
Nick Talamantes 5:21
And what geography are you looking at getting into in human first for.
Mike Karim 5:26
So we're looking at different parts of the world. But the really good thing is that whatever doctors we show this to whether it's the US, Europe or Asia Pacific, they all want to be involved in our studies in some way, shape, or form. Now, first inhuman, it's going to be about 10 patients. So we're a UK company. We're obviously looking at the UK, we've got key opinion leaders here who were interested. But other parts of Europe are potential opportunities as well, it may be that we have two or three sites in different countries, we're even looking at Australia and New Zealand as well. But we've got a bit of time to figure that out. And then after that, we plan to do a pivotal study in the US and FDA pivotal ID study.
Nick Talamantes 6:09
How has MDR sort of affected the work you guys are doing.
Mike Karim 6:13
Yeah, so, you know, MDR coming in is is a challenge. So if you go back a few years, to get CE mark for technology, you would have needed about 30 or 40 patients would have been a relatively short timescale, that's up ended that whole process. So, you know, now we are looking towards the US really to go through the pivotal stage. And that's really because I think the FDA in the US has really opened up and is willing to engage. So we've had a very dynamic discussion with them, where they've given us feedback on our preclinical test plan. We've had live meetings with them, we now have alignment, they're really pleased and excited about what we're developing because they collect the data on all the problems that happen with existing flow diverted technologies. So they see us as an answer to actually reduce the risk to patients and provide a better treatment. So they're very supportive.
Nick Talamantes 7:07
As a startup, it's important to sort of assemble the right team of people, why don't you tell me a little bit about what that experience has been about? Been like at Oxford?
Mike Karim 7:16
Yeah. So if we go back to the original proof of concept, you know, it's a professor of medicine, Professor of Engineering, who got together develop the initial concept. Now, that's one thing proving that concept, turning that into a company that can develop that to something that's going to be a commercial standard device, is a whole different ballgame. So we had to spend a great deal of time searching to find the best engineers in the business, to identify not only their technical capabilities, but actually how they work as a team, you know, what the chemistry is like, between them? Will they go the extra mile because developing a technology like this means you're going to meet many, many bumps in the road. And we've probably jumped over 1000 of those on our journey. And the only reason we've been able to do that is because of the dedication of the team, their capability and how they work together, you know, who would have known that a pandemic would have come along and disrupted, you know, that way of working. Our team came to me, several weeks before lockdown occurred in the UK and said, we can see the way this is going. We've got approval from our partners at home to relocate the technology, the equipment in the lab, to our home office. And I said, Well, I'm pleased you've said that you've got approval because I don't want to disrupt your family life, but that was a good move, because it meant we could carry on the development as these lockdowns came in and then work out a a way of hybrid working. So we just didn't stop we carried on carried on innovating.
Nick Talamantes 8:52
Now startups are known for being agile, and it sounds like your response to the pandemic happening. You truly are agile, you're responding to the situations in the world as they develop the pandemic, MDR. And it sounds like you're taking it in stride.
Mike Karim 9:07
Yeah, I you know, I think being able to be nimble is key. You know, we have a relatively small team so we can make decisions very quickly. We're very democratic. So we really encourage people to come forward and be open about the challenges because you know, if you don't do that, you'll take a device towards the market and then encounter problems later. So we've tried to spot every single problem that could occur with this type of technology on our journey, and then fix them and fix them even delaying a few things to get it right. But it's a balance. Now we're in really good shape as a result of that.
Nick Talamantes 9:41
That's fantastic. What brings you to LSI Europe?
Mike Karim 9:45
So, you know, LSI, I think has a great formula where you can hear what's going on in the marketplace, from other technology producers, from investors from analysts, so there's a it's a great networking portunity to soak all of that up, I think LSI has its finger on the pulse about what's going on in the market, the regulatory trends. So, you know, there's a kind of an eye to the future from lots of different perspectives. We're obviously raising money, that's a continual process. I've had some excellent networking meetings with investors who are really interested in in what we're doing. And we've actually got a few that are now going into due diligence on us as a result of this meeting. So it's been great value.
Nick Talamantes 10:32
That's fantastic to hear. Tell me about scaling, and what's sort of to come next when you get your raise in?
Mike Karim 10:39
Sure. So you know, the raises that we're going through now are one to be able to get through our first inhuman, get the data out of that, whilst that is ongoing, we'll already be working on a much larger pivotal arrays for that multicenter US study. So, you know, we're already thinking about that we're lining up potential investors for that we've already got a few commitments already in place, which is great. But of course, after that, it's okay, how would you then take this to market? We know that we can't do this on our own. So, you know, we're already thinking about what kind of a licensing deal would be appropriate, you know, do we use distribution? Do we go it alone? You know, what are the things you know, in my earlier careers, I've worked on that and, you know, gone through it alone and done that worked with distributors, licensing deals. So there are different models, depending on the market and the type of technology, I think, in this case, some some kind of licensing deal is, is most likely. So we'll raise enough to get through the pivotal. And then we'll be looking at how we can get it in the hands of the key doctors around the world to treat as many patients as possible. We really believe this will be a market leading device.
Nick Talamantes 11:50
If we had to peer into the Oxford endovascular crystal ball, what is the future look like? For origami technology beyond aneurysm? Is there other applications for it?
Mike Karim 12:00
It's a great question. I think you know what our engineers have learned about developing this kind of technology using origami engineering, it could lend itself to a whole host of other areas and peripheral, vascular and beyond. At the moment, we have to remain very focused on what we're doing. We've got a laser focus with our laser cut device. And, you know, we need to get this into the market. But you know, the no herring, the team is amazing. And I think that's huge value in itself beyond just the technology we have.
Nick Talamantes 12:31
Absolutely. Mike, thank you so much for stopping by and telling me about Oxford endovascular
Mike Karim 12:36
Pleasure to meet you. Thank you