Transcription
Nick Talamantes 0:16
I'm here at LSI Europe in Barcelona with Mike Karim of Oxford Endovascular, Mike, it's great to see you again.
Mike Karim 0:21
Great to be back with you, Nick.
Nick Talamantes 0:23
So it's been about 12 months or so since we last saw each other since we last sat down in the studio, why don't you go ahead and tell us what's new with Oxford endovascular?
Mike Karim 0:32
So we are entering a very exciting phase with the company. So last time, when we were met, we were finishing off the refining of the design of the technology. Pleased to report we we froze that design. And we're now in what they call the design, verification and validation testing. So going through all those regulatory tests that you have to do to produce data, to then go forward and set up a first in human clinical study,
Nick Talamantes 0:57
how soon out until you get to that first in human?
Mike Karim 1:00
So we're about 12 months away from that. It's a journey, because there are so many tests, you have to do produce hundreds and hundreds of samples. But we're just executing and working through all that.
Nick Talamantes 1:12
So the technology is a flow diverter. That's right, for the treatment of unruptured aneurysms that are prone to rupturing. Correct,
Mike Karim 1:22
Exactly. These are weaknesses in the blood vessels in the brain that form a balloon shape. And over time, they're getting bigger and bigger. Once a doctor identifies them, they'll track them in the patient, see how quickly they're growing. And then they'll make a decision to intervene. And that's where a device like ours would would come in.
Nick Talamantes 1:42
The technology itself is over a decade old now. So how has your technology compared to sort of the, let's call them the standard of care for flow diversion today.
Mike Karim 1:55
So you're right flow diversion. It's been around for a number of years, the first devices got approved around 2009. And these are tiny little metallic stents that are made of a woven mesh of strands of metal. All the devices, all the flow divers on the market have that same basic structure. They're good at dealing with diverting the flow. But the challenge is for the doctor to get them in the right position, and to get them to actually open up and about 35% of cases have failures due to the mechanical issues that those devices have. So for a long time, doctors have been looking for a better way to have a flow diverter with a better design, basically. And that's where Oxford endovascular comes in with its origami engineering.
Nick Talamantes 2:46
So how does the origami engineering work then?
Mike Karim 2:49
Okay, so rather than a woven mesh of strands of metal, what we have is a device which is laser cut from a tube of nitinol, or nickel titanium alloy, a super elastic alloy, it's put into a laser cutting machine, our unique design is programmed into that. And the laser cutting machine cuts it all in one piece. And the structure allows it to conform to whatever shape of artery in the brain that it goes into.
Nick Talamantes 3:19
So it's not just a unique design. But there's also a unique sort of mechanism of action to the device as well and that it's able to heal the aneurysm.
Mike Karim 3:28
Yeah, so exactly. So first of all, when a doctor is placing this device, they want to know that it's going to land exactly within a fraction of a millimeter in exactly the right position. Because if it doesn't, what they have to do with existing devices is recapture them and try and replace them in the correct position. And often they just keep moving out of position. And when they do this recapturing the device is actually get damaged, so they can't recover. They shape effectively, and often they have to throw them away. So with a unique design with our Origami engineering, the idea is that when we get to market, the doctors will have a device that will land and place accurately will open in the right position. And they won't have to be wasting devices.
Nick Talamantes 4:13
Ruptured aneurysms are incredibly fatal. So it's my understanding around 50% of ruptured aneurysm cases those patients will go on to die.
Mike Karim 4:23
That's right. If a patient has a rupture, then 50% of them will die within minutes or hours. So identifying them beforehand is absolutely vital. If people have a rupture, and they survive over 66% will have permanent brain damage. So this is obviously tragedy, a huge cost to society.
Nick Talamantes 4:45
You mentioned that there's complications that follow treatment with current devices. Are you guys anticipating that your technology will prevent those complications as well that brain damage that you mentioned?
Mike Karim 4:58
So if you don't get the device in the right position. And if it doesn't open, there's there's a huge risk to the patient. There's often re interventions that take place. And anything that prolongs a treatment where you're having to re intervene during that process when the patients on the table is increasing risk of more X rays. So the patient is creating trauma inside these tiny little blood vessels. And you can run the risk of getting hemorrhage, etc, and actually contributing to the damage that would actually be done by an aneurysm. No device is foolproof, of course, but the more you can reduce those mechanical failure modes in a device, the greater the chance you have of actually eliminating them. So what we're doing is we looked at all these different mechanical failure modes that you see with existing devices. We involved key opinion leaders from around the world all the way through our development program and said, What do you need the device to do? And they fed back and we iterated we iterated, we took it to them. They said, Yeah, that's good. But you need to improve this bit, and so on throughout this process, until we got it to a stage where they said, you've cracked it, you've actually done this now, move it forwards and get it into the clinic as soon as possible.
Nick Talamantes 6:15
So you've cracked it, you've developed a solution that's going to be able to prevent aneurysms from rupture and prevent those fatal complications that are often associated with a ruptured aneurysm. But there's still the challenge of identifying those patients, I imagine, are you guys collaborating with anyone in the in the ecosystem to develop solutions to help identify patients who would benefit from your technology.
Mike Karim 6:40
So for us to be able to do that collaboration, it's it's a bit early for us. But there are many companies out there who are involved in imaging who are really working to try and spread the word. Years ago, when I worked with Boston Scientific, we did a lot of work on making sure people understood the importance of stroke, and recognizing it early. So when I was in the UK, we work with a Stroke Association, we worked with members of parliament who lobbied parliament to actually show that if you have screening programs set up, it's actually a saving to society as a whole as well as saving many more patients lives. And I think that's the way that the treatment of brain aneurysms has to evolve to a stage where there are screening programs, because the market is fantastic. Right now. It's growing and growing at about 20% year on year because of better imaging, more doctors getting involved. But it can be over 100 times bigger as a market. If people got together, governments got together to to actually have screening programs, and some countries are starting to do this already.
Nick Talamantes 7:50
So getting you guys to that stage where you are more prepared you are and human to start having those conversations with potential partners on the screening side of things awareness building. I imagine you've got to raise some fund. So how is where are you guys at right now in that in order to build that treasure chest? That war chest?
Mike Karim 8:09
Yep, yep. So we have a fantastic development team who've done all this amazing innovation. And they often laugh, they say, you know, Mike gets us the money. You know, these, these are super engineers much more intelligent than I am. But of course, you can't do anything like this without keeping the funding coming in. And from an investor's perspective, they want to know that you're hitting very, very specific milestones. So that's what we've tried to do all the way through our development program is lay out very clear milestones show line by line, month by month, how we're effectively using the funds, and what our next milestone and value inflection point is. So we're on our fourth fundraise right now. And this fundraise is designed to get us first inhuman data basically, so we're doing a 6 million pound fundraise to work through this program. And then after that, the next stage will be a larger multicenter us IDE study. So whilst we're getting the first inhuman game, we'll be then working on the next fundraiser as well. So I'll be pretty busy and our team will be very busy. Last
Nick Talamantes 9:20
September, they were whisperings about the MDR has that had a those whisperings have gotten a lot louder now that it's actually in effect? How have you guys been dealing with it?
Mike Karim 9:35
Okay, so I think the the challenge with the medical device regulations in Europe is that new startups, particularly small, innovative startups, it's very hard for them to get feedback on what their device evaluation strategy is. You can't talk to the actual regulator, the private groups that actually give the CE mark the notify bodies, they now haven't got the bandwidth to talk, they're not taking on new customers typically, because they're inundated with transitioning existing technologies across to the MDR. So what's happened is that people are realizing that the only route they can go down where they will get feedback from a regulator is the US FDA route. And the FDA have an amazing pre submission program, which for SMEs is a free program, and you can make an application submit a pre submission, and the FDA will read it, they'll give you written feedback on it. And then you can set up a live discussion with them, and get a very strong interaction on your journey in great detail to ensure that you're on the correct path, and that you're not wasting money on the wrong things. So we've been through two pre submissions with FDA, they've been extremely supportive, I think they've assigned a team of about five people to our project. And because of the issues that I've highlighted, where you have these 35% of failure modes with existing devices, which the FDA actually collect data on, then they report on it. So they're we're very excited that there's a company innovating to try and improve that situation. So we'll have continued discussions as we go through our development program. So for the moment, we're focusing on heading down that FDA route to eventually set up a US ID study.
Nick Talamantes 11:35
So I'm sensing a theme overall here, which is communication is key, communicate with your partners, communicate with your investors, communicate with the regulators, and you'll set yourself up for success. Is there any other advice you might have for your peers as a seasoned entrepreneur here?
Mike Karim 11:52
So you're absolutely right, communication is key. And that's not just talking and presenting at great events like this. But it's, it's also listening to your peers listening to people who've been through it before learning from from their experience. So one of the things I tried to do is get out to key meetings such as LSI. And, you know, last year in the UK, it was a great meeting. And I got the opportunity to really expand my network, get a lot of feedback. So coming back here to Barcelona has been great. Because, yes, you have the one to one partnering meetings you set up but you could be walking down the corridor to, you know, have a break, somebody grabs you and says, Hey, I haven't managed to catch up with you. Can we get 10 minutes together? Or can we meet later over dinner or something. And, you know, it's that spontaneous discussion that you can't get through zoom calls, for example. So being here physically, I find is really valuable.
Nick Talamantes 12:49
What is something that you've learned from attending last year, that is improved the experience for you this year?
Mike Karim 12:59
When you're presenting, whether that's, you know, on the stage, and in the main auditorium, or you're presenting for maybe 15 minutes during the one on one meetings, I think you learn to adjust your presentation according to the audience. So I think coming here, having meeting setup, I always try and look at the background. So for example, it's an investor, really understand what their latest news is, where they are in the fundraising cycle, the types of companies that they're partnering with maybe where they gaps are, so that you can really adjust the information that you're delivering, to meet their needs. And ultimately, then they can meet your needs. That's the idea. So, you know, from last year to this year, a lot of learnings and you just try and build that into your your experience.
Nick Talamantes 13:47
Mike, as a market research analyst, you're speaking my language, do the homework, do the research necessary to go in and be prepared to have productive conversations with the right people? It sounds like there's a lot to be excited about with Oxford Endovascular. Also a lot of work ahead, but I'm looking forward to what the next 12 months have in store for you guys. Thank you so much for stopping by the studio and telling us about it.
Mike Karim 14:13
Thanks, Nick. We're really excited and see you next time.
© 2024 Life Science Intelligence, Inc., All Rights Reserved. | Privacy Policy
