BackTable / VI / Podcast / Transcript #406

Podcast Transcript: Biodegradable Flow Diverters for Cerebral Aneurysms

with Dr. Alim Mitha

In this episode of the Back Table Innovation Podcast, host Dr. Diana Velazquez-Pimentel, a radiologist and biomedical engineer, chats with Dr. Alim Mitha about the novel idea of biodegradable flow diverters and the future of interventional neuroradiology. Dr. Mitha is a cerebrovascular, endovascular, and skull base neurosurgeon and biomedical engineer at the University of Calgary. You can read the full transcript below and listen to this episode here on BackTable.com.

(1) What is a Flow Diverter?: Innovations in Aneurysm Treatment

(2) The Utilization of Biodegradable Flow Diverters

(3) Moving Biodegradable Flow Diverters From the Lab to the Clinic

(4) The Imaging Benefits & Material Science of Biodegradable Flow Diverters

(5) Navigating the Prototyping Stage

(6) From Idea to Reality: Entrepreneurship in Medical Innovation

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[Dr. Diana Velazquez-Pimentel]
Hello, everyone, and welcome to the BackTable Podcast, your source for all things interventional and endovascular. You can find all previous episodes of our podcast on iTunes, Spotify, and on backtable.com.

My name's Diana, and I'll be your host this week. I'm a radiologist and biomedical engineer in London, and I’m super excited to welcome Dr. Alim Mitha to talk more about biodegradable flow diverters and the future of care in interventional neurology. Welcome. Why don't we start? Why don't you introduce yourself to the audience? We can take it from there.

[Dr. Alim Mitha]
Thank you. My name is Alim Mitha. I'm a cerebrovascular, endovascular, and skull-based neurosurgeon and biomedical engineer at the Foothills Medical Center in Calgary, Alberta, Canada. I'm also an associate professor of clinical neurosciences at the University of Calgary and faculty in the Department of Biomedical Engineering.

[Dr. Diana Velazquez-Pimentel]
Why don't you tell me more about your journey? You've mentioned biomedical engineering, you've mentioned working at the University of Calgary. You gave us a very brief background, but I want to know more.

[Dr. Alim Mitha]
I was born and raised in Calgary, Alberta, and I have a background in cell and molecular biology at the University of Michigan. I did medical school at the University of Alberta in Edmonton, Alberta, and a neurosurgical residency at the University of Calgary. Then, I did a master's in biomedical engineering at Harvard University. I actually took some time out of my residency to complete that. Then following completion of my residency, I did two fellowships at the Barrow Neurological Institute in Phoenix. The first was cerebrovascular and skull-based surgery with Dr. Robert Spetzler, and then the second was endovascular neurosurgery working with Cameron McDougall and Felipe Albuquerque. Then in Phoenix, I got married to my wife, Billie, who was doing a residency in pediatrics at the time. Then, I joined here in Calgary as staff in 2011, and set up a research lab focused on tissue engineering and biomedical device development.

[Dr. Diana Velazquez-Pimentel]
That sounds epic. Tell me more, like what did that lab creation look like? You joined the staff, you said, in 2011. Did you go straight into having your own lab and working towards commercializing a product or was that something that came later?

[Dr. Alim Mitha]
Yes. I always had a love for engineering and tinkering from a young age. When I went to the University of Michigan, I actually lived on the engineering campus at the University of Michigan. If you've ever been there, it's really grand but inviting at the same time.

[Dr. Diana Velazquez-Pimentel]
Awesome. When was the shift towards endovascular? Do you mainly work in endovascular or do you still work across the board?

[Dr. Alim Mitha]
Yes, I work across the board. I still do open operations, a lot of skull-based tumors, pituitary tumors, and I also do endovascular procedures.

(1) What is a Flow Diverter?: Innovations in Aneurysm Treatment

[Dr. Diana Velazquez-Pimentel]
Great. Interventional neuroradiology might be new to a lot of our listeners, so why don't we take it right from the top? Can you just briefly explain to us what is a flow diverter and what is its role in interventional neuroradiology?

[Dr. Alim Mitha]
Yes. A flow diverter is a metal mesh that is placed inside the blood vessel to treat an aneurysm as opposed to traditional ways of treating an aneurysm through the blood vessels, which includes coiling and requiring the catheter to get into the weakest part of the aneurysm. A flow diverter is very different, in that it is placed in the main blood vessel but not into the aneurysm itself. It has enough material, typically metal, that allows it to divert blood flow away from the aneurysm, causing it to clot off.

[Dr. Diana Velazquez-Pimentel]
Awesome. Is this essentially like an endoluminal reconstruction? That is what's jumping into my mind.

[Dr. Alim Mitha]
Exactly. It's a two-phased approach to treating an aneurysm. The first phase is actually diverting the blood flow and causing the aneurysm to clot off. Then, the second phase is that endoluminal reconstruction that you mentioned, which includes endothelial cells from the patient's body, lining up over the aneurysm neck in order to completely exclude the aneurysm from the circulation.

[Dr. Diana Velazquez-Pimentel]
How have they evolved? Is this a relatively new technology or something that's now quite well-established?

[Dr. Alim Mitha]
Great question. Flow diverters started out as FDA-approved in around 2011. They haven't evolved very much over the past decade or so. They have improved in terms of things like their delivery systems, and in some of the materials that they are made with to make them more radio-opaque or visible for the interventional neuroradiologist or neurosurgeon implanting the device. Overall, the structure of the stent itself has not evolved very much over the last decade.

[Dr. Diana Velazquez-Pimentel]
What about its indications? From the experience I have in medical device development, one of the biggest challenges that we have with new uses of something like a stent, is making sure that we can use it in the patients where we think they might benefit. Has this been the case with flow diverters? What patients can you use these in? Any aneurysm or is it quite selective?

[Dr. Alim Mitha]
Flow diverters are typically used for patients with sidewall aneurysms or fusiform aneurysms. Initially, they were approved for aneurysms of the anterior circulation. Things like a superior hypothesial aneurysm, or a posterior communicating artery aneurysm, or an ophthalmic aneurysm, but that indication has expanded to aneurysms in the posterior circulation and also fusiform aneurysms in the posterior circulation.

[Dr. Diana Velazquez-Pimentel]
Can you just briefly explain what are the benefits of a flow diverter over, for example, a coiling, or an alternative treatment option in this population?

[Dr. Alim Mitha]
Yes. The benefits of flow diversion are that you put the stent inside the main blood vessel and don't actually have to go into the weakest part of the aneurysm, which is the dome. Manipulating devices or putting coils into the dome of the aneurysm is probably the highest risk of the procedure, and a practitioner typically would like to avoid that, if they can. There's a rupture rate of about 10% or so by putting devices into the aneurysm dome. Whereas a flow diverter, you stay in the main blood vessel. You simply deploy the flow diverter into the main blood vessel, without putting a catheter into the dome, and it is much safer from that perspective.

[Dr. Diana Velazquez-Pimentel]
It makes a ton of sense.

[Dr. Alim Mitha]
Yes. The downside of flow diverters, of course, is that you're putting something into the main blood vessel and something with quite a bit more metal than the blood vessel would be exposed to in the case of say, an aneurysm bridging stent. The thrombogenic risk is probably the biggest risk of a flow diverter.

(2) The Utilization of Biodegradable Flow Diverters

[Dr. Diana Velazquez-Pimentel]
Has this been the basis of your research and the idea behind biodegradable flow diverters? Maybe we should just jump straight in. Why don't you just describe what it is you're building and what are the key advantages of a biodegradable flow diverter?

[Dr. Alim Mitha]
We're getting at where did the idea for a bioabsorbable stent come from?

[Dr. Diana Velazquez-Pimentel]
Yes, let's start there

[Dr. Alim Mitha]
During my training, whenever we considered placing a stent, we always considered the age of the patient. I found it very interesting that we would always consider the age of the patient because we would be less likely to choose to put a stent in patients who are younger. Of course, all intravascular stents require antiplatelet agents. In the decision-making process for how to treat, for instance, a wide neck aneurysm in an older patient, stenting or stent-assisted coiling seems like a reasonable first choice. When you look at a younger patient, we would always put stenting lower down on the list, and often prioritizing surgical clipping in a younger patient over leaving anything behind in their blood vessel for a long period of time. This was, even more, an issue when flow-diverting stents came on the market around 2011, since these stents have so much more metal and they require even a longer duration of dual antiplatelet therapy compared to the aneurysm-bridging stent.

[Dr. Diana Velazquez-Pimentel]
Just to be explicit, your concern is them thrombosing off and causing a major stroke?

[Dr. Alim Mitha]
Exactly. We all know patients who have been on dual antiplatelet therapy and then they transition to single antiplatelet therapy after a flow-diverting stent, say even, six months later, which is when a lot of physicians recommend to stop one antiplatelet and just continue on the other antiplatelet, like aspirin. Then, they stop the aspirin at some point for whatever, a surgical procedure, and then they get a thromboembolic event. So they have to stay on the aspirin for the rest of their lives. When you want to subject a younger patient to the requirement of being on an antiplatelet for the rest of their lives, you always think twice about doing that.

[Dr. Diana Velazquez-Pimentel]
Just to bring you back to where the idea came from, you mentioned you're doing your neurosurgical residency, you're working as a neurosurgeon, and it's bizarre, you're in these MDT discussions, multidisciplinary discussions, and you're choosing not to treat young patients. What was the next inspiration? What made you think, "I've got to do something about this."

[Dr. Alim Mitha]
Thinking about how to make the technology more available and effective for younger patients without necessarily having them have the long-term repercussions of antiplatelet therapy. The most obvious thing is to actually create a stent that serves its purpose, for the time it needs to serve its purpose, and then just dissolve over time so the patient can then not worry about having to take the blood thinners.

At that time, newer materials were coming out, there were other fields that were incorporating absorbable components into their implants and devices, and so it was logical to try to make an absorbable stent. It would have been very difficult to try to get some of those stents up into the intracranial circulation through tortuous pathways. Then, we shifted our thinking a little bit and went to a braided design. With the help of very talented people and students along the way, we designed and prototyped a braided bioabsorbable stent.

[Dr. Diana Velazquez-Pimentel]
That's awesome, and tell me a little bit more about how it works. You have a young patient, they have an aneurysm, you're using this stent-flow diverter, like any other flow diverter. You're bridging the main vessel to block off the aneurysm. How long does it last? When you're consenting a patient, how long can they expect it to be there for?

[Dr. Alim Mitha]
Different materials can actually be tuned to last a different amount of time. What we were thinking about when we chose a material was how long it typically takes for an aneurysm to go away. We know that there's data out there that says aneurysms typically take about one year or more to actually occlude after you put in a flow-diverting stent, and that occlusion rate actually increases over the first couple of years.

We wanted our device to stick around for at least that long and then go away. That's how we approached choosing a material. These materials nowadays, as I mentioned, you can choose a host of different polymers that have different mechanical characteristics, and based on their processing and their molecular weight, they can dissolve at different time points.

(3) Moving Biodegradable Flow Diverters From the Lab to the Clinic

[Dr. Diana Velazquez-Pimentel]
It's so great that this is something that we can tune and that we can put into patients. Drawing from the preclinical lab experiments, was this something that had to evolve over years? It sounds like, especially when you're working in the biodegradable space, it must have been a long journey.

[Dr. Alim Mitha]
Yes, it sure has, and there's been a lot of learning along the way. The development and prototype piece is only one piece of starting a business and trying to commercialize a device. I was fortunate enough to be working with a partner, his name is John Wong, and while I brought the technical background, he brought the management background, and actually did a master's in business administration at Wharton. Together we were able to make this a viable commercial startup entity.

[Dr. Diana Velazquez-Pimentel]
What did you do? You've been working in the lab, it started in 2011? When did you incorporate a company and where did you go and look for funding?

[Dr. Alim Mitha]
Yes. We incorporated in 2012. It took us a while to come up with a workable prototype. As I mentioned, we would iterate and implant them, find out what the biological response was, and in many cases, we had to go back to the drawing board and make design changes. Then eventually, we had our workable prototype around 2019. The next thing, the big thing that happened with us is we became involved with this startup incubator out of the University of Calgary called Creative Destruction Lab. That really kick-started our thinking in terms of how to now take this prototype and raise money and then hire people and make it a business.

[Dr. Diana Velazquez-Pimentel]
Where are you at now? You have a team together and there's lots of people behind this taking this to the next step.

[Dr. Alim Mitha]
Yes, exactly. We are still primarily a preclinical company, but we recently started our first international, first-in-human, clinical trial for the stent. We are now in patients. The clinical trial is ongoing, but preliminary results have been encouraging.

[Dr. Diana Velazquez-Pimentel]
Nice. I'll have to come to the Brain conference to find them out. I've seen you on the program. We briefly touched upon it earlier, you mentioned we've got this option for a biodegradable flow diverter but I'd love to understand more. What are the advantages? As a physician, why would I choose a biodegradable flow diverter?

[Dr. Alim Mitha]
Over and above, just the fact that it will absorb over time, and in the case of a persisting aneurysm, you could potentially re-access that aneurysm, and the obvious benefits of being able to, say, discontinue your antiplatelet agents over time. It turns out there are more benefits than just those. Mechanical properties of metal are very different from polymers. How the device actually behaves, for instance, or how it conforms to the anatomy is actually more favorable for the stents made out of polymer. Our device can actually be deployed in such a manner that it can cover the neck of some aneurysm types that would not typically be successfully treated by flow diversion. It improves the chances that those aneurysms will go away over time.

Then, the material itself is actually proving to be much less thrombogenic than metal as well, which is currently the main risk of placing a flow-diverting stent into a blood vessel. There are other things like better imaging properties, allowing physicians to get more accurate information about an aneurysm in a parent vessel from non-invasive imaging like a CT or MRI scan after placement of the scent, as opposed to requiring an angiogram to get that same information.

(4) The Imaging Benefits & Material Science of Biodegradable Flow Diverters

[Dr. Diana Velazquez-Pimentel]
Let's get into the imaging a little bit more because I find that really interesting. Talk us through, why is having a polymer more beneficial to CT and MRI imaging? You mentioned that it has advantages, but can you explain it a little bit more?

[Dr. Alim Mitha]
The bioabsorbable stent also has benefits in terms of imaging because there's much less, or in some cases, no metal in the bioabsorbable stent. You don't have that artifact that you typically see with metal stents showing up on a CT scan or an MRI scan. Typically a full metal stent, in order to get really good information about any residual aneurysm or the parent vessel, whether there's things like instant stenosis or thrombus, you need to do a digital subtraction angiogram, which is, of course, a more invasive procedure for the patient.

[Dr. Diana Velazquez-Pimentel]
Not to mention, if you put the stent in a young person, over their lifetime they may need brain imaging for any other reason. There's nothing here that's going to stop them from having that, which is amazing. Great to talk through some of the benefits of the biodegradable flow diverter.

You've briefly mentioned this first-in-human trial, and I'm always curious to learn more about your thoughts, what a founder's thoughts are on clinical adoption. There's tons of innovators. They have loads of great ideas, and then when you put it out in the market, people love to ask questions. Physicians are the same all over the world, always questioning, but why? What's the early feedback you've received from physicians? Do you think that there's going to be a big challenge to overcome in getting this out there to the world once it's regulated?

[Dr. Alim Mitha]
Early feedback is very promising in terms of deliverability to be, we want to make it the same as any other metal flow diverting stent on the market that physicians are used to deploying. To actually increase adoption, we really have to approve the value propositions, which we are currently in the process of doing. I think that message will be very important about the benefits of a polymeric bioabsorbable stent compared to the metal ones. That'll be very important for early adoption.

[Dr. Diana Velazquez-Pimentel]
We're not using metal, right? What materials can you use that are stiff enough and have an appropriate mesh density, length, deployability, such that they can function as a flow diverter?

[Dr. Alim Mitha]
I think newer materials will be developed over time that can serve the purpose even better than the materials we have available now. Currently, the materials that we're looking at now to create bioabsorbable stents include things like poly-L-lactic acid, polyglycolic acid, polycaprolactone, things like that, which are polymers that essentially degrade over time.

[Dr. Diana Velazquez-Pimentel]
Are they stiff enough to achieve what a flow diverter does?

[Dr. Alim Mitha]
Yes, that's a great question. Of course, you don't want too much stiffness because metal can sometimes cause bad things to blood vessels if they're too stiff. Things like intimal hyperplasia and changing the direction of blood flow because of their stiffness or causing the blood flow to adapt more to the stent's configuration as opposed to adapting more to the blood vessel. In general, the polymers are a little bit softer and they're a little bit more yielding, so they're less likely to put as much radial force on the inside of a blood vessel but more likely to conform to the blood vessel.

[Dr. Diana Velazquez-Pimentel]
I can imagine that's a huge benefit, especially in the small arteries that are in the brain. What about its deployability? Does using polymers create a problem with the delivery system or is it quite compatible?

[Dr. Alim Mitha]
Using polymers in terms of delivering them is interesting because you don't actually find that you need as stiff of a delivery catheter to get the polymeric stent into place. In general, today's catheters are over-engineered for bioabsorbable stents that may be coming out in the future.

[Dr. Diana Velazquez-Pimentel]
Awesome. In the preclinical lab experiments or any, in the experiments that you've been involved in, how long does it take to degrade? If you put this into, say, a 35-year-old, when can they expect this to be resorbed?

[Dr. Alim Mitha]
These stents can be made out of materials that are actually chosen based on the length of time it takes for them to degrade. Of course, that in turn is typically chosen based on the application of the stent. In the case of a flow-diverting stent for an aneurysm, you usually want the absorbable material to stick around for as long as it typically takes an aneurysm to heal, which is about a year, or up to two years, in that range.

At that point, you want the stent to dissolve or most of the stent to dissolve. If you choose a material that dissolves too quickly, then there can be issues with potentially aneurysms recurring or not being fully treated, meaning that the endothelial cells don't actually line up and create that new blood vessel wall or a parent vessel wall that you want to fully exclude the aneurysm from the circulation. I would think in this application, you would want the stent to stick around for at least a couple of years.

[Dr. Diana Velazquez-Pimentel]
Has material science advanced enough so that we can be confident that it is only going to last two years? Or is this something that is still to be answered?

[Dr. Alim Mitha]
Material science has actually come a long way and you can choose the same material and actually get a different molecular weight out of that material depending on how you process it. Then, that molecular weight actually in turn feeds into how long it will take for it to absorb. You can certainly choose materials and specifically their molecular weight to actually design when you want the stent to go away.

(5) Navigating the Prototyping Stage

[Dr. Diana Velazquez-Pimentel]
I'd love to hear more about the prototyping stage, my personal favorite part. It's all of ours, isn't it? You mentioned that you and John worked together to create something physical that you could show investors, and we can't underestimate how powerful that is. I know a lot of our listeners have their heads bustling with ideas. What was it that helped you build that prototype? Was it being affiliated to an academic institution? Was it the fact that you are doing these procedures on a day-to-day basis? Or did you have the inherent skillset from your biomedical engineering background?

[Dr. Alim Mitha]
You always leave your academic program having some skills but never all the skills to actually do what you sometimes envision you want to do. Mine is in biomedical engineering and I came together with John Wong, who is my partner at work, and he's also an endovascular neurosurgeon, and his skill set was in management. He actually did a business degree, an MBA, an executive MBA through Wharton, which was very impressive because he did it while he was a staff person.

Essentially, what we had to do to get to the prototype stage was essentially work through my laboratory. I have a laboratory at the University of Calgary. It's focused on biomedical engineering and biomedical device development. We also have some tissue engineering projects going on in the lab, but we have numerous talented students, including PhDs and master's students who helped us get to this point along the way.

Essentially, the idea morphed over time. Initially, we tried to create a laser-cut stent, but polymers can actually be too brittle for doing that properly. They can be stiff when created using lasers and then very difficult to get up through the tortuous anatomy. At some point, we shifted to a braided type of flow-diverting stent and then essentially just bootstrapped that mission to get a prototype completed. Failed a couple of times, and then finally got a working prototype.

[Dr. Diana Velazquez-Pimentel]
I'm sure that that must have been a great moment where you could take this physical flow diverter to the accelerator that you mentioned. Like I said previously, we can't underestimate how powerful that is.

[Dr. Alim Mitha]
Absolutely. The interesting thing about it is that a stent is only a part of the final device. The delivery system was actually the most complicated part, even though it's not the part that you leave behind. We had to do a lot of learning in terms of how to actually deliver what we had prototyped in terms of the stent.

[Dr. Diana Velazquez-Pimentel]
What were the main challenges? I'd love to know.

[Dr. Alim Mitha]
Creating a delivery system, of course, polymers are very different in terms of how they behave. As you mentioned, they're not as stiff as metal and so you have to create a delivery system that treats the polymer gently and is able to get it up to where you need it to go.

[Dr. Diana Velazquez-Pimentel]
It sounds like you had to rationalize the engineering that had been done previously.

[Dr. Alim Mitha]
Exactly, yes. You always develop something. The first thing you do is learn what's out there already. There was a lot of learning to do.

[Dr. Diana Velazquez-Pimentel]
Nice. You've mentioned already that you've got your first-in-human trial, and after that, the big hurdles are always regulatory. Is the aim for this first-in-human trial to feed into that?

[Dr. Alim Mitha]
Yes. Our first-in-human trial is just a few patients. We're trying to learn as much as we can about the device and how it behaves. Our goal is to get just a few patients so that in our primary outcome measures would be things like technical feasibility and safety. They're always the first two things. We want to learn the most about our device in terms of a first-in-human trial and also get efficacy information as well. The goal after that is to do a larger efficacy trial where we learn about, once we prove safety, the efficacy of our device and compare it to some of the existing devices on the market.

[Dr. Diana Velazquez-Pimentel]
What do you think is going to be the biggest challenge in achieving that scale-up? I know it's difficult to say because you've only really got preclinical data today, but what do you think is going to be the biggest challenge?

[Dr. Alim Mitha]
The biggest challenge in terms of taking it to the next clinical trial? Is that the question?

[Dr. Diana Velazquez-Pimentel]
Yes. What I'm trying to hint at is do you think clinical adoption might be a challenge here? Considering how this is such a novel approach with a novel delivery system, do you think you're going to have any hurdles to overcome when thinking about clinical adoption?

[Dr. Alim Mitha]
That's a really good question too because physicians have to have a different mindset and a different purpose for putting in a flow diverter that is absorbable versus one that is permanent. Of course, ease of use is paramount. Physicians have to be able to use this easily, and not require any other resources compared to the existing flow-diverting stents. It has to be straightforward and use similar size catheters as everyone is used to. But they have to see real benefit in it and that's what we're hoping to do with the clinical trials is to actually show that there's much more benefits to an absorbable stent compared to traditional metal ones.

[Dr. Diana Velazquez-Pimentel]
What's the early feedback you have had from physicians and potential future collaborators?

[Dr. Alim Mitha]
The early feedback has been very good. There are definitely some other advantages of an absorbable stent over and above what you would think of in terms of it just going away for the most part over time. Things like its mechanical properties or being able to re-treat an aneurysm if it does stick around after flow diversion because that's one of the biggest value propositions also to an absorbable stent is that you don't permanently lose access to the dome or the sac of the aneurysm. You can reaccess it. Whereas with a metal flow-diverting stent, you've essentially lost complete access to the sac of the aneurysm in the case that it should stay persistent.

(6) From Idea to Reality: Entrepreneurship in Medical Innovation

[Dr. Diana Velazquez-Pimentel]
Great. What advice would you give to new docs or established docs that have an idea and they want to take it from the zero to one that we were mentioning? What would be your golden tips?

[Dr. Alim Mitha]
Okay, so there are a couple of things in terms of, for others who want to start on, say, an entrepreneurial journey, they have a good idea and they want to implement it, I would say it's very difficult to do it on your own. Get a good partner. There are a lot of decision points along the way and having a sounding board and someone who doesn't necessarily think the same way as you do, but has a common goal in mind is very helpful. I think that would be one piece of advice there.

There will be ups and downs along the way, try to enjoy the entire experience. Because ultimately, you should be doing this to try to give yourself some sort of satisfaction that even for a short period of time, you've actually made the world a better place or improved patient outcomes. It's a challenging journey, managing people, learning new skills, but it is definitely worth it in the end, having tried it.

[Dr. Diana Velazquez-Pimentel]
Yes, definitely worth trying to get from that zero to one, and to your point, making sure that you find other partners with a skillset. That's what we touched upon earlier, right? It's the PhDs and the master's students that are working in your lab. They're not physicians, their expertise is not the patient care and the clinical adoption, their expertise is in overcoming those manufacturing challenges and really taking a step forward. That's what really takes things forward and allows and locks the funding that we also touched upon.

I'd love to understand a little bit more about what the setup looks like with the University of Calgary. I've heard great things. I hear that it's a bed of innovation.

[Dr. Alim Mitha]
It actually is. I don't know if everyone working in an academic environment can actually say this, but the University of Calgary is one of the best places in North America right now to go from academic research to commercialization. It's interesting because in this geographic area in Canada, we've been traditionally focused on oil and gas as the main driver of our economy, but partly in response to political environmental policy changes that are shifting the way we think. Calgary, in particular the University of Calgary, is really leading the way in terms of trying to create opportunities and elevate other economic drivers in the local community like life sciences and technology. The University of Calgary is actually Canada's number one startup creator in all of Canada. This is mainly because it creates a favorable startup environment, things like removing red tape, facilitating IP protection, but allowing the creators of the IP to own their own work, creating centers for innovation within the university, including physical spaces and even investing in the startups that they create.

Many universities, on the other hand, mandate that the IP be filed and assigned to the university and then licensed by the creators. We have a very favorable environment for that. We're really fortunate to be making this effort of commercializing our stent technology from where we are. It's played a huge role in our success so far. I was focused on medicine, but I briefly considered transferring into engineering.

[Dr. Diana Velazquez-Pimentel]
Me too, me too.

[Dr. Alim Mitha]
Unfortunately, I wouldn't have been able to fit in all my pre-med courses. I bailed on that idea. Like you, then decided to do bioengineering at a later stage. I was actually fortunate to do that because then I thought about bioengineering again after I started neurosurgical residency and realized that, especially neurointervention is really heavily focused on biomedical devices, whether it be the implants or the delivery systems, catheters, things like that. More than that, I think I realized that these devices don't always work the way that physicians want them to. More importantly, they don't always work the way the patient wants them to, meaning that they're not always effective.

During my residency, it became really apparent to me that there's a lot of room for improvement with some of these devices. That's when I took a few years off of clinical residency, went back to do a master's degree in biomedical engineering at Harvard University, and worked with some great people, including Chris Ogilvie at the Mass General Hospital. He's a very good mentor and friend, and he really facilitated and fostered my interest in novel treatments. Then in his lab, and with the help of Brian Ho, another dear friend, I learned the modified elastase model that Brian initially described.

When I started on staff here, I actually brought that model back to Calgary and set it up in my lab. Having that lab piece to the company has been really important. Once we developed this idea and cultivated it to the form that it was in, into an early, early prototype stage, we obviously had to learn about how it would behave in a biological system. Having the in-vivo model at our disposal through the lab really helped us to iterate the device very quickly, which doesn't always happen in an industry-alone setting. Having that lab piece really helped us to refine the prototypes and do things like refine the delivery system and advance the product to where it is.

[Dr. Diana Velazquez-Pimentel]
That's great. It's good that you've had promising early feedback and it sounds like you have a pipeline of clinical trials that are going to lead to this adoption. It's very easy to just think about the first-in-human and not have the pipeline of evidence generation that's going to lead to this flow diverter being available in every single neuro IR and geo suite in the world. Very happy to hear more about that and super excited to see the trials in action because they'll be big ones.

[Dr. Alim Mitha]
Yes, it will be. It's really exciting. We're taking one small step at a time. Of course, we have high hopes for this and are looking forward to seeing how the rest of the story unfolds.

[Dr. Diana Velazquez-Pimentel]
Me too. It's been great to have you on the show, really incredible to learn more about biodegradable flow diverters. It's been great to hear your insights of how you can turn a medical degree and a biomedical engineering degree into a product that is out there and will be making a difference to patients pending these exciting results trials.

It's been super great to learn more about biodegradable flow diverters, and the incredible career and onward journey of where you guys are heading. Thank you for coming on Backtable and really excited to learn more and meet you in person at Brain.

[Dr. Alim Mitha]
All right, thanks for having me. I look forward to seeing you and everyone else at Brain in December.

Podcast Contributors

Dr. Alim Mitha

Dr. Alim Mitha is a cerebrovascular / endovascular / skull base neurosurgeon at the Foothills Medical Centre in Calgary, Canada, and the co-founder, president, and CTO of Fluid Biomed Inc.

Dr. Diana Velazquez-Pimentel

Dr. Diana Velazquez-Pimentel is practicing physician and an NHS Clinical Entrepreneur in London.

Cite This Podcast

BackTable, LLC (Producer). (2024, January 17). Ep. 406 – Biodegradable Flow Diverters for Cerebral Aneurysms [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.