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BackTable / VI / Article
Innovations in Cerebral Aneurysm Management: From Concept to Reality
Olivia Reid • Updated Jan 22, 2025 • 32 hits
Dr. Alim Mitha documents the pivotal steps in his journey so far as a medical device entrepreneur working on a new biodegradable flow diverter for cerebral aneurysm managment and treatment. From concept to prototype, from pre-clinical studies to clinical trials, Dr. Mitha shares his first-hand experience with the trials and tribulations of medical device development, underscoring the role of collaboration and resilience in driving innovation.
This article features transcripts for the BackTable Podcast. We’ve provided the highlight reel here, and you can listen to the full podcast below.
The BackTable Brief
• Initially contemplating the utilization of a laser-cut stent, the decision was made to transition to a braided flow-diverting stent for the biodegradable flow diverter, due to the limitations posed by polymers in laser-cut stents.
• Both collaboration and resilience are key characteristics of aspiring medical device entrepreneurs, due to the intricate design, clinical trial, and marketing processes involved.
• The continued importance of in-vivo models in refining prototypes and advancing product development, facilitating rapid iteration and enhancement, complements the indispensable role of clinical trials in generating evidence and striving for widespread adoption.
Table of Contents
(1) Concept, Design & Prototyping
(2) Resilience & Collaboration
Concept, Design & Prototyping
Creating a prototype to present to potential investors stands as a pivotal step in the device development process. Dr. Alim Mitha, in collaboration with Dr. John Wong, explored various concepts, initially considering a laser-cut stent before opting for a braided flow-diverting stent for the biodegradable flow diverter. This transition was prompted by the constraints of polymers in laser-cut stents and the benefits of the braided design's flexibility and suitability for navigating tortuous anatomy. The iterative journey of biomedical device development underscores the significance of academic affiliations and laboratory access for prototyping, as challenges persisted in material selection and delivery system design post-stent selection.
With the successful creation of a functional prototype, the device advanced into clinical trials. First-in-human trials prioritize technical feasibility, safety, and efficacy assessment, paving the way for future larger efficacy trials. Early outcomes showed promise, with absorbable stents offering multiple advantages, such as favorable mechanical properties and the capability to re-treat persistent aneurysms. Nonetheless, there are potential challenges in clinical adoption, including the necessity for a physician mindset shift toward absorbable stents and the demand for user-friendly features.
[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.
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Resilience & Collaboration
Collaboration and resilience are essential attributes for aspiring medical device entrepreneurs, given the intricate design, clinical trial, and marketing processes involved. Dr. Alim Mitha advocates for embracing the entrepreneurial journey and finding fulfillment in the prospect of enhancing patient outcomes. The convergence of medicine and biomedical engineering, exemplified by the development of the biodegradable flow diverter, underscores the significance of interdisciplinary collaboration in propelling innovation.
Looking ahead, in-vivo models will retain their pivotal role in refining prototypes and propelling product development forward, facilitating swift iteration and enhancement. Furthermore, clinical trials serve as indispensable tools for generating evidence and striving for widespread adoption of biodegradable flow diverters in neurointerventional suites globally. Excitement and optimism surround the forthcoming trials, with great expectations for their potential to positively impact patient care and outcomes.
[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.
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.
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