S4, E7: From the Archive – Revisiting Synchron and Brain-Computer Interfaces, 2 Years Later

[00:00:01] Hi everyone and happy July. As most of my listeners are in the Northern Hemisphere, summer has finally arrived, perhaps a little too intensely for many of us enduring some of the recent heat waves, but I hope everyone is staying cool, hydrated and getting into holiday mode, whether it's a vacation or a staycation. That being said, as things begin to slow down a little over the next month or so, I thought I'd revisit another episode from the Raising Biotech archive.

[00:00:31] Today's episode takes us back to November 2023, back when I started the Raising Biotech podcast. I explored the story of Synchron, a company developing implantable brain-computer interfaces or BCIs to restore communication and digital independence for people living with severe paralysis. To be honest, this was one of the most in-depth episodes I've ever produced.

[00:00:57] Alongside founder and CEO, Dr. Tom Oxley, I also spoke with Synchron's Chief Commercial Officer, Kurt Hagstrom, as well as two leading experts in the field, Dr. David Petrino and Dr. Elad Levy, who were incredible in giving the broader perspective on the technology, its clinical potential and the challenges that still lie ahead. Back then, when I recorded this episode, brain-computer interfaces still felt very science fiction-y.

[00:01:27] There were only a handful of companies pursuing implantable BCIs, Synchron had raised a pretty impressive sum of $145 million, Elon Musk was also getting involved in the space, and while the technology was incredibly exciting, it still felt like something that belonged firmly in the future. Listening back now, what stands out to me isn't just how Synchron has progressed. It's how dramatically the landscape around it has also changed.

[00:01:56] As AI becomes a much more natural interface, the idea of controlling technology directly through thought no longer feels quite as futuristic as it did just a few years ago. Synchron itself has continued to quietly execute. The company has advanced its clinical program, strengthened partnerships with major tech companies, and has raised further funds to support pivotal studies and prepare for commercialization. So we're not doing any updates in this episode.

[00:02:25] I just wanted to replay this conversation as a bit of a snapshot in time. A chance to listen again to how one of the pioneers in this field thought about the opportunities and challenges before brain-computer interfaces became more of a mainstream and realistic proposition. So whether you're taking some well-earned time off this summer, catching up on episodes you've missed, or simply just want to listen to this episode again, it's a good one. Here's my original conversation with the Synchron team and experts from 2023.

[00:02:55] Stay tuned until the very end. I'll briefly recap a few of the key milestones since the episode was first released. I hope you enjoy the episode. Welcome to the Raising Biotech podcast. I'm your host, Sarani Fernando, and thanks for tuning in. This podcast has a mission of exploring biotech's raising impressive funds to develop ambitious medical breakthroughs. I speak with CEOs and founders to get origin stories, missions, and future visions for the company.

[00:03:25] And I also talk with relevant medical and industry experts to get more context on the company's potential to really make a difference in healthcare. Today, we're talking to Synchron, not technically a biotech, but nonetheless a medtech making big strides in healthcare with its implantable brain-computer interface, or BCI, that allows patients with motor impairment to communicate via a computer or device.

[00:03:50] The company has raised a total of $145 million since inception, and that's been able to give them some meaningful clinical trial results and a lead position in a very hot BCI space. As Synchron edges closer to a potential first-in-class market approval, it will look to raise further funds. In this episode, I speak with four guests. From the company, we have CEO and founder, Dr. Tom Oxley, and Chief Commercial Officer, Kurt Hagstrom.

[00:04:20] And they'll give us Synchron's story, current endeavours, and future path forward. I'm also speaking with two principal investigators on Synchron's US trials, Dr. Elad Levy from the University of Buffalo, and Dr. David Petrino from Mount Sinai Health System. They'll give us a bit more context on the potential healthcare impact of the BCI technology and future challenges ahead. I hope you enjoy the episode.

[00:04:45] A few months ago, I surrendered the password to my Twitter account to let a person with paralysis tweet out their thoughts. That was Synchron's founder and CEO Tom Oxley giving his TED Talk in 2022. The person with paralysis was Philip O'Keefe, a sufferer of ALS who can't use his fingers to type. He created the following tweets just by thinking it.

[00:05:12] Hello world. Short tweet. Monumental progress. No need for keystrokes or voices. I created this tweet just by thinking it. My hope is that I pave the way for people to be able to tweet through thoughts. Phil. Synchron's implantable brain-computer interface, or BCI, is a medical device that gets implanted into the brain. It detects the intention to move muscles and then converts that into a wireless signal that can take over the control of a computer.

[00:05:40] So people suffering from any number of diseases that impacts a person's ability to use their fingers can now manipulate the screen through direct thoughts coming out of their brain. This technology could be potentially life-changing for people suffering from murder impairment. And Dr. Tom Oxley is at the cusp of realizing that vision. Hi Tom. Thanks for joining the podcast. Hi. Thanks for having me. Tom has a super interesting story.

[00:06:06] He's a unique breed of practicing physician, active university professor, and budding medtech entrepreneur all at the same time. He's been straddling those identities for over a decade after getting that light bulb moment for Synchron in Australia. So I was super curious to delve into his backstory. So I'm a neurologist, but I had read about brain-computer interfaces before I went into neurology. I was thinking about doing psychiatry and I was doing a bit of psychiatry.

[00:06:34] And then around that time, I read Lee Hochberg's paper in Nature in 2006, 2008 I read it. And I remember just having that moment where you're like, okay, this is something different. This is next level. This is going to change some pretty fundamental assumptions we make in medicine about what's possible. If you can bypass an entire portion of the nervous system in the body, you can bypass a range of conditions.

[00:06:59] And then the other thing I think that got me really excited was that in order to make a BCI work, you have to reverse engineer the way the brain works. And so I think it was getting to this core curiosity I have and had with the origins of consciousness and how the brain works. What's happening in the brain to manifest the sensation of consciousness?

[00:07:20] So with those conceptual and intellectual ideas, Tom also started to get excited around another fast-growing area of medicine called neurointervention, also known as endovascular neurosurgery or interventional neuroradiology. So like the cath lab is where you'd get a stent put in for a heart problem, like a heart attack. And it was starting to emerge in the brain. It started around the turn of the century with treatments for ruptured aneurysms, putting coils in blood vessels.

[00:07:50] And then in 2015, there was a breakthrough that you could now pull out big blood clots that cause strokes, which is basically plumbing, like opening up the blood vessel that's blocked to reestablish blood flow that causes a stroke. So while that was happening, I had a vision that if you could use the plumbing as an entrance into these kind of natural highways of the brain, if we could solve using that as an avenue to lace electronics into the walls of the blood vessel that sit within the brain,

[00:08:20] then, you know, that combination of things might be a solution for brain-computer interfaces. That was kind of the vision back in 2010. And it's just kind of held firm. So with this light bulb idea, Tom drafted a patent for his BCI in 2010, established the company in Australia in 2012, and moved to the US in 2015 to finish his interventional neurology training. Then shortly after that, the company raised its Series A of $10 million

[00:08:48] from neurotechnology investors and DARPA, the US Department of Defense. Now, knowing how hard it is for biotechs to launch in Australia, I asked Tom if he tried to raise money locally, or if he just knew from the start that he'd need to pitch this idea to US investors. Yeah, no, I learned the hard way. I heard from pretty much every investor in Australia that all the reasons why this wouldn't work or why it wasn't fundable. So I, you know, kind of cut my teeth trying to raise capital in Australia.

[00:09:17] And I spoke to like a lot of investors in Australia. And then I came to New York and I, within six months, I had the deal kind of almost done. So it's just totally different world. Now, to be fair, like all that practicing in Australia was probably really important, but the risk appetite was what was so obviously different. US investors were so much more willing to take on risk, but they needed to see that there was huge potential upside as well.

[00:09:45] Whereas in Australia, it was all like, well, we don't really, we're not going to value that huge upside. We're much more focused on the risk. And like, you know, we need to have a win every three bets, whereas venture capital in the US is willing to take a win every 10 bets. So after that, Synchron did what's called a Delaware flip, taking it out of Australia and establishing it as a US company. A few years later, Synchron raised $40 million in June 2021. And that was led by Kostler Ventures.

[00:10:14] And as the company started to ramp up clinical trial plans, it raised a Series C of $75 million in December 2022. And that was led by Arch Venture Partners, leading a long list of top healthcare and tech investors. Those bets have paid off as Synchron's already well into the clinic and somewhat ahead of the pack of six promising companies in the BCI space, including Elon Musk's Neuralink and BlackRock Neurotech.

[00:10:40] So of the six companies right now who are heading towards commercialization, we are the only company that has submitted a company-sponsored clinical trial and vertical stack product for approval. Now, there have been elements or components that have been tested in certain academic experimentations proving that this is working. But in terms of a company actually presenting to FDA and saying, here's our product, here's the clinical trial we want to do, and this is a submission for commercial approval,

[00:11:10] but going into human testing, we're the only one there. Now, there are some fundamental similarities and differences with Synchron's BCI versus its competitors, and that may somewhat speak to its lead in the so-called BCI race. How we're similar, and there are now six companies that are all in the field that's emerging that's pretty now generally accepted as called implantable brain computer interface. Just to jump in here, that's an important distinction

[00:11:38] with the word implantable. As if you Google BCI, that's being used quite loosely and many BCIs are not actually implanted into the brain. But out of the ones that are actually implants, there's a small pool of companies in the space. And there are a couple of different colours of types of implants. Some you have to remove the skull to get into the brain. Some you penetrate directly into the brain tissue. Some sit on the surface of the brain. We sit in a blood vessel on the surface of the brain, but we're still on the inside of the skull.

[00:12:08] So I guess the difference between us and all the other groups is that we don't cut the skull. Every other group is cutting open the skull, so it's open brain surgery. That does get you closer to the brain. So we are the furthest away from the brain of all the implantable BCI companies. And there is a scale of how close you can get down to individual neurons. The benefit of Synchron's technology is that it's theoretically safer, which still needs to be proven out. But Tom said that there's a good sense of how safe it is to put stents into the brain,

[00:12:37] because the literature exists. It's a device that goes in a blood vessel in the brain. It can't block the blood vessel. It can't migrate. And it can't cause any harm, which is sort of an obvious thing to say. So the way that we've contemplated safety hasn't really changed since our first study in 2019. So that's good, because it means that we can look all the way back and we feel like we've been capturing the right information to prove that the system is safe. The downside with what we're doing

[00:13:06] is that you don't get quite as close to the brain and you don't get as much information. Now, I have a belief that we can solve that and eventually become equivalent in terms of how much access we can get to the brain. But we've made a decision to draw a line in the sand with a particular design that we think is the right level of safety for the first iteration of this technology. And we're getting results that give us confidence. The way I think about it is the more complexity you have in these systems,

[00:13:35] the more potential you have to be able to have the system perform at a high standard. But the greater challenge you have in creating a flaw for every single user to achieve a certain level. And by that, I mean, can the system work immediately? How easy is it to use for the patient? How robust is it? Does it work out of the box? BCI has been in the academic domain for decades and the ability to decode the brain and to have it work on its own has been a great challenge.

[00:14:05] So we've made a bunch of design decisions that I'd broadly categorize as like focusing on simplicity and elegance. Synchron already has some published data on their very first study in four patients in Australia called the SWITCH study. And that was published in JAMA Neurology earlier this year. That technology is now about, I don't know, six years old. So there's a lag with what we've published and where we're at with our current technology and things are moving quite quickly. But you can get a sense of like,

[00:14:35] we were very focused on safety back then, but you could see the device was beginning to send out the signals that were useful to send control inputs that were meaningful for patients. But we've made a huge amount of progress since then. He said the study gives a good sense of safety and the technology's early efficacy capabilities. And the company will wait to see the fruits of its more advanced technology in its ongoing US-based feasibility study. That's called the COMMAND trial, which has completed enrollment of 10 patients.

[00:15:03] We'll be probably publishing the results of our current feasibility study towards the end of next year. And then hopefully at the beginning of 25, we'll be moving into a pivotal trial. And then hopefully that takes a year or so. And then we're getting ready for submission to the FDA for market approval and hopefully on track to be a first in class market approval for an implantable BCI. I spoke with Dr. Elad Levy, professor and chair of the Department of Neurosurgery

[00:15:33] at the University of Buffalo Jacobs School of Medicine and Biomedical Sciences. And he's also the co-director at the Collider Health Stroke Center. He's participating in Synchron's US command trial as a principal investigator. My career was really spent focusing on delivering technology or delivering devices through the body's natural highway system, the blood vessels, arteries, and then eventually veins. Dr. Levy played a major role in the 2015 breakthrough studies

[00:16:02] of surgical thrombectomy. That's stopping a stroke in progress by removing blood clots. And that's what Tom was speaking about earlier as some of his early inspiration for a brain implant that sits in the blood vessels. So it was sort of a very natural synergy when Synchron was developing a brain computer interface that was delivered transvascularly or through the body's highway system, through the veins, into the brain. We spoke a bit about the patient population

[00:16:29] that can really benefit from this type of technology and its clinical impact for patients who've lost muscle control but are cognitively intact. So initially the trial was based on patients who had ALS or Lou Gehrig's disease where, as you know, Stephen Hawking would probably be one of the most famous people who had that disease where people start losing function of their muscles. And eventually they can't even do the activities of daily living. So can we connect these people

[00:16:58] to the outside world again through brain-computer interface? And then the computer can dial a phone, send a message, I'm thirsty, I want to go outside, even power a wheelchair. He said the clinical impact of this BCI giving patients independence and connectivity to the world can extend to a multitude of conditions. We enrolled the first stroke patient, somebody who had a brainstem stroke. Cognitively they were intact, they can think beautifully but they just could not connect the brain

[00:17:28] with their body. So they were trapped inside their body. So we can identify patients who have severe disabling strokes where they've lost muscle control but cognitively they're still intact. ALS, which again is a disease that affects the ability to use muscle coordination or spinal cord injury. We're talking about a very substantial population globally that may benefit from BCI and certainly will expand that population

[00:17:57] as a sophistication of BCIs develops over time. I also spoke with Dr. David Petrino, Director of Rehabilitation Innovation for the Mount Sinai Health System. He's a neuroscientist and physical therapist and all about using technology to improve patient quality of life. He's also participating in Synchron's US command trial and also helping the company to design its final pivotal trial. When I met Tom and reviewed the Synchron technology, one of the things that I was immediately

[00:18:27] very impressed about was the fact that they were a technology that had gone straight to independent home use in early use trials. For me, that's something that was really important and compelling because I've seen the field of BCI emerge and sort of be at this clinical forefront for a very long time where we've made a lot of promises about the potential for BCI technology, but patients have not really benefited all that much from what we've said

[00:18:55] has been the clinical potential for the last 30 years, really. He said the focus of other BCI companies over recent decades has been more on the lines of very complex technologies that offer a high degree of freedom like controlling robotic arms or legs. But patients with neurodegenerative diseases and severe disability have many needs other than just moving around from room to room. Being able to communicate with a loved one or caregiver could be life-changing for these patients and it's a reality

[00:19:23] that seems much more within reach right now with Synchron's technology. We're not interested in the hype. We're interested in, okay, when everyone's gone away, can you actually use this thing and is it going to have an impact on your life? So when I saw that there were patients that were independently using the technology at home, it got me excited and, you know, I wanted to work with the company to help accelerate their path. Speaking to Dr. Levy and Dr. Petrino, I was curious to get their take on the data so far,

[00:19:52] particularly their own perspectives on the risk-benefit profile of the device. The outcome of the switch trial was encouraging that we didn't see any adverse events that were directly related to the implant itself. Dr. Petrino said he's seeing a similarly encouraging safety profile in the U.S. COMMAND trial, which is particularly significant considering patients are on ventilators 24-7 with little mobility and who are very vulnerable to things like pressure sores

[00:20:22] and chest infections. So certainly everything has a risk profile, right? The risk of anesthesia, the risk of infection. These are fragile patients, so certainly they need exceptional medical care prior to surgery and then following surgery. But from the risk profile of delivering something minimally invasive like Synchron, certainly there are advantages when compared to open delivery where you have to make incisions and remove parts of the skull to put it back. So the smaller the exposure,

[00:20:51] the quicker the exposure, the less invasive. In general, creates a more favorable risk-benefit profile. In experienced hands, we don't believe it's technically burdensome. So with that little peace of mind for safety, the hard part for the company is designing a pivotal study that is set up to convincingly demonstrate efficacy. Now, we still, to be clear, we still don't have the perfect benchmark on efficacy, but this is something

[00:21:20] that we're still having conversations about with both Synchron and the FDA and other regulatory agencies around what precisely they would like to see. He said this conversation has never really been had to a meaningful conclusion before in terms of what it might mean to improve quality of life in someone who is severely disabled. It's just been assumed that there's a little that can be done, but the BCI field is really changing that mindset.

[00:21:49] And so CMS, Center for Medicare and Medicaid Services and SDA are both very interested now in having these conversations and talking about what endpoints we can use or even create that will help to answer that question. Certainly, they need to demonstrate improved quality of life, improved activities and independence, which in turn potentially creates a prolonged lifespan,

[00:22:18] less admissions to a hospital, overall greater health. These are metrics that would be very interesting for third-party payers. So it's clear that as Synchron designs its pivotal clinical trial, it really has to be thinking about not only regulators like the FDA, but also healthcare insurers like, for example, CMS in the US in parallel. So we also spoke with Synchron's Chief Commercial Officer, Kurt Hagstrom, a former executive from top global medtech Medtronic

[00:22:48] with 20 years of experience in the vascular devices world. Hello. Thanks for having me. Tom and Kurt actually met in 2015 at a medical conference in Australia and in 2022, they reconnected, hit it off and it was the right time and place for Kurt to join the company to steer it to commercial success. With a technology like this, there isn't a defined reimbursement pathway. There's no predicate on the market. You know, nobody's ever done this before. So you really have to start to think about reimbursement

[00:23:17] early on. And so what are those clinical endpoints that will drive evidence that this improves the health of the patients? You know, bringing in conversations early on with groups like CMS and the different payers, right? Making sure when we do go out to market that we can leverage the pathways that they have put in place for these type of breakthrough devices. But then ultimately in the long run, you know, giving the kind of evidence we need to show that this is something that can get reimbursed for those that need it. So I think that probably is one of our bigger obstacles. The road's not paved yet for us,

[00:23:47] like some other technologies that are out there. We're going to have to build the road, right? And it's certainly not going to be perfectly straight. The biggest challenge is how do you create a outcome in the study which is clinically meaningful for patients? In most of clinical medicine, you have a drug or a device that treats a particular condition where that condition is very established and there are markers of how the condition might improve. Let's say, for example, deep brain stimulation for Parkinson's disease. It goes into your brain,

[00:24:17] you turn it on, the tremor reduces and you can just see it, you can measure it so you know whether it's working. Same with drugs for Parkinson's. For brain-computer interface, you're not actually treating the underlying condition. He said they're not just narrowing down the BCIs used to one condition like stroke, ALS, multiple sclerosis or spinal cord injury. There's a whole range of conditions that stop your body from doing what you want it to do. You're treating the fact that the signals can't get out of the brain

[00:24:47] and in this case it's the control of movement but then we've constrained that further to or what about the control of the body to control your smartphone because that's such a powerful tool that you have in your pocket and it's popped up only in the last 15 years but you can do things that mean that you can remain independent if you can control your smartphone. You can call people, you can message, you can shop, you can bank, you can manage your smart home, you can manage your medications. You can do a lot of things that you might otherwise depend on other people

[00:25:16] if you lose control of your ability to manipulate your smartphone. So Synchron is right now grappling with some questions of how to build a study that proves control over a smartphone where that smartphone changes every 12 months and the road to generating evidence around a medical device like a BCI is more like 5 to 7 years. For that, Tom said Synchron is taking a leaf out of some of Dr Petrino's research to come up with a tangible measure of a meaningful benefit for patients

[00:25:46] across various conditions. He's recently published a paper you can look it up if you search for digital motor output DMO and the concept of a digital motor output is basically that you can make the selection of the item on the screen that you intended to select. Normally you and I would either move a mouse onto the item and then click it or you might touch it with your finger or there are various ways. So at a general concept if we can restore the ability

[00:26:15] of patients to make the selection of the item on the screen that they wanted we think that's the unlock. There's this term this DMO that we're now building around that we think will form the basis of this field as it starts to emerge. Now an issue that always plagues novel drugs and devices is pricing. That's something that's going to be difficult to pin down but obviously this BCI is not going to be cheap. But Dr. Petruno said that having an idea or notion that a technology is reimbursable

[00:26:44] and saving healthcare costs in the long run is important to have from the start. In terms of market access we always want to support technologies that have a good safe basis for getting reimbursment. We don't want technologies that are just going to be only available to a subset of people who can afford to pay out of pocket for them. Dr. Petruno said that while he's by no means any pricing expert there are some ideas on what we could expect a BCI to cost. If we look at other augmentative

[00:27:14] communication technologies covered by CMS things like you know a Tobii eye tracker which you know hopefully this technology can supersede there's a sort of a reimbursement rate of around $40,000 for a technology like that one would hope that a technology like this could probably get to the point somewhere in the neighborhood of under $100,000 is sufficient to reimburse the cost of the implantation in the patient. He said that if the mastery and home use of Synchron's BCI

[00:27:43] leads to patients being able to inform care teams about their health status this can lead to better health outcomes for patients and in turn lowers overall healthcare expenditure on that patient. That initial cost is definitely recouped in a reduction in hospitalizations a reduction in medication use and so on and so forth. Dr. Levy said he expects the space to be a bit like the advent of flat screen LCD TVs initially very expensive but with time

[00:28:13] and competition the price dramatically reduced and it became more accessible. What we will be doing in five years certainly will not resemble what we're doing today but we don't get to do what we do in five years without doing what we're doing today and you know there may be a time when these different BCI technologies speak to each other perhaps they're synergies perhaps they collaborate to accelerate the development of BCIs. Tom mentioned that there's a misconception that this BCI is just for paralysis

[00:28:42] or neurological conditions but the device actually has a much wider market. There are other conditions like arthropathies and cerebral palsy and many conditions where the cognition is intact but your ability to click on the screen is impaired. We think this is actually a huge problem to the level of 100 million people annually worldwide and then 5 million of those at the severe end of the spectrum who stand to benefit from this sort of technology. It's just that we haven't

[00:29:11] thought like this before because really because the smartphones have created such a huge potential of functionality that if it's lost you know we take it all for granted. So the market in a sense has been created on account of the technology boom and then you look backwards and say okay well what are all the conditions that stop you being able to use technology and BCI fits into that gap. If successfully reimbursed Synchron's minimally invasive stentrode

[00:29:41] has some potential advantages with marker penetration and with getting it out to the masses of patients that need it. So with the traditional delivery of BCIs that require craniotomy only neurosurgeons will be able to do this. With the transvascular delivery of Synchron's stentrode Dr. Levy said that neurosurgeons will be able to do this trained endovascular neurologists will also be able to do this as well as endovascular radiologists. So there are three specialties

[00:30:10] that train in the deliveries of technologies through the body's vascular highways neurosurgeons neurologists and radiologists so just alone you have already a larger pool of physicians that can deliver this versus the traditional craniotomy which is only neurosurgeons. With his commercial hat on Kurt sees this as a massive plus for Synchron. It's very scalable there's over 2,000 physicians today in hospitals that we could get up and running to be able

[00:30:40] to do this type of implant so that's a very different approach than having a very select few physicians that could do the procedure or an expensive robot to do so because a lot of these patients can't travel everywhere they have motor impairment and being somewhere that they have accessibility to the technology in their local hospital or academic centre is critical. As Synchron has a lot of plans ahead Tom and I talked about financing and where its recent financing of 75 million

[00:31:09] back in 2022 takes them. We raised 75 million and we already had about 20 in the bank so we were lucky we raised at a really hard time and we are being pretty frugal. We think we are going to last until the beginning of 2026 with our current run rate. This round of financing was to get out of the early stage and into the late clinical stage and launch this pivotal trial. So we think that by the beginning of 2026 we will have a trial up and running and we'll

[00:31:39] have some proof points that we're on track and we've got a commercially scalable product and it's now in human testing and we're on a pathway towards a first-in-class approval and then we're getting ready for commercial scale and launch which is going to be super exciting. I asked Tom if he had any ballpark on what Synchron would need moving forward. We're not sure exactly how much yet but we're going to need another amount somewhere between 50 and maybe 75 million to get through to that PMA approval and then there's going to be a large financing for the commercial

[00:32:08] launch. We made 200 to 250 million maybe to then get ready for commercial launch and probably the other thing to say at that point, I guess we're talking about how we would raise that large round and obviously private or public financing would be possible but I think the other thing to say is it's not just a BCI company that we're building here. If you look at what happened to cardiology in the 80s and 90s, the transition from the mechanical to the electronic domain in the cardiac world with interventional

[00:32:38] cardiology into electrophysiology came with things like mapping, ablation therapies, resynchronization devices, sophisticated pacing devices. So it was the ability to both sense and stimulate through the blood vessel. That is our intellectual property position for the whole of the brain and BCI is one arm of that but we have this vision around electrophysiology for both monitoring and ablation therapies as well as deep brain stimulation. So I think by the

[00:33:07] time we're getting further down the line, we have a pipeline and pathway laid out that we think we could grow in many different directions. We're just having to stay focused right now but I think that's the potential vision for the company is neurovascular bioelectronics. You know, neurovascular bioelectronics, you know, it's a real kind of a platform play that can, you know, I think be a very, very sizable business for us. From my standpoint, you know, we're planning on building the business and a really sustainable business. One that's going to be around for a

[00:33:37] long time and a brand that's going to be around for a long time delivering amazing products. You know, the public market may make a lot of sense for us because of the, I think, potential of how we're doing things here. And so, you know, if something comes before that, strategic partnerships or whatever that may look like, I mean, again, we'll always have to see that, how that plays out. As Tom and Kurt clearly share the same preference of building the business into a multi-product, potentially publicly listed company, I did ask Tom whether a potential sale was a future possibility.

[00:34:07] How we're thinking right now, we've got this incredible opportunity where, you know, not going to say, we're going to assess every option as we go, but I think we've been working a long, long time on this and I can see huge potential and I've seen some technologies out there that have had huge potential and then didn't make it after going through an acquisition and you make a whole bunch of compromises and things get shelved and, you know, IP gets stuck. So if we had to get acquired, it

[00:34:36] would not be my chosen pathway for what I'm hoping we could be. In August 2022, Reuters reported that Elon Musk had approached Synchron to discuss a deal. And while Tom preferred not to comment on that, he did say this. His vision for where this technology can go is aligned, like he's doing this for the right reasons and I think there's some negative press around what his vision is for the company because he continues to point out of that 50-year horizon. But the reality is

[00:35:05] Neuralink are working on medical conditions that are going to have huge impact and huge benefits. So it's awesome that he's putting his time into this and what Neuralink are building is fantastic. It's just different to what we're doing. Looking into the future, Tom gives his thoughts on where Synchron might be five to ten years down the line. It's a dangerous question, isn't it? But I think on a five-year horizon, all going well, the technologies available widely across the US to patients who

[00:35:35] are in need. And it's probably just worth making the point, you know, there's this dystopian, utopian narrative that's going on with BCI where it's like, oh, what's it going to mean for society? It's like, okay, I'm not undervaluing the importance of that question 50 years ahead of time, but for right now, for the next couple of decades, this is a technology to return lost function in people who don't have any other ability to overcome their nervous system injuries. And that's a really big deal. And that's where the conversation should be focused.

[00:36:05] So that's it for another episode of Raising Biotech with a MedTech slant. This sci-fi-like innovation is much closer to reality than we'd think if everything goes well for the company. And it's going to be interesting to see how things play out, not just for Synchron, but across the BCI field. Thanks to my guests, Dr. Tom Oxley, Kurt Hagstrom, Dr. David Petrino and Dr. Elad Levy for coming onto the podcast and sharing their valuable insight and time. And thanks to you for listening in.

[00:36:35] Please remember to share this podcast with whomever you think might be interested. Follow and subscribe on Apple and Spotify to get notified of new episodes. And when you get a chance, please give us a review. But until the next episode, I'm Sarani Fernando and see you next time on Raising Biotech. Before we wrap up, here's a quick update on a few things that have happened after this episode was recorded in November 2023, about two and a half years later. Since then, Synchron has continued to move through

[00:37:04] clinical development, completing its command feasibility study, and in late 2025 announced a $200 million series de-financing to support pivotal trials and commercial launch preparations. The company also became the first brain-computer interface company to integrate with Apple's native BCI protocol, an important milestone as these technologies begin moving beyond the clinic and into the broader technology

[00:37:33] ecosystem. Meanwhile, the field has become far more active and competitive with multiple companies now in the clinic, including Elon Musk's Neuralink. The next few years should give us a much clearer picture of which approaches ultimately prove to be the safest, most scalable, and most effective. Thanks for listening, enjoy the summer, and I'll see you next time on Raising Biotech.