Latest / Vanguards of Healthcare by Bloomberg Intelligence / Synchron Can Provide Brain Computer Interface Tech Without the Brain Surgery

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Synchron Can Provide Brain Computer Interface Tech Without the Brain Surgery · Vanguards of Healthcare by Bloomberg Intelligence

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  Speaker 1: Welcome to another episode of the Vanguards of Healthcare series.
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  Speaker 1: My name is Matt Hendrickson, the medical technology analyst at
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  Speaker 1: Bloomberg Intelligence, which is the in house equity research platform
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  Speaker 1: of Bloomberg LP. We are pleased to have with us
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  Speaker 1: today Tom Oxley, founder and CEO of synchron a privately
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  Speaker 1: held healthcare company that is developing brain computer interface technology. Tom,
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  Speaker 1: thank you for joining.
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  Speaker 2: Us today, Thank you for having me, and so why
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  Speaker 2: don't we.
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  Speaker 1: Just start with the steps in your career path that
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  Speaker 1: led you to founding syncron.
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  Speaker 2: Sure so Australia Medical School Internal Medicine, Honors in Transcranial
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  Speaker 2: magnetic Stimulation Neurology Residency PhD, which was the start of
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  Speaker 2: a company back in two thousand nine eleven darper funding,
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  Speaker 2: US defense funding back in Australia, Stroke then personally clinical
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  Speaker 2: Stroke fellowship got me over to New York to then
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  Speaker 2: do a neuro interventional fellowship, and so neuro intervention has
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  Speaker 2: expanded massively over the last ten years with frompectomy and solitaril.
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  Speaker 2: The vision was was that neuro intervention would make its
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  Speaker 2: way into the functional domain and we'd see, you know,
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  Speaker 2: in the same way cardiac went from intervention to EP
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  Speaker 2: that would happen in neuro and then BCI kind of
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  Speaker 2: emerged as a thesis as I was progressing through my
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  Speaker 2: early clinical career where it seemed to be a natural
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  Speaker 2: intersection between new interventional techniques solving the craniotomy challenge of BCI.
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  Speaker 2: And so that's the origin story, Okay.
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  Speaker 1: And then it's interesting because it's interesting analogy you just
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  Speaker 1: made with the cardiology space. And just make sure I
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  Speaker 1: understand this. You're talking about, you know, a mainly invasive
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  Speaker 1: catheter for cardiology for delivering a stent, translating then into
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  Speaker 1: being able to deliver a signal with a like a
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  Speaker 1: cardiac ampleation. Is that kind of how that cardiac analogy
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  Speaker 1: progresses in the technology.
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  Speaker 2: Yeah, But the EPE catheters can do sensing and stem
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  Speaker 2: like the EP catheters that do mapping are doing a
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  Speaker 2: version of sensing, so they're mapping across a range of
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  Speaker 2: the heart to create a three dimensional electrophysiological map of
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  Speaker 2: the heart. Then they're doing ablationist therapy. But the sensing
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  Speaker 2: component is what in the brain is going to unlock
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  Speaker 2: a whole data economy within the brain. And so I
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  Speaker 2: think this is what as I've spoken to investors, this
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  Speaker 2: is what has taken a little bit for the penny
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  Speaker 2: to drop. In video is actually the one that made
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  Speaker 2: it obvious to me. In video we've partnered with came
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  Speaker 2: to us with a very clear vision that once you
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  Speaker 2: had figured out a mechanism to commercialize a device that
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  Speaker 2: generated brain data, then you can build product off the
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  Speaker 2: basis of the brain data in service of the user.
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  Speaker 2: But that's a very different basis to anything else in
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  Speaker 2: implantable neurotechnology. Right now, the industry of implantable neurotechnology is
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  Speaker 2: cochlear dbs, you know, and then there's Inspire, there's crane
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  Speaker 2: nerve implants. Primary so Metronic is now doing sensing in
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  Speaker 2: their closed loop arm of the deep brain stimulation, but
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  Speaker 2: that sensing is just in service of the stimulation parameters
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  Speaker 2: for the deep brain stimulation. BCI is primary sensing, okay.
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  Speaker 2: And so the question is which technology is going to
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  Speaker 2: scalably deliver sensors into the brain which generate data streams
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  Speaker 2: and then how do you then use the data streams
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  Speaker 2: to build product at scale? Okay?
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  Speaker 1: And maybe that's an interesting way talking about BCI or
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  Speaker 1: brain computer interface and just yep, for listeners who are
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  Speaker 1: just new to the space, and even myself in kind
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  Speaker 1: of lame in terms. What are the signals that these
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  Speaker 1: platforms are hoping to capture and then that how does
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  Speaker 1: that get translated into a data set that can be
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  Speaker 1: able to be utilized for certain cases of functionality.
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  Speaker 2: So the brain is made up of a bunch of
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  Speaker 2: neurons with different blobs all around. The different areas of
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  Speaker 2: the brain, which across the population have pretty high predictability
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  Speaker 2: on what those areas of brain do. The first wave
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  Speaker 2: of BCIs is in the domain of movement control, limb control,
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  Speaker 2: motor muscle control. So if you look at a part
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  Speaker 2: of the brain that controls muscle movement, there's a very
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  Speaker 2: predictable degree of electrical activity that can be captured in
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  Speaker 2: frequency domain and time domain, basically firing neurons causing electrical
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  Speaker 2: potential voltage changes. If you can detect the voltage changes
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  Speaker 2: and you can label that data in a way that
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  Speaker 2: you know the user is trying to perform an action
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  Speaker 2: in that case to control a muscle, then you can
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  Speaker 2: classify the signal out of the brain and use it
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  Speaker 2: and turn it into a joystick, and it would represent
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  Speaker 2: the movement control. So the first wave of BCI is
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  Speaker 2: using electrical potentials in the brain that represent movement control,
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  Speaker 2: but over time, going to different brain regions, we're going
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  Speaker 2: to label and figure out the features of brain activity
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  Speaker 2: and start to build product that represents all the different
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  Speaker 2: domains of brain activity. So they're going to cover a
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  Speaker 2: whole range of different brain conditions and solve a whole
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  Speaker 2: bunch of problems that have not been able to be
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  Speaker 2: solved up to this point.
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  Speaker 1: And it's does this feel like a kind of a
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  Speaker 1: positive feedback loop? Is the more data you get, the
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  Speaker 1: better understanding you get of these signals, which allows you
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  Speaker 1: then to collect more data in certain areas and just
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  Speaker 1: be able to build out that database over time.
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  Speaker 2: Yes. So thesis in the field in that there's an
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  Speaker 2: emerging field called NEUROAI, which posits that the pre training
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  Speaker 2: techniques that have underpinned large language models, like transformed pre
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  Speaker 2: training of large data sets where you don't fully understand
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  Speaker 2: all the rules in that data set. Training a data
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  Speaker 2: set on the basis of intracranial brain data gives you
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  Speaker 2: a foundation model of understanding how the brain works, and
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  Speaker 2: then you can post tune that model on various domains
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  Speaker 2: of brain function that represent different areas of cognition. So
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  Speaker 2: you could train a foundation model on the basis of
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  Speaker 2: scaling sensors in the brain and then use that to
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  Speaker 2: drive performance across a range of activities that the brain
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  Speaker 2: already does.
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  Speaker 1: And so one of the things you mentioned earlier was
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  Speaker 1: just creneotomy is kind of one of the ways to
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  Speaker 1: implant the BCI, and maybe this is a way to
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  Speaker 1: then introduce ourselves to your NEUROEP. What are some of
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  Speaker 1: the different methodologies for being able to pick up those signals,
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  Speaker 1: what are the different devices out there, what are the
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  Speaker 1: different procedures to implant those devices, and how does NEUROEP
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  Speaker 1: differentiate itself from that other technology.
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  Speaker 2: So, if you're a neurologist, you can do a fellowship
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  Speaker 2: in electrophysiology, but you'll primarily be working in the domain
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  Speaker 2: of epilepsy. And so maybe that's an interesting one because
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  Speaker 2: you've got neuropace out there with the responsive neurostimulation product.
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  Speaker 2: Their ability to do sensing to then predict, detect, forecast seizures,
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  Speaker 2: and then abort seizures is an example of the use
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  Speaker 2: of electrophysiological parameters that represent pathology. And then you've got
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  Speaker 2: Parkinson's disease, where closed loop features are being used to
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  Speaker 2: improve performance of stimulation. You've now got BCI where the
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  Speaker 2: use of features of motor controller used to create joysticks
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  Speaker 2: to let people who are paralyze control external products. As
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  Speaker 2: we go to different brain the next one would be speech,
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  Speaker 2: so that the next wave of BCIs are driving the brain,
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  Speaker 2: control the electrophysiological markers of speech, and then translating speech.
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  Speaker 2: And then you get into things like emotion and cognition
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  Speaker 2: and planning, and so the electrophysiological parameters of emotion would
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  Speaker 2: open up a whole new mechanism for BCIs to generate
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  Speaker 2: nonverbal communication that could overcome a whole range of conditions
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  Speaker 2: where that's a problem. What's common across all of those
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  Speaker 2: is that the electrophysiological parameters of how the brain works
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  Speaker 2: are common and preserved. So once you've built an architecture
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  Speaker 2: for decoding movement control, that will work for speech, it
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  Speaker 2: will work for motion, it will work for navigation, that
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  Speaker 2: will work for some elements of memory.
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  Speaker 1: And that kind of goes back to that positive feedback
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  Speaker 1: loop of building, collecting more data to better understand all
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  Speaker 1: the different components and then being able to build off
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  Speaker 1: of that, I.
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  Speaker 2: Think the companies that scale, but I think there's going
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  Speaker 2: to be a network effect in this industry. I think
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  Speaker 2: whichever companies can scale, burst and build this type of
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  Speaker 2: foundational model is going to have an advantage that's going
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  Speaker 2: to be hard to catch.
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  Speaker 1: Yeah, and then the other difference too. There's all the
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  Speaker 1: different functionalities, but there's also significantly different form factors that
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  Speaker 1: are being used to collect this data and be able
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  Speaker 1: to then YEP analyze this data then to create the functionality.
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  Speaker 1: How does your form factor with NEUROEP differ from some
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  Speaker 1: of the other ones that go directly to the brain.
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  Speaker 2: I love that you're calling it neuro EP is this
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  Speaker 2: new category. I love it. The major difference between us,
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  Speaker 2: the singular difference between us and every other implantable BCI
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  Speaker 2: company that's about seven at this point, is that we're
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  Speaker 2: not performing craniotomies. Okay, So craniotomy is accessing the skull
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  Speaker 2: in a neurosurgical procedure, which typically requires an or in
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  Speaker 2: a neurosurgical center, and therefore somewhat limited access around the
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  Speaker 2: country in terms of where those neurosurgical centers are, which
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  Speaker 2: has been one of the restrictions in growth of technologies
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  Speaker 2: like neuropace and cochlear and deep brain simulation. None of those.
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  Speaker 2: Cocklear I think is doing about forty thousand units per year.
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  Speaker 2: I think DVS in the US is ten thousand.
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  Speaker 1: Yeah, you hasn't really taken off the way that with
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  Speaker 1: the technology, you haven't taken off the way people were
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  Speaker 1: expecting it.
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  Speaker 2: Very effective therapies though, like responsive neurostimulation, neuropace, I think
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  Speaker 2: they're up to one thousand, one thousand cases per U. Yeah,
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  Speaker 2: so if you look at cardiac, they're kind of similar
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  Speaker 2: numbers to what was going on back in the seventies
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  Speaker 2: and eighties with thorough ecotomies or various types of procedures.
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  Speaker 2: And now with the advent of interventional cardiology techniques, those
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  Speaker 2: numbers have gone from ten to thousands to hundreds of
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  Speaker 2: thousands to now millions of procedures per year. And you
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  Speaker 2: can get a pacemaker or a stent now down at
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  Speaker 2: a secondary level hospital. So huge proliferation, and so there
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  Speaker 2: needed to be a huge market opportunity. Then there had
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  Speaker 2: to be a scalable pathway that was probably out of
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  Speaker 2: a you know, teaching hospital, out of an or and
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  Speaker 2: so I think that's what's coming in neuro and so
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  Speaker 2: neuro intervention has been now poised with the breakthrough in
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  Speaker 2: twenty fifteen of thrombectomy now getting into getting close I
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  Speaker 2: think to hundreds of that maybe like getting on about
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  Speaker 2: one hundred thousand cases. So there's been a huge proliferation
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  Speaker 2: now of neuro interventionists, not as many as interventional cardiologists,
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  Speaker 2: but actually getting the slow is high and kind of
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  Speaker 2: a view that well, there's going to be now a
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  Speaker 2: saturation of that field. But that's not what happened in cardiac.
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  Speaker 2: You then moved on to the next kind of innovation,
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  Speaker 2: and I think the next wave of the major paradigm
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  Speaker 2: shift with your intervention is going to be EP. It's
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  Speaker 2: going to be functional or electrophy. Why because the brain
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  Speaker 2: is this huge electrical organ and we've now solved getting
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  Speaker 2: to tiny blood vessels and beyond, and there are new
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  Speaker 2: techniques coming that are going to continue to break down
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  Speaker 2: the horizons.
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  Speaker 1: Is what you're providing a stent equivalent of what maybe
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  Speaker 1: was an open procedure for you know, if we think
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  Speaker 1: about cardioc cardiovascular and we're thinking about open heart surgery
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  Speaker 1: versus a stent, is that what we're thinking, is that
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  Speaker 1: how we should think about what synchron is doing. They're
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  Speaker 1: providing a stent form of that BCI that instead of
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  Speaker 1: having to open up the brain, you can just deliver
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  Speaker 1: that stent.
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  Speaker 2: It's exactly what it looks like to me, and that
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  Speaker 2: the same was in near intervention for aneurysms. It was
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  Speaker 2: open clipping or it was into vascular and I think
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  Speaker 2: that's what's happening in BCI. So there's a bunch of
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  Speaker 2: craniotomy based open basi companies and then there's an interventional approach.
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  Speaker 1: One of the things that's interesting, you know, we're talking
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  Speaker 1: about the data collections, the signals that we're picking up.
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  Speaker 1: How does a stent that gets delivered, how do you
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  Speaker 1: go about deciphering those signals through a stent through it's
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  Speaker 1: delivered through an artery or right, it's delivered through an artery,
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  Speaker 1: not a vein. Right, it's a vein. A vein, Okay, Yeah,
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  Speaker 1: that's it's just you know, it's always good to know that, well,
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  Speaker 1: it's delivered into the vein. How do you decipher those
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  Speaker 1: signals from the brain, because you know, it's got to
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  Speaker 1: be translated somewhat from the brain through the vein. How
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  Speaker 1: have you been able to build your platform, your foundational
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  Speaker 1: model to be able to detect those.
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  Speaker 2: So there are three types of signal penetrating needles into
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  Speaker 2: the brain. Yep, that's what neuralink paradromics are doing. Deeper
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  Speaker 2: in simulation, there's subdural ECoG which if you remember the
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  Speaker 2: epilepsy workups for the grid arrays they called grid arrays
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  Speaker 2: used for epilepsy detection. There's a range of there's some
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  Speaker 2: BCI companies coming up that are doing subdural so flat
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  Speaker 2: arrays on the surface of the brain that don't penetrate.
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  Speaker 2: That's a subdeol ray. And then you've got endovascular so
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  Speaker 2: the end of vascular. The blood vessel then sits on
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  Speaker 2: top of the brain, So you put sensors in the
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  Speaker 2: wall of the blood vessel that's sitting on the top
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  Speaker 2: of the brain. So it's one step removed from subdural
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  Speaker 2: in that there is a blood vessel there and the
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  Speaker 2: little blood vessels sit right on top the bigger blood
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  Speaker 2: vessels have a bit of a thicker water.
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  Speaker 1: Okay, so the vessels are are touching the.
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  Speaker 2: Brain, they're sitting on the brain. Ye, Okay, So penetrating arrays,
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  Speaker 2: record spikes, ECoG, subdriller rays ECoG or local field potentials,
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  Speaker 2: and the end of vascular as a version of that.
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  Speaker 1: Yeah, so basically you're able to get that data that way.
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  Speaker 1: We've kind of been skating in kind of the obvious answers.
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  Speaker 1: But you know, when you do such an endovascular approach,
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  Speaker 1: how does that eliminate some of the side effects of
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  Speaker 1: you know, we talked about the needles into the brain
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  Speaker 1: or even the subdural It just walk us through some
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  Speaker 1: of those side effects that those other options may have
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  Speaker 1: on those patients.
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  Speaker 2: Well, I think craniotomies are pretty well tolerated. Depending on
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  Speaker 2: the size of the craniotomy will dictate how long your
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  Speaker 2: recovery would be. I don't think you know, spending an
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  Speaker 2: extra day or two in hospital to recover is not
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  Speaker 2: probably what limits the scale of those techniques. I think
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  Speaker 2: it's the the reimbursement economics and the availability of o
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  Speaker 2: R in a very kind of resource poor environment with
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  Speaker 2: ors in hospital. Gotcha, and I believe there are waitless
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  Speaker 2: for dbs out to six to nine months. Hospitals are
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  Speaker 2: struggling to make money on the DBS cases.
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  Speaker 1: Yeah, and I think That's what you're saying, is that
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  Speaker 1: all these other cases and it goes back to just
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  Speaker 1: doing an end of vascular approach. The turnover is much higher,
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  Speaker 1: and you'll be able to get more patients done in
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  Speaker 1: their own day. And I mean expecting you to do
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  Speaker 1: I mean eventually at some point probably you can be
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  Speaker 1: able to do dozens of patients per day. But when
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  Speaker 1: you think about these stent deliveries, you can do a
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  Speaker 1: stent in an hour type of capability versus an open
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  Speaker 1: heart surgery is hours and hours to be able to exactly. Yeah.
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  Speaker 2: So then you get to they get to the economics
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  Speaker 2: of it, and I think the closest corollary I can
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  Speaker 2: think of with an end of vascular BCI is the
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  Speaker 2: cardiac pacemaker. Because it's an electrode. It gets put in
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  Speaker 2: a vein, takes an X ray. You do it an
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  Speaker 2: interventional suite. It's left in, it's permanent, it's got a battery.
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  Speaker 2: So there's a history of reimbursement that supports active plannables,
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  Speaker 2: but now you're doing it in an interventional suite. So
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  Speaker 2: I think it's that the economics point to it being
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  Speaker 2: a very potential large industry.
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  Speaker 1: Why don't we we can talk about reimbursement in a
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  Speaker 1: little bit, but you know, let's just start with the
• 17:16
  Speaker 1: path to get to approval for uzen. You know you
• 17:20
  Speaker 1: have currently the Command Early Feasibility Study. What is that
• 17:25
  Speaker 1: designed to highlight?
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  Speaker 2: The strategy in the studies is to create a stable
• 17:33
  Speaker 2: sensing platform that we can then build a training regimen
• 17:38
  Speaker 2: for the users to turn on the software onboard and
• 17:42
  Speaker 2: then learn how to navigate and select a cursor on
• 17:45
  Speaker 2: a screen to be able to control devices that will
• 17:49
  Speaker 2: improve independence. So there has not yet been an approved
• 17:54
  Speaker 2: product in the field, so and there's no validated metric
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  Speaker 2: for independent use of a BCI. We're working with the
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  Speaker 2: FDA to try to clarify what an endpoint would be
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  Speaker 2: that represents clinically meaningful efficacy and which is going to
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  Speaker 2: be reimbursable. And the thing that we're really zeroing in
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  Speaker 2: on is the improvement of independent in the lives of
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  Speaker 2: the users. And this is predominantly severely motor imped patients
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  Speaker 2: such as with als neurodegenerative disease who've lost the ability
• 18:26
  Speaker 2: to navigate with their digital devices. Okay, so it replaces
• 18:32
  Speaker 2: the use of your hands or your voice to type
• 18:34
  Speaker 2: or to push a cursor around a screen. And we're
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  Speaker 2: actually targeting working with Apple products for the first approval, okay.
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  Speaker 1: And so that's actually one of the interesting things because
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  Speaker 1: you guys did have a press release about your partnership
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  Speaker 1: with Apple. What did the details entail with that partnership
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  Speaker 1: and what are you hoping to have the patients be
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  Speaker 1: able to do.
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  Speaker 2: We are using the Apple Accessibility platform to as a
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  Speaker 2: kind of back end to send our joystick control signals
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  Speaker 2: to push the curse around the screen on the Apple device,
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  Speaker 2: because they have a mechanism to enable all sorts of
• 19:15
  Speaker 2: inputs to come in. So part of that journey with
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  Speaker 2: Apple has been to work alongside them developing the first
• 19:22
  Speaker 2: Bluetooth protocol for BCI control of products. So that's now
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  Speaker 2: released in the Apple Developer Kit. And it's interesting because
• 19:35
  Speaker 2: Bluetooth profiles they called HID Human Interface Device HID profile.
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  Speaker 2: There's a mouse one, there's a keyboard, there's an eye
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  Speaker 2: tracking HID profile, and there's now a brain BCI profile
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  Speaker 2: and it's it's becomes a sandbox for developers for BCI
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  Speaker 2: companies to send signals with a kind of pre agreed
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  Speaker 2: cal where the device recognizes that's coming from the brain
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  Speaker 2: and there's now you know what, you're kind of constrained
• 20:08
  Speaker 2: with the mouse and your fingers because you can't change
• 20:11
  Speaker 2: your inputs from your hand. But now the BCI companies
• 20:14
  Speaker 2: will be able to continually create new inputs and use
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  Speaker 2: this profile over Bluetooth too as a kind of a
• 20:20
  Speaker 2: standardized language to work within. So it's super interesting and
• 20:27
  Speaker 2: it's hopefully going to become a new industry standard.
• 20:29
  Speaker 1: So is this part of the learning process that we're
• 20:32
  Speaker 1: talking about with the you know, early feasibility study, your
• 20:34
  Speaker 1: conversation with the FBA. Are these just kind of the
• 20:39
  Speaker 1: back and forth as you try to, you know, figure
• 20:42
  Speaker 1: out the best program for the Bluetooth capabilities and you
• 20:48
  Speaker 1: kind of what have been the FBA's initial kind of
• 20:52
  Speaker 1: comments and feedback about this development.
• 20:55
  Speaker 2: Yeah, I think in order to get commercial approval you
• 21:01
  Speaker 2: have to conduct a pivotal study that demonstrates safety and efficacy.
• 21:06
  Speaker 2: So safety is pretty straightforward, like you know, how to
• 21:10
  Speaker 2: assess safety. Efficacy is not as obvious because to get
• 21:15
  Speaker 2: into a pivotal you have to have identified a metric,
• 21:20
  Speaker 2: understand the spread of the metric, understand which patient population
• 21:23
  Speaker 2: will respond to that metric, and have it validated and repeated.
• 21:28
  Speaker 2: So the back and forth you mentioned, Yes, that's been
• 21:30
  Speaker 2: the nature of the is that we build the product,
• 21:33
  Speaker 2: we go and test it, we get to a certain
• 21:34
  Speaker 2: level of function, we realize we have to do a
• 21:36
  Speaker 2: bit more, and this back and forth, and part of
• 21:40
  Speaker 2: that has been ramping up of the manufacturing to make
• 21:43
  Speaker 2: the platform stable. Every time you make a little change,
• 21:46
  Speaker 2: though we've got hundreds of components. Every time you make
• 21:48
  Speaker 2: a little change, the FDA wants a bunch of testing
• 21:51
  Speaker 2: to make sure it's safe. So you know, if you
• 21:55
  Speaker 2: look at if you look at all a Class three
• 21:57
  Speaker 2: you know, look at Inspire, look at SONICX, look at
• 22:01
  Speaker 2: those successful Class three companies, they've all gone through a
• 22:04
  Speaker 2: set Point more recently. I think set Point had three
• 22:08
  Speaker 2: feasibility studies and the lead into the pivotal. So we're
• 22:11
  Speaker 2: trying to get there as fast as we can. We've
• 22:12
  Speaker 2: just finished our second study and we're now planning our third.
• 22:17
  Speaker 2: We've just hit a pretty major design freeze with the
• 22:20
  Speaker 2: DVT with what we believe will be a commercial grade system,
• 22:23
  Speaker 2: So we're excited about that and we're now working towards
• 22:26
  Speaker 2: the clarification of what that efficacy is to then enter
• 22:30
  Speaker 2: into a pivotal study. And part of that is standardizing
• 22:36
  Speaker 2: the pipelines with which the patients do the training of
• 22:39
  Speaker 2: the back and forth between the brain data and the
• 22:41
  Speaker 2: device to get to a certain level of familiarity with
• 22:44
  Speaker 2: the user. I know when I try and do that,
• 22:46
  Speaker 2: the curse is going to do this, and it works
• 22:48
  Speaker 2: and it's stable and I can just go away and
• 22:50
  Speaker 2: use it on my own.
• 22:50
  Speaker 1: Now. Yeah, okay, And that's interesting that you're kind of
• 22:53
  Speaker 1: getting the steps closer to the design freeze because you know,
• 22:57
  Speaker 1: in my mind and then in my background as an
• 23:02
  Speaker 1: equity analyst, yep, these reports I write, I could keep
• 23:07
  Speaker 1: improving them, editing them, but I also need to get
• 23:09
  Speaker 1: something published and out the door. As you were talking
• 23:11
  Speaker 1: about those iterations and you're talking about gains the design freeze,
• 23:15
  Speaker 1: when did you get to the point where like, Okay,
• 23:17
  Speaker 1: this is good enough, we can go ahead with this.
• 23:21
  Speaker 1: And you know, how was that decision ultimately made? I mean,
• 23:25
  Speaker 1: what was something you what were the like, the the
• 23:29
  Speaker 1: boxes that you wanted to check off before you got
• 23:31
  Speaker 1: to that that freeze.
• 23:33
  Speaker 2: I think it took a bit of time for us
• 23:35
  Speaker 2: to identify the use cases in the patient population that
• 23:38
  Speaker 2: we're really going to be life changing and which were
• 23:43
  Speaker 2: not just liked by the user, but we're going to
• 23:45
  Speaker 2: be covered by CMS. So the reimbursement part of it.
• 23:49
  Speaker 2: And even you know, the FDA has also freely admitted
• 23:52
  Speaker 2: they're like not exactly that the FDA does not want
• 23:55
  Speaker 2: to approve a pivotal trial and commercial product that's not
• 23:58
  Speaker 2: going to be reimbursable. Yeah, I would say it's taken
• 24:01
  Speaker 2: time for us to realize, you know, what I might
• 24:04
  Speaker 2: call a minimal viable product that we can build that
• 24:07
  Speaker 2: can be a category defining first market approval that's then
• 24:10
  Speaker 2: going to set the bar for what will be a
• 24:12
  Speaker 2: new industry. I'm not going to admit what that was
• 24:16
  Speaker 2: on this podcast because it will keep that close to
• 24:19
  Speaker 2: our chest for the moment. But it's not obvious because
• 24:23
  Speaker 2: people want to play chess, play games, surf the internet.
• 24:28
  Speaker 2: They're very important things and a good use case for
• 24:30
  Speaker 2: a BCI, but they're not clinically significant improvements in your life.
• 24:35
  Speaker 2: So yeah, so it wasn't that obvious with what that
• 24:39
  Speaker 2: might be.
• 24:40
  Speaker 1: Well, I mean, just say anything with a new frontier
• 24:42
  Speaker 1: and everything, it's going to take a while to learn
• 24:44
  Speaker 1: what the goalposts are before you even get there.
• 24:48
  Speaker 2: Well, what I can say is, for see a big industry,
• 24:54
  Speaker 2: how would I put it a clinical care pathway where
• 24:57
  Speaker 2: the occupational therapist plays a really critical role. Okay, there's
• 25:01
  Speaker 2: a quarter of a million occupational therapists in the country.
• 25:05
  Speaker 2: They often go out to the home, they help with
• 25:08
  Speaker 2: device connectedness, and they seem to me to be the
• 25:11
  Speaker 2: obvious partner or the neurologists and rehabilitation physician who will
• 25:15
  Speaker 2: prescribe the BCI, and then the therapist will be at
• 25:19
  Speaker 2: ot who will go out and ensure the device is working,
• 25:23
  Speaker 2: the prosthetic is working in the home and is connected
• 25:26
  Speaker 2: and will troubleshoot and will you know, I think be
• 25:30
  Speaker 2: helping the patient service the continued updates that are going
• 25:34
  Speaker 2: to keep coming on the different use cases and the
• 25:36
  Speaker 2: different training paradigms.
• 25:37
  Speaker 1: Which is interesting because you know, I follow some of
• 25:40
  Speaker 1: the mechanical thronbectomy companies out there. You know, they've done
• 25:45
  Speaker 1: a great job of creating those rhynebect tomy devices, either
• 25:49
  Speaker 1: aspiration or the step retriever just treat the acute stroke.
• 25:53
  Speaker 1: But a lot of these companies had tried to put
• 25:55
  Speaker 1: in money in to try to figure out the rehabilitation
• 25:57
  Speaker 1: side of the business, and they have been successful with that.
• 26:01
  Speaker 1: I'm not sure if that's stroke rehabilitation is something that
• 26:04
  Speaker 1: is note for you, especially because you're previous neurologist, But
• 26:08
  Speaker 1: I just felt intrigued to bring that out as a
• 26:12
  Speaker 1: connection with you know, we talk about rehabilitation and the
• 26:15
  Speaker 1: ots and the therapies and everything. I'm curious if that's
• 26:18
  Speaker 1: something that's come across your mind.
• 26:20
  Speaker 2: So rehabilitation has been a very challenging domain to secure
• 26:23
  Speaker 2: reimbursement in. Traditionally, rehabilitation therapy is to promote natural recovery
• 26:29
  Speaker 2: of the body in various ways, and so the devices
• 26:32
  Speaker 2: have intended to try to demonstrate speeding up or a
• 26:38
  Speaker 2: improvement and recovery that wasn't otherwise found. BCIs are not
• 26:42
  Speaker 2: in that category. It's in the prosthetic category, so same
• 26:47
  Speaker 2: as cochlear. So cochlear is a prosthetics, and a prosthesis
• 26:51
  Speaker 2: is a device that restores a lost bodily function. And
• 26:57
  Speaker 2: so I think that's the reimbursement pathway that's going to
• 27:00
  Speaker 2: be out for INFOBCI. But then you know, as a
• 27:03
  Speaker 2: part of your approval, you're going to have to demonstrate
• 27:05
  Speaker 2: what body part you've restored. The first wave of BCIs
• 27:09
  Speaker 2: I we're calling motor neuroprosthesis because they restore the ability
• 27:14
  Speaker 2: for motor control. As normal able body people, we execute
• 27:18
  Speaker 2: motor control with our fingers, but it's under the control
• 27:20
  Speaker 2: of the brain, and we use our fingers to do
• 27:22
  Speaker 2: things on a device that can improve our ability to
• 27:24
  Speaker 2: be independent. This prosthesis will bypass the body goes straight
• 27:29
  Speaker 2: to the device, but you have to use the device
• 27:31
  Speaker 2: for ways that improve your independence in a way that's
• 27:34
  Speaker 2: economically meaningful. And what that really means is you're reducing
• 27:38
  Speaker 2: the need for care in the community or in the
• 27:43
  Speaker 2: or in the or in a facility.
• 27:47
  Speaker 1: Gotcha. As we think about that and you're working through
• 27:49
  Speaker 1: that final design freeze, what are some of the catalysts
• 27:53
  Speaker 1: we should be looking forward over the next twelve to
• 27:56
  Speaker 1: twenty four months about Okay, they're at that step, moving
• 28:01
  Speaker 1: ahead with this, getting to the final product of having
• 28:05
  Speaker 1: my brain essentially connected to the.
• 28:06
  Speaker 2: iPhone one is the pivotal ide the letter from the
• 28:12
  Speaker 2: FDA that your pivotal trial can commence. That means the
• 28:14
  Speaker 2: FDA has agreed upon a commercially approvable system and then
• 28:20
  Speaker 2: it's execution on clinical trial reimbursement in the setting of
• 28:24
  Speaker 2: the pivotal study. This population is primarily Medicare. Yeah, about
• 28:32
  Speaker 2: eighty percent of the patients with severe paralysis are on Medicare.
• 28:36
  Speaker 2: So CMS is going to be the gatekeeperfore reimbursement. So
• 28:40
  Speaker 2: any coverage decision for a pivotal trial, I think, and
• 28:43
  Speaker 2: then payment for a patient in the setting of a
• 28:46
  Speaker 2: clinical trial is a sign that it's a de risking
• 28:49
  Speaker 2: reimbursement sign.
• 28:50
  Speaker 1: Interesting the way you describe it, and maybe I always
• 28:52
  Speaker 1: want to make sure I understand this correctly. Is that
• 28:54
  Speaker 1: traditional medical technology, you get the FDA approval, which then
• 28:58
  Speaker 1: turns into the reimbursement pathway. With CMS, this makes it
• 29:04
  Speaker 1: sound like you're actually going to possibly get some CMS
• 29:07
  Speaker 1: reimbursement simultaneously with the approval to start the clinical trial.
• 29:12
  Speaker 1: Am I understanding that correctly?
• 29:13
  Speaker 2: Yeah, there's a pathway for coverage in the setting of
• 29:16
  Speaker 2: a clinical trial called Category B IDE Okay, so you
• 29:20
  Speaker 2: can apply for that. You have to have it can't
• 29:22
  Speaker 2: be considered investigational anymore. You have to have already demonstrated
• 29:25
  Speaker 2: that the device can do something useful and you're proving
• 29:28
  Speaker 2: it out in a large scale clinical study.
• 29:30
  Speaker 1: Okay, interesting, So basically that's just an added and so
• 29:33
  Speaker 1: basically the work that you're doing now with your previous
• 29:35
  Speaker 1: early feasibility study or two is kind of the support
• 29:39
  Speaker 1: that is needed for CMS to make that a potential
• 29:42
  Speaker 1: reimbursement approval.
• 29:44
  Speaker 2: That's a strategy. Okay, yeah, okay.
• 29:47
  Speaker 1: Interesting.
• 29:48
  Speaker 2: Axonics was able to enter their IPO before their PMA.
• 29:53
  Speaker 2: They did a pre revenue IPO on the basis of
• 29:55
  Speaker 2: what they demonstrate in a clinical trial. Thebursement de risking
• 30:01
  Speaker 2: is a major thing for this space because it's all
• 30:04
  Speaker 2: very new. Exonics were not first to market in that space,
• 30:07
  Speaker 2: but they had, you know, a very successful market launch.
• 30:12
  Speaker 2: So I think for BCI, big eyes on how we
• 30:15
  Speaker 2: can d risk reimbursement to bring that forward.
• 30:19
  Speaker 1: And then just you know beyond that too. I mean,
• 30:21
  Speaker 1: we were just thinking about your strategy and we're talking
• 30:24
  Speaker 1: about the capabilities of your fingers and being able to
• 30:29
  Speaker 1: just how that go directly from the brain to the phone.
• 30:32
  Speaker 1: How else do you see that expanding over time? Because
• 30:35
  Speaker 1: you know, once again we talked about the different BCIs
• 30:38
  Speaker 1: in the market and different form factors, different functionality, different
• 30:42
  Speaker 1: targets for what they're doing. Some are also looking at,
• 30:45
  Speaker 1: you know, being able to utilize an iPhone interface. Some
• 30:48
  Speaker 1: of them are looking to incorporate almost like a spinal
• 30:51
  Speaker 1: quart stimulation to provide patients to start walking again. How
• 30:56
  Speaker 1: is it just that fragmented of a mare because it's
• 31:00
  Speaker 1: so novel that there's just multiple directions to go with
• 31:04
  Speaker 1: with the ultimate treatment options.
• 31:08
  Speaker 2: Well, I think the fact that it's fragmented is just
• 31:10
  Speaker 2: reflective of the huge amounts of capital that are coming
• 31:13
  Speaker 2: into the space. Like there's multiple top tier vcs taking
• 31:17
  Speaker 2: bets on, you know, slightly differentiated pathways to market. I mean,
• 31:22
  Speaker 2: I think did you see Merge Labs just announced, Yeah,
• 31:25
  Speaker 2: with Alex Plainer and sam Ola. Yeah. I don't know
• 31:28
  Speaker 2: if the reporting was accurate, but the reporting was is
• 31:31
  Speaker 2: that Bloomberg reporting it was?
• 31:32
  Speaker 1: I don't think it was.
• 31:36
  Speaker 2: Two hundred and fifty million dollars round and an eight
• 31:38
  Speaker 2: hundred and fifty million valuation in a seed round for
• 31:42
  Speaker 2: a BCI company. They're like AI valuations.
• 31:45
  Speaker 1: No, yeah, it does seem low.
• 31:47
  Speaker 2: Yeah yeah, yeah, So I think there's different there's different approaches,
• 31:51
  Speaker 2: lots of capital coming in. What was the question you
• 31:56
  Speaker 2: had before?
• 31:57
  Speaker 1: It was just back to like more like, how do
• 31:59
  Speaker 1: you envision BCI, oh, the future applications?
• 32:03
  Speaker 2: Yeah, yeah, So well, I think it starts out with
• 32:09
  Speaker 2: a simple joystick, which restores control of lost access to devices.
• 32:16
  Speaker 2: You know what it feels like when you lost your
• 32:17
  Speaker 2: phone or can't reach your phone, it's like ah, so
• 32:20
  Speaker 2: for people who have got permanent injury or disease, it's
• 32:23
  Speaker 2: a major, major restoration of function. Then you've got speech,
• 32:31
  Speaker 2: Like so we're going to see open AI come out
• 32:33
  Speaker 2: with a new device. I think it's going to be
• 32:35
  Speaker 2: some sort of a pendant or something. They're going to
• 32:38
  Speaker 2: jeopardize the iPhone domination. So you know, we're moving towards
• 32:41
  Speaker 2: wearables that have speech integration, so the BCI can have
• 32:45
  Speaker 2: a speech integration directly to these devices that no longer
• 32:48
  Speaker 2: have to be held. And then I think beyond that,
• 32:51
  Speaker 2: you've got physical AI integrations on the horizon with robotics.
• 32:56
  Speaker 2: So direct integrations from the BCI to physical layers mean
• 32:59
  Speaker 2: that you can start to engage in control of mechanical
• 33:02
  Speaker 2: or robots, domestic robots. So I think in general i'd
• 33:07
  Speaker 2: position it as the move away from anything that you
• 33:10
  Speaker 2: have to touch. It'll all be it can be self driven.
• 33:14
  Speaker 1: Yea, which is interesting because I understand in the medical
• 33:19
  Speaker 1: device landscape where patients who have lost all control they
• 33:24
  Speaker 1: have no other choice. But for someone like we need
• 33:28
  Speaker 1: mentioned open AI and you know, I read through The
• 33:32
  Speaker 1: Battle for Your Brain, which synchron was mentioned a couple
• 33:35
  Speaker 1: of times in there for the medical device side of things,
• 33:38
  Speaker 1: but you know that finding that balance between functionality and
• 33:42
  Speaker 1: maintaining a level of privacy because once those devices get
• 33:48
  Speaker 1: into your brain, it really could collect any data once.
• 33:52
  Speaker 1: How do you see that balance and how do you
• 33:54
  Speaker 1: see that adoption? Do you see any potential pushback? And
• 34:00
  Speaker 1: like I said, the medical devices, it's different, you're dealing
• 34:02
  Speaker 1: with patients that have no other choices. But just broadly speaking,
• 34:06
  Speaker 1: how is that balance of functionality versus privacy going to
• 34:10
  Speaker 1: be entertained in the future.
• 34:13
  Speaker 2: Yeah, so it's a huge, huge question. The first thing
• 34:17
  Speaker 2: I'll say is that when I've spoken to people who
• 34:19
  Speaker 2: are paralyzed and you ask them that question, the irony
• 34:23
  Speaker 2: is that you lose privacy once you become paralyzed. So
• 34:27
  Speaker 2: the restoration of privacy ironically comes with letting your brain
• 34:31
  Speaker 2: signals be transmitted out of your brain. And you know
• 34:34
  Speaker 2: what I mean. So, yeah, but you're right like that
• 34:36
  Speaker 2: that's first wave. I think out into the future, it's
• 34:41
  Speaker 2: a huge privacy consideration. Apple has done a really good
• 34:45
  Speaker 2: job of handling privacy on device highly secure. They barely
• 34:51
  Speaker 2: send that much private stuff from the device up to
• 34:53
  Speaker 2: the cloud. Sometimes. That's why I think serious dictation is
• 34:57
  Speaker 2: not amazing because it's like not learning from you. It's
• 35:00
  Speaker 2: not like taking your data out of the phone that much.
• 35:05
  Speaker 2: So if BCIs, when BCIs get to that point, I
• 35:09
  Speaker 2: think privacy becomes a big consideration. So I think the companies.
• 35:14
  Speaker 2: So Nita Varahane you mentioned from who wrote Battle of
• 35:17
  Speaker 2: Your Brain, she's now driving a a neuro trust index
• 35:24
  Speaker 2: and her expectation or her thought is that in the
• 35:27
  Speaker 2: future companies are going to have to have a level
• 35:30
  Speaker 2: of transparency with how they handle your data, where your
• 35:34
  Speaker 2: data goes, who you're selling it to, how to use it.
• 35:39
  Speaker 2: So there's very good transparency on that. And then you've
• 35:41
  Speaker 2: got to have very good encryption standards. Nothing's perfect, but
• 35:46
  Speaker 2: and then it's going to be it's going to be
• 35:48
  Speaker 2: assessed on the merits of what it does for the user.
• 35:51
  Speaker 2: But Nita's got an idea about making it a fiduciary.
• 35:55
  Speaker 2: So it's got to have a level of trust, the
• 35:57
  Speaker 2: sort of level of trust that you give your physician
• 35:59
  Speaker 2: or your lawyer. You're going to have to have that
• 36:02
  Speaker 2: level of trust with this technology. And you know, just
• 36:05
  Speaker 2: to finish like, this technology is under the domain of
• 36:09
  Speaker 2: the FDA. So AI right now is there's not much regulation.
• 36:14
  Speaker 2: It's bit's being driven out in society and we're trying
• 36:16
  Speaker 2: to figure out regulation.
• 36:17
  Speaker 1: Now.
• 36:17
  Speaker 2: BCI is firmly under the spotlight, under the microscope, sorry
• 36:21
  Speaker 2: of the FDA, and so I think you know, the
• 36:24
  Speaker 2: FDA is going to be held accountable if anything goes
• 36:27
  Speaker 2: wrong with these technologies, and therefore they're setting standards with
• 36:29
  Speaker 2: the companies and I'll say tell you they're very, very
• 36:32
  Speaker 2: high standards to work through.
• 36:34
  Speaker 1: So yeah, no, it's going to be interesting to see
• 36:36
  Speaker 1: how that develops over time. But you know, we talked
• 36:40
  Speaker 1: about Nina Faraheiney's book. Are there any other books that
• 36:44
  Speaker 1: you've read, either recently or a while back that has
• 36:47
  Speaker 1: influenced your trek today or you know, is a good
• 36:50
  Speaker 1: understanding of where this BCI technology can go.
• 36:53
  Speaker 2: Neuroscience is dense and there's not really unifying theory of
• 36:58
  Speaker 2: how the brain works. Jeff Hawkins is an engineer actually
• 37:03
  Speaker 2: who made the Palm pilot. He wrote a book called
• 37:06
  Speaker 2: on Intelligence maybe fifteen years ago, which basically disposition that
• 37:11
  Speaker 2: the brain is this prediction machine. Then he spent the
• 37:15
  Speaker 2: next fifteen years building a lab to try to understand
• 37:17
  Speaker 2: how the brain works. And he wrote a book that
• 37:19
  Speaker 2: he just released recently called Thousand Brains, and it's a
• 37:24
  Speaker 2: really beautiful description from a non you know lately come
• 37:29
  Speaker 2: neuroscientist from an engineering brain on how the brain works.
• 37:33
  Speaker 2: And I love it. So it has informed my thinking
• 37:36
  Speaker 2: on how to think about what the future of BCI
• 37:39
  Speaker 2: is going to look like in terms of how you
• 37:41
  Speaker 2: can get to different brain regions and record from brain.
• 37:45
  Speaker 2: So he's a very good writer.
• 37:47
  Speaker 1: Yeah, pas Se, well I got to look into that
• 37:49
  Speaker 1: as well. And well, Tom, I'm looking forward to see
• 37:52
  Speaker 1: how these developments play overtime because this seems like, like
• 37:54
  Speaker 1: I said, the next frontier in medtech and in general.
• 37:58
  Speaker 1: So thank you for joining us today.
• 37:59
  Speaker 2: Thank you very much, thanks having me, and thank you to.
• 38:01
  Speaker 1: Our producer Mariam Trory for all the behind the scenes
• 38:05
  Speaker 1: work that she's done, and to our listeners for tuning
• 38:07
  Speaker 1: in today. We hope you join us for future episodes,
• 38:10
  Speaker 1: and if you'd like to stay up to date, you
• 38:11
  Speaker 1: can click the subscribe button on Spotify or your favorite
• 38:14
  Speaker 1: streaming platform. Take care,