October 2, 2025 • 37 mins
“We thought that the folks would only turn on stimulation when they felt faint or lightheaded, but in fact, they’re using the stimulation the entire waking day because the stimulation is stabilizing their blood pressure, more oxygenation is reaching their brain,” Onward Medical CEO Dave Marver explains in this Vanguards of Health Care podcast episode. Marver sits down with Bloomberg Intelligence analyst Matt Henriksson for an in-depth interview about Onward and how its developments differ from other companies that utilize brain-computer interfaces (BCI) by connecting BCI technology to its ARC platform to stabilize blood pressure and restore movement of the human body, instead of simply using the patient’s thoughts to control computer functions. Marver also discusses the initiation of its Empower BP Pivotal study to assess the use of its ARC-IM system to address blood-pressure instability after spinal cord injuries (SCI).
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Episode Transcript
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Speaker 1 (00:16):
Welcome to another exciting episode of the Vanguards of Healthcare series.
My name is Matt Hendrickson, the medical technology analyst at
Bloomberg Intelligence, which is the in house equity research platform
at Bloomberg LP. We are pleased to have back with
us today, Dave Marver, CEO of Onward Medical, a medical
device company that is driving the innovation to enable people
(00:36):
with spinal cord injury to move again aided by their
ARC therapy. You can dive deeper into the company and
its financials by typing in onwd space, bb space Equity
go on your Bloomberg terminal. Dave, welcome back and thank
you for joining us again.
Speaker 2 (00:54):
Thank you, Matt.
Speaker 3 (00:55):
It's my third time I think with you, but the
first time in person.
Speaker 1 (00:59):
Yeah. Well, welcome to the Bloomberg headquarters. I hope you
enjoy it so far.
Speaker 2 (01:03):
I am a lot of energy here.
Speaker 1 (01:05):
Yeah, in a really nice studio, so very nice. And
I think with the third one, I mean this kind
of goes to like the SNL skits where like, yeah,
posts come back for the fifth or sixth time, like
Tom Hanks. I'm thinking of like there get the crown
for going back to the fifth time. So next time,
I'll have to get you a crown for.
Speaker 2 (01:21):
Very honored.
Speaker 1 (01:21):
Well, even though this is your third time back, A
lot has happened since we last spoke. But first, why
don't we just start with a quick overview for the
listeners who are new to the story about what Onward
Medical is doing with these spinal cord injuries.
Speaker 3 (01:36):
And beyond Onward is a medical technology company and are
Our purpose is to develop therapies to help people with
spinal cord injury and other movement disabilities recover movement, but
also other functions that are lost after their injury. And
we have three technology platforms, each of which stimulates the
(01:58):
spinal cord in a very precise way. One's called arc EX,
one is called RCM, and our newest platform is called RCBCI.
We're a very innovative company. We have ten FDA Breakthrough
Device Designation awards, which is unprecedented, and already almost three
hundred patents worldwide.
Speaker 1 (02:19):
Yeah, that's fascinating. And then you know, we'll start first
with rc EX because when I went back to the
episode we did a year ago, the big talking point
during that episode was the uplift study published in the
Nature Journal at that time. Let's just start with that
as a base, because since then a lot has happened.
(02:40):
What did that trial help demonstrate for rc EX and
then arc EX is maybe a brief description of how
that is because I see it right here on the table,
but for the listeners, describe what the device looks like,
how it's designed to help treat the patient.
Speaker 3 (03:00):
Of course, so ourchaxis is our external stimulator, so it's
designed to be used in the clinic.
Speaker 2 (03:09):
Or eventually at home.
Speaker 3 (03:10):
In fact, we filed an application with FDA to get
home use approval, and it's designed to be used for
up to an hour a day, and when the stimulation
is on, it enables a person to move in a
way that they otherwise could not, and by training performing
that movement, they can recover function. That's how rchex works.
(03:30):
The Uplift study that you mentioned this was our Global
Pivotal Studies, So in biotech maybe that's the equivalent of
a Phase three but it's a large study designed to
produce the data required to get FDA approval, regulatory approval,
and as you said, our study results were published in
Nature Medicine, one of the world's pre eminent scientific journals.
Speaker 1 (03:53):
That trial demonstrated the safety and effectiveness of the vice.
Was there any specific data point that you saw that
was kind of that is the clear, you know, indication
that this device can work with these patients.
Speaker 3 (04:10):
Well, we studied whether the device could improve a person's
hand function, and what the study demonstrated is that nine
out of ten study participants improved the strength or function
of their of their hands and arms. Eighty seven percent
reported improvements in quality of life. And what was really
(04:31):
striking is we saw response up to thirty four years
after an injury. And this is this was remarkable to
us because the way things happen today is a person
has an injury, they have emergency surgery, they go into
rehabilitation and normally after three months they plateau and nothing
else can be done for them. They're sort of sent
(04:52):
home and said and until you know, good luck. And
here thirty four years after an injury, we saw a
person respond to this arcax therapy.
Speaker 1 (05:02):
And so that was then in our previous episodes. Now
we're moving to the now, and you know, this is
where the a lot comes in because for that archaex
you've received Denovo approval, you've had your first commercialization and
then you did a little bit of a spoiler alert
with the filing for the ten K for the arch
ex at home. That process between the Denovo and the
(05:25):
commercialization and the use at home, how has that launch
gone so far, and then how is the potential for
using it at home? Potentially could accelerate that launch.
Speaker 2 (05:39):
Well based on the strength of the uplift data.
Speaker 3 (05:41):
We certainly wanted to make this new breakthrough technology available
to as many people as possible, so we were keen
to launch this product at the beginning of twenty twenty five.
We did it in a phased way. Wanted to be
conservative with our capitals, so we didn't have a big
salesforce out there waiting. But once we got the FDA
clearance and it was called a Denovo clearance because this
(06:04):
is the first device of its kind, we started to
hire a sales organization. We spooled up manufacturing, and we
had a target to get it into ten US clinics
in the first quarter.
Speaker 2 (06:14):
We did that.
Speaker 3 (06:16):
We've got it that will be in thirty clinics in
the first half. We haven't reported yet, but I have
confidence that will do that. And so the uptake has
been really exceptional, and you can see that represented in
the social media that you see among the spinal cord
injury community, the clinics and the people who are experiencing
(06:38):
use of the therapy for the first time.
Speaker 1 (06:40):
Yeah, and so the in the clinics setting, a patient
will just come in, they will utilize it for the hour,
and then they will head home. How often do they
need to go back to the clinic to kind of
have that hour long treatment.
Speaker 3 (06:55):
So most of the people with injuries are coming into
the clinic to use RCHX three times week. It is
not easy for them to get to the clinic because
these are tetraplegics, meaning their arms and legs have some.
Speaker 2 (07:09):
Compromised movement.
Speaker 3 (07:10):
So that's why we filed the five ten K application
with FDA to get home use so that these folks
can use the device and gain benefit from it at
home where it's convenient for them.
Speaker 1 (07:22):
Yeah, and it's you know, I'm just curious too, is
with your conversations with the FDA, was there additional information
or data you needed to provide to them for the
in home setting or did they want to see how
it worked in the clinic setting first before then almost
kind of a real world experience before then filing for
(07:44):
the in home use.
Speaker 3 (07:45):
The primary focus of the agency's review of the five
to ten K is just the usability of the device
in the home setting without benefit of a clinician of
a trained person, and so a lot of this involves
what what's called in the industry human factors. Can they
(08:06):
open up the you know, the case in which the
device arrives, can they find it, can they find the
instructions for use? Can they operate it on their own?
Things like that things. It really makes sense that we
want the FDA to look at when it comes to
home home devices like this.
Speaker 1 (08:21):
There's that, but you're also simultaneously applying for ce mark.
Is that ce MARK in clinic approval or is that
going straight to in clinic and house approval as well.
Speaker 3 (08:34):
Indeed, in June, in addition to filing our five to
ten K with the FDA, we did submit our MDR
application for ce Mark so we can begin to commercialize
this device in Europe and other countries that accept ce I'm.
Speaker 2 (08:49):
Going to keep some things for the next podcast. I
won't tell you whether that's clinic or home use.
Speaker 3 (08:54):
We'll see, but you know, we were a mission driven
company and we very much want this to be as
accessible as possible.
Speaker 1 (09:03):
And so then just kind of, you know, for when
we do have the next episode sometime in twenty twenty six,
what are the other kind of indications that Archex can
provide beside hand sensation or is that stuff for the
next group of products of the arc IM or the RCBCI.
Speaker 3 (09:21):
ARCHX We believe does have quite a bit of flexibility.
So first, we have two upcoming catalysts we expect near
the end of this year, one being ce mark, the
other being home use with FDA. And then we have
physicians are doing a number of what we call investigator
initiated research studies interesting where they're using this now approved
(09:46):
ARCHX device and exploring whether it can be impactful for
addressing other recovery targets bladder and bowel function, blood pressure stability,
and it helps people stand and walking in these are
all off label now, it's all being done in the
context of studies by these investigators, but we're very keen
(10:09):
to evaluate how those studies progress, and indeed, if those
data are promising, we want to package them and do
what we can to add those new indications to the label.
Speaker 1 (10:21):
Well, it sounds like an opening of a Pandora's box,
but in a good way because now these devices, these
devices are in the clinic and they're being able to
then be used where you know, you couldn't have that
access beforehand.
Speaker 3 (10:34):
There was tremendous hunger for a device like this in
this field. There has not been an FDA approved device
that can restore function of this nature, and so now
that they have something like this, they're really keen to
see to identify other areas where again it can be beneficial.
Speaker 1 (10:53):
And then so then that kind of then moves us
into just the ARC I M catalysts that have taken place.
Most recently was the press release for your ID approval
for the Empowered BP study. Let's just start first with
how RCIM is similar and different to the RCX, and
(11:15):
then what the empower BP trial is going to try
to demonstrate effectiveness of the device.
Speaker 3 (11:24):
RCIM is similar to RCX, and then it stimulates the
spinal cord in a precise way. It's different and it's
a fully implanted system, so it's available twenty four to seven,
can be turned on and off and adjusted with a
smart watch. So it's really what's called a neuroprosthetic. It
replaces the body's function. And because it's implanted, and because
(11:47):
the lead that's part of the system is in direct
contact with the spinal cord, it has more precision than
the external device, so it can facilitate.
Speaker 2 (11:57):
More precise recovery.
Speaker 3 (12:00):
Now, Empower BP is a global pivotal study or Phase
three for those of you and the audience who are
more biotech inclined. And this is designed a multi center
study twenty or so centers, is designed to generate the
data we need to get FDA approval for the ARCIM platform.
Speaker 1 (12:20):
Yeah, I once again this is an audio only podcast.
I mean maybe somewhere down the road we'll have a
video one. But I'm looking at the table, I'm seeing
the device. It looks very similar form factor wise to
a spinal court stimulator SCS. But I'm assuming it is
much much more complicated than just comparing those as an
(12:42):
apples to Apple. So, when I'm thinking about a spinal
court stimulation for pain management, how what are the additional
features for the ARCIM that kind of makes it then
be able to do more and above what a SCS
can do.
Speaker 3 (13:00):
So some interesting history the founders of Onward neuroscientists and
neurosurgeons initially demonstrated proof of concept with pain neurostimulators interested ok,
but they were not capable of delivering the precise therapy
that was needed, and so that's why they founded this
company to develop this purpose built neurostimulator capable of delivering
(13:24):
the envisioned therapies. So pain stimulators tend to deliver tonic
or steady stimulation. This device can stimulate very specifically through
each of the electrodes that you see on this paddle
lead yep. And the intent is that it can replace
the brain's instructions, firing muscles in the same sequence that
(13:45):
your brain would if you were walking, for example. So
there's a lot of precision and specificity built into the system.
It is also controllable by the smart watch, which is nice.
And the other differentiator is it's designed to interface with
other devices, whether implanted or external sensors or even an
(14:07):
implanted brain computer interface. So we're gonna talk about that later,
I know, but but as long as we're talking about differences,
that's one of the differences in the architecture of arc IM.
Speaker 1 (14:17):
Yeah. And so then for the first indication you're going
for is the blood pressure management. So what's interesting too
is that you're you're saying that they control can control
it by their their eyewatch. Is that is it? Is
it only? Can it only be controlled by the eye watch? Like,
so if they feel like there's low blood blood pressure
(14:40):
or their blood pressure spiking, then they like initiate it.
Or is this something where they could potentially the system
itself could sense it and then they kind of update
it or is that something a next chapter of development
that you guys are doing.
Speaker 2 (14:52):
Yeah, very good question.
Speaker 3 (14:53):
Let me just go back one step and describe the
problem that we're seeking to address. Okay, this is not hypertension,
which is managed by drugs typically, and there's been some
devices that have been approved to try to address hypertension
as well. This is low blood pressure that's quite common
after a spinal cord injury, and it tends to present
(15:17):
when people change body position or sit upright or stand.
They feel very light headed and faint. They also have
these dangerous spikes and blood pressure because their body can't
really process autonomic signals like they have a shoelace that's
too tight, or.
Speaker 2 (15:35):
An itch or a full bladder.
Speaker 3 (15:36):
Interesting, generally we call it blood pressure instability, but most
of the time it's.
Speaker 2 (15:42):
Low blood pressure.
Speaker 3 (15:44):
So when we first embarked on this journey, we thought that,
as you suggested, the folks would only turn on stimulation
when they felt faint or light headed. But in fact
they're using the stimulation the entire waking day. Because the
stimulation is again stabilizing their blood pressure, more oxygenation is
(16:09):
reaching their brain, they're they're thinking more clearly, seeing more clearly.
The more energetic they're reporting that they have again more
energy to participate in family activities, return to work, and
so on.
Speaker 2 (16:22):
So this was a surprise.
Speaker 3 (16:23):
This is why you do clinical studies now with today's embodiment,
we call it open loop, so the person can adjust
it themselves. But because we have this device architect architected
the way it is when a good B to B
blood pressure sensor arrives on the scene, we can then
(16:45):
work on a closed loop variation.
Speaker 1 (16:48):
Very interesting, and you know you have the empower BP
trial first patients should be enrolled by the end of
this year. You also had interim results for arc IM
that you know showed improvement in the blood pressure regulation.
Where are some of the key stats for that for
(17:08):
those preliminary results that were kind of interesting to you.
Speaker 3 (17:11):
Yeah, those were top line results. Then we released in
December of twenty three, so it's been some time, but
everyone of the study participants reported improvements in quality of life.
Those who were on medications reduced or stopped the meds altogether.
(17:33):
They stopped wearing compression garments, you know, some of the
today's standard of care.
Speaker 2 (17:39):
They were able to get away from those.
Speaker 3 (17:42):
Their partners reported that the participants were more energetic and engaged.
Some of them returned to school and work. So at
that point in time, there was enough promise for us
to continue those top line results. I didn't even remember
the date because it's been a while, so those.
Speaker 2 (17:59):
Will be refreshed.
Speaker 3 (18:00):
We've already guided that we expect two top tier publications
this fall that will go into far more detail about
the clinical feasibility results. Actually, the first fourteen humans who've
had benefit of this therapy, they will be described, and
there'll be another paper that describes the mechanism of action
(18:22):
exquisite detail. So the combination of those publications will significantly
clinically de risk this therapy. Even before the pivotal starts.
Speaker 2 (18:32):
I was about to.
Speaker 1 (18:33):
Say it probably opens up the you know, once again
opens up the Pandora's box in a good way by saying,
you know, having the physicians see this data and see
the mechanism of action before the main pivotal study even
starts and gets probably Garner's more interest in that way.
Speaker 2 (18:50):
I would think so.
Speaker 3 (18:50):
And the FDA had benefit of these data when when
they assessed our application for the IDE. But you're absolutely right,
these papers will be published clinic is we'll have confidence
in the therapy, should speed enrollment in the study and
help us get this thing on the market.
Speaker 1 (19:08):
Yeah, And then have you guys commented on a timeline
for you know, you talk about the in first enrollment
being this year, but what is like, how long is
the primary endpoint? Is it a twelve month primary endpoint?
Something different? Because you know, as an analyst, I'm putting
on that hat of trying to calculate from the beginning
of the enrollment to end of enrollment to the primary
(19:29):
endpoint to then potentially you know, FDA submission. So I'll
start with is the prime what is the design for
the primary endpoint?
Speaker 3 (19:38):
So thus far this week we only announced we got
the IDE approve.
Speaker 2 (19:41):
Interesting, it gave.
Speaker 3 (19:43):
You some sense for the size of the study in
terms of the number of sites participating. On September second,
we have an earnings call. We're going to go into
more detail on the study design, okay, and then later
in September of twenty twenty five here just to reference
this for those of you who are listening. Later, perhaps
we're going to do a webinar with some clinicians and
some patients and really go into mark more detail on
(20:05):
the clinical problem itself, the study design, and the promise
of the therapy, the impact that it can make.
Speaker 1 (20:12):
Okay, very interesting, looking forward to hearing more about that then,
and then you know our next episode, you can come
on and discuss it more with me then. So then
let's just move then into the third leg of your stool,
the RCBCI and the biggest difference I saw.
Speaker 2 (20:30):
Can I stop you?
Speaker 1 (20:31):
Yeah?
Speaker 3 (20:32):
So we only discussed the blood pressure indication for rc IM.
Oh yeah, but we're using RCM and clinical feasibility studies
to help people stand and walk again. Also first in
human for urinary incontinent so underactive bladder totalate, the need
to insert catheters every time a person has to urinate
(20:52):
for upper extremity movement restoration.
Speaker 2 (20:55):
So it's also very flexible.
Speaker 3 (20:57):
Your Pandora's box that you like, Yeah, positive Pandora's body.
Speaker 2 (21:00):
Yeah.
Speaker 3 (21:01):
And all of these clinical feasibility studies are advancing with
the benefit of grant funding, so we're not having to
use the company's precious capital for that. And we have
grant support from the Michael J. Fox Foundation for Parkinson's Research,
the Christopher Refoundation, the US Department of Defense.
Speaker 2 (21:17):
And so on. So it's this is a very.
Speaker 3 (21:19):
Versatile platform and we're keen to get it to prove
for blood pressure and then follow up with a number
of other indications or recovery targets.
Speaker 1 (21:28):
Interesting and so and then how I mean is it
walk me through that then? Because that's interesting, because yep,
it's got to be a different Yeah, a mechanism of
action to treat these different ailments, whether it's you know,
blood pressure, whether it's bladder, whether it's Parkinson's disease. How
(21:50):
does that process go about? Is that something that's happening
in your internal R and D? And then you highlight
that to the clinicians. Are the clinicians being able to
be like, hey, by the way, this is what we saw.
You might want to dive deeper into this, and you're like, okay,
let's do it.
Speaker 3 (22:04):
We have brilliant scientific partners and they explore and develop
these indications, starting with basic science, pre clinical models and
then clinical feasibility studies and in that way they can
develop these with precision using our technology. So that's the partnership.
(22:25):
We then become the clinical trial and commercial engine so
there's a really nice synergy between our science partners and
then onward as a commercial enterprise. What's nice is the
IPG the neurostimulator is the same, and we have developed
a family of leads that are designed to be placed
(22:46):
in different areas of the spinal cortcha okay, and different
areas of the spinal cord are responsible for controlling different functions.
So that's how we address these various recovery targets.
Speaker 1 (22:57):
Okay. And then let me as a follow up, everything together.
So it's different leads for different areas to treat it.
But is it a different algorithm or different frequency or
different power that is required for that as well, or
is it just if I put the lead here, it
does this. If I put the lead here, it does that.
But the internal IPG it does all.
Speaker 3 (23:20):
There are different ways of stimulating to achieve each of
these results based on what we're trying to facilitate. So
and this is again the genius of our science partners,
and then it becomes embodied in our intellectual property. So
we have three hundred patents. We've pioneered this area over
ten years. So that's really a very valuable asset for
(23:44):
the company. Is that know how and the ip of
state that accompanies it.
Speaker 1 (23:49):
And then kind of the bridge as well is that
it's the same form factor for the IPG in the body.
And now this is going back to the BCI. This
is it's basically communicating with the IPG. The biggest difference
I saw from a year ago to now is the
(24:10):
partnership or maybe it's the same partnership, but it's a
different name because it used to be ARCIM plus the
Clintech Brain Computer Interface or BCI. Now I'm just saying
ARCBCI is that intentional.
Speaker 2 (24:24):
It is intentional.
Speaker 3 (24:25):
So what occurred we had been doing research in partnership
with a French government funded biomedical institute that actually part
of their nuclear research initiatives, like Los Alamos National Labs.
Speaker 2 (24:40):
If they had a medtech Army and.
Speaker 3 (24:43):
That group has a very sophisticated neurosurgery research initiative. Indeed,
that's where deep brain stimulation was invented. And now they
created this BCI or brain computer interface, and it's very
neurosurgery friendly because it was developed by a neurosurgeon, and
(25:03):
we took the opportunity strategically to bring that in house.
So now it's ours to exclusively develop. And we did
that because having that control allows us to conduct research
in a very quick and efficient manner. And we want
to do this human research or clinical research quickly and efficiently,
(25:24):
so we can get this on the market and be first.
Speaker 1 (25:26):
Yeah, and so you know, walk me through the design
of the actual BCI itself, because I see it here.
You know, it looks like a silver dollar, but thicker.
And so how does it get implanted into the brain.
Speaker 2 (25:44):
Essentially, our BCI.
Speaker 3 (25:48):
Is again for a neurosurgeon, a relatively straightforward implant. It
may sound not so simple to the general audience. So
what happens is that the neurosurgeon will create a whole
in your skull called the craniotomy, the same size as
our BCI, and the BCI will then be dropped into
(26:08):
that hole, and so it will, you know, in a sense,
form a titanium part of your skull to give you protection,
and then your skin and hair grow back on top
of it so it becomes invisible to others. And then
on the underside of that BCI are a series of
electrodes and those sit on top of the brain, indeed,
(26:30):
on top of the lining of the brain called the dura,
on the motor cortex, and that's what records a person's
movement intention.
Speaker 1 (26:37):
Okay, because that was the thing that got to me,
is I know how protective the body is to any
contact with the brain. I wanted to make sure I
understood that it's not actually touching the brain. It's touching
the dura, or the layer that covers the brain, and
that's in between the skull and the brain.
Speaker 3 (26:53):
Yeah, in our view, this is there are various varying
degrees of invasiveness than this BCI realm, and this is
the least invasive yet effective approach because it's not penetrating
the dura, it's not penetrating the brains. The brain is
not trying to defend itself by encapsulating the electrodes.
Speaker 1 (27:16):
Okay, So that's kind of the interesting about the competitive
landscape because there's different disease states, different functionality, different designs,
and so the other BCI designs, some well known, some
more private, they have to go through the dura and
connect directly to the brain. Are there any of them
(27:37):
that also just kind of go through the dura to
the brain or is it mostly the first generation of
these products are touching the brain still?
Speaker 2 (27:45):
Yeah, So they're all private companies.
Speaker 3 (27:46):
We're the only listed company with a DCI, which might
be interesting to your audience. Each of the companies has
a different approach, actually, Matt. So there's one company here
in New York that has an intravascularly delivered BCI and
so it comes up through your vascularture. So the challenge
there is can they make that small enough so it
(28:09):
can be positioned in the motor cortex such that you
can do things with it. There's another also based here
in New York. They're trying to deploy thin film electrode
under the dura on top of the brain, but under
a dura the dura, so they're working on the delivery
system for that minimally invasive but still subdual. Then there's
(28:32):
one that gets a lot of attention that's delivered by
robots where hundreds of electrodes penetrate the brain itself, which
was as its own series of questions. So lots of
flavors of BCI right now. We like ours because it
is relatively non invasive, has seven years human safety data,
the signal doesn't degrade, and we feel like having that
(28:56):
gives us a chance to get these studies done and
progress the field. However, our r IM system can receive
wireless instructions from any BCI. It is agnostic, Okay, So
we stay in touch with these companies and if they're
making good progress and we believe that those BCIs can
make our system better and offer more benefit to patients, great,
(29:20):
We're very keen to work with them in the future.
Speaker 1 (29:22):
That's interesting, Actually, that's a fun fact that I didn't
realize that it is BCI agnostic. So then you know,
walk through us through where you are in your clinical
development for your BCI. I think there's been a handful
of implants done. I know there was a news we
talked about the news article last year about Gert John.
(29:45):
I might be mispronouncing his name, who you know, and
after his cycling accident. But where are you in those
steps and kind of what are the what are the
maybe end goals for this year and maybe the next
twelve twenty four months.
Speaker 3 (30:01):
Dirt Yon, whom you mentioned, was the first human to
get one of these to facilitate thought driven walking, standing
and walking. And since we've done four more people, so
three for standing and walking and two now for hand
and arm function. And one of the uh you know
(30:23):
I mentioned before are these brilliant research partners. One of
the reasons that partnership works so well is I stay
quiet until they publish, and so I know they're keen
to publish the results from those additional people who they've implanted,
So I want to let them do that and then
I'll talk about it. They need to win as well,
and winning in their field is publishing, and then we
(30:46):
help them then scale it for the benefit of humankind.
Speaker 1 (30:49):
Very nice.
Speaker 3 (30:51):
Yeah.
Speaker 1 (30:51):
The other thing too, that is interesting over the last
year is kind of, you know, as I'm picking up
more and more about these BCI companies developments, I'm starrying
to also read more about the ethics let's call it
b C I maybe not necessarily for med tech medtech
you have you know, the you know you're you're treating
(31:13):
a disease and ailment, but you know, some of these
other b c I things for monitoring and things like that,
it opens a question of privacy ethics. And you know,
one of the things is I've been leafing through the
Battle for Your Brain by Nita Farahani. What are your
thoughts about b c I. You know, with that, you know,
balancing the benefits of BCI because some of those times
(31:35):
it's pretty interesting to have that capability without having to
use your hand and hands and things like that, or
especially for a paraplegic, being able to move your hands
again is amazing versus that kind of privacy issues, both
med tech side and just in general. I'm curious what
your thoughts are.
Speaker 3 (31:52):
Our focus is very specific on using those brain signals, yeah,
to restore movement, and and indeed our ECI sits on
the motor cortex. It's our target population. But it's good
that people like you were reading books like that, and
and I have been on panels where the ethics of
BCI have been discussed, and it is racing ahead with
(32:12):
the benefit of a lot of capital, without a lot
of contemplation about the perils.
Speaker 1 (32:19):
Well, it sounds like it almost sounds like we're shooting first,
asking later type of moment with the development because of
how quickly the technology can pretty much Murphy's law like
to be able to double every eighteen months and things
like that, just able to accelerate that way. While we're
still kind of.
Speaker 3 (32:37):
I think you're had a forty in slip because you
meant to say Moore's law, Murphy's laws. Yeah, whatever bad
thing may happened, may happen. So that's an interesting slip.
We'll we'll see again. This is it's there's a lot
happening there. There's a lot of peril and and we
just want to stay a force for good here.
Speaker 1 (32:56):
Yeah, and you're right, probably it was a little bit
of there and so then you know that kind of
just lines you up. You know, one of the things
that caught my attention was your limited launch and you know,
you you began building the salesforce kind of after the
Novo approval as a CEO decision to you know, with
you know, limiting the cash burn, which kind of caught
(33:20):
my attention because you know, every time, you know, if
you think of some of these large cap companies they're
building out that commercial team well in advance, and so
once they get the FDA approval, they can go. But
some smaller companies like Onward and other private companies, they
don't have that flexibility to just throw cash into that
like that. So I thought that was an interesting strategy
(33:40):
that you had there of being more patient and being
more methodical about your cash burn. But where are you
with kind of financing needs just kind of as you
really have a lot of different favorite children right now
that you have to cultivate and you know, bring out
into the market.
Speaker 3 (34:01):
I don't want the audience to get the wrong impression here.
We move with great urgency and velocity. We really do
because we're very mission driven and we see the needs
that are out there, unmet needs, and we see the
impact that our therapies can are having and can have.
And we're also doing a lot for a company our size,
three different technology platforms, commercializing one, conducting a pivotal study
(34:24):
on the next, and so forth. However, it's good to
be quite prudent about where one spends capital. And even
though we're doing a lot, our primary focus is commercial
commercializing Archax and then funding the pivotal study for RCIM,
and we do have the benefit of grant funding to
advance our pipeline. It has been a challenging environment for small.
Speaker 2 (34:48):
Cap medtech to raise capital.
Speaker 3 (34:50):
We've been lucky, maybe because of our execution. We raised
seventy million euros eighty million dollars.
Speaker 2 (34:57):
Last year and things are opening not been.
Speaker 3 (35:00):
Medtech in the equity capital markets. There have been several
successful IPOs this year on Nasdaq in med tech, So
I think we're entering a nice, a better era in
terms of raising capital, which may open up some some
opportunities for us. But we're you know, we're at least
the time of this recording, what two hundred and seventy
five million dollar market cap company and first year of revenue,
(35:25):
and we have a bright future, but we still have to.
Speaker 2 (35:27):
Be be prudent.
Speaker 1 (35:28):
Yeah, yeah, well, you know, I look forward to just
the rest of this year and when we see you
back next year, we'll get the crown for you for
visit number four. Kind of seeing how that develops out
over time. But Dave, thanks so much for joining us today.
Speaker 3 (35:42):
My pleasure, really nice to be in the studio with you. Matt,
Thank you Miriam for your excellent sound engineering. And look
forward to coming back.
Speaker 1 (35:50):
Oh yeah, they're the ones that make us sound good.
So and thank you to our listeners for tuning in
today and we hope you join us for future episodes.
If you'd like to stay up to date, you can
click the subscribe button on Spotify or your favorite streaming platform.
Take care,
Welcome to another exciting episode of the Vanguards of Healthcare series.
My name is Matt Hendrickson, the medical technology analyst at
Bloomberg Intelligence, which is the in house equity research platform
at Bloomberg LP. We are pleased to have back with
us today, Dave Marver, CEO of Onward Medical, a medical
device company that is driving the innovation to enable people
(00:36):
with spinal cord injury to move again aided by their
ARC therapy. You can dive deeper into the company and
its financials by typing in onwd space, bb space Equity
go on your Bloomberg terminal. Dave, welcome back and thank
you for joining us again.
Speaker 2 (00:54):
Thank you, Matt.
Speaker 3 (00:55):
It's my third time I think with you, but the
first time in person.
Speaker 1 (00:59):
Yeah. Well, welcome to the Bloomberg headquarters. I hope you
enjoy it so far.
Speaker 2 (01:03):
I am a lot of energy here.
Speaker 1 (01:05):
Yeah, in a really nice studio, so very nice. And
I think with the third one, I mean this kind
of goes to like the SNL skits where like, yeah,
posts come back for the fifth or sixth time, like
Tom Hanks. I'm thinking of like there get the crown
for going back to the fifth time. So next time,
I'll have to get you a crown for.
Speaker 2 (01:21):
Very honored.
Speaker 1 (01:21):
Well, even though this is your third time back, A
lot has happened since we last spoke. But first, why
don't we just start with a quick overview for the
listeners who are new to the story about what Onward
Medical is doing with these spinal cord injuries.
Speaker 3 (01:36):
And beyond Onward is a medical technology company and are
Our purpose is to develop therapies to help people with
spinal cord injury and other movement disabilities recover movement, but
also other functions that are lost after their injury. And
we have three technology platforms, each of which stimulates the
(01:58):
spinal cord in a very precise way. One's called arc EX,
one is called RCM, and our newest platform is called RCBCI.
We're a very innovative company. We have ten FDA Breakthrough
Device Designation awards, which is unprecedented, and already almost three
hundred patents worldwide.
Speaker 1 (02:19):
Yeah, that's fascinating. And then you know, we'll start first
with rc EX because when I went back to the
episode we did a year ago, the big talking point
during that episode was the uplift study published in the
Nature Journal at that time. Let's just start with that
as a base, because since then a lot has happened.
(02:40):
What did that trial help demonstrate for rc EX and
then arc EX is maybe a brief description of how
that is because I see it right here on the table,
but for the listeners, describe what the device looks like,
how it's designed to help treat the patient.
Speaker 3 (03:00):
Of course, so ourchaxis is our external stimulator, so it's
designed to be used in the clinic.
Speaker 2 (03:09):
Or eventually at home.
Speaker 3 (03:10):
In fact, we filed an application with FDA to get
home use approval, and it's designed to be used for
up to an hour a day, and when the stimulation
is on, it enables a person to move in a
way that they otherwise could not, and by training performing
that movement, they can recover function. That's how rchex works.
(03:30):
The Uplift study that you mentioned this was our Global
Pivotal Studies, So in biotech maybe that's the equivalent of
a Phase three but it's a large study designed to
produce the data required to get FDA approval, regulatory approval,
and as you said, our study results were published in
Nature Medicine, one of the world's pre eminent scientific journals.
Speaker 1 (03:53):
That trial demonstrated the safety and effectiveness of the vice.
Was there any specific data point that you saw that
was kind of that is the clear, you know, indication
that this device can work with these patients.
Speaker 3 (04:10):
Well, we studied whether the device could improve a person's
hand function, and what the study demonstrated is that nine
out of ten study participants improved the strength or function
of their of their hands and arms. Eighty seven percent
reported improvements in quality of life. And what was really
(04:31):
striking is we saw response up to thirty four years
after an injury. And this is this was remarkable to
us because the way things happen today is a person
has an injury, they have emergency surgery, they go into
rehabilitation and normally after three months they plateau and nothing
else can be done for them. They're sort of sent
(04:52):
home and said and until you know, good luck. And
here thirty four years after an injury, we saw a
person respond to this arcax therapy.
Speaker 1 (05:02):
And so that was then in our previous episodes. Now
we're moving to the now, and you know, this is
where the a lot comes in because for that archaex
you've received Denovo approval, you've had your first commercialization and
then you did a little bit of a spoiler alert
with the filing for the ten K for the arch
ex at home. That process between the Denovo and the
(05:25):
commercialization and the use at home, how has that launch
gone so far, and then how is the potential for
using it at home? Potentially could accelerate that launch.
Speaker 2 (05:39):
Well based on the strength of the uplift data.
Speaker 3 (05:41):
We certainly wanted to make this new breakthrough technology available
to as many people as possible, so we were keen
to launch this product at the beginning of twenty twenty five.
We did it in a phased way. Wanted to be
conservative with our capitals, so we didn't have a big
salesforce out there waiting. But once we got the FDA
clearance and it was called a Denovo clearance because this
(06:04):
is the first device of its kind, we started to
hire a sales organization. We spooled up manufacturing, and we
had a target to get it into ten US clinics
in the first quarter.
Speaker 2 (06:14):
We did that.
Speaker 3 (06:16):
We've got it that will be in thirty clinics in
the first half. We haven't reported yet, but I have
confidence that will do that. And so the uptake has
been really exceptional, and you can see that represented in
the social media that you see among the spinal cord
injury community, the clinics and the people who are experiencing
(06:38):
use of the therapy for the first time.
Speaker 1 (06:40):
Yeah, and so the in the clinics setting, a patient
will just come in, they will utilize it for the hour,
and then they will head home. How often do they
need to go back to the clinic to kind of
have that hour long treatment.
Speaker 3 (06:55):
So most of the people with injuries are coming into
the clinic to use RCHX three times week. It is
not easy for them to get to the clinic because
these are tetraplegics, meaning their arms and legs have some.
Speaker 2 (07:09):
Compromised movement.
Speaker 3 (07:10):
So that's why we filed the five ten K application
with FDA to get home use so that these folks
can use the device and gain benefit from it at
home where it's convenient for them.
Speaker 1 (07:22):
Yeah, and it's you know, I'm just curious too, is
with your conversations with the FDA, was there additional information
or data you needed to provide to them for the
in home setting or did they want to see how
it worked in the clinic setting first before then almost
kind of a real world experience before then filing for
(07:44):
the in home use.
Speaker 3 (07:45):
The primary focus of the agency's review of the five
to ten K is just the usability of the device
in the home setting without benefit of a clinician of
a trained person, and so a lot of this involves
what what's called in the industry human factors. Can they
(08:06):
open up the you know, the case in which the
device arrives, can they find it, can they find the
instructions for use? Can they operate it on their own?
Things like that things. It really makes sense that we
want the FDA to look at when it comes to
home home devices like this.
Speaker 1 (08:21):
There's that, but you're also simultaneously applying for ce mark.
Is that ce MARK in clinic approval or is that
going straight to in clinic and house approval as well.
Speaker 3 (08:34):
Indeed, in June, in addition to filing our five to
ten K with the FDA, we did submit our MDR
application for ce Mark so we can begin to commercialize
this device in Europe and other countries that accept ce I'm.
Speaker 2 (08:49):
Going to keep some things for the next podcast. I
won't tell you whether that's clinic or home use.
Speaker 3 (08:54):
We'll see, but you know, we were a mission driven
company and we very much want this to be as
accessible as possible.
Speaker 1 (09:03):
And so then just kind of, you know, for when
we do have the next episode sometime in twenty twenty six,
what are the other kind of indications that Archex can
provide beside hand sensation or is that stuff for the
next group of products of the arc IM or the RCBCI.
Speaker 3 (09:21):
ARCHX We believe does have quite a bit of flexibility.
So first, we have two upcoming catalysts we expect near
the end of this year, one being ce mark, the
other being home use with FDA. And then we have
physicians are doing a number of what we call investigator
initiated research studies interesting where they're using this now approved
(09:46):
ARCHX device and exploring whether it can be impactful for
addressing other recovery targets bladder and bowel function, blood pressure stability,
and it helps people stand and walking in these are
all off label now, it's all being done in the
context of studies by these investigators, but we're very keen
(10:09):
to evaluate how those studies progress, and indeed, if those
data are promising, we want to package them and do
what we can to add those new indications to the label.
Speaker 1 (10:21):
Well, it sounds like an opening of a Pandora's box,
but in a good way because now these devices, these
devices are in the clinic and they're being able to
then be used where you know, you couldn't have that
access beforehand.
Speaker 3 (10:34):
There was tremendous hunger for a device like this in
this field. There has not been an FDA approved device
that can restore function of this nature, and so now
that they have something like this, they're really keen to
see to identify other areas where again it can be beneficial.
Speaker 1 (10:53):
And then so then that kind of then moves us
into just the ARC I M catalysts that have taken place.
Most recently was the press release for your ID approval
for the Empowered BP study. Let's just start first with
how RCIM is similar and different to the RCX, and
(11:15):
then what the empower BP trial is going to try
to demonstrate effectiveness of the device.
Speaker 3 (11:24):
RCIM is similar to RCX, and then it stimulates the
spinal cord in a precise way. It's different and it's
a fully implanted system, so it's available twenty four to seven,
can be turned on and off and adjusted with a
smart watch. So it's really what's called a neuroprosthetic. It
replaces the body's function. And because it's implanted, and because
(11:47):
the lead that's part of the system is in direct
contact with the spinal cord, it has more precision than
the external device, so it can facilitate.
Speaker 2 (11:57):
More precise recovery.
Speaker 3 (12:00):
Now, Empower BP is a global pivotal study or Phase
three for those of you and the audience who are
more biotech inclined. And this is designed a multi center
study twenty or so centers, is designed to generate the
data we need to get FDA approval for the ARCIM platform.
Speaker 1 (12:20):
Yeah, I once again this is an audio only podcast.
I mean maybe somewhere down the road we'll have a
video one. But I'm looking at the table, I'm seeing
the device. It looks very similar form factor wise to
a spinal court stimulator SCS. But I'm assuming it is
much much more complicated than just comparing those as an
(12:42):
apples to Apple. So, when I'm thinking about a spinal
court stimulation for pain management, how what are the additional
features for the ARCIM that kind of makes it then
be able to do more and above what a SCS
can do.
Speaker 3 (13:00):
So some interesting history the founders of Onward neuroscientists and
neurosurgeons initially demonstrated proof of concept with pain neurostimulators interested ok,
but they were not capable of delivering the precise therapy
that was needed, and so that's why they founded this
company to develop this purpose built neurostimulator capable of delivering
(13:24):
the envisioned therapies. So pain stimulators tend to deliver tonic
or steady stimulation. This device can stimulate very specifically through
each of the electrodes that you see on this paddle
lead yep. And the intent is that it can replace
the brain's instructions, firing muscles in the same sequence that
(13:45):
your brain would if you were walking, for example. So
there's a lot of precision and specificity built into the system.
It is also controllable by the smart watch, which is nice.
And the other differentiator is it's designed to interface with
other devices, whether implanted or external sensors or even an
(14:07):
implanted brain computer interface. So we're gonna talk about that later,
I know, but but as long as we're talking about differences,
that's one of the differences in the architecture of arc IM.
Speaker 1 (14:17):
Yeah. And so then for the first indication you're going
for is the blood pressure management. So what's interesting too
is that you're you're saying that they control can control
it by their their eyewatch. Is that is it? Is
it only? Can it only be controlled by the eye watch? Like,
so if they feel like there's low blood blood pressure
(14:40):
or their blood pressure spiking, then they like initiate it.
Or is this something where they could potentially the system
itself could sense it and then they kind of update
it or is that something a next chapter of development
that you guys are doing.
Speaker 2 (14:52):
Yeah, very good question.
Speaker 3 (14:53):
Let me just go back one step and describe the
problem that we're seeking to address. Okay, this is not hypertension,
which is managed by drugs typically, and there's been some
devices that have been approved to try to address hypertension
as well. This is low blood pressure that's quite common
after a spinal cord injury, and it tends to present
(15:17):
when people change body position or sit upright or stand.
They feel very light headed and faint. They also have
these dangerous spikes and blood pressure because their body can't
really process autonomic signals like they have a shoelace that's
too tight, or.
Speaker 2 (15:35):
An itch or a full bladder.
Speaker 3 (15:36):
Interesting, generally we call it blood pressure instability, but most
of the time it's.
Speaker 2 (15:42):
Low blood pressure.
Speaker 3 (15:44):
So when we first embarked on this journey, we thought that,
as you suggested, the folks would only turn on stimulation
when they felt faint or light headed. But in fact
they're using the stimulation the entire waking day. Because the
stimulation is again stabilizing their blood pressure, more oxygenation is
(16:09):
reaching their brain, they're they're thinking more clearly, seeing more clearly.
The more energetic they're reporting that they have again more
energy to participate in family activities, return to work, and
so on.
Speaker 2 (16:22):
So this was a surprise.
Speaker 3 (16:23):
This is why you do clinical studies now with today's embodiment,
we call it open loop, so the person can adjust
it themselves. But because we have this device architect architected
the way it is when a good B to B
blood pressure sensor arrives on the scene, we can then
(16:45):
work on a closed loop variation.
Speaker 1 (16:48):
Very interesting, and you know you have the empower BP
trial first patients should be enrolled by the end of
this year. You also had interim results for arc IM
that you know showed improvement in the blood pressure regulation.
Where are some of the key stats for that for
(17:08):
those preliminary results that were kind of interesting to you.
Speaker 3 (17:11):
Yeah, those were top line results. Then we released in
December of twenty three, so it's been some time, but
everyone of the study participants reported improvements in quality of life.
Those who were on medications reduced or stopped the meds altogether.
(17:33):
They stopped wearing compression garments, you know, some of the
today's standard of care.
Speaker 2 (17:39):
They were able to get away from those.
Speaker 3 (17:42):
Their partners reported that the participants were more energetic and engaged.
Some of them returned to school and work. So at
that point in time, there was enough promise for us
to continue those top line results. I didn't even remember
the date because it's been a while, so those.
Speaker 2 (17:59):
Will be refreshed.
Speaker 3 (18:00):
We've already guided that we expect two top tier publications
this fall that will go into far more detail about
the clinical feasibility results. Actually, the first fourteen humans who've
had benefit of this therapy, they will be described, and
there'll be another paper that describes the mechanism of action
(18:22):
exquisite detail. So the combination of those publications will significantly
clinically de risk this therapy. Even before the pivotal starts.
Speaker 2 (18:32):
I was about to.
Speaker 1 (18:33):
Say it probably opens up the you know, once again
opens up the Pandora's box in a good way by saying,
you know, having the physicians see this data and see
the mechanism of action before the main pivotal study even
starts and gets probably Garner's more interest in that way.
Speaker 2 (18:50):
I would think so.
Speaker 3 (18:50):
And the FDA had benefit of these data when when
they assessed our application for the IDE. But you're absolutely right,
these papers will be published clinic is we'll have confidence
in the therapy, should speed enrollment in the study and
help us get this thing on the market.
Speaker 1 (19:08):
Yeah, And then have you guys commented on a timeline
for you know, you talk about the in first enrollment
being this year, but what is like, how long is
the primary endpoint? Is it a twelve month primary endpoint?
Something different? Because you know, as an analyst, I'm putting
on that hat of trying to calculate from the beginning
of the enrollment to end of enrollment to the primary
(19:29):
endpoint to then potentially you know, FDA submission. So I'll
start with is the prime what is the design for
the primary endpoint?
Speaker 3 (19:38):
So thus far this week we only announced we got
the IDE approve.
Speaker 2 (19:41):
Interesting, it gave.
Speaker 3 (19:43):
You some sense for the size of the study in
terms of the number of sites participating. On September second,
we have an earnings call. We're going to go into
more detail on the study design, okay, and then later
in September of twenty twenty five here just to reference
this for those of you who are listening. Later, perhaps
we're going to do a webinar with some clinicians and
some patients and really go into mark more detail on
(20:05):
the clinical problem itself, the study design, and the promise
of the therapy, the impact that it can make.
Speaker 1 (20:12):
Okay, very interesting, looking forward to hearing more about that then,
and then you know our next episode, you can come
on and discuss it more with me then. So then
let's just move then into the third leg of your stool,
the RCBCI and the biggest difference I saw.
Speaker 2 (20:30):
Can I stop you?
Speaker 1 (20:31):
Yeah?
Speaker 3 (20:32):
So we only discussed the blood pressure indication for rc IM.
Oh yeah, but we're using RCM and clinical feasibility studies
to help people stand and walk again. Also first in
human for urinary incontinent so underactive bladder totalate, the need
to insert catheters every time a person has to urinate
(20:52):
for upper extremity movement restoration.
Speaker 2 (20:55):
So it's also very flexible.
Speaker 3 (20:57):
Your Pandora's box that you like, Yeah, positive Pandora's body.
Speaker 2 (21:00):
Yeah.
Speaker 3 (21:01):
And all of these clinical feasibility studies are advancing with
the benefit of grant funding, so we're not having to
use the company's precious capital for that. And we have
grant support from the Michael J. Fox Foundation for Parkinson's Research,
the Christopher Refoundation, the US Department of Defense.
Speaker 2 (21:17):
And so on. So it's this is a very.
Speaker 3 (21:19):
Versatile platform and we're keen to get it to prove
for blood pressure and then follow up with a number
of other indications or recovery targets.
Speaker 1 (21:28):
Interesting and so and then how I mean is it
walk me through that then? Because that's interesting, because yep,
it's got to be a different Yeah, a mechanism of
action to treat these different ailments, whether it's you know,
blood pressure, whether it's bladder, whether it's Parkinson's disease. How
(21:50):
does that process go about? Is that something that's happening
in your internal R and D? And then you highlight
that to the clinicians. Are the clinicians being able to
be like, hey, by the way, this is what we saw.
You might want to dive deeper into this, and you're like, okay,
let's do it.
Speaker 3 (22:04):
We have brilliant scientific partners and they explore and develop
these indications, starting with basic science, pre clinical models and
then clinical feasibility studies and in that way they can
develop these with precision using our technology. So that's the partnership.
(22:25):
We then become the clinical trial and commercial engine so
there's a really nice synergy between our science partners and
then onward as a commercial enterprise. What's nice is the
IPG the neurostimulator is the same, and we have developed
a family of leads that are designed to be placed
(22:46):
in different areas of the spinal cortcha okay, and different
areas of the spinal cord are responsible for controlling different functions.
So that's how we address these various recovery targets.
Speaker 1 (22:57):
Okay. And then let me as a follow up, everything together.
So it's different leads for different areas to treat it.
But is it a different algorithm or different frequency or
different power that is required for that as well, or
is it just if I put the lead here, it
does this. If I put the lead here, it does that.
But the internal IPG it does all.
Speaker 3 (23:20):
There are different ways of stimulating to achieve each of
these results based on what we're trying to facilitate. So
and this is again the genius of our science partners,
and then it becomes embodied in our intellectual property. So
we have three hundred patents. We've pioneered this area over
ten years. So that's really a very valuable asset for
(23:44):
the company. Is that know how and the ip of
state that accompanies it.
Speaker 1 (23:49):
And then kind of the bridge as well is that
it's the same form factor for the IPG in the body.
And now this is going back to the BCI. This
is it's basically communicating with the IPG. The biggest difference
I saw from a year ago to now is the
(24:10):
partnership or maybe it's the same partnership, but it's a
different name because it used to be ARCIM plus the
Clintech Brain Computer Interface or BCI. Now I'm just saying
ARCBCI is that intentional.
Speaker 2 (24:24):
It is intentional.
Speaker 3 (24:25):
So what occurred we had been doing research in partnership
with a French government funded biomedical institute that actually part
of their nuclear research initiatives, like Los Alamos National Labs.
Speaker 2 (24:40):
If they had a medtech Army and.
Speaker 3 (24:43):
That group has a very sophisticated neurosurgery research initiative. Indeed,
that's where deep brain stimulation was invented. And now they
created this BCI or brain computer interface, and it's very
neurosurgery friendly because it was developed by a neurosurgeon, and
(25:03):
we took the opportunity strategically to bring that in house.
So now it's ours to exclusively develop. And we did
that because having that control allows us to conduct research
in a very quick and efficient manner. And we want
to do this human research or clinical research quickly and efficiently,
(25:24):
so we can get this on the market and be first.
Speaker 1 (25:26):
Yeah, and so you know, walk me through the design
of the actual BCI itself, because I see it here.
You know, it looks like a silver dollar, but thicker.
And so how does it get implanted into the brain.
Speaker 2 (25:44):
Essentially, our BCI.
Speaker 3 (25:48):
Is again for a neurosurgeon, a relatively straightforward implant. It
may sound not so simple to the general audience. So
what happens is that the neurosurgeon will create a whole
in your skull called the craniotomy, the same size as
our BCI, and the BCI will then be dropped into
(26:08):
that hole, and so it will, you know, in a sense,
form a titanium part of your skull to give you protection,
and then your skin and hair grow back on top
of it so it becomes invisible to others. And then
on the underside of that BCI are a series of
electrodes and those sit on top of the brain, indeed,
(26:30):
on top of the lining of the brain called the dura,
on the motor cortex, and that's what records a person's
movement intention.
Speaker 1 (26:37):
Okay, because that was the thing that got to me,
is I know how protective the body is to any
contact with the brain. I wanted to make sure I
understood that it's not actually touching the brain. It's touching
the dura, or the layer that covers the brain, and
that's in between the skull and the brain.
Speaker 3 (26:53):
Yeah, in our view, this is there are various varying
degrees of invasiveness than this BCI realm, and this is
the least invasive yet effective approach because it's not penetrating
the dura, it's not penetrating the brains. The brain is
not trying to defend itself by encapsulating the electrodes.
Speaker 1 (27:16):
Okay, So that's kind of the interesting about the competitive
landscape because there's different disease states, different functionality, different designs,
and so the other BCI designs, some well known, some
more private, they have to go through the dura and
connect directly to the brain. Are there any of them
(27:37):
that also just kind of go through the dura to
the brain or is it mostly the first generation of
these products are touching the brain still?
Speaker 2 (27:45):
Yeah, So they're all private companies.
Speaker 3 (27:46):
We're the only listed company with a DCI, which might
be interesting to your audience. Each of the companies has
a different approach, actually, Matt. So there's one company here
in New York that has an intravascularly delivered BCI and
so it comes up through your vascularture. So the challenge
there is can they make that small enough so it
(28:09):
can be positioned in the motor cortex such that you
can do things with it. There's another also based here
in New York. They're trying to deploy thin film electrode
under the dura on top of the brain, but under
a dura the dura, so they're working on the delivery
system for that minimally invasive but still subdual. Then there's
(28:32):
one that gets a lot of attention that's delivered by
robots where hundreds of electrodes penetrate the brain itself, which
was as its own series of questions. So lots of
flavors of BCI right now. We like ours because it
is relatively non invasive, has seven years human safety data,
the signal doesn't degrade, and we feel like having that
(28:56):
gives us a chance to get these studies done and
progress the field. However, our r IM system can receive
wireless instructions from any BCI. It is agnostic, Okay, So
we stay in touch with these companies and if they're
making good progress and we believe that those BCIs can
make our system better and offer more benefit to patients, great,
(29:20):
We're very keen to work with them in the future.
Speaker 1 (29:22):
That's interesting, Actually, that's a fun fact that I didn't
realize that it is BCI agnostic. So then you know,
walk through us through where you are in your clinical
development for your BCI. I think there's been a handful
of implants done. I know there was a news we
talked about the news article last year about Gert John.
(29:45):
I might be mispronouncing his name, who you know, and
after his cycling accident. But where are you in those
steps and kind of what are the what are the
maybe end goals for this year and maybe the next
twelve twenty four months.
Speaker 3 (30:01):
Dirt Yon, whom you mentioned, was the first human to
get one of these to facilitate thought driven walking, standing
and walking. And since we've done four more people, so
three for standing and walking and two now for hand
and arm function. And one of the uh you know
(30:23):
I mentioned before are these brilliant research partners. One of
the reasons that partnership works so well is I stay
quiet until they publish, and so I know they're keen
to publish the results from those additional people who they've implanted,
So I want to let them do that and then
I'll talk about it. They need to win as well,
and winning in their field is publishing, and then we
(30:46):
help them then scale it for the benefit of humankind.
Speaker 1 (30:49):
Very nice.
Speaker 3 (30:51):
Yeah.
Speaker 1 (30:51):
The other thing too, that is interesting over the last
year is kind of, you know, as I'm picking up
more and more about these BCI companies developments, I'm starrying
to also read more about the ethics let's call it
b C I maybe not necessarily for med tech medtech
you have you know, the you know you're you're treating
(31:13):
a disease and ailment, but you know, some of these
other b c I things for monitoring and things like that,
it opens a question of privacy ethics. And you know,
one of the things is I've been leafing through the
Battle for Your Brain by Nita Farahani. What are your
thoughts about b c I. You know, with that, you know,
balancing the benefits of BCI because some of those times
(31:35):
it's pretty interesting to have that capability without having to
use your hand and hands and things like that, or
especially for a paraplegic, being able to move your hands
again is amazing versus that kind of privacy issues, both
med tech side and just in general. I'm curious what
your thoughts are.
Speaker 3 (31:52):
Our focus is very specific on using those brain signals, yeah,
to restore movement, and and indeed our ECI sits on
the motor cortex. It's our target population. But it's good
that people like you were reading books like that, and
and I have been on panels where the ethics of
BCI have been discussed, and it is racing ahead with
(32:12):
the benefit of a lot of capital, without a lot
of contemplation about the perils.
Speaker 1 (32:19):
Well, it sounds like it almost sounds like we're shooting first,
asking later type of moment with the development because of
how quickly the technology can pretty much Murphy's law like
to be able to double every eighteen months and things
like that, just able to accelerate that way. While we're
still kind of.
Speaker 3 (32:37):
I think you're had a forty in slip because you
meant to say Moore's law, Murphy's laws. Yeah, whatever bad
thing may happened, may happen. So that's an interesting slip.
We'll we'll see again. This is it's there's a lot
happening there. There's a lot of peril and and we
just want to stay a force for good here.
Speaker 1 (32:56):
Yeah, and you're right, probably it was a little bit
of there and so then you know that kind of
just lines you up. You know, one of the things
that caught my attention was your limited launch and you know,
you you began building the salesforce kind of after the
Novo approval as a CEO decision to you know, with
you know, limiting the cash burn, which kind of caught
(33:20):
my attention because you know, every time, you know, if
you think of some of these large cap companies they're
building out that commercial team well in advance, and so
once they get the FDA approval, they can go. But
some smaller companies like Onward and other private companies, they
don't have that flexibility to just throw cash into that
like that. So I thought that was an interesting strategy
(33:40):
that you had there of being more patient and being
more methodical about your cash burn. But where are you
with kind of financing needs just kind of as you
really have a lot of different favorite children right now
that you have to cultivate and you know, bring out
into the market.
Speaker 3 (34:01):
I don't want the audience to get the wrong impression here.
We move with great urgency and velocity. We really do
because we're very mission driven and we see the needs
that are out there, unmet needs, and we see the
impact that our therapies can are having and can have.
And we're also doing a lot for a company our size,
three different technology platforms, commercializing one, conducting a pivotal study
(34:24):
on the next, and so forth. However, it's good to
be quite prudent about where one spends capital. And even
though we're doing a lot, our primary focus is commercial
commercializing Archax and then funding the pivotal study for RCIM,
and we do have the benefit of grant funding to
advance our pipeline. It has been a challenging environment for small.
Speaker 2 (34:48):
Cap medtech to raise capital.
Speaker 3 (34:50):
We've been lucky, maybe because of our execution. We raised
seventy million euros eighty million dollars.
Speaker 2 (34:57):
Last year and things are opening not been.
Speaker 3 (35:00):
Medtech in the equity capital markets. There have been several
successful IPOs this year on Nasdaq in med tech, So
I think we're entering a nice, a better era in
terms of raising capital, which may open up some some
opportunities for us. But we're you know, we're at least
the time of this recording, what two hundred and seventy
five million dollar market cap company and first year of revenue,
(35:25):
and we have a bright future, but we still have to.
Speaker 2 (35:27):
Be be prudent.
Speaker 1 (35:28):
Yeah, yeah, well, you know, I look forward to just
the rest of this year and when we see you
back next year, we'll get the crown for you for
visit number four. Kind of seeing how that develops out
over time. But Dave, thanks so much for joining us today.
Speaker 3 (35:42):
My pleasure, really nice to be in the studio with you. Matt,
Thank you Miriam for your excellent sound engineering. And look
forward to coming back.
Speaker 1 (35:50):
Oh yeah, they're the ones that make us sound good.
So and thank you to our listeners for tuning in
today and we hope you join us for future episodes.
If you'd like to stay up to date, you can
click the subscribe button on Spotify or your favorite streaming platform.
Take care,
Host
Jonathan Palmer
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