Recovering function after spinal cord injuries - Dave Marver on breakthrough therapies

00:00:00: There are tears every day.

00:00:01: The people who are moving for the first time are crying.

00:00:04: Their loved ones are crying.

00:00:06: But I think most compelling is the physical therapists are crying because they've devoted their entire career to helping these people.

00:00:15: And there's never been something like this before.

00:00:18: that's able to restore movement.

00:00:30: Hello.

00:00:30: Welcome to a taste of bionics.

00:00:34: My name is Ranga Yogeshwar.

00:00:36: And in this series, we explore how technology and biology are coming together to reshape what it means to be human.

00:00:47: Today, we're talking about one of the most dramatic franches in medicine, the treatment of spinal cord injuries.

00:00:56: Just imagine yearly about one million people worldwide experience a spinal cord injury.

00:01:05: And for decades, a severe spinal connection meant paralysis for life.

00:01:11: But this story is about to change.

00:01:15: And today's guest is Dave Marver, the CEO of Onward Medical, a company developing breakthrough therapies that use gentle electrical stimulation to help people regain movement and control after spinal injury.

00:01:33: And we will dive into this topic.

00:01:36: And yeah, I'm very excited.

00:01:38: Hi, Dave.

00:01:40: Hi, Ranga.

00:01:41: First of all, Dave, a very personal question, which I always ask my guests because this is a very special area.

00:01:48: What brought you into this area?

00:01:51: Well, I've

00:01:51: been in medical technology for my entire professional career, now almost thirty years.

00:01:58: And I was contacted about this role just over five years ago.

00:02:03: And I was really captivated by, number one, the need.

00:02:07: This is a profoundly unmet need and by the opportunity to create a company that could make a true difference in the lives of people with spinal cord injury and their families and loved ones.

00:02:20: Well, it is something very sensitive.

00:02:23: If we look at spinal cord injuries, I remember a talk at the triple AS, the American Association for the Advancements of Science.

00:02:34: And in this talk, there was a surgeon showing pictures of young people, you know, ski athletes doing acrobatics and landing in a bad way.

00:02:44: And after that, they were not even able to walk anymore.

00:02:47: So this sort of, you know, kept burned into my soul almost.

00:02:54: And if you speak about spinal cord injuries, first of all, interesting statistics, males are about three times higher, if you look at the statistics to get this injury than females.

00:03:09: You have a certain age distribution, which I looked at some data in Germany, which on one side, when people get older, age seventy.

00:03:18: But you also have these young males, you know, these guys who drive in a car and have an accident and life changes.

00:03:26: So first of all, when were you the first time confronted with people having a spinal cord injury?

00:03:34: Do you have, you know, perhaps in your family or friends?

00:03:38: I don't have anyone in my personal life, no.

00:03:41: However, as you suggested, the instant that you encounter somebody with an injury, you see that their life changes in a millisecond.

00:03:50: It's so sudden.

00:03:53: And you also see that there hasn't been enough development in terms of therapies that can help and impact these people in their daily lives.

00:04:06: And this is what's so motivating for me personally, as well as for the entire team at Onward.

00:04:12: In the old days, one would say a spinal cord injury means this is an equation.

00:04:20: you have a wheelchair for your life, you are sort of confined to a life which is literally different.

00:04:30: Can you once explain?

00:04:31: Because we as lay people, we just see the wheelchair, but perhaps some people never spoke to persons who suffer from a spinal cord injury.

00:04:44: What all is this about?

00:04:46: So it's not only that you are paralyzed, you can't move, but it's more than that, isn't it?

00:04:51: Indeed, most people associate a spinal cord injury with paralysis or loss of sensation.

00:04:59: But there are many other challenges that arise after an injury.

00:05:03: There is poor blood pressure regulation, there's incontinence, so the inability to go to the bathroom to urinate without inserting a catheter each time.

00:05:13: It can take up to two hours each day to move one's bowels.

00:05:18: There can be difficulty regulating one's body temperature, even coughing.

00:05:23: So many of these activities of daily life are challenged by spinal cord injury way up and even beyond just the paralysis.

00:05:33: So first of all one must make clear that the quality of life is not only that you cannot walk, but you mentioned blood pressure.

00:05:42: So I imagine the regulation of all that is below the area of the injury.

00:05:49: So there is no contact, no response.

00:05:52: Is that the way one should look at it?

00:05:54: You're right.

00:05:55: When a person has a spinal cord injury, every function controlled below the site of injury on the spinal cord is impacted.

00:06:03: Most people, when they have a spinal cord injury or SCI, let's call it, just to shorten it.

00:06:08: they break their necks.

00:06:10: And so they have a lot of impairment.

00:06:12: Their hands and arms don't work well.

00:06:15: Their legs don't work well.

00:06:17: And then all of the other bodily functions that I just mentioned are also impacted.

00:06:22: And among those are indeed the body's ability to regulate blood pressure.

00:06:28: Commonly after SCI, people have low blood pressure that's tied to posture or changes in posture.

00:06:37: So if they sit upright, let's say to eat a meal or ride in a car, they can feel lightheaded or faint.

00:06:44: Likewise, when they try to transition in the morning from the bed to the chair, that can take a long time because they're feeling faint and lightheaded.

00:06:53: And this is among the issues that we want to address.

00:06:59: Spinal cord injuries, well, you seem to differentiate between the complete and the incomplete SEI.

00:07:09: Could you give us an idea of these?

00:07:12: Because they will play a big importance in what we are to talk later.

00:07:17: Every spinal cord injury is different and one can assess an injury by its severity and its location on the spinal cord.

00:07:25: The most severe is called a complete injury and that's where there's a complete absence of motor function or sensation following the injury.

00:07:36: And so depending on the position, if it's higher, it's worse.

00:07:41: If

00:07:41: it's higher, it's worse.

00:07:43: If it's more complete, it's worse.

00:07:47: And in most people, their injury allows some spared connectivity between the brain and the body.

00:07:54: So some intention to move or some function can make it through the injury, but it's often not enough for function or movement to be normal.

00:08:04: I once ran through this topic.

00:08:08: This was, I think, the twenty nineteen.

00:08:10: I attended a big conference in Berlin called Falling Walls.

00:08:15: And this always takes place in November, you know, when the German, the Berlin Wall fell.

00:08:21: And this was a talk by Grégoire Curtin and Jocelyne Bloch.

00:08:27: And it was fascinating for me.

00:08:30: to see, okay, this is not a static state, but you can change something.

00:08:36: I mean, in those days, I remember in their talk, they showed the example of a rat, which had a spinal cord injury, and then they sort of stimulated, well, spinal stimulation, you call it.

00:08:52: And this, I think so, is the base of what you are also doing in your company, isn't it?

00:08:58: Indeed.

00:08:58: Professor Cortine and Dr.

00:09:00: Block, they're brilliant people.

00:09:02: Yeah.

00:09:03: And they're very committed to restoring movement and function after spinal cord injury.

00:09:08: And they're the founders of this company.

00:09:10: So they had determined through basic science and preclinical research how to stimulate the spinal cord to indeed restore movement and function.

00:09:20: But there was no technology then available capable of delivering the therapies that they envisioned.

00:09:27: So they founded the company to develop those therapies.

00:09:30: And you fast forward to today.

00:09:33: Onward now has three technology platforms.

00:09:37: all of which stimulate the spinal cord to restore movement and function.

00:09:41: after an SCI.

00:09:42: Now let's try and understand what exactly is spinal stimulation.

00:09:48: So what I imagine is you sort of try to bridge the part, but you will explain it in much better words than I can.

00:09:57: Yeah, indeed.

00:09:57: We have, as I mentioned, three different technology platforms, and they stimulate the spinal cord in different ways.

00:10:05: And indeed, as a company, we try to be quite specific in where and how we stimulate so that we get the best result for the people who need it.

00:10:14: The first technology that we've introduced, it's now FDA approved and CE mark, which means regulators have given us permission to commercialize the device broadly in the US and Europe.

00:10:25: It's called ARC EX.

00:10:28: And this is an external stimulator.

00:10:30: It stimulates the spinal cord through the skin.

00:10:33: The way this works is it's for incomplete injury, as you mentioned before.

00:10:38: And the leads or these electrodes that are placed on the skin are placed around the site of injury and they amplify, they excite the spinal cord in that area.

00:10:50: And by exciting the spinal cord in that area of injury, they allow a person to move in a way they otherwise could not.

00:10:57: A person can then train performing that movement, and by training performing that movement, they recover function.

00:11:03: We have another technology platform that's fully implanted.

00:11:06: We call that ArcIM.

00:11:08: And here, we're really replacing the instructions that would ordinarily come from the brain in a very precise way of stimulating.

00:11:16: And this is how we're addressing blood pressure and stability, restoring the ability to stand and walk, and so on.

00:11:24: So let me understand it step by step.

00:11:27: I'll start with ARCH-X.

00:11:29: So this is an external device, as you said.

00:11:33: And how can I imagine this is something like turning the volume up of the remaining nerves so that, well, they reawaken.

00:11:43: or how can I figure it out?

00:11:46: The thing we're trying to achieve with ARCH-X with the first indication that's approved is restoring function.

00:11:55: So the instruction from the brain to move one's hands is not coming through the spinal cord with sufficient strength to enable hand function.

00:12:06: normal hand function.

00:12:07: So we are indeed amplifying the spinal cord at the area of the injury, turning up the volume as you say.

00:12:15: So while that stimulation is on, a person can move as intended.

00:12:19: And then the training allows the person to recover function over time.

00:12:24: Dave, this sounds first of all fascinating because this is really breaking a sound barrier in the sense that before one felt you are confined, And now just by stimulating, you know, bridging this gap, if you will, people are able in your example to move a hand.

00:12:45: I mean, how does that feel?

00:12:47: I mean, you see a lot of patients.

00:12:49: So how does that go about?

00:12:52: That must be a sort of a fascinating moment, isn't it?

00:12:56: To answer your question, when I speak to... are people in the field who are visiting clinics and interacting with people with injuries and physical therapists, so those who treat them.

00:13:09: What they tell me is there are tears every day.

00:13:13: The people who are moving for the first time are crying.

00:13:16: Their loved ones are crying.

00:13:18: But I think most compelling is the physical therapists are crying because they've devoted their entire career to helping these people And there's never been something like this before.

00:13:30: that's able to restore movement.

00:13:32: So it's really, as you say, a breakthrough in care for people with SCI.

00:13:37: And we were very proud to have brought this forward.

00:13:41: And we feel a responsibility for this therapy to succeed, as well as all the others on which we're currently working.

00:13:47: So you just mentioned the external device, as you call it, ARUX.

00:13:54: You can use it in the US and you said CE so I presume also in Europe you can already use it.

00:14:01: So how is the treatment going on?

00:14:04: You start as a patient and then while your team or specialists come and say okay we have this external device and then well tell us a bit how step by step.

00:14:17: this works.

00:14:18: So we've currently only commercialized this in the US where we have approval to market it to these specialized rehabilitation clinics who care for people with spinal cord injury.

00:14:31: And so the way it's working now is that patients are coming into the clinic, they're using the device two to three times per week for an hour per session, and they're using it for a period of one or two months.

00:14:45: We're hoping soon We filed the application already.

00:14:48: We're hoping soon to have FDA approval for this device to be used in the home.

00:14:53: And then it's far more convenient for people who have tetriplegia to use it in the home for an hour a day and recover function in that way.

00:15:01: We recently did get CE mark authorization, so we can launch in Europe.

00:15:07: And that came a bit early candidly, so we're now putting in place the mechanisms to first launched that into clinics in Germany, and then other countries, and then later into people's homes.

00:15:19: So it's still early days, but it's going very well in the US.

00:15:23: In less than a year, we've sold seventy devices into over fifty of these specialized clinics.

00:15:30: So there's a lot of interest, there's a lot of demand for it, and that's understandable given the impact that it's having.

00:15:37: Now you mentioned as a patient, I just imagine I am a patient.

00:15:42: I come to a very specialized clinic and then they sort of stick those electrodes in the area of my injury.

00:15:55: and then you have this electronic black box I call it and somehow you have to tune it because every injury is different.

00:16:05: You have to get used to it.

00:16:06: The volume mustn't be too high.

00:16:09: So is that a lot of training going on, getting used to it?

00:16:13: And what is the feeling of the patients for the first time when you switch on the box?

00:16:18: So indeed, there's this box.

00:16:20: I'm going to hold it up here, but you may have a visual that you can share with the listeners and viewers.

00:16:27: And this connects to leads that are placed on the skin.

00:16:29: But there's also a tablet.

00:16:31: And this tablet programmer is used to optimize the stimulation parameters.

00:16:37: And we have an initial set of suggested parameters that result from the clinical studies that we've performed that have been published.

00:16:47: But then the physical therapist can.

00:16:49: tweak or modify those to suit the individual patient and his or her needs.

00:16:55: But then you have to get used to it.

00:16:58: So it's not only the stimulation by itself, but it's what seems to be very important also rehab.

00:17:05: So get used to it, understand it, live with it.

00:17:11: Well, indeed.

00:17:12: I think the simplest way to view how this therapy works is Let's say you were to sustain a knee injury skiing or something.

00:17:20: I hope it doesn't happen, Ranga, but let's say that would happen.

00:17:25: You would need to move in order to rehabilitate your knee.

00:17:28: If you have paralysis, you can't move.

00:17:31: This device allows a person to move and therefore undertake specific rehabilitation and that's how they recover function.

00:17:39: So it's the combination of specific tailored stimulation and what's called functional task practice or specific rehabilitation, both of those used in concert.

00:17:52: I looked at some of your videos, which you also have in YouTube, for example.

00:17:59: And it's almost, this sounds a bit big, but it's biblical in the sense that, you know, people suddenly who are confined to a wheelchair stand up and are able to walk.

00:18:14: Now, this first of all sounds like magic, magic of the twenty-first century.

00:18:22: But in detail, I mean, you have seen certainly such patience.

00:18:29: Just describe this moment.

00:18:30: I think so.

00:18:32: It is magic, isn't it?

00:18:34: It is.

00:18:35: You've transitioned to our second platform, which is ArcIM, our implanted platform, which we've used to help people stand and walk again.

00:18:42: And it is absolutely biblical and magic.

00:18:45: And that's what drew me to the company as well as all of my teammates here who are so driven by this mission to do something that's never been done before that can have such an amazing impact on people's lives.

00:19:00: I don't want to convey that this is a miracle that occurs in seconds.

00:19:06: If a person has been in a wheelchair for several years, it takes time for them to recover functions like standing and walking.

00:19:15: The stimulation allows them to stand and to take some steps with body weight support.

00:19:21: But then the people need to regain muscle mass, regain balance, really learn to walk again.

00:19:28: And so there's a real commitment on behalf of the person as well.

00:19:32: So we do our jobs in terms of developing the technology that can enable this movement, but then the physical therapists and the patients themselves also then need to step in and help the person regain function.

00:19:47: So in other words, it's the entire process.

00:19:50: It's on one side or the technology, but then it is very differentiated learning physical therapy, perhaps even mental therapy, because this changes the view you have on your life.

00:20:05: So it's a long process.

00:20:07: I mean, how does a weak look like for a patient undergoing spinal stimulation therapy?

00:20:16: you asked me what a week looks like.

00:20:18: It really depends.

00:20:19: So if we're still talking about somebody recovering the ability to stand and walk again, it's again like recovering from an injury for you and me.

00:20:31: It's sitting up and down process and it requires a lot of work and determination and exercise and commitment.

00:20:39: But over time, People are very encouraged by their ability to do things that they maybe gave up hope that they'd ever be able to do again.

00:20:50: And you're right, these therapies do often impact a person's mental well-being as well, because the impossible becomes possible.

00:21:00: And this is the sort of thing that... We want to enable.

00:21:04: We want to help a person enjoy life.

00:21:07: In fact, that's our vision statement.

00:21:09: Enjoy life in the ways that matter to you.

00:21:12: Maybe you want to walk again.

00:21:13: Maybe you want to go to the bathroom without inserting a catheter.

00:21:17: Maybe you want normal blood pressure.

00:21:18: Maybe you want to use your hands again.

00:21:20: And we want to use our therapies to assist in every one of these ways.

00:21:25: Well, let's focus a bit on... We spoke about walking, but... That's what gets the headline coverage, but the autonomic dysfunction.

00:21:35: So you mentioned blood pressure, bladder problems, and so on.

00:21:41: This is really a strong impact in their lives.

00:21:44: So here, well, if you take your ARC IM system, I think so.

00:21:55: something where also you can immediately change the quality of life.

00:22:00: So, I mean, if I just think of blood pressure, must you train for that also?

00:22:06: Or is that something which you just get so suddenly you can get out of bed in not hours, but perhaps minutes?

00:22:15: Indeed, if you ask people with a spinal cord injury, to prioritize the functions or activities they want to recover.

00:22:24: Often walking is well down the list.

00:22:27: They want to have normal blood pressure.

00:22:29: They want to go to the bathroom without a catheter.

00:22:32: So this is why we are putting resources into these things.

00:22:36: And you're absolutely correct.

00:22:37: One of the compelling things about the blood pressure stability indication is It does not require rehabilitation.

00:22:44: You turn it on and it works.

00:22:46: You can even see an impact during the surgery itself.

00:22:51: And this is why we've prioritized.

00:22:53: This is our first indication for ARC-IM because it can impact so many people without the need for prolonged rehabilitation.

00:23:02: I can imagine that you're mailbox is just being flooded because, as I mentioned, about one million patients a year.

00:23:14: So it's a huge volume.

00:23:16: And naturally, I mean, if I would be a patient and I would share of you, I would just spam you the whole time and say, come on, I want to have normal blood pressure.

00:23:27: I want to have bladder control.

00:23:31: So do you see there is strong sort of energy from the patients pushing this technology?

00:23:38: Yes.

00:23:39: So we've been contacted by thousands of patients and their family members around the world.

00:23:44: We've also been contacted by these specialized clinics who want to bring ARC therapy to their patients.

00:23:53: And that's why it's very important for us to scale as quickly as we can to bring this technology to people around the world for whom it would offer benefit.

00:24:05: And that's one of the reasons we were very enthusiastic and grateful to partner with Autobock, who can help us, in fact, scale these therapies and bring them to clinics and homes where they can help people.

00:24:20: Well, right now you said these technologies are about to be available for everybody, but right now it's still well in an experimental stage in the sense that Well, you have some selected patients, but it's not yet spread all over the country.

00:24:40: It depends on the device.

00:24:41: So Archeax the external stimulator is now available for any US clinic who wishes to buy it and offer it to their to their patients.

00:24:50: We're waiting for approval from the FDA to offer it for use in people's homes in the US.

00:24:56: In Europe, Archex is approved for use in clinics and homes, but we as a company are now, now that we have that approval, are now gearing up to in fact commercialize it in Germany and other countries in Europe.

00:25:09: That's ARCHIEX, so that's the furthest along.

00:25:12: ARCHIM, our implanted device, is entering what's called the Pivotal Study Stage.

00:25:18: So this is a global multi-center clinical trial with over a hundred patients.

00:25:24: And the intent behind a Pivotal Study is to collect the data required to get regulatory approval from FDA and to get CE mark and then to commercialize this.

00:25:35: And we expect the blood pressure indication for archIM to be approved in the twenty twenty eight timeframe.

00:25:42: So it's almost twenty twenty six as we record this.

00:25:45: So we're a couple of years away and and then other indications would follow such as standing and walking and urinary incontinence.

00:25:54: So

00:25:55: in other words, what I understand is you have a step-by-step approach.

00:26:00: So some functions, as you mentioned, blood pressure will be perhaps quite fast.

00:26:06: And the more complex task of learning to walk will take a bit more time.

00:26:12: Do I understand you correctly?

00:26:13: That's exactly correct.

00:26:14: That's exactly correct, Raga.

00:26:16: And indeed, the third platform that we didn't discuss enables thought-driven.

00:26:21: restoration of movement with a brain-computer interface.

00:26:24: And that's the furthest away, but perhaps the most interesting.

00:26:28: Yeah, well, we'll come to talk to that.

00:26:31: Okay, okay.

00:26:32: And I'm looking forward.

00:26:33: But if you speak about the barriers, I mean, we have naturally science on one side, we have regulatory barriers, we have financial, we have logistic barriers and so on.

00:26:47: What's been harder than you expected in bringing this fantastic spinal cord injury treatments into clinics?

00:26:56: Where should one speed up?

00:26:58: So to answer your question, Ranga, we've really had a fairly smooth path, I would say.

00:27:04: We're fortunate that way.

00:27:06: And maybe it's just good karma, so to speak.

00:27:09: So the technology development has unfolded.

00:27:14: according to plan, and in terms of the uptake in the market, that's gone quite well also.

00:27:21: The barriers that we still need to confront are as

00:27:24: follows.

00:27:25: First is reimbursement.

00:27:27: This is always problematic for any novel medical device, where it's often very clear that the device is making a profound impact, such as the case with Archi-X, and we hope will be the case with Archi-M, but one has to has to undergo what is often a rigorous process in order for governments and payers to reimburse the technology so that patients can benefit from it.

00:27:53: So this is an area that we're focused on.

00:27:56: The second area is we're the first company that's really ever done this, this sort of thing.

00:28:02: So we're creating new markets.

00:28:05: And we've been, I think, quite fortunate in our ability to raise capital.

00:28:10: We're a listed company now.

00:28:12: But I think for any company at our stage where we're still not that large, we're still not profitable, we rely on our ability to raise capital from others to support our work.

00:28:24: So this is another area that that I think remains a challenge, that I'm confident that we'll continue to surmount, but I do want to flag that as well.

00:28:33: So reimbursement and having sufficient capital to execute our full plan and realize our full potential.

00:28:40: Emotionally speaking, I mean, you meet patients, families who have very real hopes.

00:28:47: Yet, many of these therapies, like I am, are still in, well... Experimental stage.

00:28:56: so it will take time.

00:28:58: How do you manage these expectations?

00:29:01: When you're hopeful, but the science is still evolving.

00:29:05: I mean this is You know you opened the door and now everybody wants to enter.

00:29:11: Well relative to the last several hundred years or all of human history.

00:29:15: This is I I don't mean this in a joking way It is the best time to have a spinal cord injury because finally there are therapies like this that are emerging.

00:29:26: And one of them is now approved by regulators and available.

00:29:30: And another will be available, we hope, within two years.

00:29:33: So in the span of history for a person with spinal cord injury, this is not a long time.

00:29:40: And we're going as fast as we possibly can.

00:29:44: And the data, much of which has been generated by Professor Courtney and Dr.

00:29:49: Block, whom you mentioned earlier, is very high level and very rigorous.

00:29:54: Most of it is published in Nature, Nature Medicine, New England Journal of Medicine.

00:29:59: And so we're quite fortunate to have our therapies reinforced by such a rigorous and high quality clinical data.

00:30:11: So I think we're past a lot of risk.

00:30:14: Yes, we have to do the large scale studies, but it's really now an execution challenge and we're up for it.

00:30:22: But there's naturally one big question which is, will this technology not right now, because you're still sort of in a development stage, but if you scale up, very often the hope is, okay, this is also going to be a technology which is affordable, not only for the very few rich people, but for, well, people around the world who suffer from these injuries.

00:30:47: What is your vision there?

00:30:50: break down to something which will become pretty standard.

00:30:54: We're a mission-driven company and it's very important to us that people who can benefit from our therapies will have access to our therapies.

00:31:04: And we have priced and will continue to price these therapies within, we'll say, normal and accessible ranges for people.

00:31:15: Yes, we need to make a profit.

00:31:16: We need to continue to invest in research and development to bring all of these promises, promising therapies forward and to be an enduring, sustaining business.

00:31:27: But indeed, we will price these therapies in a fair way.

00:31:32: Just imagine a person suffering from a spinal cord injury, let's say in the year twenty thirty.

00:31:41: By then, things have changed.

00:31:44: What do you hope they say happened between then and now?

00:31:48: I mean, what is going to be the progress?

00:31:52: Just give us a feeling of what we could realistically expect.

00:31:56: It's my hope that both the ARC EX and ARC IM technology platforms are approved and available broadly in the US, Europe and other geographies.

00:32:08: And that our third platform that we'll get to soon will be in large scale.

00:32:13: clinical studies and on the verge of approval and availability.

00:32:17: Because once the three platforms are approved, it becomes easier for us to introduce new and expanded indications.

00:32:26: We spoke about spinal cord injuries.

00:32:30: So here the story is that you have the brain and the signal doesn't pass.

00:32:37: Sometimes it's almost the opposite.

00:32:39: I have a dear friend of mine who just a couple of months back got a diagnosis of Parkinson's.

00:32:49: So suddenly here in a certain simplistic way.

00:32:54: you have brain signals which are slowly blurry and as an effect you have all these tremors and so on.

00:33:02: And this also is a big opportunity with your company where you say we could focus on how to I don't know, filtering out the signals and the tremor, we could dampen it.

00:33:17: Tell us more about that.

00:33:19: We have promising therapies for Parkinson's disease.

00:33:23: Spinal cord injury.

00:33:26: is our raison d'etre, our North Star.

00:33:28: But we think that our technology platforms and approaches may be able to help people with Parkinson's as well.

00:33:36: So when a person has Parkinson's disease, like your friend, they often present with tremor first.

00:33:43: And then later in the progression of the disease, they may have difficulty walking.

00:33:48: They may have balanced challenges or what's called freezing of gait.

00:33:53: And here's where our implanted spinal cord stimulator, ARC-IM, may be able to help them for a period of time walk better, let's say.

00:34:05: Parkinson's is neurodegenerative, unlike spinal cord injury, so eventually the problem will become too severe for us to to help with, but we think we can potentially sustain a higher quality of life and function maybe for five or ten years than these people would otherwise have.

00:34:24: So these Parkinson's therapies are a bit earlier in development, but again they are showing promise.

00:34:30: Let's speak about one thing which is the two-way track.

00:34:35: So right now you stimulate a signal from the to, I don't know, the arm or the hand.

00:34:45: The other way around, sort of, is that also possible so that I can feel my leg, which I could not feel before?

00:34:54: Well, what happens with our therapies is sometimes there is an improvement in sensation.

00:35:01: So even if we're intending to restore movement, By helping a person train again, there is some remodeling of the nervous system, a healing of sorts, and sensation is among the functions that returns.

00:35:17: Indeed, with Archex, we found in our pivotal study, it was called Uplift, it was published in Nature Medicine, that people had restored sensation.

00:35:28: So that was a nice thing.

00:35:31: None of our therapies have that intent, but we often get a serendipitous, a positive surprise in the outcome.

00:35:41: For example, among the nine people for whom we've helped them stand and walk again.

00:35:48: One of them, for example, had his sexual function restored and he's been able to father two children.

00:35:54: Okay.

00:35:54: Previously.

00:35:55: Yes, yes.

00:35:56: So that's another promising area of inquiry.

00:35:59: now is can we indeed stimulate the spinal cord to restore sexual function after spinal cord injury?

00:36:06: So there's a broad range of things we can potentially address.

00:36:11: We just need to be focused and smart, one at a time.

00:36:15: And the bigger we get, the more we can do.

00:36:18: Well, if you look at the research itself, as I have to recall the first time I heard this talk by Grégoire Cortin and Joslie Bloch, it was a bit magical.

00:36:33: Are you sometimes afraid of, hey, we are entering a field where Suddenly we are doing things which were unheard, imaginable, still twenty years back.

00:36:46: That gives you a lot of responsibility in a certain way also.

00:36:50: Well, the research is magical and those two deserve all the credit that they receive in the scientific community and increasingly in the general public as well.

00:37:00: I think they're Nobel Prize candidates in the future, certainly.

00:37:04: My job and our job here is to make those magical discoveries real.

00:37:11: That's it.

00:37:11: Very pragmatic.

00:37:13: Right.

00:37:13: I mean, turn them into viable technologies and therapies that can be used at major hospitals and even community hospitals around the US, Europe and world on an everyday basis for the benefit of people everywhere.

00:37:29: That's our job, is to make these into real everyday scalable therapies.

00:37:36: Well, in my first explanation, I said it is a bit like turning up the volume, bridging the gap.

00:37:43: But now if you look at developments, for example, in the field of artificial intelligence, which uses, as one says, digital neural networks.

00:37:56: There is some, perhaps, I don't know, possibility to differentiate to sort of not only turn up the volume, but to be much more specific to have a deeper granularity of what you can control.

00:38:11: Do you see some opportunities there?

00:38:13: Absolutely.

00:38:14: ArchiX, that device does turn up the volume and amplify.

00:38:19: ArchiM, the implanted device, really replaces the instructions that would come from the brain.

00:38:24: are blocked by the spinal cord injury.

00:38:26: And here we try to be very, very specific.

00:38:29: And we do in fact use artificial intelligence.

00:38:34: AI is used to determine the initial programming parameters.

00:38:39: So it comes up with a suggested set of programming parameters that, and that has shortened the amount of time that's required at the beginning when a person is first implanted to get them up and functioning.

00:38:51: AI is used in... To a great extent, though, with our brain-computer interface, our thought-driven movement therapy, where we put a device directly on the motor cortex, so the part of the brain responsible for movement intention.

00:39:09: AI determines where in the motor cortex the movement intention is arising.

00:39:13: It helps to interpret those brain recordings.

00:39:17: It also helps to translate them into instructions for our spinal cord stimulation device.

00:39:23: Also, as part of the process that a patient would undergo after getting this BCI-enabled implant, they first control an avatar on a computer screen with their thoughts, and then they transition to controlling their body with their thoughts.

00:39:40: So there's a lot of AI used throughout that particular technology.

00:39:48: Brain control means naturally this is much more invasive.

00:39:53: So you can see the steps of an external device than, you know, implanting it.

00:39:58: And well, brain is always a bit touchy.

00:40:02: So this is still in a pure research stage.

00:40:05: That's what I understand.

00:40:06: The beast, we call it arc BCI.

00:40:09: Here we've.

00:40:10: we've implanted five people to help restore thought driven movement of the arms and legs.

00:40:17: And.

00:40:17: This area of brain-computer interfaces is getting a lot of attention in the public because Elon Musk has a company called Neuralink.

00:40:26: So each BCI or brain recording device is a bit different.

00:40:32: The Neuralink device is implanted with a robot and hundreds of threads are woven into a person's brain.

00:40:40: We take a much less invasive approach.

00:40:43: So our device actually sits on top of the brain.

00:40:46: Indeed, it sits on the top of the lining of the brain.

00:40:49: So it's relatively non-invasive.

00:40:51: and yet we're able to record those brain signals with enough resolution to drive movement.

00:40:58: And so we've picked a sort of a safe, relatively non-invasive approach.

00:41:03: Maybe that's because we're medical people and not technology people.

00:41:08: Yeah, and at the end it's actually also always a bit the question of if you have an easy way to go and you're not perfect.

00:41:19: use that instead of the hard way where perhaps not everybody could benefit from it.

00:41:25: Well, it's always the best approach with a medical technology to start slowly.

00:41:31: proceed carefully, learn, adapt, evolve your technology, and safety is the foremost consideration.

00:41:40: I would say, commenting on this area of BCIs, and I did say that there are several types of technologies that are being developed to record a person's thoughts or intentions.

00:41:53: We have our own BCI today, but one of the unique things about ArcIM is that it's agnostic, meaning it can receive instructions from any BCI.

00:42:03: So as technologies develop and mature, And if any of them emerge as more promising or effective than ours, we can link ArcIM to that BCI to enable thought-driven movement.

00:42:17: So we like that.

00:42:19: we have that flexibility so we can do what's best for patients over time.

00:42:24: So if you have a vision, and this is a very ethical question, you could have compatible devices.

00:42:31: So you plug your device into the rest so that it works.

00:42:37: And somebody else did the brain surgery and gives you the link to that.

00:42:43: That's how I understand it.

00:42:46: That's what's intended.

00:42:47: Again, today, our BCI has seven years of human safety data.

00:42:52: We like it.

00:42:52: We think it's the best approach.

00:42:54: But over time, if something else emerges that is safe and effective and even potentially better than ours, fine.

00:43:01: We'll link with theirs as well.

00:43:02: We want to do what's best for patients ultimately.

00:43:07: Now, we're slowly coming to the end.

00:43:09: What I find very fascinating is You are telling us the story of, well, science and then getting that out into a product so that people really can change their life.

00:43:25: Do you already have a waiting list?

00:43:27: So, I mean, you said approval is coming, you're training.

00:43:31: So is there, I mean, it could be that the one or other listening this podcast would say, hey, take me.

00:43:41: What do they do?

00:43:42: Ranga, we've heard from thousands of people around the world and their family members asking whether they can be involved in our clinical trials or how and where they can benefit potentially from our therapies.

00:43:54: And so they can go on our website and there's a form they can complete that allows us to keep their data in a very safe and private and compliant way.

00:44:04: And also, we ask their permission to potentially share their data with a caregiver in their community to let them know when we have a device in their city or community that might offer benefit.

00:44:16: So absolutely, that's the action that people who are listening can take.

00:44:19: Visit our website, onwd, onward.com, and complete that form.

00:44:26: So you gave us a lot of hope and you show already things are working.

00:44:35: This is relieving thousands of people in the future who suffer a spinal cord injury.

00:44:44: If I take you on to a vision, what is at the end your vision?

00:44:50: Will spinal cord injuries be with the help of technology something where we will not you know have a big discussion perhaps in thirty forty years?

00:45:00: but uh well we we have the technology and you can walk again you can live again you don't have all the problems.

00:45:09: i'm not sure if we can ever return people with a spinal cord injury to completely normal function but i would be very proud and i would feel that we have achieved our mission if a person has the opportunity to address any of the functions that they want to see restored, at least in part.

00:45:27: They can stand and walk again.

00:45:29: They've normalized their blood pressure.

00:45:31: They can go to the bathroom more normally.

00:45:34: They have sexual function, for example.

00:45:37: So this is my vision, almost like a menu at a restaurant.

00:45:41: I'd like to see this and this fixed, and we offer the technology that enables that.

00:45:46: Wonderful.

00:45:47: You spoke about menu.

00:45:48: We are slowly coming to the dessert.

00:45:53: And if you look at all that, I just ask you on a very personal level.

00:46:00: I mean, the one aspect is technology, which is very fascinating.

00:46:04: Science, which is very fascinating.

00:46:06: And on the other side, well, the patience, the people, the emotions.

00:46:11: What is that?

00:46:13: What really touches your soul?

00:46:18: This is a very hard job to build a business, to do something that's not been done before, to overcome challenges on nearly a daily basis.

00:46:29: And I derive incredible motivation and energy from the people whom we're helping, from the courage they show in daily life.

00:46:40: getting through the day with a spinal cord injury is not easy.

00:46:44: And whenever I feel down or discouraged, I think of one of them and I'm immediately energized.

00:46:52: And this is the same thing for our team.

00:46:55: We work extremely hard here, but we also feel very proud that we're doing this good and noble and important work.

00:47:06: And there are things to celebrate along the way, but we're by no means done.

00:47:11: We feel we're at the early stages here of this journey, and there's a lot of work to be done.

00:47:16: So, yeah, I feel very... Are

00:47:20: you offended with people with some of your patients?

00:47:22: I mean, this is a very special relationship.

00:47:25: Oh,

00:47:25: yes.

00:47:25: It is.

00:47:26: I try to have dinner with some of our patients and their family members and get to know them.

00:47:31: It helps me understand their lives and challenges.

00:47:35: Getting on an airplane, getting in and out of cars, getting in and out of restaurants, restrooms, eating.

00:47:43: So this, I definitely carve out time to do and it helps me.

00:47:49: Do my job better and understand the community of those who have injuries better, but it also provides fuel and motivation.

00:47:57: Well, if I look at it in this podcast, we covered what spinal cord injury really is, also the dimension.

00:48:07: Think of this almost one million people and how therapies like spinal stimulation are shifting the old paradigm.

00:48:17: So this has been very, very interesting, at least for me, also hearing a bit about the road ahead.

00:48:28: Our podcast is called A Taste of Bionics, and we just had a taste in a fantastic menu, as you called it.

00:48:37: And I'm looking forward to speaking to you in a couple of years again, Dave.

00:48:44: I want to say thank you so much.

00:48:46: And if you enjoyed this podcast, well, stay tuned for more topics to come.

00:48:53: Thank you, Ranga.

00:48:54: I appreciate the opportunity to share our story and our work with your listeners.

00:48:59: We don't do this alone.

00:49:01: We have some outstanding partners, patient advocacy groups like the Christopher Reeve Foundation, the German Spinal Injury Association, and Audubach, which is an outstanding partner of ours as well.

00:49:13: So I want to thank and recognize them.

00:49:17: We could not do our work without their help and support.

00:49:20: Thank you so much.

00:49:22: And well, thanks for changing paradigms, which is I

00:49:28: think

00:49:29: the power of good science and technology.

00:49:32: Thank you, Dave.

00:49:33: My pleasure.

00:49:33: Thank you.