The Silicon Hospital and a New Way to Make Medical Devices

Transcript

[Music] hi great to be here uh just first a brief intro to myself um I'm a hard tech Pioneer in moonshots I've created multiple multi-billion dollar products on the hay edge of physics former MIT professor Brown University PhD in physics and about eight years ago I started my latest project it's called open water and in rooms like these we've been building trying to look at this idea of using the

fact that our bodies can be penetrated by infrared light ultrasound and electromagnetics and a belief that maybe we could Leap Frog current Health Care Systems and even drugs by modulating the phase of light and sound so we've been doing that for a while um and and the reason that I did it is I've shipped a lot of innovative silicon ships so using silicon manufacturing that's coming online and consumer electronics and phase wve steering I knew that we could steer beams of light decode phase with interference and even selectively

select uh or destroy certain cells or stimulate certain cells so we built these systems up for about four years got pretty interesting results filed a bunch of patents a lot of work and decided in early 2020 to get them in a hospitals start testing this on people and the results are somewhat spectacular first in stroke large vessel occlusion stroke is the number two killer in the world if you could diagnose that stroke in an ambulance you could get the patient to the one of less than 5% of hospitals that could treat that stroke so the person Wouldn't Die so we built a portable that gives higher specificity and sensitivity for large vegetable

collusion stroke than we can find published anywhere in the world that's 6.5 Million Lives per year now we go over to number three uh gleo we uh gave some mice gleo blastoma and treated them and moved these mice into Mission and on autopsy uh found that we didn't harm any healthy cells Charles River couldn't find any while we were waiting to get into humans for that we take that same device and put it into humans for severe depression and a 20 person trial and we were able to turn off the overfiring neurons in the default mode Network sending these patients into remission so with that we're pretty

excited it was time to go get more money we've raised $100 million today and we're announcing today for the first time that falic gave us $50 million from the Shibu enu coin woohoo thank you non- delative and it made it's made all the difference with that money we've been able to reduce those carts from really a laser the size of a room to this that's going into production next month and those carts that were the size of the size of the rim as well to these

to little consoles and all of that's going into production next month this is a platform with a life-saving pan disease potential for not just stroke but all cardiovascular disease not just gleo blastoma but all cancers not just mental disease but potentially all mental disease and Beyond so open source is cool we're all believers but where this impacts the health care is even if you make hardware and software open source we open sourced all of our patents you still need approval to use it on somebody it's FDA it's regulatory approval the reality is in a

comprehensive paper published recently the average cost of a novel therapeutic medical device approval is now $658 million in capitalized cost in 13 years so even if you open source it huh what do you do well the key is here 85% of that cost isn't in clinical trials it's in the device so that takes a lot out further another 7% of that is in safety so share the safety do we want a safer device or a less safe device will the regular Ator be able to approve a device pan cancer disease with lots with a 100 times more

safety data will that make a choice easier or not will a doctor and patient find it easier to be able to access the safety data we think it's yes on all of those running those numbers our hypothesis is we take $653 million out of the cost of developing a novel medical device with a denovo approval so down to 5 million sub three years so how does this work phase wave modulation well these are the waves in light and sound and what we do for example on these yellow emitters is we delay the phase from emitter to emitter so we can focus that sound near or far right or left up or down anywhere we

wish to in the brain or the body so gleo blastoma cells can hide out among healthy neurons and the neurosurgeon you know they can't take a small but these cells have a mechanical property that no other cells do all aggressive cancer cells have really large nucleuses and small cytoplasms and we can exploit that like an opera singer can ping this wine glass hit that note and destroy that wine glass and harm nothing else in the room so that's what we're doing with gleo blastoma we did sonification parameter sweeps found frequencies this is low intensity ultrasound lower intensity

than used for Diagnostic reasons on pregnant women and their fetuses for the last 50 years in rich countries but these cells can't take it we're destroying them and here at a different frequency I can tell you the frequency of Ro this is 400 khz the other one is 150 khz we're able to turn on stimulate or um Des stimulate uh neurons and that's been helpful not just for non-invasive brain computer interface but also for pulling people out of mental disease addictions and so forth It's all together I think we're enabling read WR brain computer interface while we're trying to

solve mental diseases it's they're impossible to separate so another module this is our read module uses that laser I just picked up that we've reduced down this laser and a bunch of camera chips four camera chips that are in your smartphone and those camera chips are super small we take the lens off and they've got they're cheap because they're small they have pixel sizes the size of the wavelength of light so we let that light go into oh that didn't fly okay we'll let that light go into the head and what we see on that camera chip is this and it looks like the waves on the ocean and we can read the waves on the ocean like a sailor can read the waves on the ocean and know where the fish are know where

the land is here we interrogate a blood vessel and the pattern changes because where the light hits the moving blood cells it Ricochet is differently changing that pattern and we we can read blood flow very accurately with this way in fact we can read it 20 times more accurately by some measures than multi-million dollar MRI or CT scanners with this laser and some camera chips so that's not just good for stroke but all cardiovascular disease and all Micro Motions of the body we believe so to get this far we've been working with a whole bunch of great institutes but everybody wants it so

that's why we Shrunk the system down and decided to go into production and also you you can build it it's all on GitHub you can build it yourself if you'd like to everyone that wants it you can all have it you don't need permission go to our web website take it um I want to mention here there's also evidence we may be able to suppress cyto storms as Amy just discussed the impact of them treat inflammation even deactivate covid with the same way we're deactivating Leo blastoma cells there's some evidence we're working on that in our labs and we're using our devices to do research on long covid and microclots we can see if we can ID them and if we can break them apart so as we

discussed this is the problem $658 million in 13 years it's why we don't get any new devices it's why healthare we've got 20 to 40 year Innovation modes so here's what we're doing about it we're flipping it on the side to make a open- source General general purpose platform and the apps on top of these are the treatments so those are the ones with regulatory approval 3 years $5 million then we get into they call it a 510k substantial equivalence sub $1 million sub one year so the question we're for-profit company I'm just I hate to be crash but

people are sort of scratch their heads and ask me quietly afterwards and so I thought i' just come out like look it's free as in beer free as in speech not free as in beer like you can publish the recipe of the beer you can go make your own at home most of us just go to the store to buy it but by making more of something it's cheaper we enjoy a portion of that savings as profit we engender trust that's new we don't charge $1,400 for an EpiPen one day if we miss step on something if we screw up you can go get it made yourself but we ensure quality standard that's IRB ready and FDA ready we ISO 1345 compatible by safety sharing we have the

cost of clinical trials and double the speed for our customers plus everybody just benefits that's a cycle of innovation that's not a 20-year moat so here are these new units I've got them out here Liu and open motion all the electronics are going into the Mechanicals and being tested so they'll be ready next month here's more and this brings me to a moment we also did something uh just to save another $50,000 using our smartphone and metallic are you going to come up to get scanned in so this is just in so we prepped a little on this so this is the whole unit that's replacing

that room and so if we put this on you ah I can actually turn it on see it so and then I will oops the strapping is being perfected it's velcro I don't think it's sticky enough can you all right so what we do oops thank you for doing this um oops I just open the wrong nap so I'm just putting in a number here and then I start and

uh I was just saying unable to focus okay try again okay um okay so I'm just taking some pictures of him with the camera that's all you have to do is walk around and then we have to get the top of his head okay that's it so that's all um so we can take this off now although we should

leave it on if we were actually going to uh sonicate him so now we scan him in and falic has an amazing brain and we get to look at it right here although this isn't the interesting part of it this is an MRI he did last week and what we're going to do is pick a spot for a Target the anterior singlet it's going to make him happy we know that and so okay we scanned him so these are what the pictures look like and then this is making him 3D and this is so we can know where the the I'll show you what this is does so

here we overlay the 3D MRI with a scan so we match his bone structure and then we look at where the transducers are and we know exactly where they are and now we sit the Target and we compute what phase delays we need on the transducers and then we nail that Target I would love to sonicate him on stage but we don't have permission from the Thai government yet however I met somebody that got permission to do 200 people at eselon recently so next year we'll do something but yeah this is how it works for any

part in your body and the interesting part is as we develop our read part the part seing blood flow we can get away from the MRI machine and use different scanning technology that's lower cost so with that this is somewhat like a smartphone moment from 20 years ago smartphones changed our lives look a silicon Hospital can happen if you think of your smartphone there's a dozen radios in it four cameras and so forth as we populate this it can treat us for the diseases we have again you might be asking can I have one my company what

com country whatever yes everybody can have one everyone has permission you can build your own I'll be showing these types out in the hall shortly and thank [Applause] you thank you