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This is Carly Beam with the Becker Spine

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and Orthopedics podcast.

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I'm thrilled to be joined today by doctor

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Darryl De Lima, director of orthopedic research at

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Scripps Health. Darryl, thank you so much for

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being here today.

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My pleasure. Thanks for the invitation.

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Absolutely.

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Before we dive into our main discussion, can

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you share a bit more about yourself and

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your background?

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Yes. As you said, I'm a director of

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orthopedic research at Scripps Health. I

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trained as an orthopedic surgeon in India.

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And after I came to The US, I

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got a PhD in bioengineering

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at UC San Diego.

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In my role, I lead an outstanding team

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of,

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researchers and physician scientists at, what is called

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the Shiley Institute of Orthopedic Research and Education

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at Scripps Clinic.

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We call it SCORE for short.

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And,

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my employer is Scripps Health, which is,

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one of the leading orthopedic surgery

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programs in the country and perhaps even the

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world.

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Excellent.

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And I know you you're coming on here

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today to talk about smart joints replacement

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implants. Can you first just give a

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quick primer on what these are and what

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and how they stand out compared to other

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joint replacement implants?

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Right. So my definition of a smart joint,

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replacement

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implant,

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it has to serve at least two main

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purposes. First, it has to function like a

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regular conventional

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joint replacement implant

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that would be standard of care for the

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patient,

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and help them regain function after surgery.

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But more importantly and secondly, it also serves

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as a research and scientific tool.

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So the device would then contain

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sensors

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and,

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telemetry

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and a computer system for communication, for collecting

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data and transmitting data from inside the patient

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to,

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say, a cell phone or a

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receiving device or even a website.

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And, the technology might include things like, you

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know, advanced sensors,

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a chip for storing data,

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and, obviously,

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some sort of power supply. Our

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first choice is rechargeable power, so it could

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last the lifetime

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of the, the patient and the implant.

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Got it. So it sounds like with these

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devices, you're able to access more

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patient data than you ever could have imagined

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even a few years ago.

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Correct. Right. So

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we think we usually bring patients to the

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lab,

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and then we,

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you know, we give we advise them on

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certain

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activities to be done, and then we collect

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data while they're performing those actions.

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And it's very carefully choreographed.

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We have

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motions,

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motion tracking through video cameras.

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We have,

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force plate, force sensors in the on on

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the floor

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to measure the reaction

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forces as they walk.

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We have EMG that, collects, data from,

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from muscle activity.

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And then

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we then publish this data and say this

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is how patients actually perform these activities outside

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in the field.

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Unfortunately,

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that's not what what patients do

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in real life.

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So

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the data that we are collecting in the

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lab, in my opinion, is somewhat artificial.

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And and

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we are hoping with the smart implant that

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we will take the lab

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and put the lab inside the patient's shoulder.

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And therefore, the we will we'll be able

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to track and monitor these patients remotely outside,

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the lab and get more accurate, more valid

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information about how these patients perform, what sort

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of activities are they,

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are are commonly performed,

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and more importantly, which activities

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might be risky for the patient

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and which activities might be beneficial for the

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patient.

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Yeah. And I'd love to hear more about

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this shoulder research that you're talking about. Can

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you share more details?

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Right. So,

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we're still in the early phases

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of this project.

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We are developing a laboratory

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prototype, which,

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initially will just be a benchtop

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prototype to make sure all the different components

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that I mentioned, the sensors, the computer chip,

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the radio, the rechargeable battery, all of them

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work.

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And then we assemble them together in a

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working prototype

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that may not be implantable just yet because

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we need

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FDA approval and human subjects committee approval before

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we can implant this in patients, but would

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actually function

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like an implantable device

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and pass all the testing, the structural testing,

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the fatigue testing,

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the, bio,

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toxicity

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and biohazard

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testing,

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that that a conventional implant would have to

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pass.

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And then

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but would not, you

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know, might not be, implantable

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just yet. So that's our,

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present to your plan.

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Got it. And

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what's been the most challenging

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aspect of developing this implant?

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That's a good question.

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I mean, we divide the the challenges into

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the technical challenges, and those are the ones

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that I enjoy

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solving.

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How do we miniaturize

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all the components to fit inside,

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the implant, and how do we maximize

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the performance,

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for example, of, the electronics so that,

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we require the minimal,

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battery,

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storage

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for charging the implant.

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Then the second is the clinical challenges because

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we obviously don't want

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to put the patients at any risk. And

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so that then we have to rigorously test

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every component to make sure it's safe to

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be implanted in the body. And that's that

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can be challenging because, you know, we are

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hoping that these implants would last in patients

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for ten to twenty years.

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At least the life life expectancy

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of the patient.

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And then the third challenge, which, is not

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directly in my control, is the regulatory challenge.

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So that is getting

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approval from the FDA and the human subjects

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committee because

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they obviously

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want to protect a the patient population at

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large.

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And, any risks that they perceive, we would

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have to satisfy them that those risks are

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acceptable.

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And do you have a rough timeline of

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when you hope to see this implant being

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tested in patients?

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Yes. So I do have a timeline, although

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it can be a moving target because,

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regulations

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on

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so called,

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implantable electronics keeps changing.

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There's also now additional risk,

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that might,

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that we'll have to resolve things like cybersecurity

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because this data is being transmitted and it

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contains, you know, patient information.

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So our present time line is at the

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end of two years, we'll hope to have

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an implantable,

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a design of an implantable product prototype.

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In the meantime, we would partner with an

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implant manufacturing

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company.

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Neither script sales nor I want to actually

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manufacture

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these implants.

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And then in partnership with the implant manufacturing

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company, we would then apply for FDA approval

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initially just to do a research,

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trial.

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But if there's any commercial

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benefit

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of having of actually,

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selling the smart implant because,

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patients might want them because now they can

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track the activity

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and also get feedback

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about what activities they should be performing and

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what activities they should be avoiding.

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So that yeah. The second timeline is probably

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more, like, five years.

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Okay. So so relatively

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in the near future.

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And I know we've seen,

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the smart implant technology for knee replacements.

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Why is it important to focus on the

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shoulder for this particular implant?

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Right. I mean, that's, you know, a very

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good question because when we worked on the

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first the world's first knee implant, which doctor

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Caldwell

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from Scripps Clinic had implanted,

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twenty years ago. And at that time, we

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didn't know much about knee biomechanics, and we

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were designing

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implants. By we, I mean,

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the the field of, joint replacement for knees,

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and not me personally. But,

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the field was designing joint,

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implants

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and then having to wait until these were

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surgically implanted in patients and then

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and then fixing any problems that,

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that arose from the new design. And that

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cycle was just too long, too expensive, and

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too risky for patients. So

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our goal at that time was to actually

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track the activity and the forces

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in vivo so that we could more intelligently,

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design,

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knee implants. And that was, you know, very

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successful. We won, you know, several awards for

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our

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research efforts.

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We did not commercialize that, that smart implant

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because we felt that it was mainly a

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research tool just to get information to help

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the industry develop better designs.

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But in the shoulder, it's actually much more

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complex than the knee, And we know less

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about the shoulder than, than we know about,

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knee replacement.

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And it's actually the number of shoulder replacements

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in The US is rising,

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dramatically.

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And so we

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need to

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collect

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information that would,

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that would raise our understanding of shoulder biomechanics.

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And then not only benefit

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the benefits, I think, are fairly broad. One

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is benefiting me as a scientist because now

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I know more about the shoulder, know more

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about the biomechanics,

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and we increase

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the the value of shoulder biomechanics in the

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field as a whole.

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The second benefit is to implant manufacturers.

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They can now design better implants because now

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they know what forces and activities

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the patients is going to, undergo after surgery.

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The second benefit is to the hospitals and

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00:11:03,419 --> 00:11:04,480
surgeons because

287
00:11:05,084 --> 00:11:06,225
surgeons can now

288
00:11:06,684 --> 00:11:09,824
optimize or change their surgical technique because

289
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we can then provide them with

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00:11:12,605 --> 00:11:13,105
our

291
00:11:13,564 --> 00:11:14,064
intraoperative

292
00:11:14,605 --> 00:11:16,784
alignment of the implants actually

293
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relates or is associated with or predicts postoperative,

294
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function.

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So they can place these implants to say,

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for example, improve range of motion

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after,

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after surgery or

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increase the longevity of the implant by placing

300
00:11:34,024 --> 00:11:36,585
it in a position that's less less risky

301
00:11:36,585 --> 00:11:37,325
to the patient.

302
00:11:38,585 --> 00:11:41,325
The third benefit is to the patients themselves

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00:11:41,384 --> 00:11:44,585
because now they can get feedback during rehab,

304
00:11:44,585 --> 00:11:45,884
and rehab is a

305
00:11:46,240 --> 00:11:49,200
continuous process. So what we tell them on

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00:11:49,200 --> 00:11:51,440
month one will change by the time they're

307
00:11:51,440 --> 00:11:52,100
in month,

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00:11:52,559 --> 00:11:54,240
ten or at the end of the first

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00:11:54,240 --> 00:11:54,740
year.

310
00:11:55,279 --> 00:11:57,360
So they can be now told in a

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very granular fashion and intelligently

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and more important patient specific.

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So someone,

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00:12:04,664 --> 00:12:06,365
you know, who is very active,

315
00:12:07,225 --> 00:12:10,024
might need a different rehab protocol versus someone

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00:12:10,024 --> 00:12:11,324
who's who's

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00:12:11,784 --> 00:12:14,444
was relatively inactive or had

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a bad,

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00:12:16,279 --> 00:12:18,360
arthritis of the shoulder and therefore would have

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to be much more careful

321
00:12:19,959 --> 00:12:22,779
in, easing into the rehab and recovery

322
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phase of the the surgery.

323
00:12:27,079 --> 00:12:28,839
So it sounds like a real win win

324
00:12:28,839 --> 00:12:29,659
win for

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00:12:30,199 --> 00:12:30,699
everyone.

326
00:12:31,254 --> 00:12:32,454
And then I was wondering, you know, do

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you think the smart shoulder implant

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00:12:35,495 --> 00:12:38,694
technology will eventually become the standard of care

329
00:12:38,694 --> 00:12:40,154
for patients in the future?

330
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So that is my hope,

331
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and, I just don't know how long it

332
00:12:47,019 --> 00:12:48,080
will take because

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the two

334
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the two unknowns for me are the cost.

335
00:12:53,820 --> 00:12:55,200
If if we can,

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if we can commercialize smart shoulder implants without

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00:12:58,620 --> 00:13:00,615
increasing the cost, then, yes,

338
00:13:01,075 --> 00:13:04,774
I'm optimistic that would become standard of care.

339
00:13:05,154 --> 00:13:08,274
And, the second reason why I'm optimistic is

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that these implants

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we we implant hundreds of thousands of patients.

342
00:13:14,299 --> 00:13:17,759
So we have this opportunity of putting in

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00:13:18,059 --> 00:13:18,559
sense

344
00:13:19,019 --> 00:13:20,799
sensing technology and,

345
00:13:22,139 --> 00:13:24,699
wireless communication technology, which also is going to

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00:13:24,699 --> 00:13:27,179
improve over the over the future. So as

347
00:13:27,179 --> 00:13:28,559
that technology matures,

348
00:13:29,264 --> 00:13:30,245
we will be able

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00:13:31,264 --> 00:13:31,925
to investigate

350
00:13:32,465 --> 00:13:34,165
far more than just musculoskeletal

351
00:13:34,945 --> 00:13:38,785
biomechanics, which is my expertise. But, for example,

352
00:13:38,785 --> 00:13:40,785
let's say we can now track we can

353
00:13:40,785 --> 00:13:43,524
put dye, glucose sensors and track diabetic,

354
00:13:44,409 --> 00:13:47,049
you know, response to diabetic treatment, or we

355
00:13:47,049 --> 00:13:49,769
could put in motion sensors that can actually

356
00:13:49,769 --> 00:13:50,669
track neurodegenerative

357
00:13:51,129 --> 00:13:52,269
disorders and

358
00:13:52,649 --> 00:13:54,590
predict fall fall risk.

359
00:13:55,289 --> 00:13:58,090
So I'm optimistic that this will happen. I

360
00:13:58,090 --> 00:14:00,884
just don't know when because it's a combination

361
00:14:00,964 --> 00:14:02,044
of of,

362
00:14:02,704 --> 00:14:03,204
business,

363
00:14:04,144 --> 00:14:05,284
the business environment,

364
00:14:06,065 --> 00:14:07,684
the regulatory environment,

365
00:14:08,384 --> 00:14:08,884
and

366
00:14:09,184 --> 00:14:09,684
the

367
00:14:10,065 --> 00:14:11,444
risk benefit ratio.

368
00:14:11,824 --> 00:14:13,904
If the mag as we keep improving the

369
00:14:13,904 --> 00:14:16,164
magnitude of the benefit to the patient,

370
00:14:17,160 --> 00:14:19,399
then I I believe more and more patients

371
00:14:19,399 --> 00:14:21,559
will adopt us and surgeons will adopt us,

372
00:14:21,559 --> 00:14:24,059
and then it'll eventually become standard of care.

373
00:14:24,840 --> 00:14:25,340
Absolutely.

374
00:14:25,720 --> 00:14:28,620
And then I was wondering what other orthopedic

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00:14:28,840 --> 00:14:29,340
technologies

376
00:14:29,799 --> 00:14:31,740
you're keeping your eye on right now.

377
00:14:32,835 --> 00:14:35,735
Right. So my lab is pretty diverse, and

378
00:14:36,195 --> 00:14:38,995
what I'm particularly proud of is that we

379
00:14:38,995 --> 00:14:40,695
have a very multidisciplinary

380
00:14:41,394 --> 00:14:43,414
team of scientists, engineers,

381
00:14:44,195 --> 00:14:45,174
computer programmers,

382
00:14:45,955 --> 00:14:46,455
physicians,

383
00:14:47,500 --> 00:14:48,480
and, biomechanical,

384
00:14:49,820 --> 00:14:50,320
researchers.

385
00:14:51,100 --> 00:14:51,840
And so

386
00:14:52,540 --> 00:14:53,040
within

387
00:14:53,420 --> 00:14:55,519
what we call score, we do,

388
00:14:56,540 --> 00:14:59,680
the entire range of orthopedic research from,

389
00:15:00,745 --> 00:15:03,084
discovery in the lab to

390
00:15:03,384 --> 00:15:03,884
translational.

391
00:15:04,264 --> 00:15:07,304
That means testing it, before it's ready for

392
00:15:07,304 --> 00:15:11,144
clinical use to actually implementing it and following

393
00:15:11,144 --> 00:15:12,365
patients after,

394
00:15:13,870 --> 00:15:17,250
the the technology has has become clinically relevant.

395
00:15:17,950 --> 00:15:20,669
And so the other area that we're working

396
00:15:20,669 --> 00:15:21,809
on so I

397
00:15:22,669 --> 00:15:25,009
my training wasn't, joint replacement,

398
00:15:25,684 --> 00:15:27,764
but the areas that we are working on

399
00:15:27,764 --> 00:15:28,504
is actually

400
00:15:28,884 --> 00:15:32,245
what's next after joint replacement. So we're trying

401
00:15:32,245 --> 00:15:33,784
to treat patients

402
00:15:34,725 --> 00:15:38,024
before they need joint replacement and either delay

403
00:15:38,084 --> 00:15:39,865
or perhaps even remove,

404
00:15:40,600 --> 00:15:42,460
the need for, joint replacement.

405
00:15:43,240 --> 00:15:45,720
So in that, we have several projects that

406
00:15:45,720 --> 00:15:47,720
we are working on, and one is for

407
00:15:47,720 --> 00:15:49,500
knee for example, for knee arthritis,

408
00:15:49,960 --> 00:15:51,960
we are growing bone and cartilage in the

409
00:15:51,960 --> 00:15:52,460
lab.

410
00:15:52,840 --> 00:15:53,340
And,

411
00:15:54,375 --> 00:15:56,715
we think that we we can

412
00:15:57,575 --> 00:15:59,335
if this makes it to the clinic, we

413
00:15:59,335 --> 00:16:01,335
then will be able to treat patients that

414
00:16:01,335 --> 00:16:03,355
have got bone and cartilage lesions

415
00:16:03,654 --> 00:16:05,274
in the early stage of arthritis,

416
00:16:05,894 --> 00:16:07,195
which we don't have,

417
00:16:07,940 --> 00:16:10,019
right now. We don't have a treatment portfolio

418
00:16:10,019 --> 00:16:12,279
for these patients right now that's very consistent

419
00:16:12,660 --> 00:16:14,039
and works in all patients.

420
00:16:14,580 --> 00:16:16,919
And if that works, then perhaps these patients

421
00:16:16,980 --> 00:16:19,220
may not need a joint replacement in the

422
00:16:19,220 --> 00:16:22,259
future. Otherwise, in today's technology, they will end

423
00:16:22,259 --> 00:16:23,975
up needing joint replacements.

424
00:16:24,595 --> 00:16:26,134
We're also working on the meniscus,

425
00:16:26,595 --> 00:16:29,554
growing the meniscus. That's another unmet need. There

426
00:16:29,554 --> 00:16:32,455
is no clinically approved meniscus replacement,

427
00:16:33,315 --> 00:16:36,514
which, works and prevents, arthritis in the long

428
00:16:36,514 --> 00:16:38,120
term. And on the shoulder,

429
00:16:38,580 --> 00:16:40,840
same applies to rotator cuff repair.

430
00:16:41,460 --> 00:16:44,019
It's a very common injury and especially in

431
00:16:44,019 --> 00:16:45,879
older patients with large tears.

432
00:16:46,259 --> 00:16:48,679
Even after surgery, they don't heal.

433
00:16:49,315 --> 00:16:51,555
And so we're growing what we're calling bio

434
00:16:51,555 --> 00:16:52,055
tendons

435
00:16:52,595 --> 00:16:55,014
in the lab to enhance the recovery.

436
00:16:55,634 --> 00:16:58,774
And we're also dabbling with something called bioprinting.

437
00:16:59,634 --> 00:17:02,215
Mhmm. We can print live cells and tissue,

438
00:17:02,669 --> 00:17:04,910
and we can keep these tissues alive in

439
00:17:04,910 --> 00:17:05,569
the lab.

440
00:17:06,670 --> 00:17:10,269
That's a very optimistic goal and is a

441
00:17:10,269 --> 00:17:12,609
very, very long term project because

442
00:17:13,230 --> 00:17:15,950
our objective is not just printing tissues in

443
00:17:15,950 --> 00:17:16,529
the lab

444
00:17:16,904 --> 00:17:18,765
with the hope of implanting them.

445
00:17:19,065 --> 00:17:20,984
We want to take the bio printer to

446
00:17:20,984 --> 00:17:24,265
the Operating Room and actually print inside the

447
00:17:24,265 --> 00:17:25,244
patient's body.

448
00:17:26,025 --> 00:17:27,884
If we can do that, then

449
00:17:28,265 --> 00:17:31,325
we not only customize the treatment for patients,

450
00:17:31,880 --> 00:17:34,140
but we're also printing living tissue, which

451
00:17:34,519 --> 00:17:35,019
theoretically

452
00:17:35,640 --> 00:17:37,180
is has got a potential

453
00:17:37,799 --> 00:17:38,299
to

454
00:17:38,759 --> 00:17:40,680
to live the life of the patient unlike

455
00:17:40,680 --> 00:17:43,580
artificial materials, which, might break down.

456
00:17:44,505 --> 00:17:45,565
Absolutely fascinating.

457
00:17:46,265 --> 00:17:48,105
And that's all the time we do have

458
00:17:48,105 --> 00:17:50,904
for today. I wanna thank you for joining

459
00:17:50,904 --> 00:17:53,545
us on the podcast. It's been a pleasure

460
00:17:53,545 --> 00:17:55,785
speaking with you, doctor Dilemma, and I look

461
00:17:55,785 --> 00:17:57,545
forward to connecting with you again in the

462
00:17:57,545 --> 00:17:58,045
future.

463
00:17:58,900 --> 00:18:01,480
Thanks very much, Carly. Appreciate the opportunity.