Transcription
Richard Simmons 0:00
Good morning Barcelona. So first of all, thanks for your time, it's a pleasure to be here to introduce, introduce OrthoSon and our bio structural gel technology. That's it. So what is on festivals is a UK company has spin out of the University of Oxford. And I'm here really for two reasons one to introduce our bio structural gel implant platform technology and second to launch our $20 million dollar Series B round to fund a clinical program, we have an implant, which, which will both mechanically restore the intervertebral disc, but also will provide a biologically supportive structure to address the rejection of the degeneration of the disk. And we believe that structural implants of the future will have those three characteristics restore the mechanics, they'll do nothing to accelerate the degeneration, and they'll support the biology explained so our first product will be a will restore the mechanic biology of the intervertebral disc treating both the pain and the causes of degeneration. So really, why back pain so I guess we're all medtech people. So we have one thing in common, we we want to help humanity we want to help our fellow human being and and back pain is the single largest clinical unmet need certainly in the US where a staggering $130 billion is spent annually. On the on the treatment of aneurysm there's a few companies here also in the same in the same space. And so, so for us is that clinical unmet need. It's, it's, it's an obvious target. And actually, most of that back pain comes from degenerative disc disease. And that's broadly something that happens pretty early in life can happen, certainly in your 20s, it can be first symptomatic, and it means it's where the disc itself, the intervertebral disc in your spine, begins to degenerate, it dehydrates loses a bit of height. And that creates a hostile environment which which further accelerates the degeneration. So what so other technologies have looked at that mechanical side of restoration. But what's really required is a combination to address the mechanical restoration as well as the hostile environment that seller, that cellular hostile environment that creates degeneration, because that gets worse as we get older. That is the disease of a younger patient group. So if you look at, if you look at the current treatments for this patient group, it's pretty easy to see why we have challenges on on the left hand side over here, you've got some easy decisions for a patient, a young patient with back pain to take, I'm gonna have physiotherapy, I'm going to have some minimally invasive injections, and those things will address the symptoms. But then after that, everything else is hard. So I can have a maximally invasive surgery, maybe a fusion, it's going to be costly, it might not be reimbursed, there's going to be plenty of complications. And you can mask the pain with some kind of implantable implantable stimulation technology, or even with pain medication, no opioids and we kind of know where that story ends. So author song will address this unmet need head on. With a product that's an easy decision for a patient to make, because first of all, it will do no harm. It will be a micro invasive injectable treatment for the intervertebral disk. It will treat the pain by mechanically restoring the disc, but it will also address the causes of degeneration. So specifically, what is it and we call our product hydrate, and it's a low viscosity injectable technology injected into the degenerated intervertebral disk. It's got a low viscosity like milk, it looks like a white fluid injected through a tiny needle. And it's highly hydrated. It's about 82% saline water, just like the native intervertebral disc. And it first of all restore will restore mechanics of the disc. But you'll also see is when it's injected, it kind of locally follows these little fissures of degeneration. So it's locally rehydrating that dehydrating degenerating disc. So to restore the mechanics, but I mentioned before there will also be an easy option for a patient to take. And the reason for that is it's a micro invasive procedure injected through a very small bore needle complete in minutes will do nothing to to degenerate the nucleus further and it will uniquely both address the functional mechanics of the desk by increasing tension within the within the nucleus pulposus of the desk the nucleus of the desk, but also to by rehydrating it will suppress or create ate a scaffold within the desk that's, that's healthy for the biology treats the pain, and therefore the causes of degeneration too. And for clarity, this is a medical device that all these mechanisms of action are 100% mechanical. Now, actually, this is entering, entering a pretty busy market space now with new technology. So this is an area treatment of the intervertebral disk with an injectable, which has attracted almost $200 million in the last few years into into preclinical or early stage companies. Really, you can group those companies into two groups. One, you have my top left these these companies, which are mostly based upon cellular Stem Cell Technologies, which address the hostile environment that degeneration. But the trouble is, you're injecting those stem cells into a hostile environment. And they do little or nothing to address the mechanical problem with a disk. And you've got another group, which they are, which are addressing the mechanical performance of the disk. But those guys are doing nothing to address the ongoing degeneration of the disk and might even be increasing or accelerating the degeneration of the disk office on our hydrate technology is unique. In addresses, it's a combination of both both mechanical structure as well as a biologically friendly scaffold for for growth. In terms of status we have we're on the verge of of clinical trials, we have to, to large animal or sorry, one small animal, one large animal pilot to complete, we're just about to start a formal, large animal invivo trial, we're about to have published a key piece of data looking at human, human cadaveric samples in a bioreactor. And in that case, we were excited by this very small result at the bottom here, but almost complete suppression of the factors that drive the generation in the intervertebral disc, interleukin one, Adam Ts, three, GS four mp3 almost completely suppressed, and those are the key drivers of degeneration. And this is not just one product. So we are as a company focused specifically on hydrate for the moderate degeneration of moderate to intervertebral disk, but it's a platform of 10 technologies, five in the lumbar spine, and then five equally applicable in the cervical in the cervical spine. And where are we on our journey. This is a technology which was patented in 2016. And we're laying down new patents this year 2023. We're on the verge of our FDA breakthrough device designation. And we are raising the series B now to fund the clinical program which we believe will lead to FDA approval in 2029. With a great team. This is an extra international team experienced commercializing products in the US and internationally. We're supported by a first class group of us clinical and commercial advisors who have helped us develop this plan and helping us deliver it all on time and on budget. So I hope you would like to find out more there is so much more to say. Please come and find me. I'd love to talk through this in a little bit more detail. But just remember, OrthoSon bio structural solutions for back pain. So this is this is solutions which addressed the mechanics but also address the biology making a biologically friendly environment. And if you want to scan that, that QR code that takes you to for our walk through to our website, I'd love to hear from you. Thanks
Transcribed by https://otter.ai
Richard Simmons 0:00
Good morning Barcelona. So first of all, thanks for your time, it's a pleasure to be here to introduce, introduce OrthoSon and our bio structural gel technology. That's it. So what is on festivals is a UK company has spin out of the University of Oxford. And I'm here really for two reasons one to introduce our bio structural gel implant platform technology and second to launch our $20 million dollar Series B round to fund a clinical program, we have an implant, which, which will both mechanically restore the intervertebral disc, but also will provide a biologically supportive structure to address the rejection of the degeneration of the disk. And we believe that structural implants of the future will have those three characteristics restore the mechanics, they'll do nothing to accelerate the degeneration, and they'll support the biology explained so our first product will be a will restore the mechanic biology of the intervertebral disc treating both the pain and the causes of degeneration. So really, why back pain so I guess we're all medtech people. So we have one thing in common, we we want to help humanity we want to help our fellow human being and and back pain is the single largest clinical unmet need certainly in the US where a staggering $130 billion is spent annually. On the on the treatment of aneurysm there's a few companies here also in the same in the same space. And so, so for us is that clinical unmet need. It's, it's, it's an obvious target. And actually, most of that back pain comes from degenerative disc disease. And that's broadly something that happens pretty early in life can happen, certainly in your 20s, it can be first symptomatic, and it means it's where the disc itself, the intervertebral disc in your spine, begins to degenerate, it dehydrates loses a bit of height. And that creates a hostile environment which which further accelerates the degeneration. So what so other technologies have looked at that mechanical side of restoration. But what's really required is a combination to address the mechanical restoration as well as the hostile environment that seller, that cellular hostile environment that creates degeneration, because that gets worse as we get older. That is the disease of a younger patient group. So if you look at, if you look at the current treatments for this patient group, it's pretty easy to see why we have challenges on on the left hand side over here, you've got some easy decisions for a patient, a young patient with back pain to take, I'm gonna have physiotherapy, I'm going to have some minimally invasive injections, and those things will address the symptoms. But then after that, everything else is hard. So I can have a maximally invasive surgery, maybe a fusion, it's going to be costly, it might not be reimbursed, there's going to be plenty of complications. And you can mask the pain with some kind of implantable implantable stimulation technology, or even with pain medication, no opioids and we kind of know where that story ends. So author song will address this unmet need head on. With a product that's an easy decision for a patient to make, because first of all, it will do no harm. It will be a micro invasive injectable treatment for the intervertebral disk. It will treat the pain by mechanically restoring the disc, but it will also address the causes of degeneration. So specifically, what is it and we call our product hydrate, and it's a low viscosity injectable technology injected into the degenerated intervertebral disk. It's got a low viscosity like milk, it looks like a white fluid injected through a tiny needle. And it's highly hydrated. It's about 82% saline water, just like the native intervertebral disc. And it first of all restore will restore mechanics of the disc. But you'll also see is when it's injected, it kind of locally follows these little fissures of degeneration. So it's locally rehydrating that dehydrating degenerating disc. So to restore the mechanics, but I mentioned before there will also be an easy option for a patient to take. And the reason for that is it's a micro invasive procedure injected through a very small bore needle complete in minutes will do nothing to to degenerate the nucleus further and it will uniquely both address the functional mechanics of the desk by increasing tension within the within the nucleus pulposus of the desk the nucleus of the desk, but also to by rehydrating it will suppress or create ate a scaffold within the desk that's, that's healthy for the biology treats the pain, and therefore the causes of degeneration too. And for clarity, this is a medical device that all these mechanisms of action are 100% mechanical. Now, actually, this is entering, entering a pretty busy market space now with new technology. So this is an area treatment of the intervertebral disk with an injectable, which has attracted almost $200 million in the last few years into into preclinical or early stage companies. Really, you can group those companies into two groups. One, you have my top left these these companies, which are mostly based upon cellular Stem Cell Technologies, which address the hostile environment that degeneration. But the trouble is, you're injecting those stem cells into a hostile environment. And they do little or nothing to address the mechanical problem with a disk. And you've got another group, which they are, which are addressing the mechanical performance of the disk. But those guys are doing nothing to address the ongoing degeneration of the disk and might even be increasing or accelerating the degeneration of the disk office on our hydrate technology is unique. In addresses, it's a combination of both both mechanical structure as well as a biologically friendly scaffold for for growth. In terms of status we have we're on the verge of of clinical trials, we have to, to large animal or sorry, one small animal, one large animal pilot to complete, we're just about to start a formal, large animal invivo trial, we're about to have published a key piece of data looking at human, human cadaveric samples in a bioreactor. And in that case, we were excited by this very small result at the bottom here, but almost complete suppression of the factors that drive the generation in the intervertebral disc, interleukin one, Adam Ts, three, GS four mp3 almost completely suppressed, and those are the key drivers of degeneration. And this is not just one product. So we are as a company focused specifically on hydrate for the moderate degeneration of moderate to intervertebral disk, but it's a platform of 10 technologies, five in the lumbar spine, and then five equally applicable in the cervical in the cervical spine. And where are we on our journey. This is a technology which was patented in 2016. And we're laying down new patents this year 2023. We're on the verge of our FDA breakthrough device designation. And we are raising the series B now to fund the clinical program which we believe will lead to FDA approval in 2029. With a great team. This is an extra international team experienced commercializing products in the US and internationally. We're supported by a first class group of us clinical and commercial advisors who have helped us develop this plan and helping us deliver it all on time and on budget. So I hope you would like to find out more there is so much more to say. Please come and find me. I'd love to talk through this in a little bit more detail. But just remember, OrthoSon bio structural solutions for back pain. So this is this is solutions which addressed the mechanics but also address the biology making a biologically friendly environment. And if you want to scan that, that QR code that takes you to for our walk through to our website, I'd love to hear from you. Thanks
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