Louise

Once again, good evening, and a very warm welcome to our webinar on Arthrosamid injections. My name is Louise, and I'll be your host this evening.

I'm delighted to be joined by expert speakers, Mr Kumar Reddy, Associate Specialist Surgeon, and Jonathan Thompson, Contura Partnership Manager.

Tonight's session will begin with a presentation from Mr Reddy and Jonathan, followed by a live Q&A. If you have any questions at any point, please feel free to submit them using the Q&A icon at the bottom of your screen.

You're welcome to ask anonymously, or include your name, just a quick note that the session is being recorded, so any names shared may be visible in the recording.

To help us get through as many questions as possible, please do keep them brief.

If you're interested in booking a consultation, we'll share the relevant contact details and an offer at the end of the session.

I'll now hand over to you, Mr Reddy.

Mr Kumar Reddy

Hi, everyone. Good evening.

I sincerely would like to thank all of you for taking time and joining this webinar. I hope all of you will enjoy this webinar.

I'll be as brief as possible, which would enable you to ask questions at the end of this webinar.

I also would like to thank Louise and Oli, who were instrumental in organizing this webinar, and I also sincerely thank Jonathan, who's been here, spending his valuable time to participate in the webinar.

I just would like to give introduction of myself, I'm one of the associate specialist orthopaedic surgeons dealing with trauma in orthopaedics, and I've been in this field for the last 30 years.

I'm currently the Deputy Chair for Major Revision Centre at East Kent Hospitals and I'm also the site lead for William Harvey Hospital in East Kent.

I'm a member of Academy of Orthopaedic Surgeons, and also a member of BASK, British Association of Surgeons of Knee.

I've got clinical interest in primary hip and knee and revision hip replacements, which I do on a regular basis.

I do have special interest in revision hip and knee arthroplasty, orthoscopic surgeries, partial knee replacements, which include unicompartmental, medial and lateral unis, and also patellofemoral replacement surgeries and meniscal repairs.

Jonathan Thomson

Hello, and I'm Jonathan, so yeah, again, thank you for attending this evening.

So again, I've spent 15 years in medical devices, working largely on the surgical side of that sphere, and I've been at Control for three years, and I've been overwhelmed in my time at the business, the impact this technology can have for patients.

So I'm interested tonight to see some of your questions but also share some of the knowledge that we've built up over the previous few years, and look forward to sort of, yeah, giving you some insight to this technology.

Mr Kumar Reddy

Right, the topics included in the session is consultation and assessment, Knee osteoarthrosis, synovial pain and Arthrosamid overview, statistics, and results.

Procedure, how it's performed in Benenden Hospital, the risks and recovery period and the last one is a questions and answer session.

With regard to initial consultation, once you've booked an appointment to be seen in the clinic, you will be assessed with regard to your symptoms, and with regard to range of movements in your knees, and it's mainly the pain and the stiffness and the swelling that you come across, usually, with arthritis.

And what are the suitable treatments that are available for knee arthritis, both non-surgical and surgical treatments and, thereby giving you recommendations, what you need for treatment.

Again, with regard to assessing after clinical examination, we may request some imaging in the form of plain radiograms or MRI scans and also basing on your comorbidities with regard to fitness for anaesthesia.

So basically, I just would like to let you know what is knee osteoarthrosis.

This is basically a common disease affecting the joints in the body, most commonly the knee and hip.

The joint surfaces, which are covered with smooth cartilage become damaged as we get older, and gradually thin and roughen, and this produces pain, swelling and stiffness. Eventually, there may be no cartilage left and this results in bare bone.

Resulting in severe pain, discomfort, and stiffness in the joint.

Usually, morning stiffness is one of the most common symptoms, and pain on activity, and especially pain on weight-bearing and walking and as the arthritis progresses.

It reduces the walking distance, and also it gives you swelling, and pain can be at rest, and it can disturb your sleep.

The main cause, or breakdown of cartilage in the knee joint, this is age-related wear and tear, and sometimes trauma to the knee can cause into post-traumatic arthritis.

These are the statistics and public opinion about 100,000 GP consultations are related to musculoskeletal conditions on a daily basis.

25% say joint pain makes it hard to sleep or to take part in past times.

86% say physical exercise is important for mental well-being, and they're unable to do the exercise because of the pain in the joints and 58% are concerned about side effects of surgery, and 61% are anxious about surgery, and one in five ask their GP about a musculoskeletal condition yearly.

48% are worried about the long-term effects of prescribed painkillers, especially the non-steroidal anti-inflammatories, and over one in five can take

Can't take the time off to recover from surgery, and 43% willing to pay for a non-surgical procedure for joint pain, and 62% think that obesity is one of the biggest causes of knee pain.

80% think that joint pain is an inevitable part of getting older and getting aged and I just would like to give you a brief pathology, how this pain develops.

With regard to synovial pain and symptoms, synovium is a covering of the joint, and synovial pain is a common symptom experienced by patients with knee arthritis.

This is caused by inflammation of the synovial tissue, the lining inside the knee joint, and it is strongly linked with the level of pain experienced by osteoarthritic knee patients.

And the synovial tissue or fluid is damaged or irritated, the affected area of tissue becomes inflamed, causes pain, it produces fluid called synovial fluid, and inflammatory cells are produced as a response to the inflammation.

And these are released into the joint capsule to heal the damaged tissue and too many inflammatory cells can result in a buildup of enzymes responsible for cartilage breakdown, which makes the joint

Cannot heal, cartilage continues to break down, and the pain cycle repeats and continues.

Jonathan Thomson

There we go, so thanks for the introduction. So what I'm going to cover, really, is to give you a bit more basis to what Arthrosamid is, why it's different from other treatment options that might be available to you, and also go through a bit of an update about some of the data that underpins why this technology is so exciting to be considered for you as a patient.

So I think, importantly, where to start, really, is that we've now injected over 20,000 patients with technology over nearly 15 years, and part of our DNA is to help you guys to regain your life and we have, on our materials, you'll see move freely, live fully and what that means is, it's really important you've got osteoarthritis, that you don't just think you've worn your joints out. Actually, what's really important to do is to keep your motion, keep active, because actually, if knee osteoarthritis.

Yes, you experience pain, discomfort, but the other consequences are health-related, because you're moving less, potentially having cardiovascular issues, or putting on weight. So there's a lot more that can happen with knee osteoarthritis.

So, at Contura, we're passionate about actually helping you to move more, to do the activities you'd like to do with your friends and family, and to be in less pain whilst you're doing this activity.

So I think Mr Reddy also touched upon the fact that with osteoarthritis, this common conception that's just wear and tear is not strictly true and there's a couple of key concepts that probably are good to get across to you guys as an audience.

So, number one, there's other structures within the joint, not just the bone or cartilage that drive pain.

Mr Reddy's already mentioned the synovium, or this line of the joint and this is the key area for us to focus on tonight, because this is the area of impact of this technology, as I explain mechanistically how our technology works.

The other important thing to understand as patients is that, actually, osteoarthritis is an umbrella term. This is not just one disorder and actually, there's different types of osteoarthritis, and this is why it's vitally important for you guys as patients

To get properly assessed by a consultant as to what's generating that pain within your joints, and also what's the underpinning or what type of osteoarthritis you have.

So, I think we can talk a little bit more about what Arthrosamid is. So, Arthrosamid is a non-biodegradable substance which is implanted into the knee. So, unlike the other sort of injectable therapies you have that go away or dissipate from the body, Arthrosamid does not degrade, so it's actually an implant.

Now, what it actually is made up of is 2.5% of this injection is the scaffold itself, which is effectively a polymer, so it's effectively a plastic

Then this actually lines, and we'll go through mechanistic how this works, this lining that we talked about, which, again, when you develop osteoarthritis, what happens is this line of the joint becomes fibrosed, and what the consequence of that is it becomes stiffer, your knee can feel stiff, and that can generate a lot of the pain as well.

So, how Arthrosamid works is a really key thing for me to articulate because it's a very unique product that works in a different way than the other treatments out there.

With Arthrosamid, the simple steps are, it's injected into your knee with a needle, and then over a period of, sort of, four to eight weeks, it starts to integrate into the lining of that joint.

Now, because it doesn't degrade, what happens is this actually changes positively that fibrosed, scarred tissue, and actually what you start to see is that membrane starts to have more elasticity. So we're returning that membrane, which is suffering from the disease.

We're allowing it to be more flexible and that's one of the things we hope patients experience after having this treatment, is that, again, we reduce that stiffness you experience as a patient.

I think it's important for me to also articulate that we are looking into secondary positive consequences of having that elasticity change within the joint structure.

But again, it's important, because this is different from the other treatments, to understand that this isn't an overnight success, it does take time for this process to happen.

So again, we're looking at more of having a longer-term pain relief from this technology, but it does take longer for you as a patient to notice the benefit, potentially.

But when we do achieve that benefit, what we're trying to achieve is long-term pain relief from one injection, and that separates this technology from all the other injections out there. So again, having this long-term pain relief is the aim of having the Arthrosamid treatment.

So, a little bit about the background to give you guys the confidence that, most importantly, this is safe, and then I'll walk through some of the data later on in the presentation as well.

So, this bio scaffold has actually been used over 1.7 million syringes are already in humans and animals worldwide, and that's been done over a 25-year lifespan. So, again, this is not a new technology, and we've learned a lot about it over the development of this product.

So, going back into the history a little bit more, the product's actually been used for facial reconstruction.

So again, we've injected over 700,000 patients to reconstitute the structure of their face.

We've also used this in stress incontinence, and it's still a massive product globally, used as a stress incontinence product.

And also treated numerous animals, so particularly racehorses, to allow them to get back racing again when they've been suffering from osteoarthritis. So again, important for you as a patient to understand that this has been used for 25 years, and 20,000 patients have been injected with this technology.

So again, it's been proven safe and well-tolerated when you're putting a permanent substance into the human body.

I think the other sort of point we want to capture is that there are lots of options available, and we've already mentioned that osteoarthritis isn't just one disorder.

So again, going to your hospital, going to your clinician to be assessed correctly to see if this is a suitable option for you is definitely of paramount importance.

And again, what I'd also recommend is you have options, and each has a consequence, but each has a severity, or has an impact.

You have things at the shallow end, which are losing weight, taking medication, to at the steeper end of the curve, you're having surgery, which obviously is a big decision to go through, is a very good option for some, but also it's not universally positive for everyone.

So again, you want to make sure, as a patient, you've explored all the relevant options to you if you do end up having surgery as well in the future.

I'll hand back to Mr Reddy to give you a bit of insight to how at Benenden they inject this into patients.

Mr Kumar Reddy

So, once you see the clinicians, once the clinicians examined you, and once it is in your best interest to administer an Arthrosamid injection, you'll be put on the list.

once you come into the hospital, it's a simple one-step procedure performed under local anaesthetic and you will be given oral antibiotics in the form of flucloxacillin and azithromycin.

One or two hours before the injection, and people who are allergic to penicillin, we got alternative antibiotics to give.

Once you're taken into theatre, it is done in an aseptic environment and your knee would be cleaned with, clothextine, which is an antiseptic.

And once the knee is cleaned, we then do an ultrasound scan to identify the joint, and once we put the needle into the joint, you draw some fluid, synovial fluid from the joint, and then you inject Arthrosamid, which is a hydrogel polyacrylamide, into the joint.

Before you put the needle in, we give some local anaesthesia to numb the area where you'd be injected.

The knee will be cleaned again, and the clinician will remove any effusion present in the knee before injecting the Arthrosamid and the syringe will be removed.

Once the effusion has been drained, which is the synovial fluid that's been drained, and the needle will be still kept in place for the injection of Arthrosamid.

This authors need are six syringes, and it doesn't mean that we have to jab you six times. The needle will be in place, and we'll be just exchanging the syringes of six, which contains 1cc in each syringe to that goes into the joint.

And once all the six syringes go into the joint, the needle will be removed, and you'll have a little bit of dressing in the form of a plaster, and to cover the injection site.

Jonathan Thomson

Brilliant, so it's my role now to sort of briefly explain some of the clinical data that underpins this technology. So, I think, first of all, I'll explain the graph. So, what this graph shows is three of our studies.

Effectively, what the left axis shows is reduction in pain. So that's a pain score called the WOMAC system, which is universally used in a lot of osteoarthritis research and on the bottom axis, you can see time.

Anything in the green zone effectively means that this treatment is beating something called the MCID, and that stands for the minimal clinically important difference. In relation to a patient, what that means is that's a treatment that you'll notice the effect of, that warrants you having that technology.

Now, what we're really proud about and excited is that we beat this MCID at all time intervals, and that's brilliant.

But there are other technologies out there that, in the short term, can also be effective.

But where we stand alone, and where we're really proud and unique, is that there's no other technology as an injectable goes that's provided multiple years of pain relief from a single injection. You'll see here that we have data out to five years, so a single treatment of Arthrosamid provided sustained pain relief.

And again, if I go back into what the product is, because it's this permanent injection that doesn't degrade.

When we have this technology implanted in, it seems to be given patients with long-term efficacy of the treatment.

Now, it's also a really exciting time for the business. I mentioned we've treated 20,000 patients now.

But actually, we're also at a luxury where the CU Markham is granted in 2021, which effectively means we can sell the product into Europe. So we've only really been utilizing this, sort of, correctly or fully since 2022. But actually, we do have historic data going back 15 years from Denmark, where they used this before license.

In addition to that, we've got more and more evidence being generated from both UK and European clinicians, and it's really exciting. So, particularly if you look onto our website, arthrac.com, or go onto Benenden’s website, they'll keep you up to date with the new clinical studies that are developing.

So really soon, really excited, we're going to have that second three-year study, which will be followed out to five years and again, I can't share all the information now with you, but we're really happy to show sustaining pain relief out long-term still.

And also, we've had some of the UK clinicians start to sort of give us their data from their cohorts of patients they've treated. Now, something that's really encouraging and reassuring is actually some of the UK clinicians are showing improved data to what we have as a business.

So I'll reference sort of Andrew Miller, who is over in Cardiff, who's treated a couple of hundred patients. Again, he presented his data in Madrid last week at a European meeting, and he showed that actually his patients are getting a higher level of pain relief at a time interval than we are.

We're also really excited that there's a study about to be published from the own NHS, so they run a study to show that, most importantly, it works in the population.

But certainly, they're helping us answer some of the questions about we talked a little bit about how this implant helps the synovial membrane, how we're changing the elasticity in a positive manner, but also they're looking at some of the downstream positive consequences of having this technology put into your joints. They're measuring various biomarkers, etc.

So our hand back's Mr Reddy, but hopefully that gives you a brief flavour of some of the data and the main messages, this consistent and long-term effect that we're looking to achieve.

Mr Kumar Reddy

So, just going to talk to you briefly about the benefits of Arthrosamid.

Arthrosamid is the first and only approved injectable implant that permanently combines with the knee synovial tissue, decreasing joint stiffness, diminishing pain, improving the function of the knee, and enhancing your quality of life.

It acts like a scaffold, separating the inflammatory cells and the key benefits are a simple one-step outpatient procedure, no disruptive recovery period like surgery, and long-lasting pain reduction with single treatment.

Supported by two decades of research, you may experience some ache discomfort in the first few days, for which you're advised to take some painkillers and it will gradually get better.

With regard to recovery, soon after the injection, you'll be allowed to take full weight bear, and you can choose to rest the first few hours, and then you'll be leaving the hospital, and you may get some mild discomfort as the local elastic wears off.

If you develop any redness, swelling, agonizing pain, it's important that you contact the doctor for further assessment and advice.

You've got to take regular medications and painkillers, and sensation may differ due to Thicker consistency of Arthrosamid and usually the pressure effects, you may feel a lot of tightness and swelling, in the knee, because there is six 1cc of Arthrosamid, which is a thick gel that goes inside the joint.

Common symptoms are mild to moderate pain and swelling.

With recovery, it's not a quick fix like a steroid and which works Immediately, and it also wears off within maximum period of four-six weeks at the most.

Arthrosamid, it can take up to a period of 12 to 14 weeks for you to get the optimum benefit, but clinical data suggests that majority of the patients start to feel an effect within a few weeks after following the injection.

When you can you go back to normal activity? As with any invasive joint procedure, it is recommended that you avoid strenuous activity, like getting back to impact sports, like tennis, jogging.

Playing football, or long walks during the first few weeks after the injection, and you begin your exercises, static and active quartz exercises as soon as the pain allows you to do it.

With regard to side effects, the clinical trials reports that there were no serious side effects following a treatment of Arthrosamid injections.

The most commonly reported side effects is joint pain, and a sensation of joint swelling because of the thickness of the fluid, and they're mild in severity and lasting days to a couple of weeks at the most.

The overall safety profile of the injectable hydrogel has been established over the last two decades with its use of various indications in the body.

Now, coming lastly, what are the contraindications? What are the restrictions that Arthrosamid should not be injected?

Mainly if the patient has undergone arthroscopic surgery or a steroid injection within the last four to six months. However, it can be administered after a period of four to six months.

If the patient has previously received treatment with a different non-absorbable injectable, like hyaluronic acid.

And if the patient has received a knee replacement, or a partial knee replacement, either a unicompartmental, medial, or lateral, or a patellofemoral replacement, or any foreign material in the joint.

Or if an active skin disease or an infection is there, it is totally contraindicated to give Hydrogel injection into the knee joint in patients who have haemophilia, and also in patients with uncontrolled anticoagulant treatment.

However, people who are on anticoagulants, we can inject after they have stopped for 48 hours. I mean, the usual anticoagulants people take are for irregular heartbeat, which is atrial fibrillation.

They are on either apixaban, rivaroxaban, or redoxaban, which can be stopped in 48 hours, and you can administer these injections.

We've got a team of our colleagues who are here, to give these injections. We all have been trained to give these injections.

One is Mr Chipperfield, another one is Mr Oliver, Mr Thakur, Mr Goddard, Mr Mark Jones, and Mr William Dunnett.

Louise

Thank you both, let's now move on to our Q&A session.

We're really pleased to have so many with us today, sorry. So we hopefully we can get through lots of questions.

We may not be able to answer every question, we do our best to cover as many as we can.

To help us with this, if you could try and keep your questions brief, that would be great.

I can see some of the questions have been covered during the webinar, after you typed them in, so I'll prioritise those which haven't been discussed.

If you have questions on knee replacement surgery, we have a webinar focused on this in October, which you're welcome to join.

So, our first question is, is there a progression to getting Arthrosamid injection?

Jonathan Thomson

And if that's regarding probably when you'd have it compared to other treatments, Mr Reddy, possibly, we can answer that.

So when would you recommend this, or what should I try before, potentially?

Mr Kumar Reddy

When you've tried on physiotherapy, weight loss program, and all this, and again, anti-inflammatories, if you're still having pain.

And best thing is for you to come for a clinical consultation, and you'll be assessed after clinical consultation.

The imaging will be requested, which would be in the form of x-rays, and if you've got moderate osteoarthrosis or early osteoarthritis that have not responded to other non-surgical conservative methods of treatment, it would be reasonable for you to have an Arthrosamid injection.

Louise

Thank you.

Another one for you, Mr Reddy, is a knee replacement possible, if needed at a later date after these injections?

Mr Kumar Reddy

Of course, yes, I mean, after a period of three-four years, if the pain is worse, and if you and if it is bone-on-bone arthritis, certainly it is reasonable for you to undergo knee replacement surgery after these injections.

I have done this in out of 50 injections I've done only in two patients where the pain has not subsided, and they want to go for a replacement surgery.

Jonathan Thomson

We've got some other evidence on that. So actually, because we've got this historic use in Denmark, where patients are out to 15 years following this treatment, a number of them have gone on and not had a knee replacement, but some have had a knee replacement surgery following this. So again, we follow these patients out longer term.

And again, we can sort of publish that information as well in time, but it shows you don't burn any bridges. So again, by having Arthrosamid, there appears no consequence, or bridges burned to other surgical interventions should they be needed in the future.

Louise

Excellent, thank you both.

Is it suitable for a knee that's bone-on-bone?

Mr Kumar Reddy

If it is, bone-on-bone arthritis, then the chance of it working are, less. However, we, patients come asking for injection Arthrosamid injection, despite being bone-on-bone arthritis.

The reason being, they are very apprehensive knee replacement surgery and I have I have to be very truthful to you that nobody in this world can give you an absolute guarantee regarding knee replacement surgeries.

There are at least 15-20% of patients who are unhappy either with robotic knee replacements, or done by manually, or with computer-guided knee replacement surgeries. So, it is a much, much less invasive procedure, and if you've got pain, and even if it's bone-on-bone, it's worth trying. Once you have the knee replacement, you can't have this procedure.

Louise

Okay, this lady is a fit 79-year-old female. What are the chances of the procedure being successful?

Mr Kumar Reddy

I'm pretty optimistic it'll be quite successful because you're 79, you're very fit, and if it's again, you need to be seen in the clinic by one of our clinicians, and once we see and ask for appropriate imaging, and if you've got moderate osteoarthritis.

There's a very good chance of this being successful.

Jonathan Thomson

And I'll probably break that down. We also, on our website, on Benenden’s, you can look, and it's a patient brochure. From one of the clinical studies, we broke down success rates via age. Now, I would say that's a nice proxy sometimes to see.

However, age is just a number as well. There's multiple factors that go into success, and I'd always point towards having a consultation for a consultant for assessment of your type of osteoarthritis, and then that'll probably help them further predict where you fit into that potential success curve as well.

Louise

Thank you.

Does Arthrosamid prevent bone-on-bone rubbing, and hence prevent reduce the degradation of the degradation of the joint?

Mr Kumar Reddy

It is not a cure, I have to say. It is what it does is it separates the inflammatory cells and reduces the inflammatory response of the synovium.

So, it is worthwhile considering this injection, Arthrosamid, which is a thick lube gel that lubricates the joint and reduces the inflammatory response.

If you keep on having more inflammatory response with the synovitis and things, it generally breaks down the cartilage and damages the articular cartilage that you have got.

Louise

Thank you.

So this person said their medial side of their right knee has cartilage worn away. Will Arthrosamid be of any benefit?

Mr Kumar Reddy

If you've got an isolated medial compartment osteoarthrosis, if you're quite young, I think it would be reasonable to try Arthrosamid injection, which may well benefit you.

The reason being, if you're quite young, and if you wish to have this Arthrosamid injection, it's very reasonable to for you to have, because you are young, and you will continue to be active in the next 20 years or so, and the knee replacements in people who are young and active, they distribute several millions of cycles more than a 75-year-old.

So, that is one of the reasons why we tend to go for non-replacement options, like conservative methods of treatment, including Arthrosamid injection.

Louise

Pam asks, is it possible to have a sample of Arthrosamid so you can be tested for allergy to it?

Jonathan Thomson

I can probably help with that one. So actually, as part of the testing you have to do when you launch a product into the market, we have to run multiple tests and again, I'll go back to the 1.7 million syringes that are put into humans and horses.

Arthrosamid have been proven safe. In essence, it's an inert bio scaffold. So, in regard to allergies, it's not something that you'd need to be screened for in order to have Arthrosamid, and again, I'd revert you to Benenden to have a consultation to discuss that further with them, but not something that we'd do if we're going to send a sample out for testing.

Louise

Thank you. Tricia says, do I need a diagnosis of knee osteoarthritis before seeing you, or will full investigations be made by Mr Reddy as part of the Arthrosamid treatment?

Mr Kumar Reddy

Once you have got a clinical consultation, it's quite important to have a clinical consultation to see to get a diagnosis, and sometimes we occasionally get caught up when patients complain of knee pain.

Actually, they have got very advanced arthritis of the hip. It's quite important for you to have a clinical consultation and an examination, and also to request appropriate imaging and this will all be done at the time of consultation, when you come for even Arthrosamid injection or for a healthcare consultation. All this will be done at the same time.

Louise

Thank you.

For patients where injections seem to have no benefit after six months, what investigations do you carry out to find out why, and to consider a repeat treatment?

Jonathan Thomson

I'm happy to sort of take some of that, I think. So, I think if you've had no benefit from a treatment, repeating the same thing probably doesn't make sense. I think what I'd lean on as well is, I think, by having a good consultation initially, they can probably better predict success for you as a patient, but nothing in medicine and nothing in surgery is a guarantee. Mr Reddy's already referenced that 15% to 20% dissatisfaction from knee replacement.

Again, we'd love arthritis to work in 100% of patients but this is work we're continually evolving to see, can we try and predict you as a patient to be someone that does respond well to this technology, or is there cues that mean that actually there's other options available to you?

Again, I'd point you towards having a good consultation where they can assess you fully to ascertain and have that shared decision-making with you, if this is something you'd like to try as an option.

Louise

Thank you.

This is an interesting question. How do we know that Arthrosamid does not spread to other parts of the body, e.g. brain?

Jonathan Thomson

Yeah, that's a great question, and one that we have to ask for the regulators. So again, as part of this, when you have a product which is implanted into the body and it's going to be there forever, you have to basically show so we've done lots of studies to look at dissecting of various animals, and to look at histology samples, and we can confirm that when you put Arthrosamid into the knee.

It stays within that synovial lining, that lining of the knee itself, so it doesn't migrate. It's a non-migratory product, it stays within the knee, so it's not going to end up in the brain.

Louise

Okay, thank you.

Can you jog or do impact sports with Arthrosamid?

Jonathan Thomson

Again, I'm happy to answer that, yeah, yes, that's the aim. We'd say you wait that two-week window. So again, we don't have heavy impact activity initially, but again, the aim is to get you back doing activities you'd like to do.

So, again, you can point towards the Benenden website, and you can hear some stories from patients that have had the technology, and maybe, sort of, you can resonate with them.

I'd also recommend going onto our website. You can see multiple people have had this treatment of different types, and some of those people particularly are either ex-athletes or people that want to go running or play tennis, so absolutely, that's the sort of stuff we would like for you to achieve as a patient if you're successful after this technology is implanted.

Louise

Thank you. Angela asks, after injections, can patients kneel easily? And also, how soon can they fly after injections?

Mr Kumar Reddy

I can say, I mean, after the Arthrosamid injection as Jonathan was saying, about two weeks, you'll have some discomfort and things, and there's no contraindication for you to kneel or crouch after this injection, and I can I can confidently tell, I mean, a few of my patients who

So passionate about running, they could not run because of the pain in the joint and they had steroid injection, and it worked for two weeks, and they came back to see me, and I injected Arthrosamid, and they're now back running again.

Which is quite a delight for me, I mean, to see them back in their active state.

Louise

Yeah for sure, thank you.

Is this suitable for patients with osteopenia? And patients, therefore, and therefore they don't have osteoarthritis.

Mr Kumar Reddy

With osteopenia, it's a different condition where the bone mineral density is less, so unless you've got arthritis, inflammatory joint.

It is not advisable just for osteopenia or osteoporosis to have Arthrosamid, as it will not have any effect on osteopenia.

Louise

And I guess related to that, why doesn't everyone get arthritis? Just some people get it, is it a genetic condition?

Mr Kumar Reddy

It is certainly genetics play an important part with regard to arthritis, development of arthritis and also, there are several other factors where it is your lifestyle, your impact activities.

If you're a keen sportsman, playing football for several years, all these play an important role, and also a major trauma to your knee, sustaining some fractures or ligamentous injuries, all these factors, several factors that can contribute to arthritis.

Louise

Thank you.

we covered off second injections being possible, so that one I won't go through. This person had, I know, Arthrosamid injections eight weeks ago, and they felt some difference after four weeks, which is great, but then they had a fall three weeks ago.

And the knee pain started again, would a fall affect the effectiveness of the injection?

Jonathan Thomson

Well, it's a hard one for me to answer. Well, I'd say the gel is still within your knee. I think it's probably for a clinician to ascertain, is the pain as a result of the fall? And again, I think you'd have a period of settle in, but I'll hand that one over to Mr Reddy to give you a medical answer on that one.

Mr Kumar Reddy

I think the important thing is you need to have an assessment after a fall, whether you got a fraction or not, whether you got whether you've been seen in A&E and had further imaging done in the form of x-rays or MRI scans to see whether you've got a subchondral stress fracture following the fall or not.

But Arthrosamid should be in the joint, it will be in the joint, and it'll continue to work, and as I said in my early presentation, that it can take up to a period of 12 to 14 weeks for you to get the optimum benefit. But just to make sure, I would advise you to, if the pain is not settling, to get further imaging to make sure that you do not have a sub handle fracture, a stress fracture.

Louise

Thank you.

I'm just going to looking through, we've got so many questions, we've never had this many questions in a webinar before.

So, I'm just looking at some that are a little bit later on, so we don't not ones that, repeated in the presentation.

What about someone with hypermobility joint pain in the knees? Would it work for this type of person?

Mr Kumar Reddy

Yeah, they do work in hypermobility, provided they've got arthritis or inflammatory arthritis in the joint. The Arthrosamid should work in people with hypermobility.

But you won't you do not give injection for hypermobility syndrome, because you got generalized hyper ligamentous laxity. As long as you got arthritic pain, it should work.

Louise

Thank you.

This person, I can answer this one. How do we register for discounts being offered in this webinar? Is it automatically linked to our Benenden membership account?

So, if you're a member of Benenden Health, you will automatically get their 10% off when you call up and yeah, and you can have your initial consultation through the membership as well.

Just trying to see any others that would be suitable just to go through.

What are the interactions between this treatment and the use of MBST machine before or after this treatment?

Jonathan Thomson

Not saying we've ever tested or looked into, so yeah, not one I can directly answer. I mean, I don't if you see any challenges of that, Thomas, already?

Mr Kumar Reddy

No, I'm not seeing to be honest with you, I have not seen this.

Louise

Thank you. Can Arthrosamid be used anywhere else in the body?

Mr Kumar Reddy

It's a great question. At the minute, it's only licensed for knee osteoarthritis.

We are looking at how we expand indications in time, but for now, it's only for the osteoarthritis.

In UK, it's only licensed to give in the knees, but whereas in Europe, where I visited Denmark, people are giving in hips, in the finger joints, as well as in the ankles.

Jonathan Thomson

So, it has been licensed in Denmark, whereas here, we do not have licensing to do the injections in other parts of the joints. Yeah, as I say, in Europe, keep just keep to just knees for now, but yeah, we'll expand that in time as well. So, yeah. We'll let you know on the website if you follow our website when it gets expanded.

Louise

Are varicose veins in your legs, especially in the back of the knee area, likely to cause problems to the efficiency of using Arthrosamid?

Mr Kumar Reddy

Sorry Louise, can you repeat that, please?

Louise

Are having if you have varicose veins in the back of your legs, especially kind of around the knee area, is this likely to cause any problems to, like, the successfulness of having Arthrosamid or the suitability?

Mr Kumar Reddy

Should not cause any problems, as long as the surgeon avoids piercing the vein.

it should not cause any major concerns, because you're injecting into the joint area under ultrasound guidance.

That's why I always prefer to give these injections under ultrasound guidance, whereas some of the surgeons, once they aspirate the fluid, they know that they're in the joint, and they can give the injection.

But again, if the injection goes into the fat pad, it causes much more pain if the injection rather than the joint, if it goes to the fat part.

Louise

Thank you.

So, you said about, the different types of arthritis in the knee.

Could you go a little bit more detail on that?

Mr Kumar Reddy

So, with regard to different types of arthritis, you can have rheumatoid arthritis.

And you can have gouty arthritis, secondary to gout, and you can have other conditions, like psoriatic arthropathy, and the trauma when you got fractures, intraarticular fractures of the knee following an accident, or if you've got ligamentous injuries which have been ignored in the past.

That can contribute to post-traumatic arthritis, and when you got in the past, people used to do open meniscectomies, where they used to take the whole of meniscus out, especially the lateral meniscus. If they had open lateral meniscectomies, it can contribute to arthritis.

In the long term. All these are different types of arthritis, and all these are suitable for Arthrosamid injections.

Jonathan Thomson

So I'll probably add to that, and if you want to learn some more about different types of osteoarthritis, you can go to our website and learn a bit more about synovial pain and the impact that can have.

But also some great podcasts and sort of materials you can also dial into. There's a guy called Professor David Hunter of a joint action podcast, and recently had an episode nicely explained the different types of osteoarthritis, and what they might present like as well, so you might find that useful as well to digest in time.

Louise

Thank you.

What causes the inflammation of in the synovial fluid?

Mr Kumar Reddy

Synovial loses its viscoelastic properties.

The synovial membrane contains an accumulation of inflammatory cells that are a precursor for pain, stiffness, and swelling.

What Arthrosamid does is, once it's injected into the joint, it distributes the joint fluid, and it begins to adhere to the synovial lining.

Thereby, what it does is it reduces the inflammatory response of the synovial membrane and this intimal layer will act as a scaffold within the subintimal layer synovium.

Jonathan Thomson

I mean, it's a good question as well. I mean, with that, a lot there's a lot of different causes, and it's not an exact science, but again, there could be post-traumatic osteoarthritis, Mr Reddy mentioned. It can be but it's generally it can be a mechanical condition that's biologically driven, and again, the body gets into a state of almost,

knocked off haemostasis, and then that's where you get this imbalance between repair and destruction, potentially, and that's one of the things that can cause this inflammation and accumulation of synovial fluid. But again, this is, again, some stuff that's really covered very well in some of this literature and podcast. If you search for it, you better learn some more information about the drives of that as well.

Louise

Thank you.

Why do you need six syringes instead of one?

Jonathan Thomson

I can say that quite easily. So, yeah, it'd be nice to have it in one syringe, however, the gel is super viscous. So there's a couple of reasons. In order to deliver it through a needle, so rather than having to be done under surgery to deliver it through a small needle, we break into six one mil doses.

And also, we manufacture for other specialties. You saw that we've used this product in the human body for 25 years. They're all manufactured in one meal and at the moment, there's only sort of one machine that manufactures this hydrogel to the exact same standards that's manufactured out in Denmark. So again, there's been a huge resource into the manufacturing process to make sure that the gel we deliver is exactly the same every single time, so we can guarantee that product. So again, there's a practical reason of the viscosity.

And also, there's a physical reason regarding the manufacturing process as well. But, like I say, it's only one needle, it's just the exchange of the syringes for the clinician to do.

Louise

Yeah, great, thank you.

David was booked in for a knee operation with us in January but had to cancel.

In the meantime, he's been doing exercises, and his knees improved a lot. Would an Arthrosamid injection potentially be suitable for him, then?

Jonathan Thomson

I mean, I'd say what we have, and it's on our website, is a free rehabilitation program. So again, gold standard is always to work with a rehabilitation specialist, but we want to make this program accessible for you as patients and your friends and family members.

Anything you do, I think, to have combined rehabilitation is vitally important, and please go and check out the website and see this program, so you can access this. It's free of charge for you to use and share it amongst friends and colleagues.

But also, I'd say that it may well be a suitable option, and I would recommend a consultation on that basis, but it's really positive that you're having that response to rehab that you're doing and strengthen your knee. What we know with knee and osteoarthritis is if we can strengthen the joint structures around it, whatever therapy you choose to do, that will bolster your results.

So, again, I'd refer you for a consultation, and that one would be my advice, but I'm really positive and happy to hear that you're having a really good result from doing some structured rehab as well.

Louise

Great, thank you.

Related to that, Helen's asked, does one need a program of physiotherapy exercise after the injection, as after a knee replacement?

Jonathan Thomson

Yeah, so we've designed the program with some of the leading physiotherapists, designed you a program which has different levels depending on how fit you are when you enter, and it's something you can use over a period of time, but also progress in that as well.

So again, I'd say, absolutely, structured rehabilitation should be part of your Arthrosamid rehab journey and again, I'll refer you to the website we have. If you go to Arthrosamid.com.

You can see the program, and you can access that.

There is a quiz if you're uncertain to what level you would enter in at, and that will basically ask you a few questions and tell you if you go in the early, medium, or advanced stage.

But again, if you can work with a local rehabilitation specialist, would also be a great thing to do, maybe in supplement of that program, but again, definitely do some rehab as part of Arthrosamid

Louise

Thank you. What local anaesthetic is used? This person's had reactions with some of the kind of typical anaesthetics.

Mr Kumar Reddy

Usually, the local stick is given either in the form of lignocaine. I normally use a lignocaine injection, which is a one-percent lignocaine, around the skin area, where we put the needle in. Before putting the before inserting the needle, we just inject that area to numb that area.

So, if you've got any specific allergy to certain local and stick, we have got alternatives where we can give other local anaesthetic injections.

Louise

Thank you.

This person has bakers cysts. Will this cause problems?

Mr Kumar Reddy

It should not cause any major problems with regard to bakers cysts of you receiving an Arthrosamid injection. Usually, the breaker cysts are associated with the degenerative meniscal tears.

Especially the medial meniscal tear that can propagate into your cysts. These are benign cysts, that is a sac filled with fluid at the back of your knee.

And it's basically a degenerative process. So, of course, you can have an injection with the Baker's cyst.

Louise

Thank you.

How do you reduce inflammation in your cells?

Jonathan Thomson

That's a massive question, which I can't give you an answer to, and there's various things you can look at doing, and I'll hand that over for a medical answer, but again, there's various factors that drive inflammation, but I think that's ready to give you a more medical answer to that one as well.

Mr Kumar Reddy

Without inflammation, as I said to you, if it's if the osteoarthritis is untreated, the synovial fluid that is inside the joint loses its

viscoelastic properties, the annual membrane, which covers the joint, that contains and it accumulates a lot of inflammatory cells, which are a precursor to your pain and swelling.

And when you inject Arthrosamid, as I said to you earlier, it distributes within the joint fluid and begins to adhere the synovial lining. There are macrophages, like sinusitis, that enter into the hydrogel, and these are unable to multiply once they adhere to the hydrogel.

They're differentiated into fibroblasts, synovacytes, which start integrating through the hydrogel Creating a thin Vessel-bearing fibrous network.

And after that, a new layer of intima forms on the top of the integrated synovial membrane. This new layer contains scattered non-inflammatory type cells.

Which act as a scaffold within the sub layer, and this usually forms within four-six weeks of Arthrosamid injection.

This thickened synovial subintimal layer causes distancing of the inflammatory cells and breaks the inflammatory cycle, thereby reducing the inflammation.

I hope I got it in a nutshell, and yeah.

Louise

Thank you.

Just quickly scanning through If someone's had an ACL operation many years ago. Are they suitable to have Arthrosamid?

Mr Kumar Reddy

Again, I would say if you got an ACL reconstruction in the past, and if you it's quite important to have a clinical consultation by your consultant to examine you to see whether you've got instability symptoms, or whether it is pain relating to secondary osteoarthritis after your ACL reconstruction, after a long period of time.

If you've got pain, and if the relevant imaging confirms that you got arthritis, moderate amount of arthritis, yes, you're suitable for an Arthrosamid injection.

Louise

Thank you.

Right, thank you for all your questions, and for being part of this evening's session. I know there's lots we haven't covered, if you've provided your name, we will follow up with you via email, we just run out of time, I'm afraid.

Thank you, as a thank you for attending, we're pleased to offer 50% off the value of your consultation for a limited time, a callback from your dedicated private patient advisor, an email with a recording of this session, treatment information, and loyalty reward points, updates on future events and health news.

We'd really appreciate it if you could take a moment to complete a short survey at the end of this session, as it helps us to improve and tailor future webinars to your needs.

If you'd like to speak to someone after to book your consultation, our Private Patient team Advisors are available until 8.30pm this evening.

They're also available 8am to 6pm, Monday to Friday. You can see the contact number on your screen if you just go to the next slide, please.

Yeah.

We also have upcoming webinars on a range of topics, including varicose vein treatment, liver disease, and knee replacement surgery. You can sign up for these via our website.

On behalf of Mr Reddy, Jonathan, and all of us at Benenden Hospital, thank you once again for joining, and we hope to hear from you soon, so take care, and goodbye.