Understanding Absorbable Biomaterials for Hernia Repair and Soft Tissue Reconstruction, Including Treatment Algorithms for Complex Patients
Matthew Goldblatt, M.D., FACS of Milwaukee, WI, joins us to help educate Vizient members on the differences in absorbable mesh materials and biologics utilized in hernia repair and soft tissue reconstruction. Dr Goldblatt reviews the long term clinical data available and his clinical experience on these materials, discuss patient characteristics that help support choice of operative approach and mesh selection, and influences that impact patient quality of life.
Dr Goldblatt currently practices in Milwaukee, Wisconsin where he is Director of The Condon Hernia Institute, Program Director, Department of Surgery and Professor of Surgery at The Medical College of Wisconsin. He is subject editor of Surgical Endoscopy, and reviews for other journals including The Journal for Surgical Education, Annals of Surgery, and The Journal of The American Medical Association. He has published over 60 articles in peer-reviewed journals and 9 chapters in medical textbooks. Much of his published work is related to the subject matter of advanced hernia repair.
More on Dr. Goldblatt's
Virtual Case Study and Literature Summary.
Vizient Biologic Mesh.
All righty well, and I think we're about two minutes after the hour. So we'll go ahead and get started. So um I want to go ahead and kick us off. And and first and foremost really thank Gordon? And Dr Goldblatt for for pulling this together. Um This topic of those bio absorbable as an alternative to the biologics seems to really be be gaining momentum in the marketplace. So I'm really excited to have Dr Goldblatt here and really hear his perspective on the topic. Uh next slide. Um So I'm Cory Girard, I'm a senior portfolio executive here at busy and I managed the hernia agreements. We thought just to kind of set the stage, I go ahead and just go over to some real basic information. So if you go to the next slide for me. Um So yeah, before again, before I hand it off to crest. And Dr Goldblatt just wanted to mention that that the vision that the contract number is M. S. 9004. And it's got an initial term that runs through 6 30 2023. I did want to note that that we are actively working with gore to extend this agreement. So you may see something here in the new future. But products that are on the agreement, they include those synthetic mesh products in the flat sheets or the patch form as well as the staple line reinforcement products. And then they also have the bio durable mesh products that that will be talking about here today. So the contract tiers are based on spend thresholds um and do require contract activation to access any tier above that access to hear next slide, one more clip. There we go. So you know chris uh shared this slide with me a while back and I really thought that this slide that speaks to the opportunity. If you look at the pie chart, biologics only represents 8% of the devices sold for abdominal wall reap Care but but due to their high cost they represent 45% of the spend in this category. So I just when I first saw that I was really shocked by that that statistic. So um with that out of the way I just go ahead and turn this over to crest and dr Goldblatt to walk us further through the opportunity. Well thanks Corey as you point out those biologics can be quite costly and and we think we've got something to share with you today that perhaps can can help with that. So let me say thanks to you and the visiting team for all the collaboration here and bringing this forward in a fantastic effort and we really do appreciate it and just welcomed everyone who's joining us. We really do appreciate your time and attention as we talk about these material sets, how they work how they perform quickly and you know the potential opportunity for some safe with their use. So there are three products that we're going to really focus on today. The first is the gore biology, horrible tissue reinforcement. This is a P. G. A. The three D. That is fully resolvable we see most often and when there is some sort of comparison to other bio observables that may be on the market. And this offers kind of a a performance and cost advantage. And in fact it's the market leader in hydro hernia repair. The second product is the gore cynic or bio material. This is what we call a hybrid. This has a permanent component and an absorbable component. So the permanent component is made out of a P. T. F. It and then the observable is again that three D. Web made of P. G. A. T. M. C. You'd use this where you may need to bridge a defect and it does have an indication for that. And then the last one here is the gore informed bio material and this is a fully absorbable product. It's very thick, strong and confirmable one that we see most often used as the alternative to those biologics. So next slide So what you're seeing now is just kind of give you set the stage for the potential savings that are out there. This was a uh a case study that we did in conjunction with vision at a West Coast Academic Center. So we went in, we worked with the physicians, we worked at the hospital and we had a trial of about 14 procedures where they used the gore informed bio material at the end of the physicians were happy with the outcomes. They were as good or The biologics they had been using and the save were sent $1,000. So if you extrapolated that out to about 100 cases, which was what we thought they would do utilize the in form for uh in a year you'd see about a $530,000 savings. So the hospital was very excited about that as you know certain position about the outcome. But when we went back next slide after two years we actually saw that for these abdominal wall repairs. They used 350 of the Gordon for bio materials. With an average savings of about 44 $4500 per device which translated to about $1.5 million dollars in savings to this particular center. And you know that's significant. We know that these days especially savings are in short supply and you can through the product be able to save $1.5 million. That's something that I think uh everybody should be excited about. So uh I would just say this that we all certainly understand that that product performance and patient outcomes first and foremost with regards to any of these particular devices. So we're a to have really an international expert in this field of certain to join us next slide. An individual that I'll say has done, you know extensive work uh to studying these materials and working with them clinically. So let me introduce uh Dr Matthew Goldblatt honored to have him this, he is from Milwaukee where he director of the revered Condon Hernia Institute, He is the program director of the Department of Surgery and Professor of surgery at hospital a number and the Medical College of Wisconsin. So dr Goldblatt, thank you for making time again. It's an honor to have you with us today. Well, uh thank you very much and thanks for inviting me to kind of share my experiences with um with these products. Um and I just um I think the uh you know, one of the most important things to realize when thinking about these products is as you mentioned, you know, the cost savings are great, but but do they work? And that obviously is is important because as a surgeon, um you know, if if my hospital comes to me and says, hey, we can we can save a lot of money. Um My very next question is, does does this stuff work and you know, how is it going to affect my patients? So um I'll kinda hopefully be able to tell you that that not only does it work as well, but in many cases uh in fact, I think in most cases works better. Um so it's kind of a win win. Um so if you look at any material that you're going to implant in a in the human body. Um Some of the things that I think are important are that it has to be strong both immediately out of the box and um strong enough to allow wound healing and tissue healing. Um It'd be great if it was resistant to infection. Um We're gonna be talking about C. D. C. Class one uh wounds uh today. So um theoretically these are all sterile wounds but we all know that um sometimes patients don't heal and their wounds don't behave. Um As we would hope so. Um That would be a nice advantage if it is going to be placed intra abdominal e or intra peritoneal E. Uh And it would be nice if it didn't create adhesions or at least had an anti adhesion and an anti fistula barrier. And it was easy to use. Didn't have to have a significant back table prep um where it had to be thawed, warmed um reconstituted rinse, you name it. Um Some of the earlier biologics and some of the earlier products in this class really had a systemic inflammatory response which really made you concerned about the patient. They sometimes get federal and tachycardic and um just about everything on the market these days doesn't do that but we want to make sure that nothing creates a systemic response like that. And as we just talked about it would be nice if they were cost effective. So um I'm gonna go through sort of some of the mesh products. The biologics, the bio absorbable and will briefly touch on the hybrid products. Um Again sort of a nice opportunity to remind everyone that um all of these products are only cleared for the FDA to be used in class one C. D. C. Clean wounds. Um You know um they may be used off label. That's up to a surgeon's discretion. Um But I'm only going to talk about um clean wounds uh today and you know there are like we said, permanent mesh biologics, both animal and human. And then a number of markets or products on the market that fall into the bio absorbable product or category. And then some of the hybrids. And um when we go back and look at some of the data um This is a danish study. Um looking at some of the issues that were um that were brought up and and want you know with mesh. And so why do we even why are we just not using mesh for everybody? And so um you know the the Europeans, often many other countries in europe have great registries. And um in this one there's some of the findings show that you know there was a in a non mesh repair for ventral or incision a hernia. Um There is a significant increased risk of recurrence. And I think we pretty much know that at this point but the the mesh repairs have a very significant risk of a mesh related complication. And that's kind of a no brainer kind of comment. If you don't use mess you can't have a mess related complication. But on the flip side if you do use mess you do get mess related complications. And um and we've probably all seen late night tv or even uh daytime tv where lawyers are advertising for mess related complications. And and uh you know, most of all the products on the market today are you know, are on the market because they haven't been pulled from the by the vendors. But there have been some pulled because of problems and that that is typically um a mess related complication. So if we go back and look now again, these are some studies that are in the literature. Um But are are you using these products in contaminated fields? So again, I'm not trying to condone this use but but this is where a lot of the data lies. Um And um so if you look back at some of the early studies published um last decade um looking at synthetic mesh and contaminated fields there um there there has been some success but it's not perfect. Um And when you use a piece of mesh and there's bacteria that can that can uh live in the in the plastic in the in the pores and in the interstices of the of the webbing of the mesh, you um you may get away with it some of the time or most of the time but some of you know in these patients, 4% of the patients had to have their meshes removed. A number of patients needed re operations. Um Certainly some procedures, drainages, long term antibiotics. So um mesh in a contaminated field is um is not a great idea in my opinion. Um Mike Rosen as who was the lead author in that last study, has done a lot of work in these in this field. And here's another paper he published about 10 years ago looking at biologics in contaminated fields and um very large hernia, very difficult patients to deal with. And um the standard at that point was to either place a lot of these materials in the in the peritoneal cavity or sometimes even bridging them. And you can see when you do that. You get a pretty high recurrence rate in the 30%. You know range in less than two years. Which is a which is a looking back at it. It's a pretty unacceptable number. But at the time that's that's pretty good because we really didn't have any options other than primary closure back even as early as 10 years ago. And so um getting a contaminated complex hernia into a situation where you are have a closed wound and a recurrence probably changes the game and you can you can always go back and fix it later. But again the biologics um aren't aren't perfect in this situation. Um a study um that was funded by one of the biologic companies known as the rich Trial um looked at multiple centers in contaminated fields. Some of the sort of the progression of the science of how to repair these hernias was that um we we know that we learned from this study that if you can't get the fashion or the abdominal wall closed, then you have a much higher incidence of recurrence and where you put the material. In other words, if you put it inside the peritoneal cavity or you just started to see um surgeons putting the material within what's called the retroactive space within the muscle itself. Then we started to see um fewer recurrences as well. So but still a pretty substantial recurrence rate. So some of the concerns with the biologics is as was demonstrated uh with that um case review from the West Coast Hospital that they're they're pretty expensive. Um There in fact they're quite expensive and again some of them require some back table prep. Um They're derived from animal and human sources, which some people have a problem with um you know, two of the major religions of the world um have problems with pork and porcine materials. So most of these products are made from uh from porcine materials and people are concerned with human tissue even though they're tested for virus doesn't that type of thing. Sometimes people are a little bit concerned about having cadaver material in them. So um they've also been limited in size is in the past, many of them now in fairness do come in rather large sizes, so it's not as much of an issue. But the other thing that happens when we're dealing with with with tissue and collagen is that collagen is cross linked. It's it's the way that all animals um Can I try to limit the amount of breakdown of collagen from enzymes in the body called collagen? Or collagen is is um And if they're some of them are naturally cross linked and others are cross linked as part of the preparatory process of the material. And that cross linking um can help stop it from breaking down, but sometimes we want things to break down. It can inhibit in growth. It can create encapsulation where the body just sort of walls it off and doesn't grow into it and cross linking to an extreme uh is called leather. Um And that's what tanneries do. They take a piece of of skin and they and they turn it into leather and that's by cross linking. So it's in the world of hernias and and reconstruction that's we don't want too much of that in this study which just came out a few months ago again by uh by mike Rosen who's at the Cleveland clinic and his colleagues looked at using biologics and synthetic mesh in um contaminated hernias again. And um they use these all in that retro rectus space. So now we've gone to the point where we know that that retro rectus space is probably the best place to put the these materials and when they compared them to a permanent material, the biologics just really underperformed if you look at that slide on the right. Um It is the graph on the right. Um The hernia recurrence was significant using the biologics um as was fluid collections, infections, um surgical site occurrences requiring a procedural intervention. So drainage is opening the wounds, that type of thing. But as you can also see or you can't see in this slide. But I can tell you that the um the synthetic materials also had issues because they had to be rinsed thoroughly with antibiotics. They had to be, many of a number of them had to be drained as well. Um And so uh it's it really shows that the biologics can be quite problematic in in the human body. And so the the expense that we're paying um is not necessarily worth what you're getting for them. So there are absorbable materials on the market. And uh you know, if there are a lot of reasons we'll get into why patients may not want a permanent mesh um in in their body and and contamination would be one of them. But again, we're not going to be talking about using any of these products for contamination. But um but a number of patients are concerned about the use of a permanent material from a lot of it's from the marketing from the lawyers. Um Some patients have had problems with permanent mesh in the past and now this they're having a recurrent operation. They may want to have the you know something that is absorbable. And so there are a few products on the market. Um This tiger matrix is one that I think is doesn't have much market penetration. Um It's got two different types of fibers in it. Um They some of the early data shows that even at 24 months those those long slowly absorbing fibers stick around and try to demonstrate that there is some in growth around it. Um Physics mesh is probably one of the more common absorbable products. Um It's made from a mono filament scaffold using um what's called poly four hydroxybutyrate or P. Four Hb. Which is actually an extract from a bacteria that is then problem arised and and turned into a um um a mesh appearing um product it's very flat and actually doesn't look like a mesh. Um And and I'm gonna go into some of the design of these core products and I can tell you that the Um the design of the of the material has a lot to do with its function. And so um this is more of a two dimensional material. Um and it takes about 18 months for it to fully re absorb. You can see here at a year, there's still products uh in an animal study. And um there is data out there. In fact I was part of the the study uh headed by dr scott Roth from Kentucky and um and you know so just just so you know I um have sort of something experience I've had with all these products. Um This study was looking at clean wounds but ones that were at high risk for problems. So diabetics, obese patients, smokers and um some of the early findings show that you know, we had Reasonable recurrence rate at 18 months. We had a 9% recurrence rate um with none of the products having to be removed. Um and again these products could be placed in a retro rectus or intra muscular position um as well as on top of the fashion. And and one of the first things we found again is that that retro muscular retro rectus position was really the sweet spot for where to put these things. So we had our best outcomes were in that retro rectus position. But as we continue to follow these patients out here is that three years we see that the recurrence rates close to 18%. And then as we followed them out for five years, the recurrence rate went all the way up to 22%. So Um as you continue to watch these patients even though the material is gone, um you could look at that and say, well 80% of them are 78% of them had a good good outcome, but 22% of them um ended up having a recurrence. So what is it about these uh from gore that that makes them different? Well, um most of us who most of us surgeons are aware of these absorbable sutures max on is one of the brands of absorbable suture. And that's the same polymer that's used in uh in the bio way and the in form and the cynic or um But there it's not just a woven sheet of absorbable suture. Um The pores are actually smaller uh pretty essentially small, small enough that you can't see them to the naked eye, but they're large enough to allow the the host tissue to grow into it. Um Including some of the most important healing cells, the white blood cells, macrophages, fibroblasts that are the ones that are gonna go in um Set up new blood vessels, set up new layers of collagen. Um And then the material absorbs in six months, which when you look at all the wound healing data is plenty of time for a full wound healing to happen. And so um I was able to um look at my own patients at our institution years ago uh and and sort of follow them out ironically similarly that 22 month was roughly the average follow up time I had on the in this study. And like some of the other studies when we compared the products that were placed in the retro rectus position with those that replaced intraperitoneal. We saw just a dramatic difference in the outcome uh in that retro rectus position, it's just sort of that's this a perfect spot to place them, but it's not zero. And the nice thing is when you have only four recurrences in a relatively short follow up, you have the opportunity to kind of go back and evaluate your own practice. And I can tell you that all four of these recurrences, we're not the fault of the product. Uh They were the fault of the surgeon. Um And well, you know, I'm able to learn as we go. Um And for the most part, these the recurrences were due to my failure to give adequate overlap of the material into the healthy tissue. Um Because of that, it's where the hernia meets the healthy tissue, where the some of the weakest spot is. And if you don't have good coverage of the material, you're going to get a recurrence. And that's what we found. I was able to just recently, um have some help in the summer and have some medical students reach out And contact all these patients in that original study. And um not all of them responded. But using Kaplan Meier estimates were able to sort of follow these out for now, we're looking at five years out. So, pretty substantial follow up in these patients. And you can see the results that down below there 12% at four years, 15% at five years. And uh with with an end of patients, like we had just one more recurrence makes it go from 15 to 18%. But um this is, you know, compared to some of those other studies I showed you pretty, pretty comparable or even a little bit better. And actually, if you look at this, is that Captain Meyer estimate. We had one patient go, you know, a couple of patients going all the way out almost 11 years. But when you when you look in the literature now, it's not completely fair to to compare one study to another because there are differences in studies. But when you look at the literature, looking at open hernia repairs with permanent mesh, you know, the concern I think that some people have is that if you're using an absorbable mesh when it goes away, isn't the hernia just gonna come back. Well, when you use a permanent mesh, The hernia can come back as well. So, um you know, you can see ranging anywhere from 13% in one study, all the way up 23-25% in other studies. So, um just because you're you're using a permanent mesh doesn't guarantee success in these hernias. Um these are tough patients with a lot of comorbidities. And unfortunately sometimes these hernias come back. Well let me give you a real world example of of of what's going on here with these patients. So this is a CT scan of a patient of mine who had um had rectal cancer and had a uh surgery to remove the rectal cancer. And to make sure that that went well. The colorectal surgeons gave the patient a temporary Ostuni to protect the anastomosis in the pelvis. Everything went well with that surgery. He's now a year or two out and unfortunately gets a hernia at the site where the austin he was. So you can see that hernia pretty clearly here, the intestines coming through the abdominal wall. So we took him to the operating room, repaired. This used this actually used in form one of the newer products uh newer than the bio a which I'll explain in a little bit here and here. You can see three months after surgery that hernia is repaired. Um You can kind of get an indication that there's the product is in that muscle but it's on the sort of the inside surface of the muscle. Um the hernias closed the patient's healing. But this wasn't just a regular C. T. This ends up actually being a pet ct. So those of, you don't know a pet scan is used in cancer to look for highly active metabolic organs. And and findings on CT scans because certain um organs are highly metabolic the brain, the heart because they're they're working all the time. But most of our organs and most of our tissues are not that active at rest. Cancer though can be cancer is constantly replicating. And so it's a it's a good way to look for cancer recurrence. So that's what they were looking for here. But what they found instead was the highly metabolic tissue was actually going on inside the end form. Um And so it wasn't just laying there passively as the patient was healing the body um had those healing cells in there um working hard to replace uh you know, replace active tissue collagen. And and that's what sort of the secret sauce of these products. The bio and the in form is that it really allows the host to go in there um and and lay down fresh tissue. Now the first question I think a lot of people have is, well, how do you know, it's not a cancer in the mesh. Um I can tell you that there have been follow up scans. Um This was actually a few years ago. The patient's doing well. Um This has cooled down and is the hernias still healed and is um it's not it's not a cancer recurrence So that I briefly touched on the bio a um that was the original product which is now over 10 years old and still a product on the shelf. But um there were some uh a lot of US surgeons had a couple little complaints about uh by the way, it's still a good product, but it's a little bit stiff. Um It's a little bit harder to use. A little bit non difficult to place down a trucker if you um if you're gonna end up using it laparoscopically. Um Again, it's just just to be clear. The end for material is is still being um cleared by the FDA for uh laproscopic use. But um the by way, it's very difficult to get down a trucker, but so they've re um redesigned it, same polymer, same pores, but just a different way of making it. That makes it a lot more soft and pliable and flexible. And when you look at it under an electron microscope, you can see the top slide here is the end for material. Um you can see the pores, you can see how the host can grow into it. The slide underneath is is one of the more common um porcine dermal matrix is or biologics on the market, so it's much more dense, much thicker. This is the same magnification with very few pores scattered throughout the um through the biologic When you implant it in an animal and look at the animal 30 days later, it's I hope it shows up on this on the on the broadcast. But there's a lot of little purple dots here in the material. So this material is uh is the is on this slide to your left with a lot of purple dots on the slide to the right. The material is the upper portion of that slide and the purple dots are just at the layer where the material meets the tissue. Um So the in growth that we're hoping to see in the in any of these products doesn't really happen in the biologic. And that's probably one of their biggest issues is that it's just very difficult for the host to grow into it. When you quantify that. Um Using various techniques, you can see that After 30, 90 and even 180 days, 180 days is when these the in form is essentially gone. There are a lot of fibrous tissue it left behind. And this the biologic on the bottom and the black doesn't really ever reach that that level of of in growth. So just to sort of sort of go over all these again, or to summarize the bio way is is excellent, has excellent tissue reinforcement with proven safety and the results are demonstrated by clinical data. The um and form really builds on the success of the bio way. It's um it's soft, it's strong, it's pliable and um and I think that's the end of my slides but I don't quite go into um, the hybrid material. But but essentially um there are reasons why some patients you may want to use this material and a permanent um and that would be the hybrid version called cynic or um but from as far as you know because that include allows a permanent material with this absorbable product which again has that um that tissue in growth and that um that really helps the healing process and and and basically heals the hernia. So again thank you for your attention. Thanks to gore for just letting me share some of our findings and turn it back over to chris. Thank you Dr Goldblatt if you can go to the next slide here. I really think presentation was fantastic and provided some of the key ins all this material because I think can help with that value equation of having quality outcomes while you're also reducing costs. And so I think that that really helped to demonstrate that to us and and certainly you know in no we believe some of these materials may be able to provide uh some of the facilities and your members um savings. So we really do appreciate shake your time here today. Dr Goldblatt a matter of fact when we move to next is are there any for dr Goldblatt and chris while those questions are rolling in I did want to mention to the group that you know really has been been great to work with on these types of products. And we've even had some of our our vision field staff that we're able to work with the gore field reps and you know work on their presentation their notes and kind of make sure that they could go out and really articulate the value and speak to it educational. Some of these guys just they cover so much it's hard to really be able to speak and articulate some of that value. So you know if you guys do have questions or need support, feel free to reach out to myself for a crest or even the gore team as well. Absolutely. Um Next slide uh Will will have it just for questions here. People may have for dr Goldblatt and and chris I did have a question. I know why why some of those other ones roll in for dr Goldblatt. So um dr Goldblatt. Is there a certain type of hernia where these products should be used? Or are you able to use kind of these for for every type of hernia? That's a great question. And um and I think you know I work closely with our supply chain at at Froedtert Hospital and um you know you know these are sort of um these are these are high end products and so it's there are it's not not needed probably in every patient. I mean you could use it in every patient but that may be a little more than most supply chains are willing to spend. So um you know there is there are patients that um if that that can have just a kind of a relatively inexpensive um piece of mesh off the shelf? And um and things will go well. The patients though that that have um a lot of healing issues are probably the ones that you want to stimulate that that that in growth that we saw in that pet scan. So um those are patients that are morbidly obese. Uh those are patients that are smokers, we know smoking um puts patients at a dramatically increased risk of wound healing problems. And hernia recurrence is um diabetics, particularly poorly controlled diabetics also have really bad wound healing uh issues. Anyone who's on steroids immuno suppression um you know a lot of the the new um I'm gonna use the term biologic but these are biologics for chronic inflammatory diseases. So like Crohn's disease psoriasis, they're they're very focused biologic but they still do immuno suppressed. So those we've seen um still give patients a um a wound healing issue. So um those are just some examples of patients where you're worried about wound healing and you'd want to use something that can stimulate that. The the other ones as I sort of alluded to in the talk are patients who have just problems with mesh um and you know the the power of marketing a lot of five years ago, if I mentioned the word mesh in a clinic, patients would just say sure now when I mentioned the word mesh they want to know is this being recalled? Is it is there a class action lawsuit? And um you know it there are some patients you just who just don't want to have a permanent piece of anything inside their body. And this is a great option for them. I can tell them that six months down the road, the absorbable suture that I use and the absorbable mesh that I use are going to be completely gone and there's a very good chance that you're going to have a well heeled hernia, Right? Yeah. No thanks for for going into that for me. I appreciate it. Do we have any other questions in the chat or or anything else? While we're while we're looking at that dr gold Gladys is you talked about by the way um inform and maybe cynic or are there specific procedures where you may choose one over the other? Yeah. Um and I didn't go into it on this on the slide deck, but um you know, so the the bio a um in all fairness to it, it's still a great product but um we we've essentially gone to end form just because it is just that much better um easier to use, easier to handle. Um But as far as when we would use an absorbable versus the the hybrid, um there are situations where we may not be able to get a wound closed or not get a wound closed but get the hernia defect closed. And um if you can't get the muscle back together again and you end up spanning that gap with fully absorbable tissue, even with all that in growth, ultimately, it's just not gonna be strong enough to support. Um And we call that a bridge. Um So I wouldn't I would not use the absorbable products, the fully absorb all products in a bridging situation. Um but in those situations that would be a great spot to use the hybrid product, because even though the absorbable component goes away, we're gonna get the permanent material still there to hold and hopefully hold forever. It's it's not ideal. But sometimes that's what we're left with. Um a lot of these hernias. Uh you know, the patients are not completely opposed to a fully absorbable or a permanent material. And so um that's when I'll use the cynic or um even if I can get everything closed, because it's it's sort of the best of both worlds. We've got that tissue in growth that that stimulated immune response and what's left behind is a very durable strong material. That's um that in theory should give them a better chance of of a durable hernia repair. Um And so that's when I use the cynic or thank you. Thank you. Do we have other questions? I can't see is there an increase? I do I see one here, it says it looks like somebody asked about the indications for the the end form in the bio way. Yeah. And I think um I mean essentially just just just sort of answered that to some degree. Um you know, the other issue is that, you know, even in clean wounds there's a risk of contamination. And um and what I mean by that is if the wound was to start to break down for various reasons and there's bacteria that live in our skin that we're able to get in well um it'd be nice to have a material that was resistant to infection. Um So even though it was used clinically in a class one, clean wound, the wound can become contaminated. So, examples for that. Again, some of those high, high risk patients, diabetics, smokers, the other ones are high, high risk wounds. And what comes to mind are um when you're fixing a hernia in combination with a plastic surgery procedure, like a particular ectomy. So very large incisions um Oftentimes the wounds can be a little bit of scheme IQ, because the plastic surgeons are trying to take as much tissue off as possible under a little bit of tension. And so um it's not uncommon to have a little bit of wound breakdown, nothing catastrophic, but a little bit of wound breakdown. And um we know even if you if we've placed this material properly so that it's buried within the muscle itself. So it should stay isolated. The the contamination and the open wound, there's the chance that that that could make its way to the material and if you've got a permanent material in there that now has skin bacteria crawling on it, it may you may not be able to clear that eventually. And so those are perfect situations where I'm going to use either the bio A or the end form because if the if what we've seen is that even if there is a little bit of wound breakdown, the material does not have to be removed, the wounds, the fascist still heels. So the hernia still heals well. Um and if the material is gone in six months you can't have a chronic infection if there's no material. So um that's a that's a great opportunity for these these products. If I can add to that in Corey and DR Goldblatt sometimes I think when people are looking for the indications the indication for these materials or the use in reinforcement of soft tissue and that can include um soft tissue for plastic and reconstructive surgery as it applies to the abdominal wall, they are not meant for use in breast cases, breast reconstruction. So if the if the question was asking about that, I want to be sure we do reinforce that to you at this point in time, it does not have that indication. Right? I'm looking at I don't see any other questions in the chat. Okay, well um if we want to move to the next slide then if there's no more questions, I just want to say again, Dr Goldblatt, thank you so very much for your time and expertise has been very insightful. Uh Corey, you and the visiting team done amazing job, employing everyone here together. Really. Do appreciate that as well as all the gore folks who have worked on this great job. There's anything that we can do to help here, please reach out to me. Um if you want to find the presentation, it's gonna be archive, here's the here's the information there. Of course you can go to the gore website at any time and look for product information or uh Has reached out to our 3rd party coding partner, revenue cycle coding strategies. They can help you with anything there. And Corey, I'm sorry, I wanted to get your information on here as well, but I must have missed that. So I know that you'd be more than happy to help folks reach out to us as well. Yeah, most certainly, and again, dr Goebel, I can't thank you enough for for joining us and impressed for putting this together. So um yeah, if anybody has any questions, feel free to reach out to myself, um and that's Corey dot gerard at vision, inc dot com. So again, really appreciate everybody's time and thanks everyone for joining us. You all have a great rest of your week, let us know how we can help