Clinical Experience and Emerging Evidence with AmchoPlast® dHAICM in Soft Tissue Reconstruction and Chronic Wound Management

Dr. Thomas Davenport and Dr. Peter Moyer will present their clinical experience utilizing AmchoPlastTM, a sterile dehydrated human amnion intermediate layer chorion membrane allograft (dHAICM), in soft tissue reconstruction and the management of chronic wounds. This session will begin with an overview of Cellution Biologics and the scientific rationale for amniotic tissue use, followed by a detailed discussion of the tri-layer structure, including its key growth factors and associated clinical benefits. The presenters will also review interim results from a randomized controlled trial, highlighting emerging evidence supporting AmchoPlast®, and conclude with real-world case presentations demonstrating practical application and outcomes in complex wound care settings.

Transcript

John Werner:
Hi, my name is John Werner. I’m the Vice President of Solution Biologics, and it’s my pleasure today to be with two doctors who will share their experience with AmcoPlast, our amnion-chorion placental tissue.

Today, we’ll be discussing clinical experience and emerging evidence with AmcoPlast in soft tissue reconstruction and chronic wound management with Dr. Thomas Davenport and Dr. Peter Moyer.

Dr. Thomas Davenport is a board-certified plastic surgeon and partner at New York Plastic Surgical Group, a division of Long Island Plastic Surgical Group, since 2006. Dr. Davenport received his Bachelor of Science degree from Iona College and his medical doctorate from Yale University. After completing his residency in general surgery and fellowship in plastic surgery in the Harvard University program at Massachusetts General Hospital, Dr. Davenport pursued specialty training in cancer reconstruction and cosmetic surgery as a fellow at Memorial Sloan Kettering Cancer Center in New York City. During that time, Dr. Davenport was awarded the prestigious Webster Fellowship in Pediatric Plastic Surgery. He completed his training with an additional fellowship in burn and accident reconstruction for children. Since 2014, Dr. Davenport has consistently been named a Castle Connolly Top Doctor and has been featured multiple times as a Top Doctor in New York Magazine and Newsday.

Dr. Peter Moyer is a board-certified podiatrist and fellow of the American College of Foot and Ankle Surgeons, practicing at Purvis Moyer Foot & Ankle Surgery Center in Rocky Mount, North Carolina. With extensive experience serving the region since completing his residency, Dr. Moyer specializes in diabetic limb salvage, reconstructive foot and ankle surgery, sports medicine, and treating both pediatric and adult foot and ankle disorders. Dr. Moyer is recognized for his clinical expertise in managing complex wound care cases and preventing lower-extremity amputations, combining advanced surgical techniques with comprehensive patient-centered care. He is an active member of the American Academy of Podiatric Wound Care Association, reflecting his commitment to advancing outcomes in wound care and limb preservation.

Thank you, doctors.

Solution Biologics is relatively new to the U.S. market. We’ve been here for four years; however, we’re backed internationally by a company with 20 years of experience. In a nutshell, I’d say that we’re very good at processing human tissue. We offer placental grafts that are of the highest quality, and we’re also a value-based partner with providers to help you treat the patients you serve.

Our advantage is that we have a nearly unlimited supply of placental tissue. Again, we’re very meticulous with the way we process the tissue to preserve the inherent regenerative capabilities. We believe completely in harnessing the power of nature and the amazing things that cell- and tissue-based grafts can provide.

With that, I’d like to hand it over to Dr. Davenport.

Dr. Thomas Davenport:
Thank you. I’m going to give a little background first on AmcoPlast and how it’s made.

AmcoPlast is a full-thickness membrane. The membrane contains the amnion, the intermediate layer, and the chorion. When you’re looking at amnion-chorion products, there’s a breakdown of the amnion, the chorion, and some contain the intermediate layer while some do not. What’s interesting about AmcoPlast is that it is a full-thickness product. This gives you the benefits of the amnion, the chorion, and the intermediate layer. It’s a thick, very substantial graft, and that’s really one of its differentiating factors.

There is a known presence of growth factors and cytokines. I’ll talk about this in a minute, but what we’re looking at is that the product itself is differentiated as a tissue product based on its processing. You want processing that retains the growth factors, retains the structures, and retains as many of the proteins as possible as a transplanted tissue.

We have numerous tests for growth factors and cytokines: growth factors for proliferative capabilities and cytokines for anti-inflammatory capabilities. This is not truly part of its transplanted nature in terms of being a transplanted tissue, but all of these are retained and do have biological activity.

The name of the processing process is the Agnes process. It’s designed to maintain all of these components: the growth factors, the cytokines, proteoglycans, and collagen in its primary natural form. As a product, one of the other important factors is not only that it maintains these factors, which allows for better incorporation and better biological activity, but also that it comes in sizes that aid the physician in matching the size and shape of the defect. This allows us to use the product from a practical perspective.

To summarize, we have enhanced preservation secondary to its processing and the three-layer composition, which we’ve looked at and found to really fit a lot of both the biological and structural needs of the product. It’s minimally manipulated and aseptically processed, as all tissue-bank processes are, and it’s designed for clinical versatility in these cases.

It has clinical use and applications in chronic wounds, surgical reconstruction, and traumatic wounds. These are wounds that have stalled, or wounds that need additional growth factors, or where you need the product to work as a biological barrier. I’m going to talk about these properties in a second.

As a 361 tissue product, it’s tested for diseases as part of the protocol for tissue banking. This falls under the same characteristics that all tissue banks do.

Again, in summary, we have the biological advantage of its processing, the quality of the tissue bank and its certifications, and the ability to harness the power of nature. This is not a collagen product made in a laboratory; this is native tissue, which has all the advantages of being a tissue-bank product.

I’m going to present a few cases and discuss my approach to these kinds of products. I’m a plastic surgeon, so I’m going to talk about skin substitutes and how I use them.

We always talk about classification. What classifies a skin substitute is important, but how to classify a skin substitute and why I use one skin substitute over another can be complicated. There are a lot on the market: synthetics, biologics, collagen products, and others. How do I choose one over the many different products on the market?

I do it a different way. We’re not going to talk about what a skin substitute is clinically. I don’t think that’s important here. How do you classify a skin substitute? Not important for this discussion. What matters to me is what the patient needs, what my clinical scenario is, and what I use to approach that particular clinical scenario. That’s what we’re going to talk about.

I want to give my skin substitute philosophy disclaimer: this is my approach. Many people have different approaches, and many different approaches can be successful. I’m going to talk about skin substitute types from a 30,000-foot view. That means I’m going to talk about the general uses and the most general approach to what I need in the application for that particular patient, and then how I choose that skin substitute and why AmcoPlast is interesting because it fits many of these different categories.

My first differentiator is live skin versus everything else. I’m a plastic surgeon. We skin graft; that’s what we do. My first decision is skin graft versus non-skin graft. Skin grafts have been around for many years, and to be honest, placental tissue being used as a skin substitute has also been around for many years.

This is the way I classify it. First, I want to create a barrier. These are situations where the skin has a full-thickness defect, and I just want to create a biological barrier. I don’t want what’s underneath to get infected, exposed, or desiccated.

Next, I want to help the wound heal. That means I’m looking for biological activity. The wound is stalled in the inflammatory phase or stalled in the proliferative phase, and I want to get it out of that phase and assist healing. That’s what we use a lot of biologics for, including diabetic foot ulcers, venous stasis ulcers, and other wounds.

My approach as a plastic surgeon is that many times I want a combination. I want to create a neodermis. I want to put a skin graft on or I want to heal the wound, and I need to create a dermis. I need to create a base in order to put on a skin graft or do something else. A combination of the above is really the most common use as a plastic surgeon when I’m looking at a wound and need to address the next stage.

Here’s a quick example. We have a full-thickness defect of the foot, with exposed tendon and exposed nerves. What I want to do is create a neodermis, and I use a skin substitute. This is one of the most basic needs I come across as a plastic surgeon.

This is how I used AmcoPlast in this case. This patient had a Mohs defect with exposed cartilage. I would love to skin graft this and put a skin graft on. There are a couple of reasons why I don’t do that immediately. First, there would be a defect, meaning a dip and a cosmetic issue, if I just put a skin graft on. I want to create something thicker because the skin of the nose is thicker than my skin graft. At the same time, I can’t put a skin graft on because the cartilage doesn’t have a blood supply. I would be putting the skin graft on something with no blood supply.

In this case, I put on AmcoPlast. It creates a barrier because I don’t want the cartilage to get infected. It creates a neodermis. Then I put on the skin graft, and you can see on the right that it looks great, with a good color match and a great result.

This next example is something I see more often. There’s no exposed bone, and I don’t need a neodermis. This is one of the most common uses for diabetic foot ulcers, venous stasis ulcers, and similar wounds. What I want to do is utilize biological activity and barrier function.

This patient had this wound for about six months. She was at her wit’s end. This is after just two treatments with AmcoPlast. What I’m doing is using its barrier function and biological activity to heal what I consider to be a pyoderma lesion.

I want to note that I’m going to use a lot of cases coming up where I’ve used AmcoPlast. To use skin substitutes, you also need to understand reimbursement in your area and the patient’s insurance. These issues become very important because you want to use these grafts responsibly. In many of these situations, I have an understanding of that and have made all the arrangements to have that taken care of.

This is a patient who came to me after resection of a skin cancer. A lot of these cases are going to be me showing different cases and how I use AmcoPlast because of its nature. It’s thick, it revascularizes, and I can use it as a barrier and neodermis in these cases.

Here, the anterior margin was positive. This looks like something that might be pretty easy on the left. In the middle picture, we see that I had to resect a lot more. I couldn’t get it closed, so I put in AmcoPlast to act as a barrier. It protects the skull and creates a neodermis that allows me to put a skin graft on something that I otherwise could not have skin grafted.

I’m using both serial closure and AmcoPlast. In the middle picture, I put a skin graft on the area, and on the right, that area is completely healed. This could have been something that required a free flap, which is a 12-hour, very complex operation. I was able to salvage that using AmcoPlast and a skin graft.

This is a similar picture. This patient had exposed skull, and I couldn’t skin graft it. I used serial closure and AmcoPlast because I needed to create a barrier to protect the bone and also create a neodermis. Here, I did a serial closure and put on AmcoPlast. The graft was able to provide barrier function for the bone and create a neodermis. You can see that it’s starting to look a little more red. I did another graft. In this case, I actually got a little too aggressive with my serial closure and lost some skin. It didn’t matter because I could salvage it with AmcoPlast. You can see it looks a little bigger because I lost some skin, but I was able to salvage it with one more serial closure. I was able to close this without a skin graft using serial AmcoPlast and serial closure.

Again, the alternative, if this didn’t work, would be a 12-hour free flap. The reason I choose AmcoPlast is that it’s a tri-layer product. It’s very robust, it has strong biological activity, it serves as a barrier, it incorporates very well, and it saves me a lot of larger, more complex operations in these cases.

John Werner:
Excellent. Thank you. Dr. Davenport, those are some great cases. Those scalp cases are not easy from what I’ve heard from the plastic surgery field, so it’s nice to get that barrier and that neodermis. I think that’s really important and gives you something to work with.

Dr. Thomas Davenport:
What’s interesting is that years ago, these patients normally would have gone to the operating room for a very long surgery—either a flap or a very large skin graft. These patients are treated as outpatients.

John Werner:
And then you would have a second surgical site to deal with.

Dr. Thomas Davenport:
Correct.

Dr. Peter Moyer:
I’m here to discuss the clinical trials that we started roughly 12 months ago on AmcoPlast and diabetic foot infections.

We started a study, the ELITE study. I think we started it back in 2025. The goal of the study was to show that AmcoPlast would be very helpful in healing complex chronic diabetic foot wounds. We wanted to enroll 120 subjects across 20 centers, so we would have a good diverse area with different demographics.

My area is one of the more challenging demographics. Being in eastern Carolina, it’s a very uneducated area, and healthcare is tough. We have patients come 50 miles to get good healthcare.

One of the key things we wanted to look at in this study was AmcoPlast versus standard of care, which is typical in clinical trials. We also wanted to look at quality of life. I think one thing we’ve noticed in some of these studies is that patients either have dealt with their wounds for so long that they’re just used to it and it really doesn’t affect them, or it bothers them a lot. It’s one end of the spectrum or the other. That’s really what we’ve seen with this study.

We wanted to include some of the more complex patients. They were allowed to smoke, and their A1C just had to be less than 11. That almost included everyone. If they had multiple ulcers, we just needed one target ulcer. Obviously, they also have neuropathy, so they’re very hard to heal. They don’t realize they’re on their foot nearly as much as they are.

These are very complex patients. When I first started this study, I had some really good cases that we’re going to show you, because this made me a true believer in how well this product works. As Dr. Davenport was saying, durability is really important with plantar ulcers.

Through the study, we saw a 78% reduction in wound size compared with 37% for standard of care. We had really good results, and I think it’s pretty much industry standard. We had a 70% healing rate compared with 30% for standard of care. This data is still being compiled as we are ending the trial currently, but we hope to see the numbers hit all the benchmarks we’re looking at.

I’ll move to my first case. This patient came to me from a wound care center, where you would think she should be getting great care. She also saw another podiatrist during the year. She had had this wound for two years, so I said, “Let’s see what we can do here.”

We enrolled her in the study and did proper offloading. She had had some offloading when we started, but we put her in a nice offloading boot and went from there.

Her past medical history includes diabetes, asthma, bladder issues, and several surgeries. She is not the healthiest person. She takes 28 medications, so she has a lot of comorbidities.

One of the things I like to do is clean the wounds really well. I use a sonic device to help clean the wounds and get rid of the biofilm so we have a good wound base to put the grafting material on. That’s what we did.

Her starting wound size was 3.8 cm², and she had had this wound for more than two years. You can see the first application on the left. With this patient, and I’ve done this with a lot of my grafting patients, I used a foam structure to help offload the wound because they’re not always wearing the boot or surgical shoe. I’ve learned to design an offloading dressing as best I can within a private office. You don’t have as many resources because you have to pay for all your dressings.

We had foam dressings that allowed her to stay off the wound, and the foam dressings also absorbed a lot of the exudate and kept it off the wound. It was not gauze on the wound, which can cause some inflammation. I think that’s part of why we had success. You add all those things in when using these products.

Over time, you can see we had a good reduction in wound size after each application. We had a big jump from 5% to 52%. Once those biologics start changing the wound, because of the durability of the graft, we start changing the integrity of it. We get some angiogenesis, and we can really start to get the wound to heal.

As we continued, we got down to an 86% reduction. We just kept going until complete closure. I’m still seeing her, and she is still completely healed. One year later, she remains healed from a wound that she had for two years.

Case number two is another patient of mine. He was at the wound care center and saw another podiatrist. He had had these wounds for about 18 months. When you see the pictures, you can clearly see he had many issues. He had infections and amputations everywhere, so this was not his first rodeo. He had high blood pressure and kidney disease, and he had several foot surgeries over time. He had a good-sized wound.

Again, we started using the foam. This is where we started. We had a little bit of a relapse because he was on it a little bit, so the size went up. But once we started to get the biologics corrected, we started forming all these little tissue islands, and then it really started to take off. We saw a good reduction in wound size over the 10- to 12-week treatment course and got the patient to heal completely.

Through this study, I really feel that because of the integrity of the product, the structure of the product, and the fact that it is a tri-layer product, it has helped provide durability on the plantar aspect of the foot.

John Werner:
Thank you very much, both of you. It was really enlightening, and I learned a lot. I think we have a few minutes left, so if you don’t mind, I’d like to ask a couple of questions.

Dr. Thomas Davenport:
Sure.

Dr. Peter Moyer:
Absolutely.

John Werner:
Great. Dr. Davenport, you’ve had experience with a range of advanced wound care products. Can you share what specifically drives your preference for AmcoPlast over traditional collagen-based alternatives in your practice?

Dr. Thomas Davenport:
Sure. Like I mentioned in my talk, what I’m looking for is a particular answer to a problem, or an application that fits the problem. I always fit the product to the need.

What’s interesting about AmcoPlast is that a lot of the collagens we use don’t have biological activity, so you’re just using them as scaffolds. With AmcoPlast, it bridges both needs. I have a need for biological activity because I want it to vascularize quickly. At the same time, I need substance and something robust because I want it to be a scaffold and create a neodermis with thickness, since I need to put on a skin graft.

What’s interesting about using AmcoPlast as a biologic and as a skin substitute or neodermis is that, usually, you get one or the other. AmcoPlast provides the barrier, something thick and robust enough to create a neodermis, and the biological activity that adds to rapid neovascularization. I’m able to put the skin graft on a week or two sooner rather than having to wait three or four weeks for it to get vascularized enough for me to put a skin graft on.

John Werner:
Thank you. How many days after you applied it did you see granulation tissue, especially in those skull cases? Did you do any drilling into the bone, or did you just let the product do what it does?

Dr. Thomas Davenport:
That’s a brilliant question, Peter. I wish I had mentioned it. Peter is 100% right that most of the time I have to go to the operating room, take a pineapple burr, and burr down the bone to punctate bleeding. That allows me to get vascularization of one of my skin substitutes.

What is really interesting is that, and it might just be a function of the fact that I’m doing a small area, I did not do any drilling and I did not do any burring for these grafts to take, which is unusual. I attribute that to the fact that it has biological activity. Even with the most minimal vascularization from the sides, it is able to vascularize and get the tissue enough. Some of these I did two and a half to three weeks out, and that’s pretty rare. Normally, I wait three or four weeks.

Dr. Peter Moyer:
So you’re seeing granulation tissue on bone or over bone within a few weeks?

Dr. Thomas Davenport:
I start seeing some granulation tissue, even on the periphery, in about a week.

Dr. Peter Moyer:
That’s fantastic.

Dr. Thomas Davenport:
And it saves a trip to the operating room.

Dr. Peter Moyer:
And they’re happy.

John Werner:
Dr. Moyer, from a procedural standpoint, how would you describe the handling characteristics of AmcoPlast compared with other amniotic grafts you’ve used, particularly in terms of ease of application and consistency?

Dr. Peter Moyer:
Through the RCT, we were able to use it many times, over and over again. It is very consistent. The durability is good. It is easy to put Steri-Strips on it. It didn’t dissolve into the wound like a piece of tissue the way some do. With some of them, you touch it and have to be careful, because when you touch it again it might come with your finger and go onto the floor. Some are so fragile and just crumble. The durability, I think, is all about the Agnes processing. I’m a big person on tissue processing. I think that is the number-one thing that makes these products work or not work.

John Werner:
Excellent. Dr. Davenport, processing and sterilization can significantly impact both safety and clinical performance. How important are these factors, along with certifications, when you’re selecting a graft, and how does AmcoPlast meet those expectations?

Dr. Thomas Davenport:
That’s a good question because there are a lot of different placental products on the market. I think what you want to look for is that it’s marketed specifically as a barrier, but I also appreciate the biological activity as a clinician.

One of the things I’m looking for is as much biological activity as possible for that particular need. For the pyoderma patient, I needed cytokine activity. For my neodermis patients, I wanted proliferative activity.

The other thing is that when you have a very high level of sterilization and processing, which I know Solution Biologics does, you want that extra trust to know that what you’re putting on is safe and as sterile as possible, and also as minimally processed as possible to maintain as much biological activity as possible.

John Werner:
Thank you. Last question, Dr. Moyer. Beyond open wound care, where else have you seen, or do you see, a potential role for AmcoPlast in your practice, such as soft tissue reconstruction or other indications?

Dr. Peter Moyer:
That’s a great question. As our population is getting older, their skin is getting thinner, but they’re still young at heart and still active. I’ve used it a lot more in elective surgeries. There have been many times when I’ve used AmcoPlast surgically when I’m closing.

When you do the foot, you can have five incisions pretty close to each other. I will take pieces of it, put it underneath all my incisions, and close onto it. Knock on wood, when I’m nervous about wound dehiscence, I don’t get it, so I’ve been happy with that.

I had one just a few weeks ago, and he was kind of a friend of mine. He wanted to get back to golfing. He was going to go to Pinehurst, of course, and go golfing. I put a piece in there postoperatively. His skin healed very well within two weeks, with no inflammation and no pain. I think he goes in two weeks to play Pinehurst, so I think that helped a lot.

I don’t do a ton of skin flaps, but definitely putting it under any flaps or closures—diabetics, smokers—I think it adds extra nutrients and scaffolding to the wound bed and incision closure.

John Werner:
Wonderful. Doctors, thank you so much for your time and for sharing your experience with AmcoPlast. We really appreciate it. On behalf of Solution Biologics, we appreciate all you’ve done for us, and we invite the rest of the audience to consider using AmcoPlast. Thank you.