At three medical conferences throughout April, Integra LifeSciences Holdings Corporation presented new real-world data on its PriMatrix Dermal Scaffold, analyzing 985 cases involving 117 surgeons, highlighting the use of PriMatrix.
PriMatrix is a fetal bovine dermal matrix that can be used across a broad range of wound types, including surgical, traumatic and chronic ulcers, as well as complex wounds with tunneling and undermining features.
In addition, a 23-patient case series outlines clinical experience with PriMatrix in support of wound bed readiness in burn injuries, including patients with significant comorbidities.
Ray Turner, Chief Medical Officer at Integra Lifesciences, connected with
MD+DI
to discuss what makes PriMatrix different from other market offerings and how it fits into the broader wound care space.
Can you explain what makes fetal bovine dermal matrix different from other dermal scaffolds on the market?
Turner:
It's not cross-linked, so it stays more biologically active. It's easier for the body to remodel it, which is one big difference. Its tissue handling properties are really nice. Because you can stretch and pull it in different manners because of the way it's scaffolded, it can lay down nicely in very complex and irregularly shaped wounds. Irregularly shaped from both a shape and a depth standpoint. If you have valleys and crevices in the wound itself. In these kinds of harsh environments, it lays down really nicely in there. It's also super rich in fetal collagen, so from that standpoint, it promotes cell migration and speeds up the healing process and granulation tissue formation inside a wound. That really helps with getting back to your regenerative healing pathway, especially with a chronic wound that has not been healing. This kind of nudges it into the right direction. From pre-clinical studies, we know it supports a lot of new blood vessels growing in the area of the wound. If you don’t have good blood vessel growth into a wound, whether its chronic or acute, that wound just won’t heal. This is why people who are smokers or have diabetes and have poor blood vessel growth, if they get a wound it doesn't want to heal and it creates a chronic problem. We get really good vascularization into these wounds, binding growth factors and adding cellular attachments so you can get tissue remodeling and regrowth in the healing process. All of those things, from its ease of use to revascularization and how it suppose the in-growth of the tissue, that’s what really sets it apart from others.
The data covers diabetic foot ulcers, burns, and complex wounds—are there specific wound types where PriMatrix performs exceptionally well?
Turner:
We have really good data with diabetic foot ulcers and complex wounds in both clinical studies and real-world evidence. Back in 2021, we did a randomized trial of 200+ patients with PriMatrix with diabetic foot ulcers, and we saw healing in 60% of patients versus 30% standard of care. We have done other follow up studies on that. Anytime you are dealing with complex wounds, chronic wounds, burns, diabetic foot ulcers, or people that have a poor substrate for healing in general, that's where these things will really have an impact on patient care and improve healing.
How does PriMatrix fit into the broader wound care treatment algorithm, and when should clinicians consider using it?
Turner:
What's great about it is its versatility across a wide range of wound types. Not just diabetic foot ulcers, but burns as well, and chronic and complex wounds. If you also think about location, if you have a problem with healing on your calf or your forearm, that's very different than an elbow or knee wound. It's really good for a broad range of anatomies and locations where you might have a lot of movement from different forces. That's a big part of the opportunity to help patients get better and heal with PriMatrix. Healthcare providers right now, there are so many constraints thrown at them in terms of time, staffing, costs of the materials they are using, on top of all of these patient comorbidities. And that is where our portfolio, PriMatrix in particular, gives a lot of solutions to these problems. It can cover a large range of surface areas, and can stretch. We can place it in deeper wounds and more shallow wounds where there are irregularities. It really works well in difficult-to-heal lower extremity wounds like what we see in diabetic foot ulcers. With mechanically challenging areas like ankles and knees and the bottom of the foot, because of its scaffolding design, as you are moving, that material is not going to slide on the surface of the wound, it is going to stay in place. So it resists the desire to shift and move around. Whenever you have that material sliding and moving, you are not going to get good healing. We need it to get in place and stay in place, despite the fact that you might be moving the joint. PriMatrix works really well with that. I think the time is also important in how fast it can build that granulation tissue and get ready, if it's a complex wound, for that next stage of healing it needs to be in.
How is Integra Lifesciences positioning itself in the competitive wound care and regenerative medicine market?
Turner:
I think in terms of life sciences, we are able to address all circumstances and stages of wound healing. For us to be able to offer a healthcare provider a whole portfolio across a spectrum of problems they will have to fix is incredibly important to us. We want to offer patient solutions that are tailored to the problem the patient has, and are not going to be trying to make something work when it’s not ideally suited to them. Our portfolio is comprehensive enough that we can provide tailored solutions for each type of problem clinicians may encounter, and we have been doing that for decades. Ever since we came out with the Integra Dermal Regeneration Template 30+ years ago. We have been leaders in this space in helping surgeons find solutions to their problems for nearly three decades now. We have the only dermal matrix approved by FDA– it has been approved since 1996 for third-degree burns and regenerating dermis. Overall, our portfolio in wound reconstruction is backed by clinical evidence, supported by science, and by surgeons who like that we can offer tailored solutions for any problem and we have been doing it for a long time.
Beyond PriMatrix, what innovations are you most excited about in Integra Lifescience’s wound reconstruction portfolio?
Turner:
When we look at this across the entire portfolio, we want to leverage different platforms we offer to continue to restore patient’s lives and meet the needs of patients and the problems they are experiencing. We are looking at extending the portfolio, and expanding the science, to support additional randomized trials, as well as real-world evidence. The other thing we are excited about is expanding indications of surgical meshes. We are looking at being first to secure PMA approval for surgical meshes to be used in breast reconstruction. We are taking our portfolio and proving the science out in new and innovative ways that are going to help patients and solve their problems.
Is there anything else you would like to expand on?
Turner:
What I would love to stress is, we are deliberately aligning our business to make sure we are bringing innovations that are accessible to everyone, aligning with recent CMS changes, to meet the needs of patients and surgeons. If you look across our entire Integra Lifesciences portfolio, we have cost efficient and clinically appropriate options across the entire continuum of care, both inpatient and outpatient, as well as covering the breadth of problems we are trying to solve, whether its complex wounds, burns, difficult healing wounds, diabetic foot ulcers, in each of the stages of those procedures and when care needs to be provided, whether it’s early in the treatment of something or in later stages. It is all backed by science, clinical evidence, and strong data. We are excited to bring these solutions to our surgeons, and to our patients, so they can be taken care of. That is our journey; helping to restore patient’s lives.