From Uncertainty to Clarity: How MIMOSA Could Help Clinicians Navigate CTP Regulations With Objective Imaging

Disclaimer: On December 24, 2025, CMS withdrew the final LCDs for certain skin substitutes. This content was created prior to that announcement and may reference policies that are no longer active. Much of the information remains applicable under other current or future regulations. Always consult your local MAC or payor policies for the most up-to-date guidance. 

1. Payer Policy Has Accelerated the Need for Objective Evidence - New and evolving policies around CTPs and advanced therapies have made quantitative assessment and documentation mandatory, not optional. Providers must clearly show why a therapy was chosen, how the patient qualified, and whether the treatment is working—using data that payers can trust. 
2. Imaging Transforms Both Clinical Decision-Making and Documentation - Point-of-care imaging provides objective insight below the surface of the skin, allowing clinicians to evaluate perfusion, tissue health, infection risk, and healing progress. When integrated into documentation workflows, this data creates a clear, defensible clinical narrative that is far more difficult for payers to challenge. 
3. Standardization and Longitudinal Tracking Are Critical - Consistent image capture and pixel-level analysis enable providers to: 

• Compare wounds over time accurately 
• Identify plateaus or lack of response early 
• Adjust treatment plans appropriately 

This level of standardization aligns clinical rigor with payer expectations and supports delivering the right treatment, to the right patient, at the right time. 

Please note: This content is a direct transcript, capturing the authentic conversation without edits. Some language may reflect the flow of live discussion rather than polished text.  

Chris Boodoo, MSc: 

My name's Chris Boodoo. I'm the Head of Clinical Affairs here at Mimosa Diagnostics. I have a Master of Science in health services research with a specialization in health economics and health informatics. 

Karen Cross, MD, PhD: 

I'm Karen Cross. I'm a plastic and reconstructive surgeon specializing in wound care. I'm a PhD scientist. In fact, (what) we're going to talk about today is my area of expertise. I'm also the CEO and co-founder of Mimosa Diagnostics. With the ruling, there's a lot of CTP uncertainty and there has been this whole year, the last 18 months. And it's how do technology companies like ours help with a lot of this uncertainty? Especially as we know that there is an increased requirement for documentation and assessment of these patients. We also need to increase how we qualify these patients and make sure we understand if this is a responder or non-responder to the therapy and frankly, choosing the right treatment for the patient at the right time. And so I think this ruling really represents what I would call a paradigm shift in wound care where assessment now is becoming extremely important. 

And that assessment can no longer be a visual assessment. It can't be we look at something and say, I think this is the next step in treatment. We need more quantitative and objective data to support why we're making the decisions we're making. And this is where imaging modalities like Mimosa are really at that right point or inflection point. And image, and again, I'll hand this over to Chris in a second, but the image is objective. It shows, especially on the mimosa side of that vascular assessment, so is there good periwound perfusion? Is there good wound perfusion? Is it an adequate wound bed for a placement of an advanced therapy like a cellular tissue product or other advanced therapies? It gives you that information at point of care. The reality is some of these technologies have actually been around for a long time. They've been around, but they've been in the basement of a hospital or they haven't really met the patient where they're being treated. 

They haven't met the clinician where the clinician is providing service. Technology also in wound care needs to be at point of care. It needs to be handheld and easy to use. And I guess the final thing I'll say about Mimosa is I'm a clinician and I never intended to come out and be a co-founder and a CEO. But what happened is I needed tech in my practice to help solve and treat the volume of patients that I was seeing. And that's how mammals evolved. It wasn't a widget looking for a home. It was really what's the problem that we're facing and building a clinician-centric solution. And so we're very customer-centric. And I'm not sure, Chris, if you have anything to add there, but ... 

Chris Boodoo, MSc: 

Again, within this context of uncertainty surrounding CTPs and then also helping providers navigate their treatment algorithms, we know that there is this growing emphasis on delivering high quality wound care supported by strong evidence and thorough documentation. So we know that providers are now expected to show that conservative treatments have failed justify when or why specific treatments are being used, determine when a patient is a true candidate for these treatments and ultimately demonstrating how that patient is responding over time. So to meet those expectations, there's technologies out there that provide tools that allow them or providers to readily assess vascular status and then track that longitudinally. When you compare that insight with additional healing metrics like percent area reduction, thermography's a surrogate for infection, they're now able to create this comprehensive overview of a patient's tissue health and then ultimately demonstrating a clearer and more defensible clinical narrative and one that is much harder to challenge by the payers. 

Karen Cross, MD, PhD: 

Putting it all together, it's around evidence. And the payer has said that they will no longer support what we're currently doing, therefore we need to elevate that level of evidence. And back to what Chris said, the imaging modalities are here. They're available. They're in a form factor that makes sense for the practice. And so adoption is necessary, but it's also occurring at a rapid rate. What companies like ours offer with more stringent regulations around documentation in this whole new world, which is not going backwards, it's only going to go forward. And companies like ours at Mimosa, what we're able to do and how we differentiate ourselves in the marketplace is by being an imaging modality and imaging modalities and that capacity to look below the surface of the skin and see what's happening to the physiology of our organs. So the skin is an organ. 

It is your first line of defense. Imaging modalities, unlike our own eyes, can see things that you can't see. In fact, they can see them ahead of what we see downstream. They can see if a patient will respond to a hyperbaric treatment or not. They can tell if the wound bed has been prepared adequately for an advanced cellular tissue product or other energy treatments, et cetera. We can look at the efficacy of that treatment and see if that patient is plateaued. The imaging modalities have the capacity to not just qualify that patient and help you determine if this is the right next step, but also follow the progress because it's not just that initial qualifying the patient for the therapy and making sure you're justifying why you're doing what you're doing. It's also tracking the patient over time to make sure that this treatment is actually efficacious over the period or the healing trajectory. 

That is also the first time with respect to these technologies that we can take the same image each time. This is also important for the payer, which we call standard image capture. If you have a one orientation on Monday and a different orientation on Tuesday, or it's too close or too far, that also does not sit well with them. You can't analyze pixel by pixel. Mimosa, in our competitive advantage, is the only technology that can analyze pixel by pixel. And Chris, as the health economist and who really runs the clinical affairs division, can talk through how that ruling really sets a stage for Mimosa. 

Chris Boodoo, MSc: 

Within this context, again, there's this increased documentation requirement, and ultimately it's trying to demonstrate to the payers that a lot of the providers who are practicing wound care are taking that clinical rigor to ensure that they're doing right by that patient. But now it's trying to document that clinical rigor in a way that's understandable by the payer, but also meets their requirements. And ultimately, when you have assessments that also lend itself well to a documentation system or platform, you are now supporting care teams from assessment all the way through documentation. So again, I've talked about this defensible clinical narrative. A lot of the providers already do that, but having information and data and imaging to further substantiate that and have it presentable and ultimately show that there is healing that we're seeing, we are using the right treatments and modalities to heal that wound. And ultimately, we are taking the context of that patient into account when we make these decisions, having it all documented within one platform and also be able to fit within their workflow. 

Everyone's super busy, but when you're able to have this four-on-one modality that captures all the information that you need to make good decisions, as well as having it in your backend, we will see wound care become elevated and we will see, again, patients being treated with the right treatment at the right time. 

Karen Cross, MD, PhD: 

I think just, I guess to round it out, what's happening in this sector, and although we're talking about cellular tissue products, we need multiple modalities to treat a patient. So there's multiple advanced products that we're using depending on what that patient needs in that moment. This ruling really represents what's happening overall at a global level in wound care where assessment tools, but not just the charting data. It is imaging, other modalities, the laboratory tests that are going to be part of that data and information that we put into the context of the patient of how we make good clinical decisions. When we think of medicine and we think that the skin is an organ, this is the only organ that does not have an imaging modality or a way to really look below the surface to see what's happening. Imaging modalities enable us to do that. 

What I would say as a clinician, I would never say," I'm taking you to the operating room and I'm going to treat your hand fracture and I've never taken an x-ray. "I don't look at someone and say," I'm going to perform an operation. I do multiple tests prior to making a decision, and this is the last sort of standoff in medicine where we can add these modalities. It's about elevating the level of care. And the pair has just said, this is no longer acceptable. We need other ways to determine what we do next. "And so I see this as a real opportunity for this sector where we can elevate how we see these patients. People can start to look at us as advanced tissue specialists. We are taking care of the sickest people and patients in the hospital. This is a specialty in itself, and data and evidence really turn it into what I perceive, or at least we perceive as that opportunity to really become a true specialty, because a true specialty is based on evidence. 

Chris Boodoo, MSc: 

I was thinking about, again, the role of vascular assessment in the world before this new policy where workflow-wise, it was almost sometimes not possible to get that vascular assessment if you're doing a referral to a vast lab and we know that there is a lot more mobile wound care providers who need this information to make good decisions. And then within this new policy, we're seeing that definition of vascular assessment changed to now put it back onto the provider to decide what they think is that right vascular assessment modality or tool to determine that vascular status for that patient, but also recontextualizing that vascular status doesn't just mean ABI. It's really looking at the microcirculation, the tissue, how much blood flow is there in that tissue, but then with that new context, what tools exist that gives us that point of care instantaneous insight into that tissue vascularization or vascular health of that tissue? 

So I think within this new policy, we've been able to empower providers to make the decisions that align with their expectations for how they've measure vascular status, vascular health. 

Mr. Boodoo is the Head of Clinical Affairs at Mimosa Diagnostics and Dr. Cross is the CEO and co-founder.