President and CEO of CytexOrtho

CytexOrtho is based in Durham, North Carolina. We founded CytexOrtho to tackle one of the world’s most pervasive and disabling conditions: osteoarthritis. As this audience well knows, osteoarthritis affects nearly one in thirteen people globally, so it’s a big problem. Once patients reach the end stage, joint replacement becomes the only option. That’s ok if you’re sedentary but not ok if you’re 45 and are still active.

Typically, we like to think of osteoarthritis as a disease of the elderly, but the fact is that more than half of those affected are under the age of 65, and they have no good options. They’re caught in limbo, too young for a total joint replacement, yet in too much pain to live normally. Many of these patients end up managing chronic pain for eight or more years before finally undergoing replacement surgery. They deserve better options. At CytexOrtho, our mission from the very beginning has been simple yet bold: we want to preserve and restore the joint, not replace it. To this end, we’re developing regenerative implants that restore the natural structure and function of the joint.

Can you give us a brief overview of your research?
Our research centers on three-dimensional orthogonal weaving, which can be a little hard to picture at first. In essence, we’re weaving fibers in three directions: X, Y, and Z. We didn’t invent 3D weaving, but we applied it to one of the toughest problems in orthopaedics: restoring large areas of diseased cartilage caused by osteoarthritis.

In early work published in Nature Materials, my co-founders Dr. Farshid Guilak and Dr. Frank Moutos showed that by carefully selecting the right fibers (or yarns) and tuning the spacing on each axis, they could engineer a textile that replicates the unique mechanical properties of cartilage, while still remaining porous enough for cells to infiltrate, differentiate, and generate their own extracellular matrix. The result is a highly tunable, biomimetic scaffold that bridges the gap between engineering and biology.

Another hallmark of this woven architecture is its ability to be contoured into complex shapes without kinking, folding, or stacking multiple layers together. This allows us to easily form anatomically relevant geometries – whether it’s a femoral head, acetabulum, or femoral condyle – while maintaining both mechanical integrity and through-porosity. These two features are essential to the performance and success of our implants.

We’ve since combined this woven scaffold with an additively manufactured support structure using an advanced FDM-type printing process we call Tru3D printing. Unlike conventional 3D printing that stacks flat layers, we can print in continuous contours – moving the print head dynamically in all three axes as we build. That lets us precisely recapitulate the healthy anatomy of a patient’s joint and produce implants that restore natural geometry and function from day one.

Where are you now?
After years of bench testing, preclinical studies, and all the biocompatibility work that goes into proving safety, we’ve finally reached a major milestone: our first clinical trial.

We now have an FDA-approved IDE study for our ReNew™ Hip implant in the hip preservation space. The study is cleared for two clinical sites and up to fifteen patients. Our first site, Washington University in St. Louis, is led by Dr. Jeff Nepple and Dr. John Clohisy – two of the best in the field. We expect to enroll our first patient soon, and it’s an incredible feeling to see all those years of work coming to life.

The focus of this first trial is on younger, active patients – those caught in that “too young for replacement” gap. For us, this isn’t just a regulatory milestone; it’s the start of translating everything we’ve been building in the lab into something that can actually help people.

We’re also in discussions with a second site that we hope to bring online soon. Once both are up and running, we’ll be able to gather early clinical data to help us refine the technology, improve outcomes, and continue expanding to other joints over time.

It’s been a long road getting here, but reaching the clinic is a huge step toward achieving what we’ve always aimed for – moving regenerative orthopaedics from concept to reality.

How did you get involved in orthopedic research?
I actually started my career in industry, working as a product development engineer at Medtronic in their spinal division in Memphis, TN. It was a great place to learn the fundamentals of product design and development and how to take an idea from a napkin sketch all the way to a device used in patients. I was fortunate to work alongside and learn from many incredibly talented people who really understood the full process, from difficult engineering problems to translating products into the clinical.

Toward the end of my time there, I was part of the team working on INFUSE® Bone Graft (rhBMP-2) where I first saw the potential of biologics to completely change orthopaedics. It opened my eyes to what was possible when you move beyond hardware and start thinking about biology as part of the solution. That curiosity eventually pulled me back to school. I left Medtronic to pursue my PhD at Duke University, where I had the chance to work with Dr. Farshid Guilak – who really needs no introduction to this audience – and I think we can all agree he’s one of the leading minds in regenerative medicine. Under his mentorship, I learned a ton about BME, stem cells, tissue engineering, and particularly functional tissue engineering that became foundational for what would later become CytexOrtho.

Early on in the lab, we started talking about the huge unmet need in restoring joints affected by osteoarthritis, and that focus really shaped our thinking when we eventually started the company. As our research on 3D woven textiles progressed, it became clear that this work had real potential to make a clinical impact. That vision, to combine engineering precision with biological repair, has guided everything we’ve done since.

What have been some of our biggest challenges?
There have been challenges at every stage, of course, but if I had to pick one that stands out, it’s funding. Translating a great idea from an academic lab into something that can truly help patients takes an enormous amount of capital – and patience.

In academia, we had exciting data, strong publications, and some early proof that the technology worked. But once you step out of that environment, you quickly realize what it takes to actually build a company: manufacturing, preclinical studies, regulatory submissions, clinical trials, quality systems, and the list goes on. It’s a completely different scale of resources.

We’ve been extremely fortunate to have the National Institutes of Health, and the SBIR/STTR program, known as America’s Seed Fund, support our work from the very beginning. This program plays a critical role in helping early-stage companies like ours bridge the gap between promising academic research and real-world patient impact. I also want to acknowledge both the National Institute on Aging (NIA) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) for their continued belief in our mission. In particular, the Small Business Program Director at NIAMS, Dr. Xibin Wang, has been an incredible partner throughout this journey. His thoughtful guidance, steady encouragement, and commitment to advancing musculoskeletal innovation have been invaluable to us. The truth is, without the support of NIAMS, NIA, and the SBIR/STTR program, we simply wouldn’t be where we are today. They believed in the potential of translating our work from concept to clinic – and their partnership has been essential at every step along the way.

That said, the broader investment landscape in orthopaedics is still challenging. Compared to fields like oncology or cardiology, orthopaedics hasn’t traditionally attracted the same level of institutional capital, especially in Class III medical devices and regenerative medicine. But that’s also what makes this moment exciting. There’s a tremendous opportunity to reshape how people think about orthopaedics – not just as hardware, but as biology, regeneration, and restoration.

If companies like ours can show that regenerative implants genuinely improve outcomes, I believe more capital will follow – and that will be good not only for CytexOrtho, but for the entire orthopedic research community.

What is one accomplishment you are really proud of?
Being part of the team that received the 2021 Kappa Delta Elizabeth Winston Lanier Award from the American Academy of Orthopaedic Surgeons (AAOS) is something I’m incredibly proud of. The award was presented to Dr. Farshid Guilak with Dr. Frank Moutos and me as co-authors for our research on developing the technology that we’re now developing at CytexOrtho.

Farshid was the driving scientific force behind this work from the very beginning, and it was a tremendous honor to be recognized alongside him and Frank for what has truly been a shared vision. Having our research acknowledged by the AAOS at that level was deeply meaningful and not just because of the prestige of the Kappa Delta Award, but because it validated the science and years of persistence that went into it.

For me, it also represented a real bridge between academia and clinical translation. The award recognized not only the impact of the science itself but also its potential to change how we treat patients with joint disease. That acknowledgment from the AAOS gave us renewed motivation to keep pushing forward – to drive change and deliver solutions for a patient population that has been underserved for far too long.

What are you most excited about in the future of orthopedic research?
There’s a lot to be excited about right now, but what really inspires me is the growing shift toward biological personalization. We’re moving beyond the era of simply replacing damaged structures with hardware and into a new era where we can truly restore and regenerate tissue in ways tailored to each patient.

We’re starting to see materials, biologics, and digital design tools converge to make that possible. Implants can now integrate, remodel, and even adapt over time. I think that’s where the biggest breakthroughs in orthopaedics will come from: technologies that work with biology rather than around it. At CytexOrtho, that’s exactly the direction we’re heading. We started with the hip because the need is so significant and there are few effective early-stage solutions available today. But our technology is a platform, and we see a clear path to extend it to other joints such as the knee and ankle.

Our first implant is regulated as a device, but we are already exploring ways to incorporate biologics, improved materials, and cell-based therapies over time. The goal is to create regenerative solutions that are both personalized and proactive, giving patients earlier, more natural options that help them stay active and avoid total joint replacement altogether.

It feels like we’re standing at the beginning of a new era in orthopaedics, one where “repair” and “regeneration” begin to replace “replacement.” And that’s incredibly exciting.

How does our technology fit into patient care?
It’s a great question, because when you look at how patients move through the care pathway for joint disease, there’s a huge gap that’s been left unaddressed. Most people start out with conservative treatments like physical therapy, NSAIDs, or injections. In many ways, those help with symptoms, but they don’t fix the underlying problem. Eventually, many of these patients undergo arthroscopy, which may buy them some time but doesn’t have a strong track record for stopping disease progression.

After that, there really aren’t any treatments left until the end stage total joint replacement, and for younger, active patients, that’s a tough place to be. They’re often told to wait it out, manage the pain, and come back when their disease is “bad enough.” That usually means seven or eight years of chronic pain and functional limitation before they finally qualify for surgery.

The problem with joint replacement too early is that it puts the patient on a difficult path. A total hip replacement in your forties or fifties can mean a lifetime of activity restrictions or even multiple revision surgeries down the road. It’s not a great long-term solution for someone who’s still active and wants to stay that way.

Our technology is designed to fill that gap. Instead of waiting for the joint to fail completely, we aim to intervene earlier – when the cartilage and bone can still be restored. The goal is to provide a regenerative solution that allows patients to return to the activities they love, without the trade-offs of chronic pain or premature replacement.

So, in the continuum of care, our implant offers an earlier, restorative option between conservative management and total joint replacement. It’s about giving patients a path back to function and quality of life much sooner, while preserving their joint for the long term.

Why do I think investors should put their money in orthopaedics right now?
For a long time, orthopaedics has been viewed as a pretty mature field – incremental innovation around metal and plastic, new coatings, new instruments, 510(k) regulatory clearances – but not much in the way of true disruption. I think that’s changing.

We’re now at a point where biology, materials science, and advanced digital design are converging to create entirely new possibilities. The next big wave in orthopaedics isn’t going to be another incremental change in implant design; it’s going to be technologies that restore and regenerate. I see a shift where we don’t wait until end stage to intervene but instead act earlier to restore joint health. That opens up an enormous opportunity for both clinical impact and value creation.

Orthopaedics also represents a massive, growing market that affects millions of people around the world. The unmet need, especially for younger, active patients with early joint disease, is both significant and rising. These patients are looking for solutions that help them stay active without having to cope with long-term restrictions.

So, from an investment standpoint, I think we’re standing at the edge of a paradigm shift. Regenerative orthopaedics has the potential to redefine how we treat joint disease. At CytexOrtho, we’re right in the middle of that transition. We’re taking the lessons learned from decades of implant design and combining them with regenerative medicine to create something entirely new. For investors, it’s not just about the next generation of devices, it’s about being part of a movement that will change the way orthopedic care is delivered for decades to come.