While working in a burn unit at Baltimore-based John Hopkins University School of Medicine, PolarityTE founders Ned Swanson, MD, and Denver Lough, MD, PhD, grappled with the limited treatment options for patients. Inspired to provide new methods, they left their plastic surgery residency program and launched a portfolio of regenerative products.
PolarityTE Executive Vice President, COO and Director Dr. Ned Swanson spoke with Becker's Spine Review about how orthopedic and spine specialties could benefit from the company's bone and skin regeneration products and other technologies in development.
Question: How did you develop PolarityTE technology?
Dr. Ned Swanson: PolarityTE was built off of our CoreTE technology platform. The first product we took to market and commercialized is SkinTE, a skin regeneration product. OsteoTE is a bone regeneration product. All of these pipeline products begin with the concept of using the patient's own tissue. We're strong believers that for any regenerative product to develop complex hierarchical functional tissue, you need to start with the patient's tissue and cells to avoid all the immunological problems that arise when you use another person's [tissue], another animal's or another substance.
Q: How would OsteoTE work for orthopedic and spine specialties?
NS: [The provider] would start with an autologous harvest of that patient's corticocancellous bone. They would send it to our company, we would manufacture the OsteoTE product the same day and send it right back to the facility. It would arrive to them within a syringe, and they would apply it within the defect where they need to regenerate bone. So, we're talking big, traumatic orthopedic injuries where they need to regenerate a tibia, femur or humerus and putting it in the void where they're trying to span the gap. For spine, a lot of the use would be in spinal fusion, but it wouldn't be limited to very small spinal fusions like a lot of products on the market today. OsteoTE would apply to all the different specialties and markets for bone regeneration, all the way from craniofacial, neurosurgery, orthopedics, spine and foot/ankle surgery, even dental.
Q: What are the next steps in development and commercialization of OsteoTE?
NS: We're in the middle of getting through all of the large preclinical studies for [spine, hand, foot and ankle and dental] applications. We've completed our craniofacial and long bone models using OsteoTE to regenerate bone. When I say regenerate bone, we're regenerating functional bone with all of its normal layers in tact and all of the functional characteristics of bone … all the things orthopedic surgeons look for when evaluating new products. We removed a critical size piece of bone from the forelimb of a large animal, spanned that gap and regenerated fully functional bone across the entire gap. We hope to bring this to market and register the product toward the end of the year and have it on patients within all these different arenas [at the] end of this year or early next year.
Q: Where were the preclinical long bone study results?
NS: What we're seeing is with the defects being as large as they are, demineralized bone matrix, BMP-2 [and] allograft bone cannot heal and stand the gap. With our OsteoTE product, not only is the gap healed and spanned entirely, it looks like normal bone at the end of the trial period, which is between eight to 12 weeks. [We] often see the complete gap of healed bone filled with normal looking, functional bone at the eight-week point.
Q: What is happening with SkinTE and what are its orthopedic/spine applications?
NS: We're starting to broaden out the commercial use of the product to get ready for our full commercial rollout in 2019. We've seen it used in large acute burns where we've had patients with 75 percent total body surface area burns going home in six weeks, which is dramatically faster than you could expect with other treatment modalities. We've had chronic wounds that have failed [to close] with standard-of-care skin grafts and other industry products fully closed and healed [through SkinTE].
Q: Is anything similar to your products currently in development?
NS: We're not aware of any product that would fall in the framework of what we're developing. You'll probably run into other products trying to use a patient's fat to make bone. In our minds, it makes the most sense to start with the same tissue you're trying to regenerate. We utilize all components of the tissues we start with, and we do it with our micro-aggregate cell technology. We don't isolate single stem cells or single cell types from the tissue and expand in the lab; we get the full thickness, fully functional tissue sent to us. All the tissue engineering that's been taught for last two decades has taken people down the wrong conceptual framework of isolating single cells and single growth factors, making scaffolds that mimic the tissue you're trying to regenerate and combining them all into one cocktail that really hasn't produced anything clinically useful to date.
Using the patient's own tissue, trying to regenerate the tissue that you started with and using the patient as a bioreactor seems intuitively pretty obvious. We can't say why the industry or medicine as a whole hasn't landed on this conceptual framework, but to us, it makes the most sense, and it frankly has worked the best in all of our research and development. SkinTE being used clinically continues to prove our concepts are a way to approach regenerative medicine that has tangible results.
Q: What's the most important thing for physicians to know about OsteoTE?
NS: We've seen the standard of care and everything in between from where we came from in clinical medicine, and we didn't develop OsteoTE to just be an iteration of the products we're used to working with. This is being designed to bring an entirely new treatment paradigm to their fields of medicine.