This is the sixth in a series of the 6-Question interviews with the leaders who are challenging conventional thinking in Orthopedics. (read other interviews here)
Herb Schwartz has been a quietly disruptive force in the orthopedics industry for decades. He has been innovating in tissue engineering, biologics, sports medicine, and orthopedic implants/instruments and has accumulated 37 patents. I met Herb Schwartz shortly after he left DePuy and founded Schwartz Biomedical in 2004. He later successfully sold his BioDuct meniscus repair technology to Stryker. Today, his new technology company, BioPoly, is quickly gaining traction.
I sat down with Herb to ask him a few questions.
1. Before we get into BioPoly, tell me how you ventured from your doctoral work to GE Aircraft and arrived at orthopedic innovation.
I began my career at GE Aircraft Engines which gave me a strong technical, manufacturing, and business basis because of the successful business practices of GE. From LEAN manufacturing to Six Sigma to advanced materials, GE’s leadership training provided me with the necessary tools to be successful in nearly any industry, including orthopaedics. With GE’s support, I was able to pursue my true passion in the biomedical field by completing my Masters and Ph.D. work in Biomechanical Engineering at the University of Cincinnati. With my education complete, I began my orthopaedics career at DePuy Orthopaedics and was blessed to work with an amazing group of people who challenged me to innovate and develop products in orthopaedics.
2. What was the genesis of BioPoly? Where did the idea come from and how did you get it started?
The initial material was invented by a very intelligent professor (Dr. Sue James) from Colorado State University. I formed the BioPoly® company and obtained the exclusive worldwide license for all medical applications of this technology because I believed that this unique material could actually change the direction of orthopaedics. However, I knew it would require a very, very long road to get to the market. So, with the initial technology in hand, we started down the path of developing this very interesting material for use in orthopaedic applications. The initial funding for BioPoly® came from grants from the State of Indiana, the 21 Fund. Early on, my vision for BioPoly® was validated by one of the pillars of orthopaedic industry, the late Dr. Dane Miller. Dane was the industry expert on the grant committee that decided to provide the initial funding for BioPoly and told me that he believed this material had the potential to disrupt the industry. I obviously still agree with that today. In fact, I am so convinced of this fact that with the help of many hardworking and intelligent people surrounding me and with the help of committed investors, we have built an orthopaedic company on this platform technology. The BioPoly team members have changed over the years, but everyone who has touched the technology has contributed to its success. I am very proud of our team and what they accomplished as we developed this technology to the point where it is now ready for “prime time.” We continue to surpass major milestones as we are selling in the marketplace and developing and launching new applications. We have multiple product lines that are CE marked and that are being sold outside the US, and we are working toward entering the US market very soon.
3. What is the technology behind BioPoly and how does BioPoly work clinically?
The BioPoly® concept is actually very simple, although the technology itself is somewhat complicated. Essentially, BioPoly is a self-lubricated plastic material. The proper material designation for BioPoly is that it is a microcomposite of hyaluronic acid (the “Bio” portion of BioPoly) and ultrahigh molecular weight polyethylene, UHMWPE (the “Poly” portion). The “lubrication” comes from the hyaluronic acid ingredient, a component of synovial (joint) fluid. That lubrication coupled with UHMWPE (the same bearing material used in total joint applications) is what provides the backbone of the BioPoly material technology. So, basically what we have is a hydrophilic (water attracting) polymer that we call BioPoly®. The hyaluronic acid is permanently held within the polyethylene matrix, and when placed in a joint (knee, shoulder, hip, etc…) environment, it takes advantage of the surrounding synovial fluid by holding onto it during joint motion, ensuring that a layer of lubricant is between BioPoly® and whatever it is articulating with. So, an implant created from the BioPoly material has a true market advantage. When used clinically, the lubricating properties of hyaluronic acid along with the robustness of UHMWPE make the BioPoly material extremely biocompatible with orthopaedic tissues like cartilage and meniscus because BioPoly implants can carry anatomical loads yet not damage opposing soft-tissue surfaces.
4. So who is the ideal patient for BioPoly?
In the knee, the ideal BioPoly® patient is an active person who has a focal cartilage defect but is too young for a uni or total knee and too old for his/her biology to provide a predictable outcome from one of the biological fixes available. We have been implanting for almost 5 years with patient’s ages ranging from 21 to 71+ years old. The common theme that we have in our outcomes is that patients become pain-free and active very quickly. This is because the BioPoly implants are designed to allow immediate weight bearing. In fact, we recommend immediate weight bearing because load and articulation maintain healthy subcondral bone and overall for optimal joint health. So the BioPoly® patients don’t have to go through the long and painful rehab that is required by the biological treatments such as ACI or microfracture.
5. How is BioPoly different from other early OA treatments such as ArthroSurface HemiCAPs, cartilage repair technologies or micro fracture?
When comparing BioPoly to other treatments, our clear advantage stems from the BioPoly material and the design of the implants, of which we have multiple issued and pending patents. BioPoly RS Knee implants share the same indication as microfracture in the knee; therefore, as we consider competition, we need to look at microfracture as well as other biologic approaches, including ACI, mACI, OATS, and allografts. Since BioPoly is an implant, we have very predictable outcomes, and in our case, they are very positive. The BioPoly implants and surgical technique work together so that BioPoly implants share anatomical loads with the surrounding cartilage; thus, the adjacent cartilage is not overloaded or under-loaded and the opposing cartilage has the proper loading during articulation as well. The loading environment provided by the BioPoly material stiffness and surgical technique along with the “self-lubrication” inherent in the BioPoly material are what provide the positive outcomes that we’ve been consistently seeing since we started to implant almost 5 years ago. With the help of prestigious surgeon investigators in the UK, a cohort of BioPoly patients are being followed in a proper registry studys so, these outcomes are based on real patient clinical data, not just anectdotal observations. So, post-operative rehab is very minimal for our BioPoly patients which is a strong contrast to the biologic treatments. These treatments require weeks or even months on crutches followed by months of limitations and rehab. On the other hand, most of our patients are reporting to be pain free and full range of motion before 6 weeks. Many of our patients have regained their active lifestyles and are walking, hiking…even running, playing rugby, biking, skiing, and CrossFit training. Besides these positive outcomes, BioPoly also is very reliable. With a revision rate around 1%, we don’t even compare to the nearly 30% revision rate reported in most biologics.
When we compare BioPoly implants to all-metal implants, our main advantage is that we have material properties that better simulate cartilage properties. Metal has the opposite property, it’s hydrophobic (repels water). The best lubricant for a hydrophilic surface like cartilage and BioPoly is the water-based synovial fluid. Unfortunately for (hydrophobic) metal placed in the joint, the best lubricant (oil) is not present. Besides the hydrophilic/hydrophobic property mismatch, the metal that our competitors use for articulating with cartilage is approximately 25,000x stiffer than cartilage; BioPoly is only 80x; so, no matter where you position the metal implant in the cartilage bed, it will end up carrying more load than it should. Articulating metal against cartilage has been shown in multiple animal studies to cause premature breakdown of the opposing cartilage due to overloading conditions. These metallic implants will transmit these higher loads to the subchondral bone beneath the implant and could also cause overloading conditions for the subchondral bone as well.
6. What are the current applications for BioPoly and where are you going in the future?
The current applications that are CE marked include the BioPoly® RS Partial Resurfacing Knee (femoral condyle and trochear facets), Patella, and Shoulder families of implants. Additional partial resurfacing implants are being developed currently, and our pipeline is very full with new applications throughout other joints, i.e. hip, ankle, great toe, etc… In addition to partial resurfacing (where BioPoly® articulates with cartilage), we are also optimizing the material for use in total joint applications, where BioPoly® replaces the UHMWPE bearing and articulates with metal. Since we can cross link the poly portion of BioPoly®, we have seen reductions in wear rate of 30-40% when comparing to highly crosslinked UHMWPE. Our process also allows for anti-oxidant treatment; therefore, I am very excited about the future of BioPoly® in these types of applications.
For more information about BioPoly click here [www.biopolyortho.com] or email us at info@biopolyortho.com.
BioPoly, LLC
7136 Gettysburg Pike
Fort Wayne, Indiana 46804