Lacey Jones/October 23, 2017

RTI Surgical’s spine sales & marketing teams hosted a Spine Symposium and Cadaveric Training in Las Vegas on September 16, 2017. This symposium – which was the second spine-focused symposium of the year – provided orthopedic and neurological spine surgeons from across the U.S. with key information related to RTI implants and instrumentation.

Attendees were able to gain hands-on experience with RTI’s recently-introduced TETRAfuse® 3D Technology, which provides surgeons a solution they have been seeking. TETRAfuse 3D Technology is the first 3D printed polymer implant material that has demonstrated trabecular bone ingrowth while maintaining radiolucency and bone-like mechanical properties*.

TETRAfuse 3D Technology was developed to offer surgeons an interbody material that participates in the fusion process while maintaining bone-like mechanical properties and radiolucent imaging. Bringing these features together combines the osseointegrative advantages of titanium and allograft bone with the benefits surgeons experience with PEEK. RTI will soon announce the release of a family of products manufactured with TETRAfuse 3D Technology, providing a platform that will have many derivative products.

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At OrthoSpineNews, we enjoy attending all the conferences and learning about new technology. There aren’t many areas in orthopedics and spine that has seen more growth, development and enthusiasm over the past few years but one of the shining stars is the Orthobiologics space. One of the most intriguing technologies that we have seen in this segment is the bioactive glass product called Fibergraft which is manufactured by Prosidyan.

We had the opportunity to sit down with Prosidyan’s President and CEO, Charanpreet Bagga (CB) as well as one of the leading surgeons in the country, Dr. Hyun Bae to learn more about the company and the product.

How about we start out with you both taking a minute to introduce yourself for our audience. 

CB- I have been very fortunate to have worked on a variety of exciting projects and for a number of great companies over the years.  Over the last 25 years, I have worked for Howmedica, Spinetech, Orthovita, Orthofix and Prosidyan as a full-time employee and I also helped build Titan Spine and Knee Creations as a consultant.  Over the years, I am a named inventor in over 125 US Patent applications, with over 50 issued patents, spanning hardware and biomaterials associated with treatments for back and knee pain.

Bae- I graduated from Columbia in NY with a degree in Biomechanical Engineering.  Looking back the biggest impact to my career choice was working in the Orthopaedic Research Lab as an undergrad with a world renown leader in cartilage and bone biology named Dr. Van C. Mow.  His post docs are now the Directors of many leading academic institutions and are the preeminent thought leaders in the field of musculoskeletal science.  From there I completed my medical training at Yale School of Medicine and continued research during my medical training by spending a year at the NIH as a Howard Hughes Fellow.  I completed my orthopaedic training at the Hospital for Special Surgery and spine fellowship with the late Henry Bohlman in Cleveland.

What led you to create Prosidyan and more specifically, Fibergraft? 

CB- Infuse was a Billion-dollar product in 2006.  By late 2008, we had seen a rapid decline in the market share of Infuse, which created a void in the bone grafting market.  Dr. Bae and I met around that time and felt that there was an unmet clinical need for a viable synthetic bone graft. We researched the field and narrowed in on bioactive glass as the most promising material.  Bioactive glass at that time already had a strong body of research to support its amazing properties, but had the limitations of only being available as crushed glass or as solid microspheres, with no porosity.  We had learnt over the years how important three-dimensional porosity providing direct cell connectivity is for allowing bone growth.  I decided to visit MoSci, the global dominant manufacturer of bioactive glass.  It led to a joint collaboration between Prosidyan and MoSci to develop FIBERGRAFT.

As a surgeon, what about Fibergraft do you most appreciate?

Bae- I love the fact that Fibergraft is truly a paradigm shift in grafting.  Most synthetics look like cancellous bone.  The problem is that they either resorb too quickly and you are not left with much or they are inert and do not resorb.  I feel we have been disenchanted with synthetics that look good on x-ray but on reoperation are found to be present in a deteriorated state without any true bone formation.  We have learned from BMP that bone induction is less about the providing a scaffold that looks like bone but more about enhancing the cellular healing process.  Fibergraft consists of micro and nano-sized fibers that are thoughtfully engineered in a 3-D structure to specifically induce and optimize the cellular process of bone development.     

BioActive Glass products have been around since VITOSS, what makes this different? 

CB- We are the first company to commercialize nano and micro sized fibers of bioactive glass for bone grafting.  Everyone else had solid particles, with no porosity.  Fibers allow the ultimate flexibility in engineering.  Our 3-D fiber array allows not only engineered porosity but direct cell connectivity.  This makes all the difference in ability to create rapid and sustained bone formation.

We have heard many different responses from surgeons regarding the quality of a fusion. Some say it’s the implants and biologics while others will say it’s the carpentry skills of the surgeon. What have you experienced and why do you think Fibergraft is displaying such great results? 

Bae- Obviously its all of the above.  But having trained fellows for the past 15 years, I am proud to say that the level and skill of spinal surgeons have advanced tremendously.  BMP taught us that we do not need iliac crest autograft in every fusion.  By advancements in implant technology and importantly knowledge and skill of the surgeon we have been able to achieve great results and outcomes for our patients without iliac crest autograft.  Fibergraft is just a well-deserved and needed evolution in synthetic bone grafting.  The results are a simple derivative of applying sound science and innovative engineering to the field of synthetic bone biology.

All publically traded orthopedic and spine companies have noted negative pricing pressure on their quarterly calls over the past few years, how has it been to create a new and innovative company while facing the same challenges? 

CB- This is a new world.  Gone are the days when you could spend unlimited amount of money in the development cycle with the promise of huge payback someday.  We ran Prosidyan very lean right from the beginning.  I worked from my home office for the first five years until we were close to our first FDA clearance.  We spent most of our funds directly on R&D and we stayed away from any expenses which were not absolutely needed.  I am proud to share that we have been operationally profitable, right from our first full year of commercial operations.

BMP’s like Infuse took the market by storm in the early 200’s but it appears that the product has been losing market share to products like Fibergraft, why do you think that is (clinical results? Finances?) 

Bae- First I think that BMP revolutionized the grafting market.  For all intensive purposes it put an end to the use of iliac crest autograft.  I do feel like this was a great thing for our patients.  It allowed the exploration of alternatives to iliac crest to be put to use.  The two main alternatives are allograft and synthetics.  I truly feel that we just fell behind in the synthetic category.  There is no reason with the advancement of technology and science today that a synthetic bone graft cannot be engineered to equal autograft.  It just took us a long time to understand and apply technological innovations to synthetics.  Fibergraft is an incredible and thoughtful application of todays technology in synthetic bone grafting.  Its clinical results speak for themselves and it is the best synthetic bone graft available today.

Thank you both for taking the time to sit down with us and share the exciting story of Prosidyan and Fibergraft. You will be at NASS and I’m sure if anyone reading this has questions, it would be highly recommended for them to stop by your booth (#1730) while they are in Orlando. We wish you both the best of luck and thank you again for sharing this exciting story.