The traditional fusion material — collecting bone graft from the iliac crest — lost traction when BMP became available. Now, fewer surgeons are trained in iliac crest bone harvesting, says Dr. Bae, but BMP isn't always the best option for spinal fusion patients.
"As the aging population increases and we are starting to do more surgeries that require spinal fusions, we are augmenting our fusion with BMP, synthetics and allografts instead of autograft," says Dr. Bae. "BMP is a potent molecule and its commercial growth has slowed due to its side effects. The viable alternative is allograft and synthetics. We've seen multiple companies develop allograft products that retain cellular components, whether this addition improves fusion success is still unknown. What I like is the much needed research and development efforts currently in the allograft market to improve allograft performance. However, research and development in the synthetic market has been relatively stagnant. We need significant improvements in synthetic grafting as well."
Prosidyan's FIBERGRAFT received FDA clearance for spinal procedures in 2015 and by the third quarter of 2016 has exceeded over 5,000 clinical cases. The bone graft market for spine is still relatively young, with a huge potential for growth.
"We've identified a promising material in bioactive glass; it is differentiated from traditional synthetics like calcium phosphate because it can stimulate and attract cells to the grafting environment," says Dr. Bae." Bioactive glass has that capability; its interaction to the surrounding environment stimulates and attracts osteoblast to the healing site"
Bioactive glass alone is a difficult structure to handle and has no porosity. The transformation of bioactive glass to micro and nano fibers allows superior handling, direct cell connectivity and engineered porosity. "The proprietary bioactive material [for Prosidyan] is made out of micro and nano fibers that draw cells to attach and talk to each other directly," says Dr. Bae.
"If you look at the way the body heals connective tissue, whether it's tendon, bone or cartilage, the first thing your body does to heal is to produce the fibrin clot," says Dr. Bae. "If you magnify the fibrin clot, you will see a mesh of micro and nano sized fibers. Prosidyan’s FIBERGRAFT proprietary technology is the recreation of the initial healing fiber network made with a synthetic bioactive material." Bioactive glass also happens to be naturally antimicrobial.
According to Dr. Bae, Prosidyan is now working on packaging the fiber technology into a new form so surgeons can easily deliver it into the graft bed. The company expects to launch its next generation product line in the first half of 2017.
When asked about his view of the future in biomaterials, "It's about evolution in material science," says Dr. Bae. "Bioactive fibers is a really great base material for engineering; the avenues of what can be done with it are vast. Fibers of bioactive glass can be arranged in a pattern to also give it superior compression strength. This would allow the creation of a completely bioactive interbody fusion device"
The whole device would allow for osteogenesis. The new composition is currently being tested in small and large animals and showing osteogenesis as well as bone healing.
"I do think we are going to see more bioactive synthetic grafts in the future," says Dr. Bae. "We are going to see differentiation in the synthetics and it will enhance the spinal fusion space."
Prosidyan, (www.prosidyan.com) headquartered in Warren, NJ & founded in 2009, focuses on developing the next generation synthetic bioactive bone graft substitutes. Prosidyan’s proprietary technology called FIBERGRAFT is based on using micro and nano fibers of bioactive glass contained within porous spheres. The company's Chief Executive Office (CEO), Charanpreet Bagga (“CB”), has more than 100 patents and patent filings to his credit, including the FIBERGRAFT implant for spinal surgery.