Bone Substitutes: Swapping Autograft for Bioactive Glass

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Autograft has long been the standard for reconstruction surgery when patients need bone substitutes. However, new studies show that use of bioactive glass is a viable treatment for complete bone repair, and it may come at a cheaper cost.

Recent short-term studies conducted in Finland and Ireland¹ showed that osteoconductive bone substitute demonstrated excellent results in patients who suffered from chronic osteomyelitis. Cost savings have also been noted. One hospital estimated that patients who suffer from chronic bone infection who are treated with bioactive glass could see an 80% reduction in their number of procedures, a total savings of $20,000 per patient.²

BonAlive Biomaterials Ltd., headquartered in Turku, Finland, has expanded its bioactive glass products to cater to the orthopaedic market, and is planning a launch in the U.S. market.

BONEZONE spoke with Fredrik Ollila, Ph.D., BonAlive Biomaterials Chief Executive Officer, about the science behind its bioactive glass, BonAlive®.

BONEZONE: How would you describe BonAlive?

Fredrik Ollila, Ph.D.: BonAlive is a 100% synthetic silica-based bone graft substitute which we deliver as granules in syringes for use in orthopaedic surgery, craniomaxillofacial and ear, nose and throat indications. The unique feature of BonAlive is that it inhibits bacterial growth while promoting bone growth.  Bone formation_cr_i_640x265

BONEZONE: What is the material breakdown of BonAlive? How does it behave?

Ollila: BonAlive (S53P4 bioactive glass) can be regarded as a new generation synthetic bone graft substitute. BonAlive is not only osteoconductive, but due to its bioactive composition, it stimulates or promotes new bone formation. It works by leaching out ions that react with the body fluids, which results in transforming the granule surface chemically into one that resembles the chemical composition and structure of natural bone tissue. Leaching of the ions stimulates continuous bone tissue growth (osteostimulation) and is also the reason for the unique bacterial growth inhibiting property. In short, BonAlive is a synthetic, osteoconductive, osteostimulative and bacterial growth-inhibiting material, composed of SiO2 53%, Na2O 23%, CaO 20%, P2O5 4% by weight.

BONEZONE: In what orthopaedic applications is it used?

Ollila: The BonAlive granules are currently not available in the U.S. for orthopaedic applications.

In Europe and the rest of the world, BonAlive is used for bone cavity filling in both osteotomies and fracture repair. In the filling of bone defects derived from radical debridement in chronic osteomyelitis, BonAlive brings significant benefits by combining its unique effects of inhibiting bacterial growth and stimulating new bone formation through osteostimulation. Official indications in Europe are bone cavity filling and bone cavity filling in the treatment of chronic osteomyelitis.

BONEZONE: What are the benefits of using bioactive glass instead of a bone graft?

Ollila: Up to now, the gold standard has been to use the patient’s own bone (autologous bone graft) to fill bone defects. However, the popularity of autologous bone is steadily decreasing due to the drawbacks relating to its harvesting and use: painful for the patient because of bone harvesting from iliac crest, risk of infection because of secondary surgery site, delayed operation time, risk of nerve damage, limited amount of high quality bone. However, the main benefit is that BonAlive inhibits bacterial growth, which is a property that bone graft does not have.

BONEZONE: What results have arisen regarding patient outcomes and procedure costs?

Ollila: The clinical use of BonAlive is supported by a 20-year research history, including several randomized prospective trials in the field of spine, benign bone tumor and trauma surgery. More than 50 peer reviewed articles have been published about BonAlive. There are a number of randomized prospective clinical trials that present data showing excellent results in patients who have been treated with BonAlive. There are significant savings in overall procedure costs which result from the avoidance of the secondary surgery. The largest cost savings becomes evident when a chronic disease that has been treated for decades with numerous revision surgeries can be cured.

BONEZONE: In which applications is BonAlive being used? How do you see the use of BonAlive expanding in orthopaedics, in the future?

Ollila: We have a strong position in orthopaedics, especially in cases involving the resolution of infection complications after trauma. The main applications are tibia and femur fractures, large bone aneurysmatic bone cysts in the long bones and complex non-union treatment in the distal tibia.

BONEZONE: In what countries does BonAlive have regulatory clearance? Do you see this expanding? Do you plan to expand in the U.S.?

Ollila: For orthopaedic surgery, BonAlive is available in all European countries, Israel, Turkey, Australia, New Zeeland, Malaysia, Saudi Arabia and Brazil.

We have a 510(k) for the granules, and we are actively promoting BonAlive in the U.S. in head and neck indications involving chronic infections in the mastoid and frontal sinus areas. We will be launching an innovative and competitive product line for the orthopaedic surgeon community in the near future, and that will be the right time for us to enter the U.S. orthopaedic market.

 

REFERENCES
1. Bioactive glass S53P4 as bone graft substitute in treatment of osteomyelitis, N.C. Lindfors, P. Hyvönen, M. Nyyssönen , M. Kirjavainen, J. Kankare, E. Gullichsen , J. Salo http://www.ncbi.nlm.nih.gov/pubmed/20624692 and Through the looking glass; bioactive glass S53P4 (BonAlive_) in the treatment of chronic osteomyelitis, J. McAndrew, C. Efrimescu, E. Sheehan, D. Niall http://www.ncbi.nlm.nih.gov/pubmed/23292733

2. Tullamore Hospital pioneers usage of new Bioactive Glass in treatment of resistant osteomyelitis http://www.hse.ie/eng/services/News/newsarchive/2012archive/nov12/bioactiveglass.html

Fredrik Ollila, Ph.D., obtained his doctorate in biochemistry from Åbo Akademi University, Finland and has also studied marketing and finance at the Business School in Turku, Finland. Between 2003 and 2006, he held several positions at Novartis Pharma AG in Basel, Switzerland, with increasing levels of responsibility. Dr. Ollila managed the FiberLive technology at Vivoxid Ltd. between 2006 and 2008, and from March 2008 he was responsible for the Global Sales and Marketing of BonAlive® at Vivoxid Ltd. Dr. Ollila was the key architect in executing the management buy-out of the BonAlive technology from Vivoxid Ltd. Please reach Dr. Ollila at fredrik.ollila@bonalive.com.

BonAlive Biomaterials Ltd.
www.bonalive.com

 

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