Lund, Sweden, 08.00 CET, 10 April 2019 – BONESUPPORTTM, an emerging leader in orthobiologics for the management of bone voids, today announced the publication of new radiographic and histological data, which for the first time provides clinical evidence of CERAMENT® remodeling into bone in humans.
“This publication describes for the first time in detail radiographic and histological features in humans, which demonstrate, that the radiographic changes seen over time are due to active bone formation and not residual bone graft substitute. This correlates with good clinical outcomes in a challenging indication, where generally less impressive results in infection recurrence and fracture rates would be expected. Additionally, no patient required any autologous bone grafting procedure.” said lead author of the study Mr. Jamie Ferguson, Consultant surgeon at the Nuffield Orthopaedic Centre, Oxford University Hospitals.
The study ‘Radiographic and Histological Analysis of a Synthetic Bone Graft Substitute Eluting Gentamicin in the Treatment of Chronic Osteomyelitis’ is published in the Journal of Bone and Joint Infection (JBJI 2019; 4(2): 76-84). (http://www.jbji.net/v04p0076.pdf)
“This study represents an important step for BONESUPPORT, radiographically and histologically validating active bone remodeling in CERAMENT in humans with associated impressive clinical outcomes truly makes our case stronger for orthopedic surgeons using CERAMENT.” said Emil Billbäck, CEO of BONESUPPORT.
The Oxford Bone Infection Unit, led by Mr. Martin McNally reviewed retrospectively serial radiographs (x-rays) of 163 consecutive patients. 138 had adequate radiographs at a minimum of one year follow up. Nine patients had surgery not related to their infection, enabling opportunistic biopsy for histology between 19 days and two years. Radiographic data showed a mean bone void filling rate of 73.8 percent at twelve months, and progression of bone formation over two years in two thirds of the patients studied.
The data also correlates with the recently published animal model in sheep by Hettwer et al. in APMIS Journal of Pathology, Microbiology and Immunology (https://onlinelibrary.wiley.com/doi/10.1111/apm.12918)
BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CERAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver and a Premarket approval filing with the FDA (USA) for its gentamicin eluting product is planned in 2020. The company is based in Lund, Sweden, and the net sales amounted to SEK 97 million in 2018.
Please visit www.bonesupport.com for more information. BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.
For more information contact:
Emil Billbäck, CEO
+46 (0) 46 286 53 70