Lund, Sweden, 30 August 2016 – BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that presentations and posters covering research with its CERAMENT™ G and CERAMENT™ V will feature extensively at the upcoming 35th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) taking place September 1-3 in Oxford, UK – which is a key congress for physicians and surgeons managing patients with bone infections. CERAMENT™ G and CERAMENT™ V are the only CE-marked injectable antibiotic eluting bone graft substitutes which provide local sustained delivery of gentamicin and vancomycin, respectively.
The EBJIS annual meeting will feature 25 abstracts highlighting research and clinical findings with CERAMENT™ G and CERAMENT™ V. This is a significant increase in the number of presentations and posters that were made at the 34th Annual EBJIS meeting reflecting the impressive clinical performance reported, the launch of CERAMENT™ V in 2016 and the growing interest in the only injectable antibiotic eluting bone graft substitutes that are available in Europe. Both CERAMENT™ G and CERAMENT™ V are able to deliver an initial high concentration of antibiotic to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to promote and protect bone healing and remodeling.
Richard Davies, CEO of BONESUPPORT, said: “The broad range of research and clinical data on CERAMENT™ G and CERAMENT™ V being presented at this year’s EBJIS Annual meeting highlights the significant increase in interest in these novel injectable antibiotic eluting bone graft substitutes. The new data also underscores BONESUPPORT’s commitment to supporting high-quality research that will help improve the management of important bone diseases. We are confident that the growing body of clinical evidence in support of both CERAMENT™ G and CERAMENT™ V will allow them to be used increasingly in patients with problematic bone infections including osteomyelitis, as well as prophylactically in patients at risk for developing an infection.”
BONESUPPORT recently received approval from the US Food and Drug Administration (FDA) to begin the FORTIFY study, an IDE (Investigational Device Exemption) study, with CERAMENT™ G. This study is a randomized multicenter controlled trial that will evaluate the safety and efficacy of CERAMENT™ G as part of surgical repair of open diaphyseal tibial fractures. The first patient is expected to be recruited into the FORTIFY study by the end of 2016. Data from the FORTIFY study will be an important component of BONESUPPORT’S planned PMA to gain US approval for CERAMENT™ G.
EBJIS is a European association of orthopedic surgeons, trauma surgeons, infection specialists and microbiologists. The aim of the Society is to promote the knowledge of all infections affecting the Musculoskeletal system (bone and joint infections) and to promote the prevention and treatment of these infections. The complete program of the EBJIS meeting is available at http://ebjis.org/.
Notes to Editor
BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT™|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.
CERAMENT™‘s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.
CERAMENT™|G and CERAMENT™ V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT™|G and CERAMENT™ V are available in the EU.
BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.
BONESUPPORT™ is a registered trademark.
Citigate Dewe Rogerson
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