Comprehensive Summary Of Preclinical Data And Clinical Applications Of CERAMENT™|BONE VOID FILLER Published In Expert Review Of Medical Devices
29 Oct, 2013, 09:30 ET
LUND, Sweden, Oct. 29, 2013 /PRNewswire/ -- BONESUPPORT AB, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced that a comprehensive review article summarizing available published and presented data for composite products containing calcium sulphate and hydroxyapatite, extensively refers to preclinical studies and clinical applications published on CERAMENT™|BONE VOID FILLER. The article was published in the latest issue (n:o 5, 2013) of the journal Expert Review of Medical Devices. The authors conclude that the preclinical and clinical data to date support the safety, efficacy and bone remodeling performance of CERAMENT™. Furthermore, the authors found good clinical outcome in various applications such as osteotomies, cyst and defect filling, skull deformations, vertebroplasty and diabetic foot infections, with healing occurring in both normal and osteoporotic bone.
"Bone is the second most transplanted tissue, after blood, and the current standard of care is autografts which is associated with high donor site morbidity," said Professor Ming Hao Zheng, lead researcher in this study. "There is a significant need for a superior injectable bone substitute and CERAMENT™ offers good clinical outcomes in a wide range of applications. Moreover, the drug release capability, in addition to the osteoconductivity of CERAMENT, offers a promising breakthrough for treatment of deep bone infections and joint prosthetic infections."
"Scientific research of CERAMENT™ spans more than ten years and nearly fifty studies, the most for any injectable bone substitute on the market," said Lloyd Diamond, CEO of BONESUPPORT. "Our success as a next-generation bone graft substitute will be measured by the difference we can make in the lives of patients fighting serious disease. We are pleased to see the positive outcomes validated once again in this comprehensive study."
BONESUPPORT is an emerging leader of injectable bone graft substitutes for orthopedic trauma focusing on bone infection, instrument augmentation and spinal applications. CERAMENT™ is an injectable, synthetic bone substitute that mimics the properties of cancellous bone, allows for controlled resorption to support future bone ingrowth and is injectable under local anesthesia for minimally invasive surgery. CERAMENT's unique biologic properties deliver a consistent, pre- packed and ready-to-use formulation to facilitate optimal delivery. CERAMENT™|G is the first CE-marked injectable gentamicin antibiotic eluting ceramic bone graft substitute. CERAMENT™|G is indicated to promote and protect bone healing in the management of osteomyelitis, (bone infections) in CE marked countries. CERAMENT™|G is not available in the United States.
CERAMENT™ is a fully developed product platform that is commercially available in the U.S. and Europe and is revolutionizing the treatment of fragility and other fractures caused by disease and trauma. Scientific research of CERAMENT spans more than eleven years. Over forty-five pre- clinical, clinical and animal studies have been conducted and more than 6,000 patients have been treated with CERAMENT. The company was founded in 1999 and is based in Lund, Sweden with subsidiary locations in the US and Germany. To learn more about BONESUPPORT please visit www.bonesupport.com.
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