LUND, Sweden, March 1, 2016 /CNW/ -- BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced an extension to the CERAMENT™|G product portfolio, adding a 5 mL volume to further develop the management of osteomyelitis (OM) and infection prophylaxis in diabetic foot and small extremities. CERAMENT™|G, which releases Gentamicin, received CE-mark in 2013, and is the first injectable antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of bone infection. CERAMENT™|G is now available in 5 mL and 10 mL in CE-mark countries.
The new smaller 5 mL volume further expands the application of CERAMENT™|G in small joint and extremity indications, including osteomyelitis in the Diabetic Foot. The efficacy of CERAMENT™|G in the management of this indication was recently demonstrated in two studies presented at the 34th Annual Meeting of the European Bone and Infection Society.
"CERAMENT™|G has demonstrated efficacy in the management of bone infections, and the new 5 mL volume will allow us to utilize this product in a larger number of patients with extremity infections as well as prophylactically in indications where a high risk of infection exists," said Professor Lars Jens Perlick, Chief of Trauma and Orthopaedics, Asklepios Paulinen Klinik Wiesbaden, in Germany.
"We are pleased to be able to address the market's demand for CERAMENT™|G in a smaller volume," said Richard Davies, CEO of BONESUPPORT™. "Physicians in Europe are clearly recognizing the benefits of our novel antibiotic eluting CERAMENT™ technology, and we continue to look forward to initiating a pivotal U.S. clinical trial for CERAMENT™|G in the second quarter of 2016."
BONESUPPORT™ is an emerging leader of injectable bone graft substitutes for orthopedics, and 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™|G and CERAMENT™ V are the first CE-marked injectable antibiotic eluting ceramic bone graft substitutes indicated to promote and protect bone healing in the management of osteomyelitis, (bone infections). CERAMENT's unique biologic properties deliver a consistent, pre-packed and ready-to-use formulation to facilitate optimal delivery. CERAMENT™|G and CERAMENT™ V are not available in the United States.
CERAMENT™ is a fully developed product platform that is commercially available in the U.S., Europe, SE Asia and the Middle East. CERAMENT™ is revolutionizing the treatment of fragility and other fractures caused by disease and trauma. Scientific research of CERAMENT™ spans more than eleven years. Over fifty pre-clinical, and clinical studies have been conducted and more than 20,000 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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