CERAMENT™|G 5 mL to be utilized for infection management and prophylaxis in diabetic foot procedures and small extremities
Lund, Sweden, (PRNEWSWIRE) March 1, 2016 – 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.”
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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