CERAMENT™|G Shown to Decrease Infection and Increase New Bone Growth in a Pivotal Animal Model
LUND, Sweden, Oct. 20, 2015 /PRNewswire/ -- BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced data from the first U.S. study of CERAMENT™ with Gentamicin in an infected rat model as presented by the Hospital for Special Surgery (HSS) at the recent European Bone & Joint Infection Society (EBJIS). The study was a comparative evaluation to determine improvement of new bone growth and decrease in infection rate after debridement in a rat osteomyelitis model with use of CERAMENT™|G as compared with CERAMENT™|BONE VOID FILLER without antibiotics and compared to no void filler. The study showed no evidence of infection and greater new bone growth at six months when treated with CERAMENT™|G, compared to the other two control groups.
"This study supports the use of CERAMENT™|G as a readily available void filler which could be used in the management of osteomyelitis," said Dr. Mathias P. Bostrom, Orthopaedic Surgeon, Hospital for Special Surgery. "We look forward to continuing our clinical research of CERAMENT™|G and helping to bring this much needed product to the U.S. market."
CERAMENT™|G received CE-mark in 2013 and is the first antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of osteomyelitis. The Company is currently pursuing a pathway for FDA clearance, which would bring this novel treatment to the U.S.
"This is an extremely important study for CERAMENT™|G, as it paves the way for our approval process in the U.S.," said Lloyd Diamond, CEO of BONESUPPORT™. "CERAMENT™|G is a breakthrough advancement in the management of osteomyelitis and we look forward to bringing the outstanding clinical outcomes to the United States market."
About BONESUPPORT™
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, clinical and animal 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.
Press Inquiries:
Offer Nonhoff
Chief Financial Officer
Phone +46 46 286 53 60
Published at PR Newswire
No comments:
Post a Comment