- Pivotal Rat Study Presented at 2015 Orthopedic Research Society Annual Meeting
LUND, Sweden, May 27, 2015 /PRNewswire/ -- BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced results from a pivotal pre-clinical study of CERAMENT™|G as presented at the 2015 Orthopedic Research Society (ORS) Annual Meeting. The study assessed the efficacy and safety of CERAMENT™|G, the first injectable gentamicin eluting bone substitute, in the completeness of bone healing after surgery and in the eradication of chronic infection. Study results demonstrated that CERAMENT™|G increased new bone growth and decreased the rate of infection as compared to treatment without a bone filler and treatment with CERAMENT™|BONE VOID FILLER without gentamicin.
"Treatment of chronic osteomyelitis often leaves a large critical defect which requires a bone void filler, yet current void fillers are inadequate because of donor site morbidity, expense or their propensity to encourage infection, " said Dr. Mathias P.G. Bostrom, Orthopedic Surgeon at Hospital for Special Surgery (HSS) in New York and co-author of the study. "This study showed CERAMENT™|G to be effective in decreasing the rate of infection and simultaneously increasing new bone growth, two essential functions for successful management of osteomyelitis."
CERAMENT™|G is an injectable, resorbable bone graft substitute designed to fill bone gaps and voids and to augment hardware and bone fractures during surgical procedures. CERAMENT™ has been shown to remodel into healthy native bone within 6 to 12 months. The efficient elution profile and the focused local delivery of gentamicin obtained with CERAMENT™|G is intended to prevent colonization of sensitive microorganisms, thereby protecting the bone healing, particularly in challenging cases of deep bone infection.
"This is the first animal study to evaluate CERAMENT™|G in a septic condition and we were very pleased with the results," said Lloyd Diamond, CEO of BONESUPPORT. "Clinical investigation has always been the foundation from which we have built a robust portfolio and it will continue to play an important role as we expand into new markets and new indications with our proprietary drug-delivery platform."
Osteomyelitis, or Bone Infection is a $1.7 billion market where prolonged, long-term antibiotic therapy, multiple surgical interventions and the threat of amputation are the current standard of care. Rising prosthetic infections, diabetic ulcers, war injuries, sports injuries, and an increasing resistance to antibiotics contribute to this growing condition.
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 forty-five pre-clinical, clinical and animal studies have been conducted and more than 10,000 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.
Chief Financial Officer
Phone +46 46 286 53 60
PR 0425-01 en