TWELVE-MONTH FOLLOW-UP OF CERAMENT™ WITH GENTAMICIN CONFIRMS SIGNIFICANT AND SUSTAINED ERADICATION OF CHRONIC INFECTION AND DEMONSTRATED FORMATION OF NEW BONE
New data presented at the 33rd Annual Meeting of The European Bone & Joint Infection Society (EBJIS)
Lund, Sweden, (PRNEWSWIRE) September 24, 2014 – BONESUPPORT,an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced new twelve-month follow-up data from an on-going clinical trial investigating the safety and efficacy of CERAMENT™|G in chronic bone infection and the completeness of bone healing after surgery. Results showed complete wound healing in all patients treated with CERAMENT™|G, and full bone remodeling of the void in 75% of patients at 6-months with evidence of ongoing bone remodeling in 80% of the remaining patients. The results were presented for the first time at the 33rd Annual Meeting of The European Bone & Joint Infection Society (EBJIS) and confirm significant and sustained eradication of chronic infection with formation of new bone.
“These clinical trial results provide important evidence and confidence for surgeons that CERAMENT™|G provides a safe and effective delivery of antibiotics into bone defects and is an important advance in the management of chronic bone infection,” said Mr. Martin McNally, presenter and Lead Surgeon of the Bone Infection Unit at the Nuffield Orthopaedic Centre in Oxford, United Kingdom. “Moreover, CERAMENT™|G was administered in a one-stage procedure and demonstrated concomitant ingrowth of new bone in many cases, with significantly low rates of infection recurrence (2.4%), wound complications and fracture rates as compared to previous published series using other absorbable carriers.”
CERAMENT™|G is the first injectable antibiotic eluting bone substitute indicated to promote and protect bone healing being jeopardized by infection. These data report on a series of 41 patients with chronic osteomyelitis present for a mean of 10.4 years. Thirty-two of the patients had undergone previous surgery. The mean follow-up time was 13.2 months.
“We are pleased to see that the twelve-month CERAMENT™|G study data deliver highly significant results,” said Lloyd Diamond, CEO of BONESUPPORT. “This evidence reinforces our belief that CERAMENT™|G has the potential to impact the surgical strategy for managing osteomyelitis, by providing a more effective delivery of antibiotics with concomitant full bone healing in a one-stage procedure, thereby reducing treatment time, minimizing surgical interventions and lowering healthcare costs.”
Osteomyelitis (bone infection) is a $1.7 billion marketwhere prolonged, long-term antibiotic therapy, repeated unsuccessful surgical interventions and the threat of amputation are the current standard of care. An increase in prosthetic infections, diabetic ulcers, war injuries, sports injuries, and antibiotic resistance contribute to rising rates of osteomyelitis and increased costs to the healthcare system.
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 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 close to 9,000 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 visitwww.bonesupport.com.
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