- Oxford Early Results with CERAMENT™|G show no recurrence of infection, no toxicity and no renal complications in the forty-one patients treated.
- No late wound leakage and 78% of patients showing complete bone ingrowth at 6 months.
LUND, Sweden, April 15, 2014 /CNW/ - BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced the first patient outcomes data of CERAMENT™|G pertaining to an ongoing clinical trail in patients with osteomyelitis, as presented at The 4th Annual Oxford Bone Infection Conference. In the report, forty-one patients treated with CERAMENT™|G had no recurrence of infection, no late wound leakage, no toxicity and no renal complications at a mean follow-up of 9 months. Additionally, 78% of the patients demonstrated complete bone remodeling at 6 months.
CERAMENT™|G is the first injectable antibiotic eluting bone substitute indicated to promote and protect bone healing being jeopardized by infection.
"Local antibiotic management of osteomyelitis provides a much needed treatment option for people who suffer from chronic bone infections," said Mr. Martin McNally, Lead Surgeon of the Bone Infection Unit at the Nuffield Orthopaedic Centre in Oxford, United Kingdom. "We are pleased by early results and are optimistic that CERAMENT™|G offers the potential to improve health outcomes, lower healthcare costs and deliver a higher quality of life for patients suffering from this devastating disease."
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.
"The CERAMENT™ platform has a long standing safety profile and we are pleased to see this once again confirmed in the CERAMENT™|G study," said Lloyd Diamond, CEO of BONESUPPORT. "CERAMENT™|G is an important advancement in the treatment of bone infections and we are proud to be at the forefront of this advancement in care."
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 visit www.bonesupport.com.
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SOURCE: BONESUPPORT AB
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