CERAMENT™ with Gentamicin Shown to Decrease Recurrence of Infection and Increase Bone Formation
LUND, Sweden, Sept. 24, 2015 /PRNewswire/ -- BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced the presentation of new clinical data with the Company's platform bone void filler, CERAMENT™ with antibiotics which was presented at the 34th Annual Meeting of the European Bone & Joint Infection Society (EBJIS) on September 10-12 in Lisboa, Portugal. CERAMENT™|G is the first CE-marked antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of osteomyelitis and was prominently featured at EBJIS, a European association of orthopedic surgeons, trauma surgeons, infection specialists and microbiologists.
"The prominent role of CERAMENT™IG at this year's EBJIS demonstrates BONESUPPORT's commitment to advancing the scientific understanding of osteomyelitis," said Lloyd Diamond, CEO of BONESUPPORT™. "Our research and development efforts are focused on multiple pathways for our unique platform technology which we believe may lead to new treatment options for patients."
"EBJIS is an important scientific meeting to expand and share knowledge of bone and joint infections, which affects 150 million people worldwide each year," said Martin McNally, Lead Surgeon of the Bone Infection Unit at the Nuffield Orthopaedic Centre in Oxford, UK and President-Elect of EBJIS. "CERAMENT™IG offers an exciting advancement in the management of osteomyelitis, compared to previous antibiotic delivery systems and I am pleased to share the favorable results that we have seen in our study."
Key data presented represent findings from benchmark testing, pre-clinical and clinical studies in a wide range of indications and representing several key centers throughout Europe and the United States.
- A comparative study of three bioabsorbable antibiotic carriers in chronic osteomyelitis: 313 patients with minimum 1 year follow-up. M. McNally, et al – Oxford University Hospitals, Oxford, United Kingdom. Results: 50% less fractures and infection recurrence with CERAMENT™|G as compared to other two products.
- CERAMENT™|BONE VOID FILLER with gentamicin increases bone formation and decreases detectable infection in a rat model of debrided osteomyelitis. A. Dvorzhinskiy, M. Bostrom, et al – Hospital for Special Surgery, New York, United States. Results: Significant decrease in infection, increase in bone growth and no infection recurrence at 6 months with CERAMENT™|G.
- Use of a new antibiotic bone substitute to induce healing of osteomyelitis in the diabetic foot. C. Whisstock, et al – Diabetic Foot Clinic, Foot and Ankle Clinic, Abano Terme, Italy. Results: Rapid resolution of osteomyelitis with rapid tissue closure and preservation of diabetic feet with CERAMENT™|G.
- In-vivo gentamicin concentrations in plasma and drain fluid after bone defect reconstruction using a gentamicin-eluting bone graft substitute. P. Horstmann, W. Hettwer, et al – University of Copenhagen. Results: The high local peak concentration of gentamicin found in this study would be expected to deliver a substantial prophylactic effect after long operations with an increased risk of intraoperative bacterial contamination.
- An injectable bone substitute eluting antibiotic in the treatment of traumatic bone defects and its prophylactic effect. D. Papadia, et al – Trento, Italy. Results: No infections in 15 patients treated prophylactically following open fractures with a mean follow up of 11 months. Rapid bone formation noted at 6 months.
- CERAMENT™ with gentamicin regenerates bone in osteomyelitis with muscle acting as an osteoinductive niche. Raina, W. Hettwer, M. McNally, L. Lidgren, et al – Lund University Hospital, Lund, Sweden. Results: Clinical observations with rapid bone formed in CERAMENT™|G and in some cases in the muscle indicate osteoinductive potential.
- The efficacy of injectable biphasic calcium sulphate/hydroxyapatite bone substitute CERAMENT™|G in the treatment of severe bone infections. C. Pempinello, et al – S. Gennaro Hospital, Napoli, Italy. Results: Three septic non-union cases treated with CERAMENT™|G with 8-18 months follow-up. There were no recurrences of infection and bone growth occurred in all cases.
- Antibiotic loaded resorbable bone-graft substitute: A new treatment for osteomyelitis in diabetic foot syndrome. B. Gachter, et al – Locarno and Lugano, Switzerland. Results: A one-step surgical approach with CERAMENT™|G allowed for a minimal meta tarsal head resection while foot structure was maintained in the diabetic patient.
- Analysis of drain fluid particle content after implantation of an antibiotic-eluting bone graft substitute close to a partial pelvic replacement. W. Hettwer, et al –Denmark and Sweden. Results: SEM imaging demonstrated that no potentially wear inducing HA particles originating from CERAMENT™|G were observed in the drain fluid of patients in this pilot study.
- Use of a gentamicin eluting bone graft substitute in the treatment of peri-prosthetic joint infection in a tumor shoulder replacement. C. Jensen, W. Hettwer, et al – Rigshospitalet, Copenhagen, Denmark. Results: CERAMENT™|G used in a second stage re-implantation of an infected proximal humeral replacement. At 18 months post-op, the patient's shoulder remains pain free and stable without signs of persistent or reinfection.
- Staged ankle fusion using a hindfoot nail and CERAMENT™|G in cases of ankle osteomyelitis after open pilon fractures. P. Corona, et al - Vall d'Hebron University Hospital, Barcelona, Spain. Results: CERAMENT™|G used in a series of challenging foot and ankle cases with compromised soft tissue. Fusion was achieved at 4 months in all cases.
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.
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