- 93% of patients had full or partial cyst resolution at 12 months
- No post-operative infections reported during follow-up period
- No fractures reported during the follow-up period
LUND, Sweden, Dec. 10, 2015 /PRNewswire/ -- BONESUPPORT™, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced that the Company's platform technology, CERAMENT™ has proven effective in the management of benign bone tumors in a prospective pilot study. The results were published in the December issue of Biomed Central Musculoskeletal Disorders.
Surgical management of benign bone tumors can create a residual bone defect that requires void filling to prevent infection or fracture. Synthetic bone substitutes offer significant advantages over traditional autograft and allograft, which are associated with high morbidity and risk of disease transmission.
The results of the prospective pilot study demonstrate full or partial cyst resolution with CERAMENT™|BONE VOID FILLER in 93% of the patients (13/14), with complete cyst resolution in 11 of the 14 patients (78%) at 12-month follow-up. No postoperative infections or fractures were reported during the follow-up period.
"The immediate pain relief, full weight-bearing recovery, bone consolidation and incorporation as well as the structural bone integrity and durability demonstrated in the study indicate that CERAMENT™ can provide a safe and effective long-term solution for the treatment of benign bone tumors, making it an attractive alternative to autologous bone or allograft. Of special interest is the ability of percutaneous transcortical injection under fluoroscopy in patients with juvenile cysts," said Jacek Kaczmarcyk, MD, PhD, Department of Orthopedics and Traumatology, Poznan University of Medical Sciences, Poznan, Poland, and principal investigator for the study.
"CERAMENT™ continues to demonstrate superior bone remodeling capabilities which we believe contribute directly to infection and fracture prevention," said Lloyd Diamond, CEO of BONESUPPORT™. "We expect to see more such shifts in surgical management as additional data becomes available for a variety of indications."
CERAMENT™|BONE VOID FILLER is FDA cleared and CE-mark approved and commercially available in the U.S., Canada, parts of Europe, SE Asia and the Middle East. Zimmer Biomet is the exclusive distributor of CERAMENT™|BONE VOID FILLER in the U.S.
The manuscript is available at: http://www.biomedcentral.com/content/pdf/s12891-015-0828-3.pdf
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, and clinical 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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