Rigshospitalet to evaluate CERAMENT™ platform for use in bone tumors
Lund, Sweden, (PRNEWSWIRE) January 7, 2016 – 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 has signed a research collaboration with Rigshospitalet, Copenhagen University Hospital, the largest hospital in Denmark, whereby the institution will evaluate BONESUPPORT™’s platform technology, CERAMENT™, in the management of bone tumors.
The study will retrospectively evaluate clinical results using bone allografts, and prospectively evaluate clinical results using CERAMENT™lBONE VOID FILLER and gentamicin eluting CERAMENT™lG, for prophylactic use in bone tumor patients. CERAMENT™ will also be evaluated in combination with different substances in order to achieve enhanced bone healing.
Surgical management of bone tumors can create a residual bone defect in highly compromised patients, which 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.
“We are excited to evaluate the CERAMENT™ technology platform in this research collaboration,” said Michael Mørk-Petersen, Professor, MD, DMSc, Rigshospitalet, who will oversee the study. “Both autologous bone and allograft have some disadvantages and risks associated with their use. We believe CERAMENT™ can provide a safe and effective alternative long-term solution to these technologies.”
“BONESUPPORT™ is pleased to enter into this collaboration with such a prestigious medical institution,” said Dr. Eva Lidén, VP of Research and Development of BONESUPPORT™. “Our CERAMENT™ technology platform continues to gain momentum with the physician community in Europe, and we will continue to invest in important research to validate our technology and improve upon the standard of care.”
CERAMENT™|G is CE-mark approved and is commercially available in parts of Europe, SE Asia and the Middle East. CERAMENT™|BONE VOID FILLER is FDA cleared and CE-mark approved and is 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.
Ends
Notes to Editor
About BONESUPPORT™
BONESUPPORT AB has developed CERAMENT™ as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to twelve months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT™|BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT™|BVF is commercially available in the U.S., EU, S.E. Asia and the Middle East.
CERAMENT™‘s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT™|G and CERAMENT™ V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.
CERAMENT™|G and CERAMENT™ V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT™|G and CERAMENT™ V are available in the EU.
BONESUPPORT AB was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The company is based in Lund, Sweden.
BONESUPPORT™ is a registered trademark.
Contact Information
Citigate Dewe Rogerson
David Dible, Andrea Bici, Mark Swallow
+44 (0)20 7282 2949/1050/2948