BONESUPPORT Announces CE-Mark of CERAMENT™|V, the First Injectable Vancomycin Eluting Bone Substitute in the Management of Osteomyelitis
Apr 29, 2015, 09:30 ET
LUND, Sweden, April 29, 2015 /PRNewswire/ -- BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced that it has received CE-mark for CERAMENT™|V, the first injectable vancomycin eluting bone substitute indicated to promote and protect bone healing in the management of osteomyelitis. CERAMENT™|V is an extension of the company's antibiotic eluting bone substitute portfolio which includes CERAMENT™|G, the first injectable gentamicin eluting bone substitute. Vancomycin is used to treat gram-positive bacteria that are known to be resistant to most antibiotics, including Methicillin-resistant Staphylococcus aureus (MRSA). The Infectious Disease Society of America recommends vancomycin as first-line therapy for these complicated infections, which include bone, and joint infections. The company is launching CERAMENT™|V immediately in all CE-mark countries.
"Antibiotic resistant infections are among the most challenging clinical conditions to manage," said Pablo S. Corona, M.D., PhD, from the Reconstructive and Septic Surgery Division, Department of Orthopaedic Surgery, Hospital de Traumatologia y Rehabilitacion Vall d'Hebron, Barcelona, Spain. "Local, high dose antibiotic delivery is particularly effective in managing and preventing infections, as seen with CERAMENT™|G. Now with the availability of CERAMENT™|V, surgeons have two powerful weapons that address the most common bacteria in the fight against osteomyelitis."
CERAMENT™|V is an injectable, resorbable bone graft substitute which remodels into healthy native bone within 6 to 12 months, and is designed to fill bone gaps and voids and can augment hardware and bone fractures during surgical procedures. The efficient elution profile and the focused local delivery of vancomycin obtained with CERAMENT™|V is intended to prevent colonization of sensitive microorganisms, thereby protecting the bone healing, particularly in challenging cases of deep bone infection.
"Expanding our portfolio of drug-delivery therapeutics is an important part of our growth strategy and we are proud to be executing on that with the launch of CERAMENT™|V," said Lloyd Diamond, CEO of BONESUPPORT. "As a pioneer of antibiotic eluting bone substitute technology, the launch of CERAMENT™|V marks the first ever injectable bone substitute with two drugs, vancomycin and Iohexol, to receive approval. This is an important milestone because it paves the way for future drug delivery combinations using our propriety technology and the CERAMENT™ platform."
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.
About BONESUPPORT
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 forty-five pre-clinical, clinical and animal studies have been conducted and more than 10,000 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