BoneSupport Announces CE-Mark and Launch of CERAMENT|G
2/13/2013 8:27:51 AM
LUND, Sweden, Feb. 13, 2013 /PRNewswire/ -- BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced today that the next generation product of the CERAMENT family, CERAMENT|G has received CE-mark. It is indicated to promote and protect bone healing being jeopardized by infection. CERAMENT|G is the first injectable antibiotic eluting, osteoconductive, ceramic bone substitute to receive CE-mark and is supported by the robust clinical evidence of CERAMENT, including data from more than 4,000 patients with outcomes reported up to four years. The company is launching CERAMENT|G immediately in CE mark countries.
"The extraordinary antibiotic eluting properties of CERAMENT|G allow surgeons to manage challenging bone infection cases with confidence," said Lars Lidgren, Professor of Orthopedic Surgery at Lund University Hospital in Sweden. "CERAMENT|G is an important advancement in the management of osteomyelitis with great potential to enhance outcomes for patients, and improve the health economics of infection management by reducing the systemic antibiotic burden, with less surgical interventions per patient, and less risk of developing antibiotic resistance."
Osteomyelitis, or Bone Infection is a $1.7 billion market where prolonged, long term systemic antibiotics over months and sometime years combined with surgical debridement and management of the resulting dead space is the current standard of care. Emerging prosthetic infections, diabetic ulcers, war injuries, high energy trauma and sports injuries, combined with an increasing resistance to antibiotics; are today in immediate need of new therapeutic solutions.
CERAMENT|G is an injectable, resorbable, ceramic, biphasic 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 gentamicin obtained with CERAMENT|G is intended to prevent colonization of sensitive microorganisms, thereby protecting the bone healing, particularly in challenging cases of deep bone infection.
"Osteomyelitis affects 150 million people worldwide each year, " said Lloyd Diamond, CEO of BONESUPPORT. "Many of these people suffer from deep bone infections and face years of antibiotic therapy, multiple surgical interventions and ultimately the threat of amputation. Expanding the CERAMENT portfolio to include this first in class antibiotic eluting formula provides a critical bone healing treatment option for the management of this debilitating condition, and continues our commitment to improve outcomes for physicians and patients."
BONESUPPORT is an emerging leader of injectable bone substitutes for orthopedic trauma focusing on bone infection, instrument augmentation related to orthopedic surgery 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 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 and over forty-five pre-clinical, clinical and animal studies have been conducted. More than 4,000 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 visitwww.bonesupport.com.
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