Launch Of New CERAMENT™|G Registry To Collect Data In The Management Of Bone Infection
LUND, Sweden, Feb. 19, 2014 /PRNewswire/ -- BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced today the launch of a new registry to collect long term data of CERAMENT™|G, the first injectable antibiotic eluting, osteoconductive, ceramic bone substitute indicated to promote and protect bone healing being jeopardized by infection. The registry is part of the company's Centers of Excellence expansion plan and aims to advance research, discovery and the development of improved treatment protocols for osteomyelitis.
"This registry will allow us to compare the outcomes of treatment strategies in a large group of patients who have previously been very difficult to study. Local antibiotic management of osteomyelitis is an attractive and valuable addition to current treatments and may offer greatly improved outcomes for the many people around the world who suffer from chronic bone infections" said Mr. Martin McNally, Lead Surgeon of the Bone Infection Unit at the Nuffield Orthopaedic Centre in Oxford, United Kingdom.
The CERAMENT™|G registry will allow participating doctors the ability to collect, access and publish research results both independently and collectively. Additional key features of the registry include:
- All registry participant data is accessible through a unique identifier and offers the highest level of privacy protection.
- An authorized and secure third party provider manages registry data in a single location.
- Researchers using the registry can access current and past data, resulting in enhanced understanding of bone infection over the course of treatment and recovery.
"We believe CERAMENT™|G offers significant potential to improve health outcomes, lower healthcare costs and deliver a higher quality of life for patients suffering from chronic bone infections," said Lloyd Diamond, CEO of BONESUPPORT. "This registry is an important milestone in our commitment to advance the standard of care for bone infections and we are proud to partner with researchers at the forefront of this condition."
"The potential for the CERAMENT™|G Registry to deliver game-changing results for surgeons and their patients is significant," said Professor Carlo Romano, Istituo Ortopedico Galeazzi, Milan, Italy. "There is a great need and desire for this kind of technology and we look forward to participating in the Registry."
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, high-energy trauma and sports injuries, as well as an increasing resistance to antibiotics contribute to this growing condition.
CERAMENT™|G received CE-Mark approval in February 2013. It is the newest generation product in the CERAMENT™ platform, which has been shown to remodel into healthy native bone within 6 to 12 months. It is designed to fill bone gaps and voids and augment hardware and bone fractures during surgical procedures. 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.
Learn more about the new CERAMENT™|G registry at www.bonesupport.com
BONESUPPORT is an emerging leader of injectable bone graft substitutes for orthopedic 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's unique biologic properties deliver a consistent, pre-packed and ready-to-use formulation to facilitate optimal delivery. CERAMENT™|G is the first CE-marked injectable antibiotic eluting ceramic bone graft substitute. CERAMENT™|G is indicated to promote and protect bone healing in the management of osteomyelitis, (bone infections) in CE marked countries. CERAMENT™|G is not available in the United States.
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. Over forty-five pre-clinical, clinical and animal studies have been conducted and more than 6,000 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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