Lund, Sweden, (PRNEWSWIRE) January 5, 2016 – BONESUPPORTT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, today announced data from two studies confirming the efficacy of the Company's CERAMENTT antibiotic eluting bone substitute technology as a step in the management of osteomyelitis (OM) in infected diabetic foot. CERAMENTT’G, which releases Gentamicin, received CE-mark in 2013, and is the first approved antibiotic eluting bone substitute indicated to promote and protect bone healing in the management of bone infections.
Contiguous bone infection is a common complication of diabetic foot ulcers, and overall approximately 20% of patients with a diabetic foot infection (and over 60% of those with severe infections) have underlying osteomyelitis.¹. Prevalence of diabetes is growing rapidly and is the most common cause of non-traumatic lower limb amputation, with approximately 30% of patients with a diabetic foot ulcer leading to amputation. The risk for amputation in acute diabetic infections is four times higher with OM than with soft tissue infection alone². Additionally 50% of patients will go on to another amputation within 3-5 years, and 70% percent of patients die within 5 years of an amputation for diabetes.
Overall, the studies confirmed previously unpublished experience with CERAMENTT’G and published off label clinical use of CERAMENTT which was shown to induce bone and soft tissue healing and preservation of proper anatomy in the infected diabetic foot. Of significance, 11 of 12 patients who had mid-foot or hind foot partial resections healed rapidly, with the other patient follow up ongoing. In the second study six patients with OM of the metatarsal head were managed with CERAMENTT’G, with none requiring additional surgery.
“The results of these studies confirm that CERAMENTT’G has the potential to be an effective new surgical option for patients with osteomyelitis,” said Enrico Brocco, Chief, Diabetic Foot Unit, Policlinico Abano Terme, Diabetic Foot Referral Center, Italy, and author of one of the studies. “In these studies, CERAMENTT’G was associated with the rapid resolution of osteomyelitis, rapid soft tissue closure and preservation of the foot structure. We are very optimistic that CERAMENTT’G holds great promise in the management of osteomyelitis in diabetic foot ulcers.”
“The data generated from these studies support the feedback we've received from European physicians regarding the efficacy of CERAMENTT’G,” said Lloyd Diamond, CEO of BONESUPPORTT. “Importantly, our physician adoption rate in Europe continues to grow significantly, and we anticipate initiating a pivotal U.S. clinical trial for CERAMENTT’G in the second quarter of 2016.”
The results from these studies were presented at the 34th Annual Meeting of the European Bone and Infection Society in September. BONESUPPORTT is currently pursuing a pathway for FDA clearance in order to bring this novel treatment to the U.S.
BONESUPPORTT is an emerging leader of injectable bone graft substitutes for orthopedics, and trauma focusing on bone infection, instrument augmentation and spinal applications. CERAMENTT 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. CERAMENTT’G and CERAMENTT 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. CERAMENTT’G and CERAMENTT V are not available in the United States.
CERAMENTT is a fully developed product platform that is commercially available in the U.S., Europe, SE Asia and the Middle East. CERAMENTT is revolutionizing the treatment of fragility and other fractures caused by disease and trauma. Scientific research of CERAMENTT 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 CERAMENTT. The company was founded in 1999 and is based in Lund, Sweden with subsidiary locations in the US and Germany. To learn more about BONESUPPORTT please visit www.bonesupport.com