Michael Barbella, Managing Editor08.19.22
BONESUPPORT is touting results of a new study that shows the use of CERAMENT G and a surgical debridement can help clear infections and save previously infected limbs.
The study measured CERAMENT G's efficacy in managing patients with diabetic foot infections. As the first injectable combination antibiotic bone graft substitute, CERAMENT G can be used in a single-stage procedure to simultaneously support bone remodeling and locally elute Gentamicin (antibiotic) to protect bone healing. Study data show CERAMENT G's infection clearance rates at nearly 90% and limb salvage rates at 94%.
“The clinical study is powerful validation of our technology for the management of diabetic bone infection, especially in a challenging cohort of patients,” said Michael Diefenbeck, executive vice president of Medical & Clinical Affairs and chief medical officer at BONESUPPORT. “The result of this protocol demonstrating significant limb salvage success, is an improved quality of life for patients and an improved outcome for surgeons. We know this is just the beginning of the impact of our technology for supporting the treatment of bone infections.”
Diabetic foot infection is associated with high morbidity and is one of the leading causes of lower limb amputation. It can often be irreversibly debilitating, is susceptible to infection recurrence, and can lead to limb amputations. The authors of the new study presented results of 47 patients from two centers in the United Kingdom. Their multidisciplinary protocol involved pre-operative assessment, debridement, culture-specific systemic antibiotics, and local antimicrobial management with an antibiotic eluting biocomposite from BONESUPPORT. Researchers noted that “this is a safe procedure with no local or systemic adverse effects.”
BONESUPPORT received market authorization from the U.S. Food and Drug Administration (FDA), for CERAMENT G, for the indication of bone infection (osteomyelitis) in May.
BONESUPPORT develops and commercializes injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CERAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. The company is based in Lund, Sweden, and the net sales amounted to SEK 213 million in 2021.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.
The study measured CERAMENT G's efficacy in managing patients with diabetic foot infections. As the first injectable combination antibiotic bone graft substitute, CERAMENT G can be used in a single-stage procedure to simultaneously support bone remodeling and locally elute Gentamicin (antibiotic) to protect bone healing. Study data show CERAMENT G's infection clearance rates at nearly 90% and limb salvage rates at 94%.
“The clinical study is powerful validation of our technology for the management of diabetic bone infection, especially in a challenging cohort of patients,” said Michael Diefenbeck, executive vice president of Medical & Clinical Affairs and chief medical officer at BONESUPPORT. “The result of this protocol demonstrating significant limb salvage success, is an improved quality of life for patients and an improved outcome for surgeons. We know this is just the beginning of the impact of our technology for supporting the treatment of bone infections.”
Diabetic foot infection is associated with high morbidity and is one of the leading causes of lower limb amputation. It can often be irreversibly debilitating, is susceptible to infection recurrence, and can lead to limb amputations. The authors of the new study presented results of 47 patients from two centers in the United Kingdom. Their multidisciplinary protocol involved pre-operative assessment, debridement, culture-specific systemic antibiotics, and local antimicrobial management with an antibiotic eluting biocomposite from BONESUPPORT. Researchers noted that “this is a safe procedure with no local or systemic adverse effects.”
BONESUPPORT received market authorization from the U.S. Food and Drug Administration (FDA), for CERAMENT G, for the indication of bone infection (osteomyelitis) in May.
BONESUPPORT develops and commercializes injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CERAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. The company is based in Lund, Sweden, and the net sales amounted to SEK 213 million in 2021.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.