Injectable Bone Substitute Launched in Europe

Bonesupport AB of Lund, Sweden, a company that produces injectable bone substitutes for orthopedic, trauma and bone infections, announced that its next generation of the Cerament family, called Cerament|G, has received the CE mark and that the company is immediately launching it in CE mark countries. Cerament|G is the first injectable antibiotic eluting, osteoconductive, ceramic bone substitute to receive the CE mark. The product is supported by the clinical evidence of Cerament including data from more than 4, 000 patients with outcomes reported over a period of up to four years.

“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.”

According to PR Newswire, 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. Bonesupport officials claim that 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.

Bonesupport representatives describe Cerament|G as an injectable, resorbable, ceramic, biphasic bone graft substitute which remodels into healthy native bone within 6 to 12 months. It is designed to fill bone gaps and voids and can augment hardware and bone fractures during surgical procedures.

“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.”