Swedish orthopedic trauma products maker Bonesupport won CE Mark approval in the European Union for its next-generation Cerament|G injectable antibiotic-eluting bone substitute.
The Cerament|G product is an osteoconductive, ceramic substance designed to promote bone healing while preventing bone infection, or osteomyelitis The resorbable bone graft substitute is designed to remodel into healthy bone within 6-12 months while preventing colonization of microorganisms, especially in cases of deep bone infection.
"The extraordinary antibiotic eluting properties of Cerament|G allow surgeons to manage challenging bone infection cases with confidence," Lund University Hospital orthopedic surgery professor Lars Lidgren said on behalf of the company. "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."
The global osteomyelitis market is estimated at about $1.7 billion, and treatment sometimes takes months or years, including surgical debridement and management of the empty space left in bones, according to a press release.
"Osteomyelitis affects 150 million people worldwide each year, " Bonesupport CEO Lloyd Diamond said in prepared remarks. "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 1st 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."