The company’s antibiotic-eluting product CERAMENT G has been approved by Health Canada.
CERAMENT G is a CE-marked gentamicin-eluting injectable ceramic bone graft substitute on the market. CERAMENT G sales have been growing strongly based on the clinical benefits it delivers when used for indications where infection may be present or of concern.
The company is currently conducting the FORTIFY trial to assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union. The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.
Expected launch 2021
Positive data from the FORTIFY trial will be used to support teh company’s PMA (Premarket Approval) filing for CERAMENT G in the US, where the product is expected to be launched in 2021.
“We are looking forward to commercializing CERAMENT G in Canada following its approval by Health Canada. CERAMENT G will be the first injectable antibiotic eluting ceramic bone graft substitute to be launched on the Canadian market. We are currently in dialogue with potential distributors to assist us in bringing this novel product to orthopedic surgeons managing bone voids where infection is present or an important risk,” said Emil Billbäck, CEO.