BoneSupport said today it won Health Canada approval for its Cerament G bone graft substitute.
The Lund, Sweden-based company touted it as the first and only CE Marked gentamicin-eluting injectable ceramic bone graft substitute on the market.
Bonesupport said it is currently engaged in a trial of Cerament G exploring it’s ability to improve standard-of-care management of patients with open fractures of the tibial diaphysis. The study is slated to enroll 230 patients at 30 centers in the US and Europe, with primary endpoints including the absence of deep infection at the fracture site and a lack of secondary procedures.
The company said it is hopeful that data from the trial will support its FDA premarket approval application in the US, where it is hopeful it will launch 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,” CEO Emil Billbäck said in a press release.
In May, Bonesupport said it plans to expand its sales force, adding an additional 13 sales representatives in “key markets” this year.