Sweden-based BoneSupport AB is getting ready to gather data to support a premarket approval application (PMA) to the FDA for the company’s Cerament G bone graft substitute.
On August 17, 2018, the company took a step along that process by announcing that Health Canada granted approval for the product. The product already has CE Mark, making it the only CE Marked gentamicin-eluting injectable ceramic bone graft substitute on the market. The company hopes to launch the product in the U.S. in 2021.
The fact that BoneSupport is pursuing the lengthy and expensive PMA process instead of the 510k clearance route, means the product has no predicates and is unique.
The company says it is currently conducting a trial, called FORTIFY, to assess the product’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 the product and enroll up to 230 patients at up to 30 centers in the U.S. and Europe.
“Cerament is a synthetic bone graft substitute that consists of a powder component: 40% hydroxyapatite (HA), 60% calcium sulfate (CaS), and a liquid component (iohexol), which are mixed to form an injectable paste. It is used to fill gaps or voids in bone to promote bone healing.”
According to the company, “The type and ratio of HA and CaS in Cerament gives it unique material properties including the ability to remodel into host bone within 6-12 months.”
“The product can be injected through a 16G needle, allowing for minimally invasive procedures. Injectability is enhanced by the shape of the hydroxyapatite (HA) particles, enhancing flow and enabling injection to be performed without the need for high pressure.”
The product “does not create heat during setting, so there is no risk of thermal injury to tissues…Setting time and handling properties are consistent irrespective of the temperature of the operating room. The product is stored at room temperature.”
“The pre-filled, sterile, mixing and injection device ensures hassle-free preparation and delivery. The mixing device is simple to use and helps to achieve a homogenous paste, enhances rheology (flow characteristics) and reduces waiting time prior to application. It also reduces the risk of contamination, and there are no toxic or unpleasant fumes,” states the company.
Gentamicin, according to DrugBank, is a bactericidal antibiotic that works by irreversibly binding the 30S subunit of the bacterial ribosome, interrupting protein synthesis. This mechanism of action is similar to other aminoglycosides. Gentamicin is one of the few heat-stable antibiotics that remain active even after autoclaving, which makes it particularly useful in the preparation of some microbiological growth media.
“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. The company expects to expand its sales force, adding an additional 13 sales representatives in “key markets” this year.
Is this product injectable in an artificial hip where there is a deep bone infection and bone deterioration?