BoneSupport said today that the 1st patient has been enrolled in the pivotal investigational device exemption trial for its injectable antibiotic-eluting bone graft substitute.
The company’s Fortify trial plans to evaluate Cerament G’s ability to improve the traditional management of patients with open factures of the tibial diaphysis. The trial is slated to enroll up to 230 patients and the primary endpoints are the absence of deep infection at the fracture site and the lack of secondary procedures designed to encourage fracture union.
BoneSupport’s bone graft substitute releases an initial high concentration of gentamicin to the bone fracture and then provides a longer, sustainable dose to prevent infection at the fracture site. Cerament G won CE Mark clearance in the European Union in February 2013.
“I am excited to take part in the Fortify clinical trial. The open tibial fracture remains the most common and 1 of the most troublesome open fractures managed by orthopedic surgeons,” principal investigator Dr. Douglas Dirschl said in prepared remarks. “Even with modern treatment protocols, patients suffering this fracture continue to be at substantial risk of infection, fracture non-union, and prolonged disability. A product that could be inserted into the fracture site at the time of definitive treatment that could promote bone formation at the same time as reducing the risk of subsequent infection, would be a major advance in the treatment of these troublesome fractures and would have the potential to provide benefit to thousands of patients each year in the United States.”
“The treatment of the 1st patient in the Fortify trial is another key corporate milestone for BoneSupport. This clinical trial in a complex trauma indication is designed to demonstrate proof-of-concept that Cerament G can be used to improve and protect the healing process in open bone fractures in combination with standard procedures, minimizing the risk of deep infections which would result in the need for additional remedial procedures,” CEO Richard Davies added. “We plan to use the clinical data to support our planned PMA filing for Cerament G in the US. We also intend to generate additional clinical data with Cerament G to gain a broad US label for this novel, injectable antibiotic-eluting bone graft substitute, which is rapidly being adopted in Europe.”