BONESUPPORT Announces First Patient Enrolled in FORTIFY Trial With CERAMENT G, a Novel Injectable, Antibiotic-eluting Bone Graft Substitute - Seite 2

Douglas R. Dirschl, MD is the Lowell T. Coggeshall Professor of Orthopedic Surgery and Chairman, Department of Orthopedic Surgery and Rehabilitation Medicine at The University of Chicago Medicine.

"The treatment of the first 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," added Richard Davies, CEO of BONESUPPORT. "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."

CERAMENT G combines the bone healing and bone remodeling properties of CERAMENT with the antibiotic, gentamicin. CERAMENT G drug-eluting properties enable it to provide an initial high concentration of gentamicin to the environment of the bone fracture and then a longer sustainable dose above the minimum inhibitory concentration of many of the bacteria that could cause a bone infection at the fracture site. This unique antibiotic-eluting profile helps protect the bone healing process and to promote bone remodeling.

CERAMENT G received the European CE Mark in February 2013 and is now marketed in 19 countries outside the US.

About BONESUPPORT:

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.