BONESUPPORT - Solutions for Ceramic Vertebral Augmentation and Bone Void Fillers

BONESUPPORT™ is a Swedish medical technology company that has developed CERAMENT™ - a unique, injectable, bone-like material based on biocompatible, synthetic ceramics. CERAMENT is ideal for use in a wide range of clinical applications and has been developed to bring people with bone and joint diseases, such as osteoporosis, back to an active life.

To date, two products have been developed on the Cerament platform - CERAMENT SPINE SUPPORT and CERAMENT BONE-VOID FILLER. Ideas for new products and applications are constantly being developed.

THE SOLUTION FOR VERTEBRAL COMPRESSION FRACTURES

CERAMENT is a biphasic material composed of calcium sulfate and hydroxyapatite mixed with the radio contrast agent, iohexol.

CERAMENT's wide range of clinical benefits make it the ideal solution for treating vertebral compression fractures. CERAMENT is also perfect for use as bone filler.

NATURALLY CONTROLLED BONE INGROWTH

With CERAMENT, the calcium sulfate component is gradually resorbed leaving space for bone ingrowth while the more permanent, osteoconductive hydroxyapatite component armors the damaged bone.

CERAMENT's other features include:

• Osteoconductive - bone healing in voids is enhanced
• Ideal compressive strength similar to that of cancellous bone
• Excellent injectability and moldability - access to any site of the skeleton is quick and simple
• High penetrability - bone is uniformly reinforced and held in position for future bone ingrowth
• Non-exothermic - biocompatible setting temperature
• Radiopaque - easily traced in fluoroscopic images
• Fully biocompatible
• Non-toxic - safe handling and no toxic or unpleasant fumes
• High purity and reproducibility

INJECTABLE CERAMIC BONE SUBSTITUTE

CERAMENT SPINE SUPPORT is an injectable ceramic bone substitute intended for use in osteoporotic vertebral compression fractures. After immediate curing (less than one hour) in the fractured osteoporotic vertebra, CERAMENT SPINE SUPPORT stabilizes the vertebral body, providing immediate pain relief and allowing fractures to heal.

The procedure is minimally invasive and can be administered in an outpatient setting.

BONE-VOID FILLER FOR ORTHOPEDIC APPLICATIONS

CERAMENT BONE-VOID FILLER is intended only for orthopedic applications as filler for gaps and voids that are not intrinsic to the stability of the bony structure. It is indicated to be injected into bony voids or gaps in the skeletal system, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone.

SMOOTH, HOMOGENEOUS CONSISTENCY

CERAMENT SPINE SUPPORT and CERAMENT BONE-VOID FILLER are precisely measured for exact dosages and guaranteed to be sterile. Prior to injection, iohexol, the radio contrast agent, is added to CERAMENT CMI, the combined mixing and injection device, where it is mixed to a smooth, homogeneous consistency. The material flows well and is easily injected into bone through the injection device, even when very narrow needles are used.

CERAMENT SPINE SUPPORT is not available for sale; it is for investigational use only. CERAMENT BONE VOID FILLER has FDA 510(k) clearance. European approvals are pending.