Bonesupport gets EU product approval for Cerament Bone Void Filler


The company is now launching an aggressive marketing campaign targeting selected markets within the EU, with its ceramic bone substitute.

Bonesupport has announced that it has received EU approval for Cerament Bone Void Filler, a ceramic bone substitute, primarily used for the treatment of osteoporotic fractures.

Approval for Cerament bone void comes close on the heels of Bonesupport being awarded a CE mark within the EU for its key product, Cerament Spine Support, in November 2008. The product is about to be launched in Germany, Austria and Italy.

“The approval of Cerament Bone Void Filler enhances our product portfolio. We foresee opportunities to capture significant market shares with our synthetic bone substitute, which offers doctors a further practical and cost-effective therapeutic option”, said Bonesupport CEO Fredrik Lindberg.

Cerament Bone Void Filler is used as an alternative to bone grafting in the treatment of bone defects and osteoporotic fractures. The product will initially be used in spinal and fracture surgery, with other broader orthopaedic applications being added later.

In conjunction with the approval, Bonesupport is launching an aggressive marketing campaign in selected markets within the EU. The company has already set up a subsidiary in Germany with responsibility for sales in central Europe and signed a distribution agreement with OsteoGen srl for the Italian market. Negotiations are on with regard to distribution in Spain, Portugal, Austria, Belgium, the UK and Ireland.

The injectable bone filler Cerament has major worldwide market potential, with the global orthopaedic market generating billions of dollars in sales every year. In Europe, the market for the treatment of vertebral fractures is valued at €377 million.

Following clearance from the Food and Drug Administration, Cerament Bone Void Filler has been available on the North American market since 2008. Hundreds of patients have been treated with the product to date with excellent clinical outcomes.

Alongside its presence in the North American and European markets, Bonesupport is looking to launch its products in other markets such as Asia and South America in the longer term.

About Cerament

• Cerament is an injectable ceramic bone substitute which reinforces the decalcified bone while allowing the patient’s own bone tissue to grow into and replace the implanted material.

• Cerament has near-physiological “orthobiological” properties based on natural minerals.

• Depending on the indication, Cerament can be injected under local anaesthetic and the patient becomes pain-free as soon as the bone substitute material has set and the fracture has stabilised.

• The treatment is quick, easy and safe to perform.