ApaTech, a global leader in synthetic bone graft technologies, today announces the completion of enrollment into its AIIS study, a prospective comparison of Actifuse™ and the leading rhBMP, Infuse® Bone Graft. The Actifuse Infuse Interbody Study is an international trial designed to compare the clinical performance of Actifuse™ Synthetic Bone Graft with Infuse in interbody* spine fusion.

Additionally ApaTech confirms the rapid uptake of Actifuse Advanced Bone matriX (ABX), its novel moldable bone graft system. Following its launch in June, Actifuse ABX, the first synthetic bone graft specifically indicated for use in posterior lumbar fusion (PLF), in conjunction with stabilizing hardware, now accounts for over 70% of US sales and is on track to become the fastest bone graft material launch in the USA.

Commenting on these developments, CEO Simon Cartmell said “Ease of use coupled with rapid bone formation means that surgeons need look no further than Actifuse ABX for the majority of their bone grafting procedures. We are on track to end the financial year with a run rate of $20m and to be profitable. With 6 product launches scheduled in the next 12 months, ApaTech is well positioned for further growth.”

Steve Czick, President of ApaTech Inc., commented “the indication for use in PLF in conjunction with hardware is a first and significantly differentiates Actifuse from the other synthetics and BMPs. We can now provide surgeons with a cost effective, on-label alternative for their PLF procedures and are launching a new pack variant specifically suited to PLF use at NASS 2007. We look forward to the results from the APPRAISE study, the prospective comparison of Actifuse and Infuse in this indication, which will reinforce our distinct position in this market place.”

The unique, silicate substituted calcium phosphate chemistry of Actifuse Synthetic Bone Graft is a significant advance in synthetic bone graft technology and provides surgeons with a safe and effective alternative to autograft, allograft, DBMs and BMPs. Actifuse Synthetic Bone Graft enhances the formation of bone and improves the subsequent organization and strength of the graft/host bone composite structure. Unlike traditional calcium phosphate based products, Actifuse is steadily and predictably remodeled by the host biology over time, ensuring that sufficient conductive scaffold remains for the duration of new bone growth and its subsequent maturation.

* This information concerns a use that has not been approved or cleared by the US Food and Drug Administration.



Further Information:

Simon Cartmell, CEO +44 (0)20 8731 4640
simon.cartmell@apatech.com www.apatech.com

Steve Czick, President, ApaTech Inc 1 508 542 0700
steve.czick@apatech.com www.apatech.com


About the APPRAISE study

A Prospective PLF Randomized Actifuse InFuSe Evaluation is a multi-center international study designed to compare Actifuse granules mixed with operative site blood versus InFuse Bone Graft used per the manufacturer’s recommendations in posterolateral lumbar fusion with stabilizing instrumentation. Statistically powered to demonstrate no clinical difference this landmark study continues to recruit well and in line with the study schedule.

The objective of the APPRAISE Study is to assess bony fusion in patients requiring one or two level instrumented posterolateral lumbar spine fusion. Clinical outcomes will be assessed using standard measures. Evaluations will be done before surgery, prior to hospital discharge, then at four months, one year, and two years following surgery. These will include radiographs and CT scans at appropriate intervals.

About the AIIS study

The Actifuse Infuse Interbody Study is designed to evaluate the clinical performance of Actifuse and InFuse bone graft in one or two level interbody spine fusions utilizing plain film and/or CT scans at three, six, twelve and twenty four months.

About ApaTech

ApaTech Limited, based in London, England and Foxborough, MA, is a world leader in bone graft technologies. Founded in 2001 and based on research and intellectual property from London and Cambridge Universities, ApaTech has introduced a novel silicate substituted calcium phosphate bone graft material, Actifuse globally. The company believes that Actifuse is the first of a new class of bioactive synthetic bone graft materials that combine osteoconductive and osteo-stimulatory activities.

Actifuse is available as a range of granule and microgranule formulations, including in an EasyPrep applicator and as an Advanced Bone matriX, Actifuse ABX.

To date the Company has raised £11.5m of equity from 3i plc and MTI and £3.5m of debt from Noble Venture Finance. ApaTech commercializes its products, Actifuse and ApaPore in 19 countries around the world and is achieving rapid sales growth.

ApaTech has locations in Elstree, UK, Berlin, Germany and Foxborough, MA, USA. The Company sells in the US, UK, Germany and 16 other countries around the world. ApaTech was recently recognized as Britain’s fastest growing medical technology company in the 2007 Sunday Times Fast Track 100 fastest growing private companies review.