18th Jun 2007, ApaTech announces 510k clearance of ActifuseTM ABX E-Z-fil Putty
First synthetic graft material specifically indicated in instrumented posterolateral spine fusion
ApaTech, a global leader in synthetic bone graft technologies, today announces the 510k clearance to market by FDA of Actifuse ABX E-Z-fil Putty. The indications for use specify use in posterolateral spine fusion with appropriate stabilizing hardware; the first time a synthetic graft material has been indicated for this widely used technique. Actifuse ABX is also indicated for use in general bone void filler applications.
Actifuse Advanced Bone matriX (ABX) provides surgeons with Actifuse granules as a moldable, cohesive mass in an easy to use applicator. As a result, Actifuse ABX can be placed directly into the operative site. Actifuse ABX provides surgeons with the handling benefits associated with demineralized bone matrix putties but in a product with a high volume of osteoconductive scaffold.
Commenting on the FDA clearance, 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. While convenient to use, DBMs have up to 40% carrier that has no useful biological function and needs to be removed prior to bone formation. 96% of Actifuse ABX volume is osteoconductive scaffold, formulated in a way that provides excellent handling and placement characteristics.”
Steve Czick, President of ApaTech Inc., commented “the PLF indication 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, approved on-label alternative for their PLF procedures.”
The unique, silicate substituted calcium phosphate chemistry of Actifuse 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 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.
Distinct from allograft and demineralized bone matrix sourced from cadaveric bone, Actifuse ABX E-Z-fil putty is synthetic and, as a result, free of pathogens. This means that there is consistency lot to lot and no risk of infection due to human or animal infective agent transmission from the graft material, and being synthetic, there have been no reports of adverse immunological reactions.
Further Information:
ApaTech
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 ApaTech
ApaTech Limited, based in London, England and Foxborough, Mass, 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, ActifuseTM globally. The company believes that Actifuse is the first of a new class of synthetic bone graft material that combines osseo-conductive and osseo-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 Easyfill Putty.
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, Mass, USA. The Company sells in the US, UK, Germany and 16 other countries around the world. More details can be found at the website, www.apatech.com
