ApaTech(R) Launches the Actifuse(R) MIS Bone Graft Delivery System: Reaching New Levels in Synthetic Bone Grafting

ELSTREE, England, November 10 /PRNewswire/ -- ApaTech, the rapidly growing orthobiologics company, announces the global launch of the Actifuse(R) MIS Bone Graft Delivery System, a revolutionary addition to the Company's product line.

Growth of Minimally Invasive Surgery (MIS) and surgeon demand for devices to precisely deliver graft material to the surgical site has led to the development of the Actifuse(R) MIS System. Actifuse MIS provides extended reach, controlled delivery and precise placement for surgeons performing open and minimally invasive procedures and who require a synthetic bone graft substitute. The product is ready for immediate, off the shelf use.

The Actifuse(R) MIS System is ideal for use in a range of spinal and orthopedic procedures including posterolateral fusion, bone void filling and acetabular cysts. The applicator facilitates controlled bone graft delivery through 200mm x 8mm pre-filled devices with replacement cartridges available for additional volume requirements.

The Actifuse(R) MIS System contains Actifuse(R) ABX, a unique osteostimulative bone graft characterized by:


        - Acceleration of bone formation.

        - Physiologically mediated resorption.

        - Demonstrated clinical success.

Actifuse ABX contains 96% granules and can be placed directly into the operative site with no need to mix with blood or bone marrow aspirate. The silicate substituted calcium phosphate chemistry of Actifuse offers a significant advance in synthetic bone graft technology.

Commenting on the launch of the Actifuse(R) MIS System, ApaTech CEO Simon Cartmell said "We are leaders in the science of silicon and its stimulative effects on bone biology. We are also innovators in applying our technology to meet customer needs. The Actifuse(R) MIS System is another example of ApaTech listening to our customers and bringing novel delivery devices to bone grafting."

Dr. Louis Jenis of The Boston Spine Group commented: "A growing number of less invasive procedures are being performed, reducing the impact of surgery on patients. The Actifuse(R) MIS System will play a key role in the delivery of high quality bone graft to difficult to access sites and help us to achieve our goal of successful fusion. The Actifuse(R) MIS System gives me the flexibility to respond to varying volume requirements and the ability to place graft precisely where I need it."

Notes to Editors:

About ApaTech

ApaTech specializes in producing synthetic bone repair material. It has operations in London, England, Foxborough, MA, USA, and Berlin, Germany, and is a world leader in bone graft technologies, selling its products in 33 countries around the world.

The Company has developed a novel silicate substituted calcium phosphate bone graft material, Actifuse(R), which underpins the Company's leadership in applying the science of silicon to bone graft technologies. Actifuse is the first of a new class of synthetic bone graft materials that combine osteoconductive, osteostimulatory and bioactive qualities resulting in accelerated bone growth.

ApaTech is backed by international investors, Encore Ventures and Healthcor and following its formation in 2001, the Company has raised more than $60m from investors.

ApaTech is committed to delivering shareholder value by using its scientific leadership to provide targeted solutions to physicians, allowing them to significantly improve patient outcomes.

ApaTech has received several corporate business and research awards, including the Frost & Sullivan '2009 North American Biologics Company of the Year' as a result of its success in the US orthobiologics market. More recently, ApaTech was awarded 3rd place in the UK Deloitte Technology Fast 50 (2009), in addition to being recognized as Britain's fastest growing medical technology company 3 years running in 2009, 2008 and 2007 by the Sunday Times (London) Fast Track 100 fastest growing private companies review.

More details can be found at http://www.apatech.com

About Actifuse

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 both autograft and allograft. Actifuse stimulates 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.

Actifuse is available as a range of granule and microgranule formulations which include Actifuse E-Z Prep delivered in a granule applicator. Actifuse is also available as an Advanced Bone matriX; Actifuse ABX, in a standard applicator and now in a purpose designed minimally invasive applicator, the Actifuse MIS System.

Actifuse family of bone graft substitutes are CE marked and U.S. FDA 510(k) cleared for use as a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    Further Information:


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

        Waughton
        Robin Hepburn, +44-(0)-20-7796-9999
        rhepburn@waughton.com


SOURCE ApaTech




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