Overview
ApaTech is a world leader in synthetic bone graft technologies. Our mission is to provide surgeons with superior, proprietary, bone graft solutions, helping them improve clinical outcomes and patient quality of life.
ApaTech was formed in 2001 with the rights to bone materials research and IP from London and Cambridge Universities. The company retains pipeline agreements with founding inventors, including Professor William Bonfield, CBE and Queen Mary University of London. CE Mark and 510K clearance for its first bone graft substitute ApaPore and for Actifuse, a new class of bone graft material that combines osteoconductive and osteo-stimulatory activities, in a wide range of orthopaedic and spinal applications.
Actifuse is being used in Europe, the United States and Australasia for spinal fusions, bone tumor void filling, fractures and including use in the spine.*
The HQ and manufacturing facility are based in Elstree (Northwest London) England, with the U.S. operations located in Foxborough, MA, in the greater Boston area.
Technology
ApaTech's technology is based on initial research to engineer the optimum structure and chemistry for a safe, effective bone graft material that closely approximates natural bone, thus providing an osteoconductive scaffold for new bone growth. This led to the introduction of ApaPore in a range of tightly controlled porosities that provide different properties tailored to differing surgical applications.
This research has been extended to examine the effect of novel chemical formulations of calcium phosphate, the basis of all ceramic synthetic bone graft substitutes, on bone growth. This resulted in a new class of bone graft substitute, based on silicated calcium phosphate, called Actifuse. The company believes it combines the optimal scaffold and surface chemistry to facilitate fast and sustained bone ingrowth, since Actifuse combines osteoconductive and osteo-stimulatory activities.
In Actifuse, phosphate groups have been selectively replaced by silicate groups. This creates a material that, in addition to the clinically proven interconnected macro and microporous structural properties of ApaPore, enhances the deposition and function of the proteins involved in bone growth, thus stimulating rapid formation of bone and improving the subsequent organization and strength of the graft/host bone composite structure. Unlike a number of 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.
* In the U.S. Actifuse is a bone void filler intended only for orthopaedic 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, spine, and pelvis. 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.
Pipeline and Product Development
ApaTech is committed to fully demonstrating the clinical superiority of its technology and has a range of comparator clinical studies ongoing in multiple European countries and the USA. In particular Actifuse is being tested against the 'gold standard' bone graft material, autograft bone, rhBMPs and against other approaches.
The Company has a range of line extensions in development or pending regulatory approval, all aimed at making the surgeon's utilization easier and to extend the range of indications for the products.
In addition ApaTech has continuing in house and academic collaborations to develop a range of more biologically active ceramic bone graft substitutes, to develop weight-bearing applications and to develop composite polymer/ceramic and ceramic/biological entity products.
