Clinical Need
A major and largely untapped market exists for a successful spinal bearing
implant which involves the replacement of a damaged spinal disc with an artificial
implant that allows full, pain-free movement of the vertebrae. Such an arthroplasty
(disc replacement) procedure has significant and obvious benefits over the
current arthrodesis (vertebrae fusion) procedure which impairs spinal movement
and often leads to collateral damage of adjacent vertebrae and soft tissue.
The size and growth potential of the market for an effective spinal disc implant
compares well with the tremendous growth realised with artificial hip implants
as the market transforms from arthrodesis to arthroplasty procedures.
Conventional compliant spinal discs for replacement procedures are currently either manufactured using a single hardness material (single durometer) or using two materials of different hardness with a lower modulus core and a higher modulus shell (dual durometer). The former requires an uneasy compromise in material specification to balance strength and wear resistance with compliance. The latter often generates in-use problems caused by a progressive failure along the material interface between the two components. RANIER Technology has addressed these concerns innovatively and developed a totally new approach to spinal disc design by developing a disc material with a graduated hardness from the hard external surfaces to the softer centre of the disc within one homogenous component. With our concept, which is essentially not new but cannot be produced with currently available manufacturing technology, it is possible to provide a graduation in material properties that will offer a seamless transition from one set of material properties to another (anisotropic). The ability to give this product its unusual properties arises from patented processes employed by RANIER and its academic collaborators.
Current Development
Status
The spinal implant is currently a core development programme for RANIER Technology.
Mouldings of materials with graduated modulus have been manufactured successfully
using our patented process and the development of the moulding shape and filling
techniques will be demonstrated in our next development phase. The work done
to date verifies our conceptual theory and gives us an extremely high assurance
of our capability to deliver products which meet our desired design parameters.
Intellectual Property
RANIER has submitted an international patent application covering the manufacture
of a variable modulus spinal disc.
Commercialisation
The market for this product is large. The worldwide spine market in 2001 was
estimated to be valued at $2.48 billion and projected growth indicates a future
market value of $5.13 billion in 2005 (source: Viscogliosi Brothers).
RANIER are currently looking for a strong partner, a market leader in the orthopaedic prosthesis field, who will achieve a significant market share of this sector with our product design.
