Spinal fusion - new technology

Purpose and goal:

The aim was to create a safe and predictable method for spinal fusion surgery. A resorbable ceramic implant that is osteoinductive, ie the material stimulates bone formation, has been placed between vertebrae in an animal model. In the project, resorbable cages (spinal cages) have also been produced with 3D printing.

Analysis of regulatory landscape and path to market have been described. Expected results and effects:

The project has been successful; spinal fusion has been obtained without fixation of the vertebraewith metal implants. A company has been founded, with the aim to commercialize the technology;investors have been attracted.

Regulatory landscape and route to market have been analyzed in the project; the information wasimportant in the process of attracting investors.

Commercialization of the ceramic product is about to start. The project with the resorbable cages is still in a pure research phase. Approach and implementation: In an animal model, the ceramic implant was tested; material was placed between vertebrae. Examination with CT was done regularly; at postmortem, the tissue was further analyzed.

Consultants have been used to describe legal perspectives: requirements for quality assurance andthe regulatory affairs. Fully ISO-certified contract manufacturers have been used to manufacture products.