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EnBIO's OsteoZip™ is an HA surface. It is an alternative to all roughened surface technologies and, in particular, to plasma spraying technology - the work-horse for applying HA to all orthopaedic implants. The key value proposition is that the CoBlast™ process provides an HA coating using a less complex, manufacturing friendly, lower cost solution.
This technology will also be of interest to dental implant manufacturers where there is less adoption of HA coating and more traditionally a focus on the use of roughening technologies. The key value proposition to this industry is the offer of a superior surface (HA) at costs which are similar to those of roughening.
EnBIO's in-vivo (animal trials) and in-vitro experiments completed to-date and the data from them confirm that an OsteoZip™ surface has better bone fixation than any other osteoconductive surface.
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EnBIO has also placed two other osteoconductive surfaces, Fluroapatite and Bioglass, both materials which have superior osteoconductive benefits than HA for some applications. Flouroapatite contains fluorine and will be of particular interest to the dental implant market. Many dental implants fail because of loosening associated with bone degradation. Bioglass has been shown to improve osteointegration compared to HA in weak bone.
A full specification on the surface is contained in the Datasheet.
Advantages
- Most of the osteoconductive surfaces described are roughened titanium rather than an HA coating. It has been widely shown that an HA coating is the optimal osteoconductive coating available today. Therefore EnBIO's HA coating is fundamentally better than all the roughened surfaces described.
- It is a room temperature process. Therefore there is no alteration to the dopant material deposited, i.e. the HA is not heated and goes down in its pure form. With the Plasma Spray approach (the only other method used in volume to apply an HA coating in the orthopaedic metallic implant industry), the HA is heated and the implant coating ends up with calcium phosphate compounds which are resorbable. This disturbs the osteointegration process. The literature states that 22% of the HA placed using the plasma process is converted into these calcium phosphate compounds.
- It is a chemical free and vacuum free process. Many of the other processes use various chemicals
- It is a non-complex process. The majority of other techniques described earlier are complex (many require lasers).
- CoBlast™ has an attractive cost base, i.e. both the application system and the process. The 3D/metal foam/laser techniques described do offer excellent bone fixation but both the process and the equipment are extremely expensive and complicated.
- As a new technology it opens the door for the implant manufacturer to create unique high-tech branding around the surface and its functionality.
- It is a stepping stone technology (HA > Antimicrobial > Drug Eluting). The HA coating is the foundation on which the other functionalities can later be added.
- There is no laminate layer - one interface (therefore it is not a coating), resulting in no delamination and no loss in strength relative to the bare metal.
- Using CoBlast™ as your surface modification technology should result in a fast track to regulatory approval. It utilizes known and regulated techniques, substrates, materials, and processes that have an extensive history of use on regulated devices.
- It is easy to integrate the CoBlast™ system into a manufacturing environment. The single CoBlast™ processing step (using conventional equipment) plus cleaning replaces five steps required to obtain an HA coating using the plasma spray, i.e. the CoBlast™ process integrates roughening and the application of the HA in one step. Additionally, the robotic and nozzle system used to apply HA means that it is possible to target the coating to specific areas and masking is not required. This leads to significant savings in production costs and is reflected in the Financial Section analysis.
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