First and foremost, what is Silicon Nitride (Si3N4)? It is a hard ceramic with an exceptional modulus of elasticity, it is inherently resistant to fracture and has superior wear resistance. It has been used in gas turbines, automobile engine components, and has been used in the main engine of the NASA Space Shuttle. This material has a ceramic substrate, a substance acted upon an enzyme, that produces a chemical change, acting as a catalyst, mimicking natural cancellous bone.
Amedica's claim to fame is developing Si3N4 for a Spinal Spacer that is 20% stronger than PEEK, it is radiolucent, and does not produce MRI or CT artifact. But the question must be asked; Has anyone in the industry had a problem with PEEK? If anything, INVIBIO needs competition to drive down the cost of their license, which is an estimated $225k over a three year period and material? Up until this point, they have had a monopoly. So what challenges does a company like Amedica face?
First of all, their product portfolio is made up of "me-too" products. Does the industry need another pedicle screw and cervical plate? Probably not! Though their interbody devices are manufactured with Silicon Nitride, to our knowledge, no one has complained about the performance of PEEK interbody spacers. There could be a potential financial advantage that this product could offer if this material is cheaper than PEEK. The TSB would be interested in knowing what the comparative cost is between these materials.
In closing, the rumor on the street, and that is strictly a rumor, is that this company has been challenged in developing traction in the marketplace. TSB is not sure that the newest addition to this company, Ben Shappley has the firepower to get the job done. The TSB wants to know what its readers know about this product and what they think?