Tetratherix says the US Food and Drug Administration has accepted the core of its application to sell Tegenix, its bone regeneration product.
According to Tetratherix, the review confirmed the device classification, the nominated predicate device and the performance testing data. The company said the regulator has requested extra detail on basic chemical characterisation and final product labelling.
Tetratherix said it expected questions like this because Tegenix is built on its Tetramatrix platform polymer, which is entering the FDA pathway as a novel material. The company and its partners are now gathering the information they already have so they can respond quickly. Tetratherix called the update a material validation of both the submission and the platform.
Chief executive Will Knox said the regulator had gone to the heart of the application. "The FDA has examined the foundations of the Tegenix submission. Importantly, there were no questions raised on the classification, the predicate and the performance data. Those elements carry the substance of any 510(k), and for a new material they carry the most risk."
He said the remaining questions reflected how new the material is. "The Tetramatrix platform polymer is being reviewed for the first time by the FDA, its questions on chemical characterisation and labelling are the questions a careful regulator asks of something innovative. Our task now is to deliver our response with the same rigour and speed that brought the submissions this far."
"The timing of a clearance decision will rest with the FDA, and we look forward to reporting it to the market when it comes," Knox added.
