By Nanovis
Nanovis® maintains a robust intellectual property portfolio consisting of several owned or licensed patents. All nanoVIS Ti™ Surface Technology components are protected by a series of patents. Additionally, the proprietary process used to produce our unique surface is safeguarded by multiple trade secrets. Nanovis® has achieved several significant regulatory milestones: NanoVIS Ti™ Surface Technology is the only widely available platform nanotechnology to achieve FDA’s nanotechnology designation. We are the first company worldwide to obtain FDA clearance and nanotechnology designation for a pedicle screw system. We are the second company worldwide to receive FDA clearance and nanotechnology designation for an interbody fusion cage. The Master File for nanoVIS Ti™ Surface Technology has been referenced for multiple 510(k) clearances across two different product types in spine. The application of nanoVIS Ti™ Surface Technology utilizes a validated manufacturing process that can fit within any supply chain. The flexibility of our proprietary process allows for the support of a wide range of quantities, both large and small, in an economical way. Clinical Advantages - FDA nanotechnology designation. First company in the world with designation on PEEK + Ti interbodies (CP Ti) and Open/MIS pedicle screws (ELI Ti). - Statistically significant and superior comparative surface data in the label – hMSC mineralization and osteoblast mineralization at 21 days, in vitro. Commercial Benefits - On-label marketing for superior positioning and messaging. - Superior FDA label used to drive new surgeon conversions, hospital approvals, and technology price premiums. - Surface-on-a-surface story — add a nano surface to a macro-porous 3D-printed surface or a micron-roughened base. - Surgeon engagement at a scientific and innovation level, enabling studies, papers, podium presentations, etc.
