The US Food and Drug Administration (FDA) has cleared Xenix Medical’s interbody fusion implants that feature the company’s proprietary nanotechnology.
Florida, US-based Xenix Medical developed nanotechnology for its neoWave line of interbody fusion implants – devices used for the treatment of degenerative lumbar disease.
In a statement announcing the 510(k) clearance from the FDA, Xenix Medical said it designed the nanotechnology, called NANOACTIV, to improve fixation to the adjacent bone. The company says its micro and nano-roughened surface has demonstrated the ability to elicit an endogenous cellular and biochemical response.
The neoWave implants themselves consist of a 3D-printed lattice, with Xenix Medical saying the matrix increases endplate surface area and resists subsidence compared to traditional implants. The company says more than 7,000 of its devices have been implanted in the US.
A market model by GlobalData estimates the spinal fusion device global market will be worth $11.1bn by 2033, with the interbody devices market segment contributing $5.4bn.
Justin Brown, associate professor of biomedical engineering at Pennsylvania State University, said in the company statement: “Our evaluation of the NANOACTIV surface technology revealed that the micro- and nanoscale features generated a bioinstructive interface that promoted robust osteogenic differentiation of mesenchymal stem cells.”
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By GlobalData
Nanotechnology is a promising area in medicine – with applications in areas such as cancer research, regenerative medicine and orthopaedics. The National Institutes of Health says it invests more than $200m a year in nanotechnology research.
In September 2023, the White House Office of Science and Technology Policy and the National Nanotechnology Coordination Office held a summit to discuss streamlining and advancing nanotechnology research.