Wednesday, October 11, 2023
Xēnix Medical, a company specializing in surgical implant development with a focus on innovative solutions for patients requiring spinal fusion surgery, is pleased to announce that it has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the nanotechnology classification of its neoWave™ line of interbody fusion implants, featuring their proprietary NANOACTIV™ surface technology.
This nanotechnology designation further enhances the credentials of the neoWave cervical and lumbar interbody devices with NANOACTIV surface, which have already seen over 7,000 successful implantations in the United States.
The NANOACTIV surface is micro and nano-roughened, specifically designed to enhance fixation to adjacent bone. It incorporates nano-scale surface features at the nanometer (10-9) level, which have shown an ability to trigger a cellular and biochemical response. This response is evident through the differentiation of human mesenchymal stem cells along the osteogenic lineage and the production of a mineralized matrix in vitro, as compared to an untreated surface. The NANOACTIV implant surface encompasses characteristics considered in the FDA's nanotechnology guidance document.
Prominent neurosurgeon Robert Hirschl, MD, Founder of Xēnix Medical, expressed, "Compared to previous generation interbody technologies I have used in practice, I have found that the neoWave implants provide the best opportunity to achieve a robust arthrodesis. Based on my clinical experience with these implants, I am confident that the distinctive fully porous implant design, extensive endplate contact area, and nano-scale surface play a pivotal role in helping patients attain the best possible clinical results. This not only reduces the occurrence of subsidence but also ensures favorable imaging characteristics. The FDA's recognition of the NANOACTIV nanoscale surface advantage over conventional 3D printed surfaces reinforces my findings and underscores this implant's unique position in its own class."
Justin Brown, Ph.D., Associate Professor of Biomedical Engineering at The Pennsylvania State University, added, "Our assessment of the NANOACTIV surface technology revealed that the micro- and nanoscale features created Aabioinstructive interface that stimulated strong osteogenic differentiation in mesenchymal stem cells. It is exciting to witness advancements in Ti6Al4V surface technology that mirror the bioinstructive features we aim to integrate into biomaterial scaffolds. In my view, the NANOACTIV surface technology has the potential to significantly enhance patient outcomes."
The neoWave interbody technology boasts a patented 3D-printed lattice design, offering structural superiority. This design increases endplate contact surface area and resistance to subsidence, all while reducing device stiffness without relying on a traditional implant framework or solid walls.
Ryan Phillips, President of Xēnix Medical, stated, "Securing FDA clearance for our neoWave interbody systems with nanotechnology marks a significant milestone and achievement for Xēnix. This accomplishment positions the neoWave implant systems within a distinct category, shared by only a select few companies in the industry. As we actively advance a comprehensive range of neoWave interbody devices, the integration of the NANOACTIV surface promises to be a predominant enhancement in future implant systems. The unique synergy between nanotechnology and a fully lattice-designed implant represents a profound advancement in the treatment of patients requiring interbody fusion. We are confident that this recognition underscores the potential of nanotechnology to enhance patient outcomes and elevate the standard of care.". This clearance is testament to our remarkable team who have dedicated years to the development and research of NANOACTIV."