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ZFUZE™ Composite Polymer

ZFUZE is a composite polymer derived from PEEK and negatively (-) charged ceramic aluminum silicate molecules. ZFUZE is a hydrophilic load bearing medical polymer, that provides for bony ingrowth into the implant and affords the surgeon the ability to verify fusion radiographically.

CT SCAN PEEK

Micro Imaging vs PEEK Zeolite (ZfuzeTM)

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BIOmechanical testing

Shows Comparable Biomechanical properties to

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SEM

SEM Imaging of ZFuze

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CEll DATA

H&E Stain: PEEK vs PEEL Zeolite (ZfuzeTM) and Goldners Trichrome Stain.

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CT SCAN: ZFUZE vs PEEK

Greater bone ingrowth on ZFUZE 12 wks post-op

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BIOMECHANICAL TESTING

ZFUZE performs as well or better than PEEK on all indices

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ELEMENTAL MAPPING

ZFUZE’s unique topography (EDS/SEM map overlay)

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CELL DATA

Histology shows ZFUZE’s superior bone ingrowth without fibrous encapsulation

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Stephen Badylak McGowan Institute of Regenerative Medicine

ZFUZE™: Positive Immune response

A recent study done by Dr. Stephen Badylak’s team at the McGowan Institute for Regenerative Medicine compared macrophage expression changes in vitro with ZFUZE and PEEK. Dr. Badylak’s team has tested over 300 biomaterials using these same M1 to M2 immunomodulation assays. ZFUZE is the first and only man-made material that consistently demonstrated the ability to shift the M1 to M2 phenotype in a rapid and predictable manner at Day 4-5.

BASIC TITANIUM IMPLANTS

Recent studies have now shown that an inert polymer is less favorable to basic titanium implants in that there is “fibrous encapsulation” of the PEEK implants because it is an inert material and the body sees it as a foreign material (Rene Olivares-Navarrete et.al; SPINE 40, 6, 399-404). Surgeons have foregone the visualization and modulus of elasticity benefits of plain PEEK for a “negatively charged” surface of titanium.

ZFUZE device

ZFUZE is a patented PEEK Composite Polymer which is made by compounding various forms of negatively charged Zeolites into the PEEK polymer. This fundamentally changes the surface chemistry from inert as in PEEK to negatively charged as in titanium while preserving the visualization, modulus and strength benefits of PEEK.