THE ZFUZE® ADVANTAGE

One Material. A Biological
Chain of Events.

Anionic Surface
Anionic Surface
ZFUZE begins with a hydrated, negatively charged material interface.
Protein Organization
Protein Organization
The surface is designed to influence how beneficial proteins organize and present themselves.
Cell Recognition
Cell Recognition
Cells recognize the material and begin to respond to its surface signals.
Healing Biology
Healing Biology
This leads to tissue regeneration and a healing biological response.

Watch Our story

Dr. Badylak serves on DiFusion’s Scientific Advisory Board.

THE SCIENCE BEHIND ZFUZE®

Three properties. One biologically active interface.

ZFUZE®'s permanently anionic surface chemistry orchestrates the earliest events of healing, guiding biological
interactions from protein organization through durable bone regeneration.

THE FOUNDATION

Anionic surface charge

ZFUZE® creates a permanently anionic
surface designed to influence the earliest
interactions at the material interface.

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THE INTERFACE

Hydrophilicity

A water rich interface supports the
organization and presentation of proteins at
the ZFUZE® surface

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THE RESPONSE

Host Response

ZFUZE® is engineered to influence the host response toward a more constructive, pro healing environment.

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Two FDA 510(k) Clearances

K190544 PLIF / TLIF

10+ Years of Research
Human Outcomes

From Mechanism to Human Outcomes.

ZFUZE shifts macrophage behavior toward a pro-reparative response.

/ McGowan Macrophage

ZFUZE shifts macrophage behavior toward a pro-reparative response.

TIER

Mechanistic View the Evidence
Osteogenic gene and protein expression up (BMP-7, osteocalcin, ALP).

/ McGowan Osteogenic

Osteogenic gene and protein expression up (BMP-7, osteocalcin, ALP).

TIER

Mechanistic View the Evidence
New bone forms directly on and through the material (rabbit, micro-CT at 8 weeks).

/ DaVinci Critical-Size Defect

New bone forms directly on and through the material (rabbit, micro-CT at 8 weeks).

TIER

Preclinical View the Evidence
Pro-inflammatory cytokines reduced versus PEEK (IL-1 beta down 88%, IL-6 down 41%).

/ Cheng Ovine

Pro-inflammatory cytokines reduced versus PEEK (IL-1 beta down 88%, IL-6 down 41%).

TIER

Peer reviewed · Spine 2023** View the Evidence
92.3% interbody bridging at month 8 across 39 levels.

/ Medical Metrics CT

92.3% interbody bridging at month 8 across 39 levels.

TIER

Human · Independently adjudicated View the Evidence
94.6% fusion across 498 evaluable levels; independent CT ratification underway.

/ Comparative Clinical Series

94.6% fusion across 498 evaluable levels; independent CT ratification underway.

TIER

Human · Surgeon reported View the Evidence

Keep the platform. Rethink the material.

ZFUZE machines and molds like the polymers you already run, so it drops into existing geometries, instruments and
technique. An FDA Master Access File, validated by device clearance, ready to reference in your submission.

For OEM Partners
/ 01

Integrate

Bring ZFUZE® into established implant platforms while maintaining familiar product designs, instrumentation, manufacturing processes, and existing commercial workflows.

/ 02

Manufacture

Manufacture ZFUZE® using bulk rod stock, injection-moldable pellets, or 3D printing filament to support a range of established production methods.

/ 03

Differentiate

Create a stronger commercial story with a therapeutic biomaterial supported by mechanistic, preclinical, peer-reviewed, and human clinical evidence.

Engineering Materials to Participate in Healing

Therapeutic biomaterials are designed to interact with biology at the implant interface, influencing the earliest events that shape the healing environment.

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Engineered for the Biology of Healing

ZFUZE is a load bearing therapeutic biomaterial designed to organize the healing environment at the implant surface rather than sit passively inside it.

Explore ZFUZE® Science

From Mechanism to Human Outcomes

Follow the evidence across mechanistic, preclinical and human studies, from early cellular response through bone formation and clinical outcomes.

Explore the Evidence

Bring Therapeutic Biomaterials Into Your Platform

Explore how DiFusion partners with medical device companies to bring differentiated biomaterial technology into existing and next generation product platforms.

Explore OEM Partnerships

The Science Behind the Implant

Explore the biology, evidence and clinical experience behind ZFUZE and its approach to the implant healing environment.

Orthopedic Surgeons

Programmable Therapeutic Ion Delivery

Explore DiFusion investigational MITA platform and the development of programmable ion exchange technologies for future biomaterial applications.

MITA Pipeline

Expanding the Biological Interface

Explore DiFusion investigational peptide platform and the development of surface bound biological functionality for future applications.

Peptide Pipeline

Regenerative Medicine

DiFusion investigates how biomaterial surfaces influence protein organization, cellular recognition, and biological responses associated with healing.

Clinical Evidence

Human clinical evidence includes independently adjudicated CT assessments and surgeon-reported outcomes from spinal interbody applications.

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Surgical Solutions

ZFUZE® has been incorporated into cleared spinal interbody devices, with additional orthopedic applications under development.

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Research Partners

DiFusion's research includes independent clinical imaging assessments, peer-reviewed animal studies, and investigations into biomaterial interactions with cells.

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Company Overview

DiFusion develops therapeutic biomaterials that combine material science, biological research, and clinical evidence for medical device applications.

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Bone Integration

ZFUZE® supports bone integration through engineered surface properties, with osteoconductive performance investigated in preclinical and human studies.

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Preclinical Studies

Preclinical research examines inflammatory markers, bone response, and implant integration using laboratory and animal models.

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Manufacturing

ZFUZE® can be machined from rod stock or molded from pellets for integration into medical device designs.

Implant Platforms

ZFUZE® is designed for integration into existing implant geometries, instruments, and surgical techniques.

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Careers

Learn about DiFusion's work advancing therapeutic biomaterials and opportunities to contribute to its scientific and technology development.

View Openings