DiFusion to Define Therapeutic Biomaterials Category at NASS 2026

AUSTIN, Texas, Sept. 29, 2026 (GLOBE NEWSWIRE) -- DiFusion Therapeutic Biomaterials today announced that it will use the North American Spine Society 2026 Annual Meeting in San Antonio, October 14-17, to define an emerging orthopedic category: therapeutic biomaterials.

Neil N. Patel, MD, MBA, FAAOS, a Dallas spine surgeon, will present “Evolution of Biomaterials: Inert to Therapeutic” in the NASS Red Theater on Friday, October 16, from 12:30 to 12:50 p.m. The DiFusion-sponsored session will trace the progression from titanium, which established structural strength, to PEEK, which added radiolucency and a modulus closer to bone, and then to materials deliberately engineered to influence biology at the implant-tissue interface.

Conventional implant materials were developed to be biotolerable: mechanically capable and sufficiently tolerated to remain in the body. Therapeutic biomaterials establish a higher standard. They are engineered to influence the host response toward a defined therapeutic objective, including the macrophage phenotype and signaling environment present at the interface, downstream osteoblast activity and tissue integration.

“The question is no longer whether the body will tolerate the material. The question is whether the material is helping the patient heal. Therapeutic biomaterials begin where biotolerance stops: at the deliberate engineering of the host response.”
Derrick Johns, founder and chief executive officer, DiFusion

From passive tolerance to biological participation
Every implanted material initiates a biological response. The consequential question is not whether a response occurs, but what kind of response develops and what follows from it. The interface may progress toward integrated bone and constructive remodeling, or toward persistent inflammation and fibrous tissue. A therapeutic biomaterial is therefore evaluated not only by mechanical performance and traditional biological safety, but also by the biological environment it is designed to support.

DiFusion’s ZFUZE® biomaterial provides the company’s commercial proof point for this category. ZFUZE is a proprietary bioactive composite used in FDA-cleared spinal implants. It preserves the imaging advantages, handling characteristics and bone-compatible mechanical profile associated with polymer implants while addressing the historical biological limitation of conventional PEEK through evidence supporting bone formation and tissue integration.

An evidence chain centered on early healing
DiFusion’s category thesis rests on directionally aligned evidence across mechanistic, preclinical, animal and human settings. The datasets differ in design, endpoints and evidentiary weight. They are reported separately and are not pooled.

• Mechanism, McGowan Institute for Regenerative Medicine. In macrophage and osteoblast assays conducted in the laboratory of Stephen Badylak, DVM, PhD, MD, ZFUZE demonstrated reduced iNOS, increased FIZZ1 and increased osteogenic markers relative to the tested conventional PEEK and nano-textured titanium controls. The results support a phenotype and signaling environment associated with constructive remodeling; they do not reduce macrophage biology to a binary M1/M2 switch or independently establish a clinical therapeutic effect.

• Preclinical, rabbit critical-size defect model. In a defect designed not to bridge spontaneously, bone formation was observed across the ZFUZE material. The finding supports an association with osseoconductive behavior in this model without reliance on a porous cage architecture.

• Animal, nonplated ovine cervical model. In the peer-reviewed Cheng et al. study, ZFUZE demonstrated significantly lower IL-1 beta and IL-6 than PEEK at 26 weeks. The study used no anterior plate, allowing the implant-tissue interface to be evaluated under load. Cheng B. et al., Spine. 2023;48(16):1174-1180.

• Human, independently reviewed CT pilot. Medical Metrics, Inc. reported a 93.2% fusion rate at six months using CT-based assessment, with no patients excluded from the analysis. Fusion required endplate-to-endplate bridging bone. This independently adjudicated pilot is reported separately from the expanded comparative series.

• Human, expanded comparative TLIF series. The retrospective, consecutive, non-exclusionary review included 498 operated levels in 364 cases across four interbody arms and retained smokers, patients with diabetes, patients with osteopenia and revision cases. In surgeon-reviewed results, ZFUZE led the four arms in per-level fusion at 94.6%, compared with 90.1% for PEEK, 86.7% for static titanium and 81.2% for expandable titanium. Grade 2 subsidence was 0.8%, 20.7%, 29.8% and 58.0%, respectively. A matched 27-pair analysis also favored ZFUZE over static titanium in definite subsidence and segmental lordosis. Independent third-party radiographic analysis is in progress, and the manuscript is in preparation.
  

The through line is early healing. A constructive host response may support earlier bone formation and biologic fixation during the period when the endplate and motion segment are most vulnerable. Earlier fixation may help preserve disc height, segmental lordosis and mechanical stability. The findings are directionally aligned across the evidence chain while remaining subject to the limitations, assessment methods and follow-up of each study.

“A category becomes credible when mechanism, animal performance and human outcomes begin to converge. The evidence now gives surgeons, researchers and OEMs reason to ask a more demanding question of every implant material: what is the material doing in the biology of healing?”
Derrick Johns, founder and chief executive officer, DiFusion

Designed for practical OEM adoption
DiFusion is building a therapeutic biomaterials platform, not a conventional implant company. Its commercial model is broad, non-exclusive OEM licensing. ZFUZE can be machined from bulk rod stock, injection molded from pellets or additively manufactured from filament. This manufacturing flexibility allows OEMs to introduce a differentiated material while preserving established implant geometries, instrument systems, surgical technique and commercial infrastructure. The result is a material-level innovation that does not require replacement of millions of dollars in deployed instrument sets.

The platform extends beyond the current ZFUZE formulation. DiFusion’s MITA program incorporates therapeutic ions, including magnesium, strontium, copper, zinc and silver, into formed components. A silver-functionalized formulation is supported by a separate FDA Master File and is being developed around a biofilm-inhibiting material property, with dental applications as the lead commercial target.

A second program uses plasma-enabled peptide functionalization to place bioactive signaling capability on selected implant surfaces. DiFusion has a published and pending manufacturing-process patent and three embodiment provisional patent applications supporting the program. Development work is evaluating location-specific peptide presentation for indication-specific biological function. The therapeutic-ion and peptide-functionalized programs remain investigational and are not cleared or approved for any indication.

About DiFusion Therapeutic Biomaterials
DiFusion Technologies, Inc., doing business as DiFusion Therapeutic Biomaterials, is an Austin, Texas-based platform company developing materials engineered to participate in the biology of healing. Its lead material, ZFUZE®, is used in FDA-cleared spinal implants and is supported by two FDA Master Files, two 510(k) clearances and a mechanistic, preclinical, animal and human evidence portfolio. Based on company distribution records, ZFUZE devices have been used in more than 5,500 procedures. DiFusion scales its platform through broad, non-exclusive OEM licensing.

Media contact
Scott Selby, PhD
DiFusion Therapeutic Biomaterials
scotts@difusiontech.com

Regulatory and evidence notice. FDA clears finished medical devices, not materials. Material-level biological findings described here are not device indications for use. Clinical results are reported from the named datasets and are not pooled. The expanded comparative series is surgeon-reviewed and is undergoing independent third-party radiographic analysis. Pipeline programs, including therapeutic-ion and peptide-functionalized variants, are investigational and are not cleared or approved for any indication. ZFUZE® is a registered trademark of DiFusion Technologies, Inc.