DiFusion Activates Operating Board to Scale Therapeutic Biomaterials Platform

AUSTIN, Texas, Sept. 30, 2026 (GLOBE NEWSWIRE) -- DiFusion Therapeutic Biomaterials today announced the activation of a five-member operating board built to work alongside management as the company scales the therapeutic biomaterials category. Michael Callahan, Kevin Cordell and Stephen Bartol, MD, join Dan George, MD, and DiFusion founder and chief executive officer Derrick Johns on a board structured for active execution rather than passive oversight. Cordell has been elected chairman of the board.

The new composition aligns board expertise with DiFusion’s next phase: expanding adoption of FDA-cleared spinal devices made from ZFUZE, converting active OEM programs, strengthening quality and regulatory infrastructure, securing growth capital and advancing the company’s peptide-functionalization and therapeutic-ion pipelines.

“DiFusion no longer needs a board that observes the company from a distance. We need an operating board that can help management convert technology, evidence and OEM interest into disciplined scale. This group was selected because each director brings judgment and operating experience directly connected to the work in front of us.”
Derrick Johns, founder and chief executive officer, DiFusion

An operating board aligned with execution
The board combines materials-platform leadership, global medical-technology operating experience, spine innovation, clinical judgment, company building and capital formation:

• Michael Callahan. The former president of Invibio brings direct experience translating an implantable polymer platform into broad OEM adoption. His background is closely aligned with DiFusion’s non-exclusive licensing model and the commercial task of moving a differentiated biomaterial across multiple device companies and indications.
• Kevin Cordell, Chairman. Cordell brings more than three decades of medical-technology leadership across Wright Medical, Cordis and DJO. As chairman he adds operating discipline across commercialization, organizational scale, strategic partnerships and complex medtech markets, and leads a board that includes the company’s founder as chief executive officer.
• Stephen Bartol, MD. Bartol is an orthopedic spine surgeon, former Henry Ford Health System innovation executive and founder of Sentio, which was acquired by Johnson & Johnson in 2017. He contributes clinical judgment, product-development experience and the perspective of a surgeon who has built and exited a spine-technology company.
• Dan George, MD. George provides continuity, physician leadership and institutional knowledge as DiFusion moves from proving ZFUZE in cleared spinal applications to scaling a broader therapeutic biomaterials platform.
• Derrick Johns. Johns founded DiFusion and leads its category srategy, intellectual-property development, capital formation and OEM licensing model. He will continue to serve as chief executive officer and as a member of the operating board.
  
  
  

The board’s immediate priorities include OEM conversion, capital formation, quality-system and regulatory scale-up, commercialization of the current ZFUZE portfolio, and disciplined development of the peptide-functionalization and MITA pipelines.

Cleared devices now and programmable surfaces next
DiFusion’s lead biomaterial, ZFUZE, is already used in FDA-cleared spinal implants and is supported by two FDA Master Files, one for ZFUZE and one for the silver-functionalized formulation, together with two 510(k) clearances and mechanistic, preclinical, animal and human evidence. Based on company distribution records, devices made with ZFUZE have been used in more than 5,500 procedures. DiFusion’s commercial model is broad, non-exclusive OEM licensing rather than operation as a conventional implant company.

The next expansion of the platform is peptide functionalization: a manufacturing process designed to place selected biological signals at defined locations on an implant surface. The process begins with controlled surface preparation, uses plasma or corona discharge to activate the polymer interface, and then covalently attaches a selected peptide. This approach is intended to create a stable interface that presents bioactive signals while preserving the underlying material and mechanical properties.

DiFusion has a manufacturing-process patent application published in July 2025 and pending, together with three embodiment provisional patent applications. The portfolio is designed to protect both the surface-functionalization process and product-specific uses, including the potential for location-specific or zonal presentation of different peptides on a single implant.

In recent in vitro work, the leading RGD-functionalized ZFUZE condition, ammonia pretreatment followed by corona discharge and RGD, produced roughly a sixteen-fold increase in day-three cell response against untreated ZFUZE, measured by metabolic-activity assay in Saos-2 osteoblast-like cells. A second condition produced roughly an eleven-fold increase. DiFusion is advancing confirmatory testing, surface characterization and attachment-retention work before translating the platform into product claims.

“ZFUZE established that the bulk material itself can participate in healing. Peptide functionalization gives us a path to program the tissue interface for a specific biological task. The strategic progression is from a therapeutic material to a therapeutic materials platform.”
Derrick Johns

MITA adds therapeutic ions within the material
DiFusion’s MITA program extends the platform through therapeutic ions incorporated into formed components. Development programs include magnesium, strontium, copper, zinc and silver, allowing the company to investigate material-level functions such as osteogenic signaling, tissue support and biofilm inhibition. The silver-functionalized formulation is supported by its own FDA Master File, the second of the company’s two, with dental applications as the lead commercial target.

In a double-blinded Clemson University MRSA challenge study, silver-doped zeolite ZFUZE screws and PEEK control screws were placed through the spinous process in the same animals. No biofilm was observed on the ZFUZE screws despite a direct 1,000 CFU MRSA inoculation at implantation, while the paired PEEK controls were colonized. Histology was reported to show maintained bone integration at the implant interface. These animal findings support continued development of the silver program and are not a cleared antimicrobial indication.

Together, peptide functionalization and MITA create two complementary development paths. Peptides are designed to present selected biological signals at defined surface locations. MITA is designed to place therapeutic ions within the formed material. Both programs build from the same operating premise as ZFUZE: the material should do more than occupy space and tolerate the body; it should be deliberately engineered to participate in a defined biological objective.

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
[email protected]

Regulatory and evidence notice. FDA clears finished medical devices, not materials. Material-level and preclinical findings described here are not device indications for use. The peptide-functionalization and therapeutic-ion programs are investigational and are not cleared or approved for any indication. The reported peptide results are in vitro findings measured against untreated ZFUZE by metabolic-activity assay and require confirmation and further characterization. The Clemson result is from an unpublished animal model, data on file, and does not establish clinical effectiveness. ZFUZE® is a registered trademark of DiFusion Technologies, Inc.

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