DiFusion Therapeutic Biomaterials Activates Operating Board to Scale Platform

AUSTIN, Texas, Sept. 30, 2026 /CourierPR/ -- DiFusion Therapeutic Biomaterials has announced the activation of a five-member operating board aimed at scaling the company's therapeutic biomaterials platform. The new board, which includes Michael Callahan, Kevin Cordell, and Stephen Bartol, MD, alongside Dan George, MD, and the company’s founder and CEO, Derrick Johns, will work closely with management to drive the company’s next phase of growth.

Cordell, who has been elected chairman of the board, brings extensive experience in medical technology from his roles at Wright Medical, Cordis, and DJO. His background in translating implantable polymer platforms into broad OEM adoption aligns well with DiFusion’s non-exclusive licensing model.

Bartol, an orthopedic spine surgeon and former innovation executive at Henry Ford Health System, adds clinical judgment and product development experience to the board. His role as the founder and CEO of Sentio, which was acquired by Johnson & Johnson in 2017, provides a unique perspective on building and exiting a spine-technology company.

Dan George, MD, provides continuity and physician leadership as DiFusion moves from proving ZFUZE in cleared spinal applications to scaling a broader therapeutic biomaterials platform. George’s institutional knowledge and experience will be crucial as the company advances its peptide-functionalization and therapeutic-ion pipelines.

The new 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.

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 a mechanistic, preclinical, animal, and human evidence portfolio. Based on company distribution records, devices made with ZFUZE have been used in more than 5,500 procedures.

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.

MITA, DiFusion’s other 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.