As iGii moves deeper into health and diagnostics, biocompatibility has become a major focus. Many advanced materials perform well in the lab but struggle in clinical settings.
Alongside its high electrochemical performance and scalability, Gii now has a safety profile to make it a compelling choice for use in diagnostic devices that interact directly with the body.
(ISO 10993-17)
(14- and 28-day exposure)
In both in vivo and in vitro models, Gii showed no adverse biological effects. There were no signs of irritation, no allergic responses and no cytotoxicity. Sub-chronic exposure caused no histopathological changes and no observable harm.
This provides confidence for applications involving direct contact with the skin, mucosa or internal tissues including wearables, point-of-care diagnostics and implantable formats.
Biological compatibility depends on how a material interacts with cells as well as what it contains. Many carbon-based materials rely on solvents, catalysts or binders that can leach out and cause harm.
Gii is different. Its electrically powered process requires no chemical inputs, no heavy metals and no secondary purification. There are no reagents involved at any stage.
To verify chemical safety, we carried out a full extractables and leachables (E&L) study under ISO 10993-12 and 10993-18. This included exposure to polar, non-polar and semi-polar solvents to simulate a range of biological environments.
No compounds were detected above threshold levels. Trace elements were present at levels far below clinical concern. An independent toxicological risk assessment confirmed that Gii poses no toxicological risk under intended use.
Biocompatibility removes a major barrier to real-world application. It supports regulatory submissions and shortens product development timelines. It also enables the safe use of Gii in emerging diagnostic formats that require direct or repeated contact with the body. This includes wearable sensors, saliva-based diagnostics, veterinary tools and implantable biosensing systems.