Why medical device coatings need a PFAS-free alternative
The EU is tightening PFAS rules, and medical device coatings are in scope
LipoCoat® mimics living cell membranes. A single bilayer measures about 5 nm and stacks to the thickness your device needs.
The European Union is considering a strict ban on over 10,000 PFAS chemicals due to their risks to the environment and human health. For the medical and pharmaceutical sector, the challenge is to find safe alternatives. LipoCoat helps you future-proof your portfolio with a bio-inspired coating that offers comparable performance specs, without the risk of regulatory bans.
Our platform technology has been evaluated according to ISO 10993-1. The formulation contains no active pharmaceutical ingredients, PFAS or silicones, and LipoCoat® acts as a passive, biocompatible barrier. Because the coating adds no active substance, your device stays on the regulatory route it follows today.
Of our coating formulations contain PFAS, silicones or active pharmaceutical ingredients.
Coatings that release silver ions, antibiotics or other biocides lower the bacterial load at first. As the release rate drops, surviving bacteria are exposed to sub-lethal concentrations, which is the condition under which resistant strains develop. Antimicrobial resistance is now treated as a public health priority, and a device that carries an antimicrobial substance follows a heavier regulatory route than a device that does not.
LipoCoat® takes the other route. It forms a passive hydration layer that reduces adhesion of proteins and bacteria without releasing any substance. Nothing leaches, nothing is consumed, and there is no mechanism through which the coating drives antimicrobial resistance.
No active substance, nothing that leaches, and no pathway to antimicrobial resistance.
Active coatings carry a risk that grows over time
Protect the device for its full service life without adding an active substance
How to find the best alternative for PTFE, PVP and Silicones?
LipoCoat® offers a bio-inspired alternative that enhances lubricity and is thinner than conventional coatings available on the market.
Coatings are applied to medical devices to increase lubricity, improve maneuverability, and minimize tissue trauma. However, traditional materials such as PTFE, PVP, and silicone carry a structural risk: they can detach from the substrate. This coating separation (flaking or particulate shedding) poses serious patient safety risks, prompting regulatory agencies like the FDA to issue safety communications regarding these lubricious coatings.
LipoCoat® offers a bio-inspired alternative to PTFE, PVP and silicone coatings. Our platform technology uses a nanothin lipid-based coating free of PFAS, silicones and active pharmaceutical ingredients. The coating attracts water molecules, forming a smooth and stable hydration layer that delivers surface lubricity.
Our multi-layer coating technology allows for thicknesses starting at 5 nm and can be built up to thicker layers, customized to your needs.
A platform technology powered by biological intelligence
LipoCoat® technology is engineered to mimic the human cell membrane. By combining cell biology with nanotechnology, we developed a coating that is free of PFAS, silicones and active pharmaceutical ingredients. LipoCoat® technology generates a thin hydration layer on your medical device, working as a shield that reduces pathogen and protein adhesion.
Interested in enhancing your portfolio with our platform technology? Compare our mechanical and biological properties with existing industry standards by downloading this comparison table.
An medical coating that is suitable for various clinical applications
Tailored to your specific application
Whether you need a thinner, smoother finish, or enhanced wettability and lubricity, we understand that every application has unique requirements. Thanks to the LipoCoat® platform technology, we can tailor our coatings to your exact specifications without altering the device's underlying mechanical properties or dimensions.
Catheters
LipoCoat® catheter products provide a passive, drug-free solution that reduces biofilm formation, improves blood compatibility and lowers surface friction.
Needles
LipoCoat is the biological alternative to (traditional) silicone coating used on needles.
Contact Lenses
LipoCoat contact lens products are aimed at improving comfort and safety properties of the contact lens materials by increasing surface wetting, increasing surface lubricity and reduce surface contamination by reducing deposits and bacterial build-up on the lens material.
Versatile medical coating solution
Our technology replaces persistent chemicals and active drugs with a passive, biocompatible barrier, creating a more durable coating
Safe by design: forms a passive hydration layer that reduces adhesion of pathogens and proteins on the device surface.
ISO 10993 validated: Fully tested and passed all relevant biocompatibility tests
Non-Animal Components: The coating is derived exclusively without animal products.
Non-Thrombogenic & Hemocompatible: It significantly reduces hemolysis, platelet activation, and protein adsorption (such as fibrinogen and albumin),
Fouling reduction
Anti-fouling defense
Compared to uncoated control samples, LipoCoat®-treated surfaces sustained near-complete inhibition of biofilm formation for up to 29 days under continuous exposure.
Tailormade coating thickness
LipoCoat medical coating can be customized from a 5-nanometer monolayer to a thicker multilayer medical coating.
Coating thickness
API, Si and PFAS
Bio-Inspired medical coating technology
LipoCoat® works as a passive physical barrier that reduces pathogen and protein fouling. It contains no active substances, so nothing leaches and there is no pathway to antimicrobial resistance.
Easy to integrate
In your production process
LipoCoat® can be integrated on top of your existing product portfolio without the lengthy pharmaceutical classification processes. Furthermore, the coating requires no specialized handling, utilization, or disposal protocols, facilitating seamless integration into existing manufacturing workflows.
Documented for your submission
Full ISO 10993-1 programme passed, with test reports available for your technical file
Low barrier to entry
No curing or complex equipment required
FAST dip-coating process
Compatible with standard dip coating at room temperature.
Low material usage
Minimal material consumption during application.
FAQ
The most frequently asked questions about the LipoCoat® platform technology.
Traditional medical coatings typically rely on thick synthetic polymer matrices (such as PVP or PTFE) or active leaching biocides (such as silver ions or antibiotics). In contrast, LipoCoat® is a bio-inspired technology that mimics the natural phospholipid bilayer of human cell membranes and uses whole lipids and lipid derivatives. It turns the device surface into a passive anti-fouling interface that reduces adhesion of proteins, platelets and bacteria.
The nanoscale structure is a major engineering advantage. The coating attracts water molecules to form a dense, stable hydration layer. Because LipoCoat® is bound at the molecular level rather than applied as a thick, brittle polymer film, it is designed to minimise delamination, cracking and particulate generation (flaking), a common point of failure flagged in FDA safety alerts for traditional lubricious coatings. Particulate behaviour is verified for your device and substrate during testing, and durability is tuned through coating composition and layer thickness.
The LipoCoat® technology platform offers broad surface compatibility across a wide range of medical materials, including:
Polymers: Polyurethane (PU), Polyvinyl Chloride (PVC), Silicone, PEBAX, PEEK, Nylon, Hydrogels, and Silicon-hydrogels.
Rigid Substrates: Rigid Gas Permeable (RGP) contact lens materials and metallic/ceramic components.
Primary device applications include central venous catheters (CVCs), peripherally inserted central catheters (PICCs), Foley/urological catheters, contact lenses, vascular access sheaths, and implantable medical components.
Because LipoCoat® is applied at a nanoscale thickness, it has virtually no impact on the mechanical specifications, wall thickness, outer diameter (OD), inner diameter (ID) or fluid flow dynamics of your device. Dimensional impact is confirmed on your device during feasibility testing.
LipoCoat® is designed for scalable manufacturing integration. The application process is a single-step dip-coating method that operates under mild ambient conditions. It requires no UV curing, thermal polymerization or complex chemical cross-linking steps. Process parameters and coating thickness control are programmed into the molecular formulation, so OEMs can upgrade existing production lines without capital-intensive facility re-engineering.
LipoCoat® has been evaluated according to ISO 10993 and passed the applicable endpoints for the device categories tested. The coating contains no antimicrobial compounds and no leaching substances, so it does not create a pathway for antimicrobial resistance (AMR).
Still have questions?
Please contact us to discuss your project.