Biocoat Earns Patent for PFAS-free Coating for Medical Devices

A PFAS-free hydrophilic medical coating designed for use in the inner diameters of catheters and other devices has earned a patent for Biocoat Inc.

Biocoat’s patented Lumen Coating Method and Apparatus is a thermal-cure hydrophilic coating engineered specifically for use in the lumen, or inner diameter, of devices used in many medical specialties, including cardiology and neurology.

PFAS-related health concerns

Concerns have been raised over PFAS, or per- and polyfluoroalkyl substances, which are long-lasting chemicals that break down slowly over time. According to the US Environmental Protection Agency, studies have shown that exposure to PFAS could be linked to harmful health effects in humans and animals. PFAS have been found in the blood of people and animals worldwide and are present in low levels in some food products. Thousands of PFAS chemicals are found in consumer, commercial, and industrial products.

"This patent is a testament to Biocoat's commitment to developing innovative and responsible technologies that address the evolving needs of the medical device industry," said Jim Moran, president and CEO at Biocoat. "Our unique, hydrophilic, non-PFAS coating technology is a game-changer for devices that require the coating of internal surfaces like catheter lumens. This innovation will give medical device manufacturers coating options that align with global efforts to reduce reliance on PFAS materials."

Related:Battelle Helps Medtech OEMs Navigate PFAS Regulations

A lubricious and durable coating

Biocoat’s new material exhibits superior lubricity, durability, and low particulate counts, added Bob Hergenrother, vice president of research, development, and innovation at Biocoat. The technology’s lower curing temperatures don’t affect common polymer substrates, he added, noting the technology has been used for more than 30 years in hundreds of 510(k)-approved products. The FDA’s 510(k) pre-market notification clearance process lets the agency determine whether a new device is equivalent to an existing device in one of three categories.