LiquiGlide has announced that the U.S. Food and Drug Administration (FDA) has accepted a Device Master File (MAF) from LiquiGlide’s biomedical division for its novel, patented coating platform.
LiquiGlide’s friction-reducing, adhesion-preventing, safe, and environmentally friendly technology can be used to enhance the performance of a wide range of medical products, including vascular access and implantable devices; surgical products; medical device instrumentation and processing; biomedical packaging; and syringes, containers, and delivery systems for biologics, pharmaceutical therapeutics, and vaccines. It can also help reduce yield loss of high value medicines in the manufacturing and production process.
LiquiGlide recently announced partnerships with Colgate, which has launched Elixir in Europe, a new toothpaste brand featuring a LiquiGlide-enabled clear, recyclable package, as well as the Mibelle Group, a leading Swiss consumer, cosmetics, and pharmaceutical products company that is using LiquiGlide’s technology to reduce waste in its manufacturing process. Building on this, LiquiGlide is expanding its range of solutions for a multitude of applications in the biomedical domain, where laboratory and preclinical studies have shown that LiquiGlide can dramatically reduce thrombosis and biofilm formation.
Dan Rippy, executive vice president and general manager of LiquiGlide Biomedical, said: “This MAF is an exciting accomplishment for LiquiGlide. Our submission provides rigorous testing and analytical quality and makes it easier for our partner companies to integrate our technology into their workflows and obtain approval for new medical products that utilise LiquiGlide’s first-of-its-kind patented technology. We expect this MAF to be the first of many submissions that LiquiGlide Biomedical makes to the FDA.”
By adopting LiquiGlide’s technology, biomedical partners may significantly improve product performance, save costs, and improve patient outcomes. The MAF includes proprietary information regarding LiquiGlide’s coating formulation and processes that will help facilitate regulatory review of company partners’ product submissions, and LiquiGlide is able to provide letters of authorisation to partner companies.
Jonathan Zhang, vice president of research & development for LiquiGlide Biomedical, said: “We are pleased to have included a number of important performance parameters in our MAF submission, which underscore the utility of our patented technology. These include measurements of lubricity, biocompatibility, and occlusion reduction as well as animal testing demonstrating patency, safety, and antithrombogenicity.”
