LiquiGlide Announces FDA Device Master File (MAF) for Its Breakthrough Technology to Enable Accelerated Development of Medical Devices
Submission reflects the expansion of its biomedical division and enhanced quality offerings for future partnerships
CAMBRIDGE, Mass., June 15, 2021 /PRNewswire/ -- LiquiGlide, the inventors of a breakthrough technology that's revolutionizing products, packaging, processes, and patient experiences by eliminating the friction between solids and liquids, 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. In addition, it can 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 success, 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.
"This MAF is an exciting accomplishment for LiquiGlide," said Dan Rippy, Executive Vice President and General Manager of LiquiGlide Biomedical. "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 utilize 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 authorization to partner companies.
"We are pleased to have included a number of important performance parameters in our MAF submission, which underscore the utility of our patented technology," said Jonathan Zhang, Ph.D., Vice President of Research & Development for LiquiGlide Biomedical. "These include measurements of lubricity, biocompatibility, and occlusion reduction as well as animal testing demonstrating patency, safety, and antithrombogenicity."
LiquiGlide's Master File has been issued submission document control number MAF3464. To learn more about the LiquiGlide Device Master File, its contents, and discuss potential authorization for product registrations, please visit: https://liquiglide.com/industries/medical/.
About LiquiGlide
LiquiGlide commercializes a revolutionary technology that eliminates the friction between liquids and solids to allow liquids to flow with ease. Invented at MIT by Dave Smith and Professor Kripa Varanasi, its technology eliminates a fundamental design constraint that enables real, powerful breakthroughs across industries and transforms the way we manufacture and package viscous consumer and pharmaceutical products. LiquiGlide Biomedical aims to improve quality of life and patient care by reducing medical device complication rates and improving the processing and delivery of new drugs and biologics otherwise too viscous to be made or administered. To learn more about LiquiGlide, please visit: https://liquiglide.com/.
SOURCE LiquiGlide
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