Novel medical-grade nanosilver technology instrumental in healthcare
In Q2 2021, HeiQ acquired RAS AG (DE), and thereby secured agpure, an ISO 13485 certified medical grade nanosilver technology platform, selected as the world standard reference material for nanosilver by the Organisation for Economic Co-operation and Development (OECD), under the code NM-300, and the European Food Safety Agency (EFSA).
As the OECD and EFSA reference nanosilver material, agpure is at the forefront of international research, production and development, in applications ranging from medical research to textiles and even food safety. EFSA recently showed that the agpure silver nanoparticles do not leach from embedded polymers, do not migrate, and resist release by abrasion – thus minimizing unintentional exposure and toxicological concerns.
HeiQ is pleased to have received written confirmation by the United Kingdom Biocides Division that nanosilver and products containing nanosilver in Product Type 2, 4 and 9 will remain on the UK market independent of the European Union Brexit. Further we are proud to announce that plating systems coated with agpure nanosilver for the prevention of recurrent infection at bone implant sites developed with our German partner AAP Implantate were awarded ethical and regulatory approval for a clinical study by the German Federal Institute for Drugs and Medical Devices (BfArM).
Three implanted patients have already shown no surgical site infection or signs of incompatibility. HeiQ and AAP will work jointly to complete the clinical study, and expect to receive CE approval in Q1 2022. In collaboration with its German partner BHS Medical Solutions GmbH, our joint silver nanoparticle product AgSept® has been approved to be used as drug in treatment of severe COVID-19 patients in an investor-initiated study with 40 patients by the Indian ethical committee.
HeiQ has initiated the process of technology licensing with pharmaceutical players. Together with our partner, approval for an emergency use authorization for India is aimed and anticipated by the end of the year. HeiQ recently launched HeiQ SanPure, a durable nanosilver-based antimicrobial and antiviral coating to reduce the risk of nosocomial infections, pathogen- and multi-resistance development in healthcare facilities.
HeiQ SanPure was studied in a project sponsored by the German Federal Ministry of Education and Research through the Research for Civil Security, conducted with the University Hospital of Regensburg. HeiQ is proud to be using novel medical-grade nanosilver technology to save lives, protect hospitals and patients, prevent food spoilage and waste, and contribute to better hygiene in critical pandemic scenarios. We are confident that our technology platform of medical grade nanosilver and nanosilver-derived coatings will be instrumental in the healthcare environment going forward.
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