Bio-Gate Reaches Milestone With Clarification Of FDA Approval Process For Coating Technology HyProtect ™
Bio-Gate AG (ISIN DE000BGAG981), a leading provider of antimicrobial products and multifunctional surfaces for medical devices, has completed a pre-submission application to the FDA for its HyProtect™ coating technology. HyProtect™ is an ultra-thin plasma coating of pure silver and polysiloxane that protects the surfaces of medical implants from bacterial colonization.
Bio-Gate has identified the regulatory approval route for HyProtect™ via the FDA’s pre-submission process. For certain orthopedic products, a 510(k) approval pathway without human data is, according to the FDA, possible. Bio-Gate collaborates with orthopedic companies interested in commercializing HyProtect™ technology in the US and European markets.
In addition, Bio-Gate made good progress in the area of HyProtect™ coating of custom-made products and healing trials. In the past 2 years, more than 15 patients in Germany, Australia and New Zealand have been treated with HyProtect™-coated implants. With none of the cases an infection occurred afterwards. Several cases are published scientifically.
You can find the complete article in German at this address.