Bio-Gate clarifies FDA regulatory pathway for HyProtect™

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Bio-Gate AG, concluded a pre-submission with FDA regarding its HyProtect™ coating technology, which is an ultrathin plasma coating containing pure silver and polysiloxane that protects the surfaces of medical implants against bacterial colonization.

Via the FDA’s pre-submission process, Bio-Gate clarified the regulatory paths. For a certain range of orthopaedic products, a 510(k) pathway without human data is possible. Bio-Gate is in collaboration and communication with orthopaedic companies interested in the commercialization of the HyProtect™ technology in the US and European markets.

Located in Nuremberg, Germany, Bio-Gate AG is an ISO 13485 certified contract service provider for medical devices that include HyProtect™ and MicroSilver BG™ technologies, and the ISO 17025 certified subsidiary QualityLabs, a laboratory for biological and chemical testing.

About Bio-Gate AG
The medical technology company Bio-Gate AG develops and markets applications which use unique silver technology to help prevent infections and thus to improve health. Bio-Gate AG’s specialty is using pure silver to treat materials and surfaces that are used in all areas of daily life – thus providing long-term and medically effective protection against bacteria, microorganisms and other pathogens. Bio-Gate AG works in three fields to supply a variety of products that provide antimicrobial protection: material enhancement, surface coating and testing the antimicrobial or anti-adhesive properties of materials. The Nuremberg-based company offers systems that stretch across the entire value-adding chain, from development to approval to production. For more information, please visit www.bio-gate.de.

Bio-Gate AG
Neumeyerstr. 28-34
D-90411 Nürnberg
www.bio-gate.de

Disclaimer:
This publication constitutes neither an offer to sell nor an invitation to buy securities. The shares in Bio-Gate AG (the «Shares») may not be offered or sold in the United States or to or for the account or benefit of «U.S. persons» (as such term is defined in Regulation S under the U.S. Securities Act of 1933, as amended (the «Securities Act»)). The securities have already been sold.



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