Bio-Gate clarifies FDA regulatory pathway for HyProtect™

/ins Nuremberg, 29 January 2019 – 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.


Please contact for North America:

Karl F Richter

President

RFH BioTek Inc

27 Taylorwood Avenue,

Bolton, Ontario,

Canada  L7E 1J5

Phone:           +1-905-857-0219

Email:  rfh@rfhbiotek.com


Please contact for Europe:

Thomas Konradt

Director Business Development

Bio-Gate AG

Neumeyerstrasse 28-34

90411 Nuremberg, Germany

Phone:           +49 (0) 911 / 477523-108

Fax:               +49 (0) 911 / 477523-101

e-mail:    thomas.konradt@bio-gate.de


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.

 

Rating:

vote data

Let us know if you are going to use this press release. Thank you!

 

Company Information

Bio-Gate AG Logo


Bio-Gate AG

Neumeyerstrasse 28-34
90411 Nuernberg
Germany

Phone: +49 (0) 911 / 47 75 23 – 100

info@bio-gate.de
www.bio-gate.de

Press contact


Gerd Rückel
rikutis consulting 
gr@rikutis.de

presse@bio-gate.de

Phone: +49 (0) 6172 807309
Mobile: +49 (0)152 34221966

 







Company Information

Bio-Gate AG logo


Bio-Gate AG

Neumeyerstrasse 28-34
90411 Nuernberg
Germany

Phone: +49 (0) 911 / 47 75 23 – 100

info@bio-gate.de
www.bio-gate.de

Press contact


Gerd Rückel
rikutis consulting 
gr@rikutis.de

presse@bio-gate.de

Phone: +49 (0) 6172 807309
Mobile: +49 (0)152 34221966









About Bio-Gate AG


Bio-Gate AG is technology health company and is one of the world's leading providers of innovative technologies and individual solutions for health and hygiene, which can make living together safer, more carefree and healthier and improve the well-being of every individual. Bio-Gate specializes in providing materials and surfaces with antiviral and antimicrobial properties. Bio-Gate AG refines materials and products, especially in the field of medical technology, such as the coating of implants or wound dressings. In addition, Bio-Gate technologies are used to uniquely enhance topical wound care products, skincare and cosmetics, consumer and industrial products such as paints and varnishes and antimicrobial plastics.

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.

 

Publications