/INS. Nuremberg (Germany), Bio-Gate AG (ISIN DE000BGAG981), is a leading provider of antimicrobial products and multifunctional surface coatings for the medical device industry. Bio-Gate has successfully coated multipurpose stainless-steel bone plates for BioMedtrix, a US manufacturer of veterinary implants. Data from a patient observation on dogs will be presented in mid-October by BioMedtrix at the ACVS conference (American College of Veterinary Surgeons).

•    Multicentric 70 patient observation study
•    HyProtectTM coated implants demonstrate excellent biocompatibility and no infections

The Bio-Gate coated bone plates were used for veterinary medical care of family dogs. In the course of a 3-month US patient observation coated bone plates were implanted into 70 dogs during routine veterinary practice. The animals were discharged and sent home on the day of surgery. Therefore healing took place under usual home conditions and not under the protected and hygienic conditions of a veterinary practice.

Surgeries were carried out at seven veterinary medical institutions. Postoperatively the animals were monitored for further 3 months. With positive results: There was no case of an infection, nor could other adverse effects or implant-associated afflictions be diagnosed. The infection rates for such type of surgical interventions can be higher than 20%. With these very positive results the manufacturer of veterinary implants BioMedtrix will present the patient observation data  at the American College of Veterinary Surgeons (ACVS) meeting in San Diego. Here the leading veterinary surgeons of North America are holding their annual ACVS summit. All participants of the observation study have assured their interest in continuing to use HyProtectTM-coated bone plates also in the future.

Coatings with antibacterial properties are of high importance for the medical device industry. In Germany the annual number of implanted human total hip endoprosthesis is about 214,000 and the number for the annual implantation of total knee endoprosthesis is 160,000. Infections can occur already in the course of these primary interventions. Multiresistant bacteria are especially dangerous as infectious agents in such cases, because they cannot be eradicated without availability of suitable antibiotics. In Germany, this has led to a high number of revision surgeries and implant exchanges. In 2011 there were approximately 36,000 hip implant revisions and 26,000 knee implant revisions.  The Bio-Gate HyProtectTM coating can play a crucial role in the improvement of product safety.  

Karl Richter, CEO of Bio-Gate AG: “This data which was compiled under conditions of daily routine proves that our coating technology can provide a sustainable product protection which is also functional against unwanted multresistant germs.” We are able to coat implants with our technology without impairing the biocompatibility or the biomechanical properties of the implant. Since our HyProtectTM coating can be applied to very diverse materials (e.g. stainless steel, titanium, CoCr steel, PEEK and also other polymers) our customers have ample options for applications that greatly improve their products in human or veterinary implants. Thanks to the ultrathin coating thickness even micro-structured surfaces can be coated without loss of structure or function.”

Likewise, further animal studies by Bio-Gate customers also showed that the HyProtectTM coating can confer an excellent osseointegration for all coated implant materials.  Despite its antibacterial efficacy HyProtectTM does not have negative effects on the bone-building cell systems (e.g. osteoblasts). Customer biomechanical tests on the ingrown implants were also successful. These findings complement existing veterinary data, which Bio-Gate has published for coated stainless steel implants together with the University of Gießen (Germany). Here it could be shown that HyProtectTM-coated implants are antibacterial against multiresistant germs over months after the implant surgery. The HyProtectTM coating is therefore especially advantageous for human and veterinary medical implants in the field of endoprosthetic and trauma applications.

Should you be interested in additional information about our antimicrobial technologies please contact:

For North America: Mr. Karl F Richter, President

RFH BioTek Inc.
27 Taylorwood Avenue,
Bolton, Ontario,
Canada  L7E 1J5
Tel:     +1-905-857-0219
Email:  rfh@rfhbiotek.com

For Europe: Mr. Thomas Konradt, Director Business Development

Bio-Gate AG
Neumeyerstraße 28-34
90411 Nuremberg, Germany
Tel:        +49 (0) 911-59724-8329
Fax:       +49 (0) 911-59724-8301
Email:    thomas.konradt@bio-gate.de

About Bio-Gate:

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'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, micro-organisms and other pathogens. Bio-Gate works in three fields to supply a variety of products that provide antimicrobial protection: material refinement, 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. In addition, the development and marketing of cosmetics and body-care products are concentrated in its subsidiary, BioEpiderm GmbH. Bio-Gate’s most important customers include, for example, the cosmetics manufacturer LR Health and Beauty Systems, Stada AG and leading international companies working in the medical devices sector.

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.

Summary of the research report:

HyProtect™ Coated MPP Bone Plate
Prospective Veterinary Patient Observation
A Preliminary Report
Matthew Rodriguez, Christopher Sidebotham
BioMedtrix
09-11-14

All implants are susceptible to infections at the surgical incision site and on the surface of the implant. In the latter case, when the infection is isolated to the proximity of the implant, it is called a periprosthetic infection. The MPP bone plate was designed to accommodate several clinical indications including partial carpal arthrodesis, iliac shaft fractures, tibial plateau leveling osteotomy (TPLO), distal radial fractures, inter-trochanteric osteotomy and pelvic osteotomy.

In this type of procedure regular infection rates can range from 20% to 30%. In the case of corrective actions the cost increase to the patient-owner expense can be up to $1500.

In the case of external fixators infections have been reported to occur in up to 40% of the cases.

This prospective patient observation is a pilot study to confirm that coating a bone plate can provide protection against a wide spectrum of bacteria during the early post-op period and to verify that there are no complications or side effects. This study has been developed to understand the potential improvement of an antimicrobial coating for bone plates composed of a patented Silver and SiOxCy-coating matrix called HyProtectTM. Since Bio-Gate’s HyProtectTM silver coating technology has been successfully tested in previous animal trials and has also been successfully used in a human case study no complications or side effects associated with the HyProtect silver coating were anticipated.

Seven from the top BioMedtrix bone plate customers were chosen to participate in the survey, a prospective patient observation. The observation study was done using ordinary family dogs that were treated in veterinary medical offices and centers. Most of the healing took place at home since the dogs were discharged soon after treatment. Observations were made over a three months period after surgery. The results are as follows:

Preliminary results from the study indicate that all patients had healed their osteotomy wounds.
There have been no complications or infections associated with the antimicrobial coating.



A complete and detailed report of the patient observation will be presented by BioMedtrix in San
Diego at the ACVS (American College of Veterinary Surgeons) Summit on October 16th/17th 2014.

Additional studies with the HyProtect coating are listed.

1. Khalilpour P, et.al: Ag/SioxCy plasma polymer coating for antimicrobial protection of fracture
fixation devices. J Biomedical Materials Research Applied Biomaterials, Vol. 94B, Issue 1, July 2010.
2. Weik, T. (2014), “Werkstoffe und Beschichtungen orthopädischer Implantate”, in „OTTI 2014,
Anwenderforum: „Funktionale Implantate und Implantatoberflächen“, Regensburg, Germany