EPIEN Medical, Inc.

Veterinary Products

Thank you for your interest in EPIEN Medical

This section is currently under construction.  Please check back soon.

Specialty Sterilants and Disinfectants

Thank you for your interest in EPIEN Medical

This section is currently under construction.  Please check back soon.

Professional Wound Care

Thank you for your interest in EPIEN Medical

This section is currently under construction.  Please check back soon.

Professional Skin Care

Thank you for your interest in EPIEN Medical

This section is currently under construction.  Please check back soon.

Cosmetic Exfoliants

EPIEN Medical is interested to develop professional cosmetic exfoliants for dermatologists.

The capacity of EPIEN’s patented sulfonated aromatic compounds for denaturation can be incorporated into exfoliating skin products.  By denaturing the outermost layers of skin (stratum corneum), this layer sheds off, revealing newer skin underneath.  Preliminary studies indicate that performance of EPIEN’s products as exfoliants will not penetrate into the stratum granulosum and have less potential to damage skin, as alpha hydroxy acids (AHAs) can.

Specific formulations for different types of skin (face, hands, feet) are being considered.

Pipeline

Product Pipelines

The fundamental focus of EPIEN Medical’s research and development is the use of materials that alter the micro-environment at the surface of tissue for therapeutic benefit.  Using materials that will desiccate, denature, exfoliate, and condition the superficial layers of skin EPIEN is developing professional dental products, professional skin exfoliants, professional skin care products for the treatment of mild to moderate inflammatory disorders, acute and chronic wound care, specialty sterilants, and veterinary products.

Thank you for your interest in EPIEN Medical.

Products

HybenX® PLAQUE BIOFILM REMOVERS

HybenX® PLAQUE BIOFILM REMOVERS have not been approved by the FDA and are sold outside the United States.  Approved as a Class I medical device in the European Union and Canada, HybenX® Plaque Biofilm Removers are available to dental professionals in Europe and Canada as an adjunctive focal irrigant intended for the removal of dental plaque biofilm.

HybenX® PLAQUE BIOFILM REMOVERS are used by dental professionals as an adjunctive treatment for removing dental plaque whenever there Is a need to remove more plaque biofilm than is possible using standard methods alone.  When HybenX® PLAQUE BIOFILM REMOVER is applied to plaque biofilm, it causes rapid absorption of water out of plaque, leading to the precipitation and collapse of organic material within the plaque, causing the plaque to completely detach itself from tooth surfaces.

For more information, please visit www.HybenX.com

DEBACTEROL

DEBACTEROL® is sold in the United States by prescription only and is not offered directly to consumers.

DEBACTEROL® Canker Sore Pain Relief is a liquid, topical, debriding agent used for treating ulcerating oral mucosal lesions, commonly referred to as canker sores, aphthous ulcers, or oral ulcers, as well as minor oral abrasions. DEBACTEROL® has unique chemical and physical properties that are particularly beneficial whenever a dental or medical procedure in the mouth requires controlled, limited debridement of necrotic or damaged tissues.

DEBACTEROL® is prescription treatment for Aphthous Stomatitis that completely stops oral ulcer pain, seals damaged oral mucosal tissues, and forms a protective barrier after just one application.

For more information, please visit the DEBACTEROL® website.

Oral Ulcer Treatments

EPIEN Medical has developed products used to treat oral ulcers, also referred to as canker sores, apthae, or aphthous ulcers. These products are sold in Europe, Canada, and other countries outside the United States under the brand name ORALMEDIC® Mouth Ulcer Pain Relief.

The unique physical properties of these products are particularly useful whenever a consumer or clinician needs a controlled superficial treatment for ulcers or minor abrasions.  These products are intended to be used to relieve the local pain and discomfort caused by superficial disease or minor injury to oral tissues. They act through a physical process that produces superficial tissue denaturization following a brief direct topical application to the site of the lesion. Superficial tissue cleaning and coagulation leaves behind a thin barrier that protects the ulcer from further painful stimulation to allow for natural healing.

For more information please visit:

• Oralmedic.com
• Oralmedic.co.uk

Terms of Use

LEGAL DISCLAIMER AND TERMS OF USE FOR THIS INTERNET SITE

This page provides the terms and conditions under which you may use this web site (“Terms and Conditions”). EPIEN Medical, Inc. (”EPIEN”) may update this posting and may modify the Terms and Conditions at any time at its discretion. PLEASE READ THESE TERMS OF USE CAREFULLY. THESE TERMS MAY HAVE CHANGED SINCE YOUR LAST VISIT TO THIS INTERNET SITE (”SITE”). BY USING THIS SITE, YOU INDICATE YOUR ACCEPTANCE OF THESE TERMS. IF YOU DO NOT ACCEPT THESE TERMS, THEN DO NOT USE THIS SITE.

ACCESS TO THIS SITE

EPIEN may alter, suspend, or discontinue this Site at any time for any reason, without notice or cost. The Site may become unavailable due to maintenance or malfunction of computer equipment or other reasons.

By using this Site, you agree to indemnify, hold harmless and defend EPIEN from any claims, damages, losses, liabilities, and all costs and expenses of defense, including but not limited to, attorneys’ fees, resulting directly or indirectly from a claim by a third party that alleges injury, damage or harm in whole or in part arising from the provision by you of information from, or claimed to be from, this Site, or that in any way arises from your use of this Site or information provided by this Site in violation of these terms.

FORWARD-LOOKING STATEMENTS

This web site may contain forward-looking statements, which reflect EPIEN’s current expectations and are based on the information available to it at this time. These forward-looking statements may include, but may not be limited to, statements regarding anticipated scientific progress on and expenses of EPIEN’s research programs, development of product candidates, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for product candidates, and other statements regarding matters that are not historical facts. The forward-looking statements involve risks and uncertainties. EPIEN can give no assurance with regard to these statements. Actual events, results or performance could differ materially from any future events, results or performance expressed or implied by statements on this web site, and depend on a number of factors, including successful and timely completion of clinical studies, uncertainties related to the regulatory process and commercialization of products thereafter. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, EPIEN assumes no obligation to update these forward-looking statements.

NOT INVESTMENT INFORMATION

The content that is made available to you on this web site is for information purposes only and is not intended to constitute an offering of securities in any jurisdiction. Information disclosed under the corporate and securities laws of the United States, Canada, and/or other foreign jurisdictions is applicable to EPIEN is not intended to be in any way qualified, amended, modified or supplemented by the information otherwise available in, through or on this web site.

INTELLECTUAL PROPERTY NOTICE

Copyright© 2009 EPIEN Medical, Inc. All rights reserved.

EPIEN either owns the intellectual property rights in the underlying HTML, text, audio clips, video clips and other content that is made available to you on this web site, or has the right to use such content. All such content is protected by copyright, patent, trademark and other intellectual property laws of the U.S., Canada, and/or foreign jurisdictions. Except as expressly allowed by these Terms and Conditions, all rights are reserved by EPIEN. Unauthorized use of the content may violate applicable copyright, trademark or other intellectual property laws or other laws.

LICENSE GRANT

Subject to the Terms and Conditions set forth herein, EPIEN grants to you a limited, non-transferable, non-exclusive license to print, download and use materials and information on this web site only for non-commercial, personal purposes. Except as expressly allowed by these Terms and Conditions, nothing contained in this Section shall be construed as conferring any right in any copyright, trademark or other intellectual property of EPIEN or any other person who owns the copyright or other intellectual property in the content provided on this web site. You agree not to copy, modify, adapt, frame, mirror, reproduce, translate, distribute, transmit, reverse engineer, decompile, or disassemble any aspect of the web site and materials and information contained therein without the express consent of EPIEN.

NO WARRANTIES

Medical information that appears on this web site is for informational purposes only and is not, nor is intended to be, a medical diagnosis or a replacement for advice given by a physician or other medical professional. Reliance on any materials and information, including but not limited to such medical information, provided on this web site (“Content”) is solely the responsibility of the individual. While EPIEN makes commercially reasonable efforts to ensure the timeliness and accuracy of the Content present on this web site, EPIEN does not warrant the timeliness, accuracy, quality, or completeness of any Content on this web site. Further, EPIEN makes no representations about the suitability of any Content on this web site for any purpose. All Content is provided “as is” without express or implied warranty or condition of any kind. This web site may include inaccuracies or typographical errors.

LIMITATION OF LIABILITY

In no event shall EPIEN or any third party mentioned at this web site be liable to you for any damages whatsoever, including direct, special, indirect or consequential damages or loss (including but not limited to loss of profits and data), arising out of or in connection with the use of this web site and any reliance on the information and materials available on this web site, even if EPIEN or any such third party has been advised of the possibility of such damage or loss.

LINKS TO OTHER SITES

This web site may contain links to other web sites which are provided solely as a convenience to you and not as an endorsement by EPIEN of the contents of such other web sites. EPIEN shall not be responsible for the content of any other web sites and does not make any representations or warranties regarding any other web sites or the contents or materials on such web sites. If you decide to access other web sites, you do so at your own risk.

MISCELLANEOUS

This web site is controlled and operated by EPIEN from its offices in the state of Minnesota in the United States. These Terms and Conditions are governed by and to be construed in accordance with the laws of the State of Minnesota without regard to its conflict of law provisions.

EPIEN, the EPIEN logo, and the terms HybenX® and Debacterol® are trademarks of EPIEN Medical, Inc. Any use of such marks without the express written permission of EPIEN is strictly prohibited.

Sitemap

Overview

The HybenX®-enhanced oral hygiene procedures are characterized by an unprecedented level of plaque biofilm removal from teeth and soft tissues of the oral cavity. The HybenX® oral products not only kill the microbes in oral plaque biofilms on contact, but they also completely destroy the plaque biofilm matrix without causing any damage to the underlying host tissues or dental materials. HybenX® denaturants have been shown to be harmless to oral soft tissues, including vital pulp tissue, and to be less erosive of enamel and dentin than many common foods and beverages. HybenX® formulations are not antiseptics or antibiotics. They remove oral plaque biofilm by denaturing the physical structure of the microbes and the matrix on tissue surfaces, not by disrupting physiologic or metabolic processes. Microbes cannot develop resistance to the mechanism of action of the HybenX® formulations.

The demonstrated efficacy of HybenX® formulations in the removal of plaque biofilms combined with a wide safety margin creates an opportunity to develop HybenX®-based products for the professional dental market where the ability to thoroughly remove microbial plaque biofilm from oral tissue surfaces is considered to be critically important by dental practitioners.  The HybenX® products are useful as adjunctive agents in all standard mechanical dental procedures, both therapeutic and preventive, because an application of a HybenX® denaturant provides an exceptional level of plaque biofilm removal that is far better than any mechanical hygiene method can achieve alone. The simplicity of the procedure and the minimal time required for application of the HybenX® formulations means that an oral hygiene treatment based on HybenX® Technology can be easily included as a component of any standard professional dental procedure.

One of the most important clinical benefits of HybenX treatments is that they generally result in a marked increase in patient comfort, especially noticeable after any anesthesia wears off.

Regulatory Information

HybenX® is approved as a Class I medical device in the European Union and Canada. The HybenX® formulation called ORALMEDIC® is already being sold to consumers in Europe, Canada and the Middle East as a Medical Device Class I and has been since 2005. EPIEN Medical manufactures ORALMEDIC® and recently completed a one year clinical study at the Eastman Dental Institute, University College London.

Safety Studies

EPIEN Medical is committed to the continuous safety testing of all the products we develop. HybenX® products are designed to denature and coagulate microbial biofilms, yet have insufficient denaturing potential to harm healthy oral mucosa. This has been confirmed by a number of non-clinical and preclinical studies.

Standard biocompatibility testing was completed on HybenX® formulation materials by AppTec Laboratories according to ISO 10993-1.

An internal histologic study was conducted in conjunction with the Oral Pathology Department, University of Minnesota Dental School of canine models of exposure of vital pulp tissue and periodontal tissue to a HybenX® formulation. The studies clearly demonstrated no adverse effect on pulp or periodontal tissues from contact with the formulations.

The impact of HybenX® exposure on tooth enamel and dentin was evaluated in an internal study of a standard bovine tooth erosion model with assays for calcium release by ion chromatography and standard microhardness measurements. A 2-minute exposure to HybenX® formulation was determined to be less erosive than citric acid at a concentration commonly found in fruit juice and less erosive than lactic acid at levels commonly found in yogurt. Furthermore, contact of HybenX® formulations with bovine enamel and bovine dentin for up to 30 minutes of constant exposure was determined to have no measureable change in microhardness.

Biological Activities

Mechanism of Action

Many attempts to control and eliminate biofilms focus on disrupting nutrient channels, inhibiting quorum sensing compounds within the exopolysaccharide matrix, activating or deactivating specific bacterial genes to alter the form of the biofilm, and attempts prevent the initial formation of a microbial biofilm. Countless studies have shown that established microbial biofilms are very resilient to many chemical and mechanical removal procedures. EPIEN Medical has taken a different approach altogether. Through our studies, we have discovered that biofilm matrix is very susceptible to irreversible desiccation and denaturation. The company’s patented HybenX® products have been designed to solvate and irreversibly denature tertiary and quaternary protein and polysaccharide structures, leaving coagulated materials on the surface of the tissue.

The hygroscopicity of the sulfonated aromatic compounds in HybenX® causes immediate denaturation of the superficial layer of biological materials of oral tissues through highly localized and controlled contact desiccation. The process is inherently self-limiting: once the compounds in HybenX® are solvated by water molecules, no further desiccation or denaturation occurs. Because HybenX® has low water content the sulfonic acids are not disassociated, and HybenX® has the properties of an intense desiccant rather than those of an acid. Our safety studies have confirmed this action on soft and hard oral tissues.

Contact Us

Investment Opportunities

News

Profile

EPIEN Medical is a privately-held biotechnology company focused on developing a new era of powerful, non-antibiotic agents capable of removing biofilm and microorganisms on contact.  The company’s patented HybenX® technology utilizes unique mechanisms unlike any other products found in the marketplace to safely remove a wide variety of microbial biofilms, including MRSA (staph infection).

Products containing HybenX® technology are approved as Class I medical devices in the European Union and Canada.  The company currently has products for sale in 23 countries throughout Europe, the Middle East, and Africa, as well as Canada and Australia through contracted distributor relationships.  EPIEN also manufactures the drug Debacterol, which is sold to dentists in the United States as a unique treatment for Aphthous ulcers (canker sores).

EPIEN has developed HybenX® technology for a variety of professional dental applications, including a general-purpose focal dental irrigant for the eradication of biofilm inside and outside of the oral cavity.  EPIEN’s future activities will focus on the development of products to treat a variety of topical skin infections ranging from ailments such as athlete’s foot to more severe conditions such as diabetic chronic wounds.

Technology

EPIEN’s patented HybenX® Technology is defined as techniques, information and chemical formulations for performing selective, self-limited denaturation and coagulation of superficial biological structures on tissue and environmental surfaces using proprietary liquid desiccating agents.

A Focal Dental Irrigant for Real-Time Eradication of Biofilm and Biofilm Matrix

Contrary to the general perception, the physical microstructure of any microbial biofilm matrix, including dental plaque biofilm, is actually relatively unstable, unprotected and vulnerable to modestly disruptive physical forces. Plaque biofilm is dependent upon a relatively stable physical environment to maintain functionality and growth of the matrix and microbes.

Among the destabilizing forces that can rapidly disrupt the stability of a biofilm matrix is desiccation of the biofilm environment. Our studies have shown that contact desiccation will quickly disrupt the environment that supports the biofilm matrix, causing the substance of the matrix to very quickly denature, precipitate and coagulate. Denaturation and coagulation of the matrix causes the biofilm to detach from the surface where it originated, where it can be rinsed away.  Biofilm matrix can be eradicated by relatively simple physical processes if they are applied directly to the matrix and if it is done properly.

Links

Company

EPIEN Medical is a privately-held biotechnology company focused on developing a new era of powerful, non-antibiotic agents capable of removing biofilm and microorganisms on contact.  The company’s patented HybenX® technology utilizes unique mechanisms unlike any other products found in the marketplace to safely remove a wide variety of microbial biofilms, including MRSA (staph infection).

Products containing HybenX® technology are approved as Class I medical devices in the European Union and Canada.  The company currently has products for sale in 23 countries throughout Europe, the Middle East, and Africa, as well as Canada and Australia through contracted distributor relationships.  EPIEN also manufactures the drug Debacterol, which is sold to dentists in the United States as a unique treatment for Aphthous ulcers (canker sores).

EPIEN has developed HybenX® technology for a variety of professional dental applications, including a general-purpose focal dental irrigant for the eradication of biofilm inside and outside of the oral cavity.  EPIEN’s future activities will focus on the development of products to treat a variety of topical skin infections ranging from ailments such as athlete’s foot to more severe conditions such as diabetic chronic wounds.

Home

EPIEN Medical is a biotechnology company engaged in the discovery, development, manufacturing and licensing of innovative topical therapies that condition damaged tissue and control microbial biofilms.