BioNeutral’s planned germicidal formulations are being designed to avoid many of the shortcomings associated with other germicidal technologies currently on the market, as summarized below:

• Alcohol and alcohol gels – Disadvantages include potential loss of effectiveness upon dilution, limited germicidal activity (efficacy is quickly lost with rapid drying), and highly flammable nature. They are not effective against spores or biofilms, a film excreted by bacteria to protect themselves.

• Hypochlorite (bleach) - Disadvantages include short shelf life, strong odor, harshness, corrosiveness, and destruction of protective coatings and synthetic materials such as floors, walls, table tops. It is not environmentally friendly and reacts with many organic materials to produce carcinogens; it is also inactivated by organic material, such as dirt.

• Gluteraldehyde and orthophthalaldehyde are toxic, have a disagreeable odor, and cause eye, nose, lung and throat irritation. Their use is limited to specially designated and specially constructed areas/equipment.

• Iodophors (iodine-containing solutions) – Disadvantages include severe staining of surfaces, volatility and rapid loss of efficacy at modest temperatures – room temperature and above. They are not consistently sporicidal or effective against biofilms. Efficacy is also rapidly reduced by proteins, such as those in the targeted germs.

• Chlorhexidine gluconate is deactivated by anionic surfactants (typically used in laundry detergents) and inorganic anions, making it difficult to use and limiting efficacy.

• Hexachlorophene has limited use as it is only effective against gram positive organisms and has no broad spectrum efficacy. It also has been shown to be a neurotoxin.

• Halogenated phenolics have a low degree of efficacy, especially against viruses and fungi, poor surface cleaning capabilities and adverse environmental impacts since they are difficult to degrade. Efficacy is inhibited by anionic surfactants.

• Triclosan is not effective against spores and has only moderate bactericidal activity which limits its utility. Recently, concern about its dispersal in the environment is prompting regulatory pressure to eliminate or minimize its use in Canada and other countries.

• Chlorine dioxide is a toxic gas that requires complex capital intensive equipment and trained personnel to generate and apply. It is unstable in moist air and water. Concentrations in air must be limited because of the explosive hazard. Starting materials are hazardous and fire hazards. It can only be used in special situations and must be contained.

• Ethylene oxide is a reactive, flammable gas that is irritating to skin and lungs, is a potential carcinogen, mutagen, and sensitizer and requires specialty equipment and trained personnel for use. It can react violently with many common materials found in health care environments and must be contained.

• Quats have narrow antimicrobial activity and are not effective against spores, gram negative bacteria, biofilms and certain viruses. They are deactivated by anionic material.

• Phenolics are not acceptable in food handling areas as they can be easily absorbed through an individual’s skin with adverse effects. Repeated use on synthetic materials degrades them and makes them sticky. They are not widely accepted for use.

• Heavy metals such as copper, tin and silver require special processes and equipment to properly incorporate into an antimicrobial formulation. Ubiquitous ions such as chloride ion precipitate silver out of solution requiring the use of purified water and in the proportion of silver containing antimicrobials. They have limited efficacy and are not effective against spores or biofilms. Many silver salts are degraded by light and have limited water solubility.

BioNeutral’s goal is to develop product formulations that avoid the shortcomings and undesirable properties associated with other germicidal technology. Our goal is to make antimicrobials with broad spectrum efficacy that are easy to use and have little or no negative impact on the items being treated and on the environment generally.

There has been a long standing need for an easy to prepare or manufacture germicidal solution – one that uses readily available chemical components, is easy to use or apply, is a rapid acting broad spectrum antimicrobial—i.e.,, one that is virucidal, protozoacidal, and sporocidal as well as eradicates biofilm--and is not detrimental to the materials, articles and surfaces being treated.

Since the inception of our work, we have been extremely successful in developing a robust technology platform and understanding the controlling effects of key variables. Our current technology platform capitalizes upon the synergistic effects that we discovered among the components and preparation processes of our formulations. In addition, our new technology platform is very versatile and provides us with the potential to formulate differing products with differing levels of antimicrobial efficacy which will allow us to address a vast range of end-use applications segments, ranging from common household applications to addressing the demanding requirements of eradicating very difficult to kill microorganisms, including spore forming microorganisms. In addition, we plan to develop antimicrobial formulations designed to address the problem of harmful mold contamination in buildings that result in “Sick Building Syndrome” and the consequent threats to public health of residents and workers. All of these products will be registered with EPA as required based upon their antimicrobial efficacy and intended usage.