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ToeMate ® Nail Soak Fungus Treatment Kits (https://thetoematestore.com): Why Topical Nail Fungus (Onychomycosis) Treatment Needs a Device

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January 11, 2020

ToeMate® Nail Soak Fungus Treatment Kits (https://thetoematestore.com) Why topical nail fungus (onychomycosis) treatment needs a device

 

 

 

Penetration

For the medication to penetrate and reach the infection through nail keratin (which absorbs water and repels water insoluble drugs) the treatment must be at least partially water soluble. The most effective way is to immerse the infected nails in an antimicrobial that is dissolved in water to give nails absorption time. Of the 125 or so treatments for nail fungus, only three are at least partially water soluble (Kerydin, Loceryl and ToeMate® Nail Soak).

Scientifically, nail keratin is hydrophilic and Kobayashi et al 1999 found that the permeation through nail keratin of a water soluble drug was much greater than a non water soluble drug of similar molecular weight by a ratio of 90 to 1.

Energy
When nails soften in a warm shower, they’re absorbing water. Water uses heat energy to penetrate the nail but most medications are applied at room temperature. This means that most medications lack the energy to penetrate the nail. Of the 125 or so treatments for nail fungus, only one uses additional energy to help penetrate (ToeMate® Nail Soak).

Scientifically, Gupchup-Malhotra et al 2000 determined the energy necessary to drive the permeation of water through a normal nail is 7.2 kcal/mole. All but one of the currently available therapies (ToeMate® Nail Soak – 7.7 kcal/mol) are applied at room temperature (about 0.5 kcal/mol).

Nail Thickness
Infected nails become thicker as the infection spreads making it more difficult for the medication to penetrate. To thin the nail, a cleaner can be applied to remove excess nail and facilitate the delivery of the medication.  ToeMate® Kits include a cleaner that breaks up the infection creates micro-channels to help the thermal solution penetrate deeper into the nail.

Scientifically, as keratin debris accumulates, the nail becomes thicker and increases the barrier to treatment. Kobayashi 2004 found that nail penetration decreases linearly with increasing nail thickness. Quintanar 1998 found that the application of a topical keratolytic reduces nail thickness and the energy required for penetration. Keratolytics such as salicylic acid, papain and urea are available OTC under brand names Zanaquick and Gold Cosmetics. Salicylic acid 30% is included in ToeMate® Kits.

Electrostatic Repulsion
Just like two magnets that repel each other, the nail plate repels medication that prevents it from penetrating (since most antifungal medications were developed to penetrate skin, not nail). To reduce repulsion and increase penetration, ToeMate® kits include a neutralizer that reduces the repulsion and allows the medication to penetrate the nail.

Scientifically, also known as the Donnan effect, Kobayashi 2004 found that electrostatic repulsion further inhibits nail permeability between the keratin membrane and the diffusing molecule. QAC, a cationic antimicrobial surfactant used in ToeMate® Kits reduces or eliminates the repulsion and allows the diffusing molecules to enter more readily (Unhoch 1997).

Antifungal strength
Modes of action are the mechanisms antifungal medications use to eliminate infections (e.g., attack cell membrane, disrupt DNA or protein synthesis). Of the 125 antifungal medications, only two have more than one mode of action (cyclopirox and ToeMate® Nail Soak) and only the latter disrupts spore development (without it infections reoccur).

Scientifically, research from Baran et al 2005 suggests that combination therapies that use two or more antimycotics with complimentary modes of action lowers overall MIC values (disabling many cellular functions simultaneously) compared to values for the antimycotics applied individually. Infections with combinations of dermatophytes, yeasts and molds are thought to be common but difficult to diagnose (Elewski et al 2015). Ciclopirox and ToeMate® Nail Soak demonstrate more than one mode of action and ToeMate® exhibits activity against spore outgrowth that prevents reinfection.

Safety
Salicylic acid, PHMB and QAC, the active ingredients in ToeMate® Kits, and have been safely used in dermatology, cosmetics and public water treatments for the last sixty years.

Reduced Treatment Times & Expense
Combining ToeMate’s® benefits into one treatment shortens the protocol down from 18 to 3 months or less (depending on the severity) with a simultaneous cost reduction per ounce from $4,700 for Kerydin to about $0.50 per ounce for ToeMate®.

Market Opportunity
Estimated market size, 2 billion people world wide.

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FDA
Regulated cosmetic

IP
U.S. Patent 7,793,666,  two additional patents pending.  ToeMate® is a registered trademark.

Status
ToeMate® Kits and refills are sold online through Medgadget, Newegg and https://thetoematestore.com.

Competition
Loceryl, Penlac, Kerydin and about 125 others from $46 per ounce for Penlac to $4,700 per ounce for Kerydin (cure rates under 20% and 9 to 12 month courses of treatment) for mild infections not involving the nail bed  Estimated  90% cure rate for all infections ($0.50 per ounce with a 3 month protocol) versus 18% for Jublia (efinaconazole from Valeant $3,750 per ounce & 12 month course) only for mild infections not involving the nail bed.

Platform
ToeMate® is a platform that treats nail infections – 50% of which are onychomycosis with an estimated 2 billion people infected world-wide. The other 50% include bacterial infections, onycholysis, paronychia, psoriasis, and melanonychia.

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