A brick wall…the single best metaphor around for describing the structure of skin and nails. The bricks are a protein called keratin and the mortar between the bricks is lipids (aka fat). They function in symbiosis as the protective walls that keep bad stuff out of our body. Skin is obviously much thinner than nails and more easily breached, plus infected nails thicken, making them even tougher to penetrate with medicine. I’ve seen infected toenails reach 10mm (~0.4 in.) thick. But all in all, good or bad days, skin and nails are a pretty darn good protective system that have served humankind well since the dawn of time.
You are waterproof.
Now that we understand skin and nails from a structural perspective, when was the last time you took a bath, left the drain plug in, and the water disappeared into your skin? Our skin is not a sponge…it’s waterproof, which is why we don’t melt like the wicked witch when we go out in the rain. We fall for a lot of marketing tricks to use fancy, water-based cosmetics on our skin. To be fair, skin is thinner than nails…we can probably get through the first couple of layers with enough work. But infected nails? It’s borderline insulting that there are super expensive prescription topical drugs for toenail fungus with water bases. Water cannot penetrate a nail. Even the American Academy of Dermatology publicly states “Medicine applied to the nails has a low cure rate.” The most popular brand name prescription topical achieved a max of 17.8% complete cure in its clinical trials used for new drug approval. So, it should not be surprising that experts estimate ~85% of people with toenail fungus don’t seek treatment. And the 15% who do? Most take the oral antifungal pills that require monthly liver tests due to side effects.
Literature states 10% of the general population has toenail fungus. There are 8 billion people on Earth. Using those numbers, that places the total addressable global market for toenail fungus at ~800,000,000 people.
Now, I’ve admitted openly that toenail fungus was not a disease I was targeting when inventing our tech. Experts like Dan Davis, DPM, showed me the potential with independent publications, case studies, photos. So, in my typical spirit of “why is it working,” I ran the most widely acknowledged in-vivo model to see if we could, in fact, penetrate an infected nail. While the other products tested in the publication above didn’t, we did (insert another: “why?”).
Ever heard opposites attract? That may be true with personalities, but with skin and toenails, like prefers like. Like I said above, that mortar between the keratin bricks is made of fat. Petrolatum is also a fat. And inside of our particular petrolatum carrier are little suspended liquid nanospheres containing an ingredient that has been proven to kill fungus. So what happens when you lay our formula on one of those lipid channels between the bricks, let alone all of them? When the petrolatum reaches body temperature, it melts, releasing the liquid ingredients which then passively travel down the fat channels to the site of the infection. We actually have a 3D video describing this on Vimeo that has been viewed over 63,000 times; as it attempts to show, the body cooperates with the technology, rather than fights it.
So, we’re going after toenail fungus indications! Not doing so would be a lost opportunity to improve the quality of life of 100’s of millions of people, and surely a lost business opportunity given the insights we have. We met with FDA about our clinical trial plan. We know what we have to do/prove to achieve the right to market via new drug approval. And we believe we can achieve these goals. We just need to get the capital in place to execute.
I do hope you enjoy reading these educational updates as much as I am enjoy writing them, and I am once again grateful to all of our new investors who are helping us pursue these potential expansion indications.
