Business opportunities for Fungy Nails

Superior ratio: Clinical benefit vs risks for adverse events and antifungal resistance

A patent (EP, (US), JP, CN) is for sale through direct assignment or licensing. 
The patent covers mild removal of nail fungus.

Non-touch felt-tip pen easy and hygienic to use, with fresh minty odour.

Patented Nail Treatment shows clinical superiority in the interim analysis of a randomized Postmarket Clinical Follow-up study.

No drug resistance and no skin irritation in a human patch test (ISO 10993-10:2010). 

Fungy Nails

Infections in the nails by fungi affects 2–18% or more of the world’s population. The market revenue for topical treatment is estimated to US dollar 422 Mil (IQVIA Database, 2022). The prevalence of onychomycosis increases with age, and 1 out of 5 persons are affected!
The reasons for the age-dependent prevalence may be poor peripheral circulation, smoking habits, diabetes, nail trauma, long exposure to pathogenic fungi, suppressed immune functions and inability to maintain good foot care.
The thickness and hydrophilicity of the nail plate makes it a formidable barrier to anti-fungal drug delivery. The size of drug molecules, such as ciclopirox, efinaconazole, tavaborole and terbinafine is very large, making it extremely difficult to achieve effective concentrations in the infected area. The complete cure for the drug products is reported to be only beetween 4% and 15% (Cochrane).
Therefore, the present substance-based medical device using the several times smaller glycolic acid is a better option than the drug molecules. Acidic environments are hostile to fungi!
Other Medical Devices use a great variety of substances with unknown efficacy. They may also be classified as Class III devices according to the MDR due to their contents of drug molecules

What is antifungal resistance?

Antifungal resistance occurs when an antifungal medication no longer works to treat a fungal infection. The fungus can fight off the medicine’s effects.
Drug resistance is a serious global health problem. It greatly limits treatment options. If a fungus doesn’t respond to one of three available classes of antifungal drugs, the other options may be less effective. Some drugs cause more severe, potentially toxic side effects.
The increase in fungal resistance to e.g. terbinafin is an emerging finding, making CE-device a safer option, see below:

The efficacy and safety of Patented Nail Treatment.

The performance of Patented Nail Treatment is currently evaluated in a postmarket clinical follow-up (PMCF) study using the internationally established medical device named Nalox® (Naloc, Emtrix®, Kerasal Nail; manufacturer Mylan/Viatris) as comparator. Nalox contains lactic acid, propylene glycol, urea, EDTA and water.

The PMCF-study is randomized (concealed allocation), web-based and using patient-reporting outcomes, including photographs and DNA-test for detection of dermatophytes. 
So far, 100 patients are included, and the interim analysis shows superiority to Patented Nail Treatment.

Ingredients in Patented Nail Treatment

►Glycolic acid - Acidifies and makes the environment hostile to fungi 
►Water - Solvent
►Zinc sulfate heptahydrate - Protecting astringent
►Methyl salicylate - Minty, fresh odour
►Oleth-20 - Stabiliser


1.           Kwok CS, Gibbs S, Bennett C, Holland R, Abbott R. Topical treatments for cutaneous warts. Cochrane Database Syst Rev 2012(9):Cd001781.
2.             Kilkenny M, Merlin K, Young R, Marks R. The prevalence of common skin conditions in Australian school students: 1. Common, plane and plantar viral warts. Br J Dermatol 1998;138(5):840-5.
3.             Faghihi G, Vali A, Radan M, Eslamieh G, Tajammoli S. A double-blind, randomized trial of local formic acid puncture technique in the treatment of common warts. Skinmed 2010;8(2):70-1.
4.             Bhat RM, Vidya K, Kamath G. Topical formic acid puncture technique for the treatment of common warts. Int J Dermatol 2001;40(6):415-9.
5.             Baswan S, Kasting GB, Li SK, et al. Understanding the formidable nail barrier: A review of the nail microstructure, composition and diseases. Mycoses 2017;60(5):284-95.
6.             Foley K, Gupta AK, Versteeg S, et al. Topical and device-based treatments for fungal infections of the toenails. Cochrane Database Syst Rev 2020;1:Cd012093.

Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters[EN ]
1. A topical composition comprising: an alpha hydroxy acid selected from the group consisting of lactic acid, malic acid, and glycolic acid, and combinations thereof in a total amount of from 50 to 80 % by weight; 0.1 to 10 % by weight of methyl salicylate; and, a wa ter soluble zinc salt in an amount of from 0.2 to 4% by weight of the formulation calculated as Zn.
2. The composition of claim 1, further comprising a solubiliser in an amount effective for solubilizing the methyl salicylate in the formulation.
3. The composition of claim 2, wherein said solubiliser is an ethoxylated fatty alcohol.
4. The composition of any one of the preceding claims, wherein the the total amount of the alpha hydroxy acid is within the range of 50-70 % by weight.
5. The composition of any one of the preceding claims, wherein the amount of methyl salicylate is 0.2-10% by weight.
6. The composition of any one of the preceding claims, wherein the alpha hydroxy acid is glycolic acid.
7. The composition of any one of the preceding claims, wherein the water soluble zinc salt is one or more members selected from the group consisting of zinc sulphate, zinc chlo ride, zinc acetate, zinc glycolate, zinc gluconate, zinc carbonate, zinc oxide, zinc oleate, zinc stearate, zinc propionate, zinc salicylate, zinc lactate, zinc coceth sulphate, zinc citrate, zinc ascorbate and zinc glutamate.
8. The composition of claim 7, wherein the water soluble zinc salt is zinc sulphate.
9. The composition according to any one of the preceding claims, wherein the amount by weight of zinc is from 1.0 to 2.5%, glycolic acid is from 55 to 65 %, and methyl salicylate is from 2 to 5 %, respectively.
10. A kit comprising a container holding the composition of any one of claims 1-9, and an applicator for topical application of the composition.
11. An applicator comprising a felt tip, a brush tip, or a roller ball tip attached to a con-tainer holding the composition of any one of claims 1-9, from which container the composi-tion can be delivered to the tip of the applicator.
12. A pen containing the composition of any one of claims 1-9 for the topical administra tion of the composition from a tip of the pen to an affected skin area for the treatment of warts.
13. A method of treating warts wherein the composition of any one of claims 1-9 is ap plied to an affected skin area of a subject.
14. A method of treating of treating fungal infections of the toenails or fingernails, wherein the inventive composition of any one of claims 1-9 is applied topically to an area of affected nail.


  • CN112312891
  • EP3801455
  • US20210212930
  • JP2021525808

LODÉN, Marie
SWAHN, Britt-Marie
Priority Data
Publication LanguageEnglish (en)
Filing LanguageEnglish (en)