Cold Laser Toenail Fungus Removal
Toenail fungus, medically known as onychomycosis, is a widespread problem affecting up to 10% of American adults, or 23 million people. This condition results in toenails that are thick, yellow and sometimes smell bad.
People who have nail fungus spread it by shedding invisible spores when they walk barefoot in locker rooms or across carpets.
Currently there is no 100% effective cure. The current options are:
- Lacquers and ointments
- Homeopathic remedies like tea tree oil, Listerine, Vicks VapoRub and Clorox
- Cold laser treatments.
The root of the problem is that toenail fungus is very hard to kill. The toenail fungi are so hardy, in fact, that popular anti-fungal pills are effective less than 50% of the time, and they carry a small risk of liver damage. Pharmaceutical giants like Schering-Plough and Novartis are developing new products to address this market but these options continue to have unforeseen side effects that can cause permanent damage. Prescription lacquers can be painted on the toenails, but this treatment is effective less than 10% of the time and requires daily treatment for 48 weeks.
Currently, there is not data on homeopathic remedies since these cures are not regulated. Typical homeopathic remedies include using Clorox, tea tree oil, Vicks VapoRub and even Listerine. These product are all known for their anti-bacterial properties, but to get the solution under the toenail is difficult, if not impossible.
The forth option is the use of low level lasers to kill the fungus. This is the opposite of most therapeutic laser applications that promote natural healing growth using laser light. Super-low power UVC (ultraviolet-C) light is commonly used to disinfect and sanitize so it follows that higher power levels of the correct wavelength of light could be used to penetrate the toenail to blast the fungus. Currently there are 2 major players in the cold laser toenail fungus removal market: Nomir and PathoLase.
Nomir Medical Technologies is a company in New York formed in 2003 that is developing a laser called Noveon for treatment of diseases like antibiotic-resistant staph infections as well as toenail fungi. The Noveon laser, which cost about $20,000, projects two different wavelengths of near-infrared light at toenails to selectively kill fungi.
The results of an early clinical trial were presented at a national dermatology meeting. Their trial resulted in a 50% cure rate after four treatments and a 76% cure rate after six months. The trial included a somewhat limited trial size, just 39 toenails. Richard F. Burtt of Nomir said the company was preparing to submit the data to the Food and Drug Administration, hoping to receive clearance to market Noveon for this application. The FDA has already cleared Noveon for use on the skin and in nasal passages.
PathoLase is another company selling a cold laser to address the market for anti-fungal nail treatments. Their product, the PinPointe Footlaser, is an adaptation of a laser that has FDA approval as a dental laser, but the company does not currently have approval to sell the product for the treatment of toenail fungus. Since the product has been sold for use on toenail fungus to about 70 different companies prior to getting federal permission to begin marketing the device, the company is currently in a pickle.
According to the Center for Devices and Radiological Health at the FDA, companies are legally allowed to market a medical device only for the specific use for which it had been granted clearance. Selling or promoting a device for unapproved indications is illegal.
Although nail infection is primarily a cosmetic issue like balding and cellulite, it can lead to serious health problems for people with diabetes and immune disorders. Although the treatment of cold laser toenail fungus removal therapy is currently not FDA approved, it is coming. If Nomir and PathoLase can get their approval and stay out of trouble, they are poised to dominate this 1.2 to 3-billion-dollar market in the coming years.
On October 20, 2010, Pin Pointe announced the Pin-Pointe Foot-Laser received clearance from the US Food and Drug Administration (FDA) for the treatment of nail fungus (onychomycosis). During the procedure, which is administered by podiatrists, a specially-designed laser beam is directed across the nail.