Cold Laser Toenail Fungus Removal
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
- Hot 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, however this treatment is effective less than 10% of the time and requires daily treatment for 48 weeks.
Currently, there is no 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 know for their anti-bacterial properties but getting the solution under the toenail is difficult, if not impossible.
The forth option is the use of a hot laser to kill the fungus. This is the opposite of most therapeutic laser applications that promote natural healing growth using lower levels of power to heal the cells. The newest solution is based on using a class 4 laser that is typically used for healing but the emitter is specifically created to focus and drive the energy through the toe nail. By swapping out the large treatment area probe with a pinpoint probe, a system with as little as 10 watts can blast the energy throught the toe nail and kill the fungus under the nail. As the same time, this system helps promote healing of the surrounding tissue because of the natural properties of the laser.
Aspen Class 4 10-watt 980nm Dual Application Laser System
Dual system for both Therapy and Toe Nail Fungus.
The Aspen system includes a large 9 inch touch screen with internal protocols. This system uses a cooled German-made laser module inside the controller and a fiber optic cable to transfer the energy to the probe. This system also comes with a 3-year warranty and the price includes training and installation. The system is, also, about the half the cost of any other professional toe nail treatment system.
In addition to the Aspen solution, there are 2 other players in the cold laser toenail fungus removal market, Nomir and PathoLase. Both these product are FDA cleared for toe nail fungus only and should not be used for laser therapy or as a pain control device.
Nomir Medical Technologies is a company in NY 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 PathoLase announced the Pin-Pointe Foot-Laser received clearance from the U.S. 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.