Toenail Laser Review…Why PinPointe?

The purpose of this site will be to present information about the existing laser technologies available for the treatment of toenail fungus (onychomycosis).  It will focus on the availability of these treatments in the USA.  It is mainly a comparison of Pinpoint vs CoolTouch or Pinpoint vs CoolBreeze, as well as Pinpoint vs Genesisplus. This will allow the reader to compare in one place all the real meaningful data that I can find on this topic.  I will provide FDA study links where possible as well as any other well done double blinded studies that I can find.

This site presents the reader with information that I gathered in the process of deciding which laser to use in my own podiatry practice and can also be used by prospective patients to help them decide which laser treatment for toe nail fungus they want for themselves.

This site is a work in progress and will be updated as new information is made available.  There will be charts and pretty color pictures.  There will also be physics…..you have been warned!

This site will concentrate on a comparison of the PinPointe FootLaser vs Noveon vs CoolBreeze vs Genesisplus or Patholase vs Nomir vs CoolTouch, vs Cutera to name the parent companies, as they are the only 4 companies with viable technologies that were under FDA investigation for use specifically on onychomycosis.  As of October 15, 2010, the Pinpointe FootLaser has been granted FDA clearance for use on onychomycosis, and as of Feb 7, 2011 it was granted a Health Canada clearance. The Genesisplus was also granted FDA clearance in 2011. Coolbreeze received FDA clearance in late 2011. The remaining company is still being investigated. It is important to note that the companies receiving FDA clearance after Pinpointe are basing much of their claims on data produced by Pinpointe, not by their own lasers. Since Pinpointe uses a patented pulse modulation method the other companies can’t copy, whatever they do is less effective.

A quick comparison is as follows:

Pinpointe FootLaser:

  • In wide use around the world (USA, England, Europe, Turkey, Australia) for treating toe nail fungus….YES
  • Laser energy designed to be absorbed by the fungus, rather then the patient…YES
  • Patented optimized pulse modulation to insure maximum uptake by fungus…YES
  • Perfect safety record…YES (nearly 1,000,00 nails treated)
  • Proven efficacy with extensive multi-year studies involving hundreds of patients…YES
  • Number of treatments required in standard protocol…1
  • Government certifications for treating toe nail fungus: 4
  • ****FDA cleared (United States)-YES
  • ****CE Mark (Europe)-YES
  • ****TGA (Australia)-YES
  • ****Health Canada (Canada)-YES

CoolBreeze:

  • In wide use around the world (USA, England, Europe, Turkey, Australia) for treating toe nail fungus….NO
  • Laser energy designed to be absorbed by the fungus, rather then the patient…No
  • Patented optimized pulse modulation to insure maximum uptake by fungus…NO
  • Perfect safety record…NO (1 patient in 38 experienced a burn)
  • Proven efficacy with extensive multi-year studies involving hundreds of patients…NO
  • Number of treatments required in standard protocol…2 or 3
  • Government certifications for treating toe nail fungus: 1
  • ****FDA cleared (United States)-YES
  • ****CE Mark (Europe)-NO
  • ****TGA (Australia)-NO
  • ****Health Canada (Canada)-NO

Noveon:

  • In wide use around the world (USA, England, Europe, Turkey, Australia) for treating toe nail fungus….NO
  • Laser energy designed to be absorbed by the fungus, rather then the patient…YES
  • Patented optimized pulse modulation to insure maximum uptake by fungus…NO
  • Perfect safety record…YES (only 26 nails treated in study)
  • Proven efficacy with extensive multi-year studies involving hundreds of patients…NO
  • Number of treatments required in standard protocol…at least 3
  • Government certifications for treating toe nail fungus: 0
  • ****FDA cleared (United States)-NO
  • ****CE Mark (Europe)-NO
  • ****TGA (Australia)-NO
  • ****Health Canada (Canada)-NO

Genesisplus:

  • In wide use around the world (USA, England, Europe, Turkey, Australia) for treating toe nail fungus….NO
  • Laser energy designed to be absorbed by the fungus, rather then the patient…YES
  • Patented optimized pulse modulation to insure maximum uptake by fungus…NO
  • Perfect safety record…YES(only 7 patients in their study)
  • Proven efficacy with extensive multi-year studies involving hundreds of patients…NO
  • Number of treatments required in standard protocol…at least 2
  • Government certifications for treating toe nail fungus: 1
  • ****FDA cleared (United States)-YES
  • ****CE Mark (Europe)-NO
  • ****TGA (Australia)-NO
  • ****Health Canada (Canada)-NO
The following information lists the above 4 lasers plus several more, and provides more in depth information about them.

In alphabetical order they are:

1) CoolBreeze (CoolTouch)  In Podiatry, this laser is being marketed as a  “Cool” laser and also as a “Newest Laser” .  It is actually neither.

First…It is anything but cool.  This should not be confused with a “cold laser” which cannot be felt when in use and does not heat tissue to any appreciable degree. CoolBreeze laser energy is designed to be absorbed by human tissue, which is why it has been used for hair removal, acne scar removal, etc.  They have also found it can have an effect on toenail fungus, but it has to heat the entire nail & nail bed to get the desired effect.  It treats a large area at one time, up to10 mm (approx 3/8″), so if anything goes wrong, the entire nail bed can be injured.  This actually happened in their earliest clinical trials of only 38 patients.

Second…It is not new or “newest”.  It has been in use since 1994 for other purposes.

Originally described to me by a company representative as a “dual wavelength” laser, all the data I can find on it suggests it operates at one wavelength, 1320nm.   It is a modified CoolTouch CT3Plus 1320 nm 18W pulsed Nd:YAG laser.  The CoolTouch has been in use for many years treating a variety of conditions such as acne, hair removal, varicose vein & spider veins, liposurgery and more.  Here is what the company says about the use of their device for onychomycosis:

The CoolTouch CT3PLUS 1320nm laser, also known as the CoolBreeze laser, has been the “gold standard” for non-ablative laser skin rejuvenation, wrinkle reduction, acne and acne scarring since 1994. The CoolBreeze hand piece allows the physician to provide PAINLESS treatments without any downtime from regular activities.

CoolBreeze laser features:

  • 1320nm mid-infrared wavelength, energy absorbed by water in tissue with no collateral damage to surrounding tissue or vessels, safe for all skin types (I-VI) without pigmentary changes
  • CoolBreeze hand piece with safety spacer
  • Variable spot size (3mm-10mm) for smaller or larger treatment areas
  • Thermal feedback, a CoolTouch exclusive, which precisely adjusts the laser power to safely reach target temperature
  • Adjustable precision-pulsed cryogen cooling to maximize patient comfort

The CT3PLUS is FDA cleared to market for dermatological general surgery, hemostasis, ablation, wrinkle reduction, mild to moderate acne vulgaris & acne scarring. Under clinical investigation for onychomycosis. CoolBreeze lasers are manufactured under patents and patents pending: 5820626; 5976123; 6413253; 6451007; 7122029; 7637906; 5814040; 5979454; 6171301;5595568; 5735844;

In a paper released by the company dated March 2010, titled “Onychomycosis Trial Preliminary Results Using a 1320nm Mid-infrared Laser”, they describe treating 38 patients with a total of 54 toes treated.  The protocol involved 2 treatments but was unclear as to how far apart they were given and they suggest 2 or 3 treatments would give the best results.  They reported a 79.6% positive response after 2 treatments.  It is important to note that they also graded the amount of pain the patients experienced during and after the treatment.  Although most patients reported no to slight pain, there was 1 patient in 38 who experienced an adverse event reported as “a localized, sharp pain like sensation in the large toe that resolved within 2 months.” This laser generates a lot of heat, so much so that it has to monitor the thermal take-up of the tissues and when a threshold temperature is reached, it sprays a liquid cryogen (cooling spray) to avoid tissue damage.

They have almost no track record in the field for use with onychomycosis and are only now starting to try to market the device for use by podiatrists for the treatment of toenail fungus.  Its use for this purpose is considered off label by the FDA.  When questioned by me about the status of ongoing FDA trials, a spokesman for the company refused to provide a substantive answer.

2) The Genesisplus laser manufactured by Cutera is the only other laser to have an FDA clearance for use on onychomycosis in the United states. style=The Genesisplus is operated “freehand”, that is there is no standoff or other device to insure that the handpiece is kept at the same distance during treatment. Because the laser energy experienced by the target tissues varies with the distance in a logarithmic fashion this is very important. What this means is if you are twice the distance, you get the square root of the energy, not merely half as you would think. Conversely, as the distance is halved, you get the square of the energy delivery. Cutera attempts to control this measuring the temperature of the target and varying its power output. Since there is a lag in the amount of time it takes the tissue to heat up and radiate back to the temperature sensor, this is not an optimal method to maintain consistent laser energy delivery to the (target) fungus. Cutera’s Genesisplus is a 1064nm pulsed NdYAG laser, similar to the Pinpointe. Similar is not the same, however. Where Patholase spent a lot of time on R&D for a pulse modulation that maximizes the uptake of laser energy by the target fungus, and then patented that feature, Cutera had to use a different modulation that is less effective. There is a sharp contrast between the minimal study performed using the Genesisplus to the extensive studies performed by Pinpointe. It is also important to note that there is only 1 clinical study involving only 7 patients demonstrating a lower efficacy (70%) of the Genesisplus laser’s combination of wavelength and pulse modulation after 2 treatments, as compared to the Pinpointe’s efficacy after only 1 treatment as demonstrated in their multi-year multi-center studies involving hundreds of patients. Furthermore, the FDA clearance for onychomycosis is granted for a 2 mm spot size. The company has to use a device to change their 5 mm spot to 2 mm and measurements have shown the amount of laser energy delivered is now approximately 1/3 of what the Pinpointe delivers.

3)  Noveon (Nomir Technologies) is a low power laser that is currently in use for dental work, cataract surgery and hair removal. The laser beam has two different wavelengths of near-infrared light, which causes photo inactivation of the fungi that cause onychomycosis. The device uses specific infrared wavelengths that have the ability to cause photo damage to microbes.

Nomir Noveon laser for Onychomycosis

In a pilot study on 26 patients, Noveon treatment had a 76 percent clinical improvement.  The Noveon protocol requires 3 treatments spaced several weeks apart. At this time, Nomir Medical has a FDA 510(k) clearance for the Noveon laser and is pursuing approval for onychomycosis.  This means that using the Noveon to treat toenail fungus is an “off label”use of the device.   Link to abstract of pilot study.

As of June 2010, there still are no Noveons in regular use in the field and podiatrists who have contracted with the company don’t know when or if they will receive the laser.  The company appears to be in financial trouble again and may be bought by another firm.  Another aspect is the cost of using the laser for the doctor.  The Noveon requires the use of disposable toe clips, one for each toe, that must be replaced for each patient treatment.  Since the protocol is 3 treatments, if all 10 toes are treated, that means 30 toe clips at about $25 each or an overhead of $750 per patient.  It is probable that to save overhead, only the obviously infected toes would be treated, leaving sub-clinical infections present in the untreated toes that would then increase the likelihood of reinfection.

4)  PinPointe FootLaser (Patholase) is a new high powered Nd:YAG pulse laser operating  near 1064nm that targets the fungus responsible for causing onychomycosis and related fungal infections. According to Patholase, usually only one treatment is necessary although further study is ongoing. No anesthesia or other drugs are necessary. Patients who have undergone the treatment typically report no pain and promising results have been reported. In early clinical trials an 88% success rate was reported.  The current protocol is a single treatment. An FDA trial involving a large number of patients in multiple settings was started in June 2009 and completed in  August 2010.  Pinpointe Footlaser at clinical trials.gov

Pinpointe FootLaser for treatment of onychomycosis

The PinPointe FootLaser has received FDA clearance for use in podiatry. As of October 15, 2010 the Pinpointe FootLaser has received full FDA clearance for the treatment of onychomycosis. It is the only laser that is FDA cleared for the treatment of onychomycosis.  In Europe, it received the CE Mark approval (certifying that it has met EU consumer and health safety standards) for the treatment of toenail fungus.  It has also received TGA approval for use in Australia for the treatment of toenail fungus.  It has been in use around the world treating toenail fungus in podiatrists offices since late 2008.  As of early November 2010 a spokesperson for the company says about 50,000 cases have been done worldwide.  Because the protocol is treat all 10 toes, that means about 500,000 toes have been treated world wide with no reported adverse events. The cost of the procedure varies with geographical location and degree of infection.  In the USA the cost varies from approximately $750 to $1,200.

5)  Transungual laser therapy (TLT, Arpida) is a new device which makes partial micro-holes to the dorsal nail plate. This facilitates the permeation of terbinafine to the ventral side of the nail. Patients then apply a daily topical formulation of a terbinafine lacquer solution and ethanolic liquid on a daily basis. A European regulatory agency has initiated a phase III clinical trial to evaluate the efficacy, safety and tolerability of the TLT therapy.  Because this treatment involves using a laser to drill micro holes to facilitate topical drug penetration of the nail and is not actually treating the fungus itself, and also because it is not available in the USA at this time, it is beyond the scope of this page which focuses on the use of lasers to directly treat the fungal infection.  I also can’t find any information about this therapy after January 2008.  Link to Arpida information.

There are also companies that make lasers for treating other conditions such as chronic pain & wound healing.  The K-Laser is one such example, used by chiropractors, veterinarians, trainers and physicians.  It is a low power unit that comes in several types including small desktop and battery powered devices.  There have been a few mentions of the use of  the K_Laser for treating onychomycosis, but it should be made clear that the device was never designed for this purpose and there are no clinical trials testing it for this purpose.  It is not being considered for FDA approval for use on onychomycosis and it’s efficacy is totally unknown and unproven.

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