I can see the logic in focusing the LASER through the nail plate and vaporizing the onychomycosis but this will be variable at best and could cause burns to the nail bed. The patients want something that will make there nails look like they did when they were children. That just isn't going to happen unless you catch it before damage occurs at the nail bed level. Early treatment with topicals or oral antifungals still seems to be the best treatment in my book. I hope I am wrong. This LASER thing would be great if it works. Not only for the patients but for all of podiatry.
For professionals in the Podiatric community that are interested, here is the current information on the Pivotal Study for the Noveon Laser device from Nomir Medical Technologies.
There were 36 subjects (53 Toes) enrolled in the study.
Starting after the completion of the second of the four treatments, all subjects were required to use a non-prescriptive topical agent: 1% topical terbinafine cream applied only between the toes to control or prevent tinea interdigitalis.
Patients were instructed to not get any cream on the nails.
Use of this topical between the toes only, was in accordance with the current listed product information and is neither FDA indicated, nor FDA cleared as a treatment for onychomycosis. Other adjunctive actions that are "standard of care", such as nail debridement or nail trimming, were allowed at each investigator’s discretion.
Control subjects were handled identically in all respects to those who were treated, except for, of course, with sham “treatment” there was no energy delivery. The highest treatment site temperature was 100.5°F.
All study subjects had to have laboratory confirmation of onychomycosis by either positive culture using a selective dermatophyte test medium, or positive periodic acid-Schiff staining (PAS) from a toenail sample.
The mycology was followed and data taken for the 180 day balance of the study.
The top-line preliminary 120-day data analysis that was presented at the Council for Nail Disorders 13th Annual Scientific Meeting, and demonstrated that after Noveon treatment, 76.3 percent of the treated toes showed evidence of clinical improvement (p
This data was based on at least 120 days of follow-up on all enrolled patients. Additionally, no significant adverse events were reported.
The final 180 day data, is currently under review by the FDA in an application for 510(k) approval for Onychomycosis treatment, and has been accepted for publication with a Podiatric peer-review journal.
Completed pilot study data with this device can be found at:
Bornstein, E.S., A.H. Robbins, M. Michelon (2008) Photo-inactivation of fungal pathogens that cause onychomycosis in vitro and in vivo with the noveon dual wavelength laser system. 2008 New Cardiovascular Horizons Meeting Abstracts.
A lengthy discussion on this and other light-based onychomycosis technologies can be found at:
Chief Science Officer
Nomir Medical Technologies
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