When I was a kid, the thought of lasers were always synonymous with outerspace and weapons of the future but in the last quarter century lasers technology have expanded from a "tactical to practical"  application in medicine for tattoo removal, laser-assisted in situ keratomileusis (LASIK) , hair removal.  Though FDA approval is pending, many practitioners have turned their sites on Digger the Dermatophyte, treatment of onychomycosis.  The laser wavelength of the Noveon beams emits two different wavelengths of near-infrared light which is targets  fungi.  One nonpublished study presented at a national dermatologic society meeting notes greater than 70% resolution nail infection at 6 months after 4 treatment however does not report whether this is clinical or mycotic cure.  Other clinical studies are pending.  There is an obvious financial incentive with an out-of-pocket charge of $1000 - 1400 for 4-6 treatments and followup--therefore a lucrative venture.  I know there are many offices that offer this new innovative treatment and I am all in for a cure of this chronic problem.  The bottom line is does it work?   Is this a fad or a trend for treating our crusty friend? What are your thoughts and do you have any results to share (please post pics).

A colleague of mine (and former co-resident) is now one of the few "certified laser specialists" who utilize the pin-pointe laser modality in the treatment of onychomycosis, and she as reported largely favorable results (although she has only recently started to perform the procedures).

I took the opportunity to sit in on several of the treatments with her, to get the feel for things, and it seems to be fairly user-friendly.  I have encouraged her to track her cases to perform a comparative study to generate some data on this topic --the limited amount of study data is a concern that I have about this product/procedure.  While there is limited EBM available to support efficacy of such a treatment modality, i have difficulty trying to "sell" the idea of paying cash out of pocket for such a procedure....

Ryan,

I agree with your concerns about an unproven modality with a high out of pocket cost.  Before Terbinafine went generic and places like WalMart started carrying it for a steal ($10 for 90 pills) it was impossible to convince a patient to pay out of pocket for it (assuming their insurance didn't cover it).  Even when insurance did cover it patients constantly complained about the actual cost (granted it was quite overpriced before Novartis lost its patent).  If patients have concerns about the medication I'd have trouble seeing how many of them would agree to a $1000 or so out of pocket cost for an unproven procedure.  Hopefully we'll start seeing some longer term positive data.

In Central Oregon we have one podiatrist who's certified in this procedure.  Apparently it takes about 40 minutes to systematically laser the affected nails. 

I tried calling the company to find out more info but never received a call back.  Not sure why.

Interesting.  I'm told the company limits the number of physicians that they will "certify" which allows the company and t(he physicians involved) to maintain the idea of the exclusiveness of the treatment (perhaps thus attempting to justify the cost?).

Podiatrists with freakin' laser beams...... :)

You're right about the certification.  The podiatrist in Central Oregon that does the procedure is, as I'm told, the only one in the state that's certified.  I'm not sure if that's the smartest business model, but to each his own.

I'm sure if a good study comes out showing the laser is efficacious against onychomycosis they'll "allow" more podiatrists to become certified.

After googling for a little bit, I found a good review article on the treatment from the New York Times (link here)

Excerpt:
After four treatments with Noveon, about half of the 39 toenails tested no longer had active nail infections, according to the results of a clinical trial that the company presented this month at a national dermatology meeting. Six months after the initial treatment, about 76 percent of the volunteers had clear nail growth, the study reported.

...Americans currently spend about $1.26 billion annually on oral and topical prescriptionsfor nail fungus, according to IMS Health, a health care information company. That is in addition to millions spent on unproved home remedies like tea tree oil, Vicks VapoRub, Listerine and Clorox. Industry analysts and executives estimate that more effective treatments could expand the market to as much as $3 billion annually.

I personally think that it is great to have an alternative to anti-fungal pills and topicals for the treatment of onychomycosis. Having said that, I wonder what would the recurrence rate be, if they just kills the fungus in the nail beds and not treat the tinea pedis?

I also found a treatment video on Youtube and it looks pretty simple to do. You just treat the nail bed and the nail matrix cells (just proximal to the nail) with the laser. 

I recently spoke with some company representatives, may have been the reps, but lets say they were nice and professional but less than helpful in discussing any data.  Not that I was planning on becoming the fungi laser expert but they were evasive about discussing me using this in Florida.  May have been the franchise territory issue.

May be a great treatment modality but that interaction left me doubtful.

Karr 

Not that this helps, but....

There is another DPM in my plaza that currently is the "certified" doctor for the procedure.  About 10 patients have come over to my office complaing that it:

a)  Didn't work
b)  Cost was excessive
c)  DPM burned the skin
d)  They were not provided EBM
e)  Told that the cost was $1500 and it was due up front

Now, if you ask me, there seems to be a couple of problems with this technology in that:

a)  If was the greatest thing since sliced bread, then you would think that MEDICARE would cover the procedure and
b)  EVERYONE would be doing it!!!!

I find it funny that I believe this was attempted about 20-30 years ago (some of the more experienced DPMs can eloborate) but I thnk that since its a non-adjustable laser set at a specific wavelength, you cant alter the wattage for different thickness nails.   Not EVERYONE has the same thickness of onychomycosis....

again, just my 3 cents....

Collegues:

I would like to take the opportunity to present some basics in laser/tissue interctions, so that Podiatric Physicians can read and better understand some of the photobiology involved in the issues being discussed, with potential onychomycosis therapy with lasers.

A free running pulsed (FRP) Nd:YAG laser is capable of pulse durations in the millionths of a second (10-6 sec), that allow for very high peak powers (1-2 thousand watts/pulse) for safe and rapid ablation of tissues.

Exploiting this laser-tissue interaction, a clinician using a FRP Nd:YAG has the ability to apply an intense burst of laser energy, for a very short time interval, to effect a desired outcome. As previously described, this has been successfully peer-reviewed and applied in vitro for photo-disinfection experiments, (2, 3, 4) and in humans for periodontal therapy. (1)


1) Harris, D., Gregg, RH., McCarthy DK. et al, Laser-assisted new attachment
procedure in private practice, General Dentistry, Sept-Oct 2004, Vol52 No 5,
pp396-403

2) Harris DM and M Yessik: Therapeutic ratio quantifies laser antisepsis: Ablation of Porphyromonas gingivalis with dental lasers. Lasers Surg Med 35:206-213, 2004.

3) Harris DM: Laser antisepsis of Phorphyromonas gingivalis in vitro with dental lasers. SPIE Proceedings 5313-22, 2004.

4) Harris DM, SE Jacques: Monte Carlo Simulation of depth of kill of P. gingivalis in dentin based on experimental damage threshold. Abstract presented at ASLMS, Orlando, FL, April 2005.


A continuous wave (CW) or gated diode laser (such as the Noveon device- Nomir Medical Technologies) does not have the high peak power or microsecond pulse abilities of the FRP Nd:YAG. A CW Diode laser has far longer pulse durations in milliseconds (10-3 sec or thousandths of a sec), with far less peak power, that will not reach the ablation threshold in soft tissues. (5, 6)

5) ALD (The Academy of Laser Dentistry). Featured wavelength: diode – the diode
Laser in dentistry (Academy report) Wavelengths 2000: 8: 13.

6) Bornstein E, Near-infrared dental diode lasers. Scientific and photobiologic
principles and applications, Dent Today. 2004 Mar;23(3):102-8


The abilities of the FRP: Nd:YAG can cause quick, safe and precise ablation of soft tissues involved, (7, 8) as long as the physician performing the procedure is particularly careful not to employ a manual method called pulse stacking.

Pulse stacking is an overlapping localization of laser pulses (going over the same small spot more than once) that occurs from the inconsistent manual aiming of small to medium laser spot sizes over large areas of tissue. This can lead to excessive heating of areas of treatment, and potentially ablate healthy tissues.(9).


In careful hands, this can be avoided and pulse stacking is not partial to the Nd:YAG laser, but is a phenomenon associated with all micro-pulsed lasers such as the Er:YAG, CO2, Homium:YAG and Nd:YAG (9)

This issue is the same universally based on Photo-physics with micro-pulsed lasers.

I am not knocking Nd:YAG lasers.


7) Marjaron B, Plestenjak P, Luka CM: Thermo-mechanical laser ablation of soft biological tissue: modeling the micro-explosions. Applied Physics B 69:71-80, 1999.

8) Venugopalan V, Nishioka NS, Mikic BB: The thermodynamic response of soft biological tissues to pulsed infrared-laser irradiation. Biophysical Journal 70:2981-2993, 1996.

9) Dawson E, Willey A, LEE K: Adverse events associated with nonablative cutaneous laser, radiofrequency, and light-based devices. Semin Cutan Med Surg 26:15-21, 2007.


The Noveon (Diode laser) works on a completely different mechanism of action. This device expands the laser/spot size to 1.5 cm diameter (vs 1mm for most FRP systems through a fiber), to cover the entire nail area simultaneously, in a hands free manner, vs a spot by spot manual procedure with a FRP laser.

With the Noveon, the device can make use of the non-ablative ability, to stay below the Thermal Threshold in the treatment of skin and nail.

The Thermal Threshold Power Density for near-IR laser energy (W/cm2), that will produce Thermal Interactions with tissues and will permanently alter the tissues, is about 10 W/cm 2 (This is 2-3 Log less than ablative lasers).

According to Henriques (10) and Eichler and Seiler (11) and Dewhirst (12) producing voluminous data, it can be deduced that as long as the tissue temperature being irradiated (with any system) is at or below about 45 C (113 F), there is little chance of Irreversible Tissue Damage. The Noveon therapy, in peer-reviewed publications and under IRB guideance does not go over 101 F when treating human nails. (13, 14)

Hence, to separate out (non thermal) unique photo-biological effects of 870nm/930nm, the Noveon has a Power Density that is below the 10 W/cm2 threshold, so that the photobiology of the wavelength can be the dominant interaction, instead of thermal tissue changes. This is the basis for the noveon therapy. (13, 14)

10) Henriques and Moritz, Am. J. Path., 23,. 531-549 (1947)

11) Eichler and Sieler, Lasertichnik in der Medizin, Springer, Berlin (1991)

12) Dewhirst MW, et al. Basic principles of thermal dosimetry and thermal thresholds for tissue damage from hyperthermia. Int J Hyperthermia. 2003 May-Jun;19(3):267-94. Review.

13) Bornstein E., Hermans W., Gridley S., and Manni J. Near infrared Photo-inactivation of bacteria and fungi at physiologic temperatures. Photochemistry and Photobiology

14) Bornstein ES: A Review of Current Research in Light-Based Technologies for Treatment of Podiatric Infectious Disease States Journal of the American Podiatric Medical Association Volume 99 Number 4 348-352 2009

With the Noveon device, there is:

1) no ablation,
2) no manual moving of a fiber handpiece or holding an individual toe,
3) no worry of pulse stacking,
4) and no skill involved.

The device delivers the same therapy every time, at the same dose, to four toes simultaneously, independent of the user.

The Noveon Device has finished its Pivotal FDA study, and the FDA is currently reviewing the data under the 510(k) application process.

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com

Dr. Bornstein, 

Thank you for your input. 

I think having a new and alternative treatment for any common pathology is great. The only thing that bothers me about this laser nail treatment is, it is only apply to the nails and toes.

Clinically speaking, I believe that every patient with onychomycosis has some degree of tinea pedis. In my opinion, unless we eradicate the tinea pedis (fungus on skin) and institute a good hygiene protocol, I would imagine that onychomycosis would recur fairly quickly. That's a disservice to our patients. 

I wonder if you recommend any treatment protocol or concurrent treatment of tinea pedis?

 

There is almost always some form of Tinea Pedis in patients with Onychomycosis, and re-infection from one to the other (TP to OM) is extremely common.  In fact, there is almost a four-fold increase in risk of Onychomycosis with some types of Tinea Pedis.

­­Sigurgeirsson B, Steingrímsson Ó. Risk factors associated with onychomycosis. J Eur Acad Dermatol Venereol 2004; 18(1):48-51.


In the reverse, Onychomycosis also serves as a reservoir for T. rubrum (and others) that can easily infect the skin.
 
Walling HW, Sniezek PJ. Distribution of toenail dystrophy predicts histologic diagnosis of onychomycosis. J Am Acad Dermatol 2007; 56(6):945-948.

Hence, a maintaince program of good hygeine, Tinea Pedis (cream or spray) and shoe disinfection should be mandatory with any topical light therapy.  

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies

I followed this link to the PinPoine Laser website to obtain some information on the science behind this modality...... however if seems as there is no specific information regarding the evidence behind this modality and instead provides only information regarding locating a provider to perform the procedure.....

Is this marketing or medicine?

Collegues:

I would like to take the opportunity to present some basics in laser/tissue interctions, so that Podiatric Physicians can read and better understand some of the photobiology involved in the issues being discussed, with the different potential onychomycosis laser therapy devices.

A free running pulsed (FRP) Nd:YAG laser is capable of pulse durations in the millionths of a second (10-6 sec), that allow for very high peak powers (1-2 thousand watts/pulse) for safe and rapid ablation of tissues.

Exploiting this laser-tissue interaction, a clinician using a FRP Nd:YAG has the ability to apply an intense burst of laser energy, for a very short time interval, to effect a desired outcome. As previously described, this has been successfully peer-reviewed and applied in vitro for photo-disinfection experiments, (2, 3, 4) and in humans for periodontal therapy. (1)


1) Harris, D., Gregg, RH., McCarthy DK. et al, Laser-assisted new attachment
procedure in private practice, General Dentistry, Sept-Oct 2004, Vol52 No 5,
pp396-403

2) Harris DM and M Yessik: Therapeutic ratio quantifies laser antisepsis: Ablation of Porphyromonas gingivalis with dental lasers. Lasers Surg Med 35:206-213, 2004.

3) Harris DM: Laser antisepsis of Phorphyromonas gingivalis in vitro with dental lasers. SPIE Proceedings 5313-22, 2004.

4) Harris DM, SE Jacques: Monte Carlo Simulation of depth of kill of P. gingivalis in dentin based on experimental damage threshold. Abstract presented at ASLMS, Orlando, FL, April 2005.


A continuous wave (CW) or gated diode laser (such as the Noveon device) does not have the high peak power or microsecond pulse abilities of the FRP Nd:YAG. A CW Diode laser has far longer pulse durations in milliseconds (10-3 sec or thousandths of a sec), with far less peak power, that will not reach the ablation threshold in soft tissues. (5, 6)

5) ALD (The Academy of Laser Dentistry). Featured wavelength: diode – the diode
Laser in dentistry (Academy report) Wavelengths 2000: 8: 13.

6) Bornstein E, Near-infrared dental diode lasers. Scientific and photobiologic
principles and applications, Dent Today. 2004 Mar;23(3):102-8


The abilities of the FRP: Nd:YAG can cause quick, safe and precise ablation of soft tissues involved, (7, 8) as long as the physician performing the procedure is particularly careful not to employ a manual method called pulse stacking.

Pulse stacking is an overlapping localization of laser pulses (going over the same small spot more than once) that occurs from the inconsistent manual aiming of small to medium laser spot sizes over large areas of tissue. This can lead to excessive heating of areas of treatment, and potentially ablate healthy tissues.(9).


In careful hands, this can be avoided and pulse stacking is not partial to the Nd:YAG laser, but is a phenomenon associated with all micro-pulsed lasers such as the Er:YAG, CO2, Homium:YAG and Nd:YAG (9)

This issue is the same universally based on Photo-physics with micro-pulsed lasers.

I am not knocking Nd:YAG lasers.


7) Marjaron B, Plestenjak P, Luka CM: Thermo-mechanical laser ablation of soft biological tissue: modeling the micro-explosions. Applied Physics B 69:71-80, 1999.

8) Venugopalan V, Nishioka NS, Mikic BB: The thermodynamic response of soft biological tissues to pulsed infrared-laser irradiation. Biophysical Journal 70:2981-2993, 1996.

9) Dawson E, Willey A, LEE K: Adverse events associated with nonablative cutaneous laser, radiofrequency, and light-based devices. Semin Cutan Med Surg 26:15-21, 2007.


The Noveon (Diode laser) works on a completely different mechanism of action. This device expands the laser/spot size to 1.5 cm diameter (vs 1mm for most FRP systems through a fiber), to cover the entire nail area simultaneously, in a hands free manner, vs a spot by spot manual procedure with a FRP laser.

With the Noveon, the device can make use of the non-ablative ability, to stay below the Thermal Threshold in the treatment of skin and nail.

The Thermal Threshold Power Density for near-IR laser energy (W/cm2), that will produce Thermal Interactions with tissues and will permanently alter the tissues, is about 10 W/cm 2 (This is 2-3 Log less than ablative lasers).

According to Henriques (10) and Eichler and Seiler (11) and Dewhirst (12) producing voluminous data, it can be deduced that as long as the tissue temperature being irradiated (with any system) is at or below about 45 C (113 F), there is little chance of Irreversible Tissue Damage. The Noveon therapy, in peer-reviewed publications and under IRB guideance does not go over 101 F when treating human nails. (13, 14)

Hence, to separate out (non thermal) unique photo-biological effects of 870nm/930nm, the Noveon has a Power Density that is below the 10 W/cm2 threshold, so that the photobiology of the wavelength can be the dominant interaction, instead of thermal tissue changes. This is the basis for the noveon therapy. (13, 14)

10) Henriques and Moritz, Am. J. Path., 23,. 531-549 (1947)

11) Eichler and Sieler, Lasertichnik in der Medizin, Springer, Berlin (1991)

12) Dewhirst MW, et al. Basic principles of thermal dosimetry and thermal thresholds for tissue damage from hyperthermia. Int J Hyperthermia. 2003 May-Jun;19(3):267-94. Review.

13) Bornstein E., Hermans W., Gridley S., and Manni J. Near infrared Photo-inactivation of bacteria and fungi at physiologic temperatures. Photochemistry and Photobiology

14) Bornstein ES: A Review of Current Research in Light-Based Technologies for Treatment of Podiatric Infectious Disease States Journal of the American Podiatric Medical Association Volume 99 Number 4 348-352 2009

With the Noveon device, there is:

1) no ablation,
2) no manual moving of a fiber handpiece or holding an individual toe,
3) no worry of pulse stacking,
4) and no skill involved.

The device delivers the same therapy every time, at the same dose, to four toes simultaneously, independent of the user.

Here are the most recent published abstracts for the material we have been discussing. These are directly from from PubMed, for thoes intrested.

The JAPMA article is available at their web site for $12 US, and the Photobiology article should be available soon, when the next journal is published.


J Am Podiatr Med Assoc. 2009 Jul-Aug;99(4):348-52. Links
A review of current research in light-based technologies for treatment of podiatric infectious disease states.Bornstein E.
Nomir Medical Technologies, Inc, 307 Waverley Oaks Road, Suite 109, Waltham, MA 02452, USA. ebornstein@nomirmedical.com

Recently, there has been a resurgence of interest in potential phototherapy technologies for the local treatment of bacterial and fungal infection. Currently, onychomycosis is the principle disease that is the target of these phototherapies in podiatric medicine. Some of these technologies are currently undergoing in vitro and in vivo trials approved by institutional review boards. The three light-based technologies are ultraviolet light therapy, near infrared photo-inactivation therapy, and photothermal ablative antisepsis. Each of these technologies have markedly dissimilar mechanisms of action. In this review, each technology will be discussed from the perspectives of history, photobiology, individual mechanism of action, safety, and potential clinical efficacy, with data presented from published material. This review is intended to give podiatric physicians detailed information on state-of-the-art infectious disease phototherapy.



Photochem Photobiol. 2009 Aug 26. [Epub ahead of print]Links
Near-infrared Photoinactivation of Bacteria and Fungi at Physiologic Temperatures.Bornstein E, Hermans W, Gridley S, Manni J.
Nomir Medical Technologies, Waltham, MA.

Abstract We examined a laser system (870 and 930 nm), employing wavelengths that have exhibited cellular photodamage properties in optical traps. In vitro, with 1.5 cm diameter flat-top projections (power density of 5.66 W cm(-2)), at physiologic temperatures, we achieved photoinactivation of Staphylococcus aureus, Escherichia coli, Candida albicans and Trichophyton rubrum. Using nonlethal dosimetry, we measured a decrease in trans-membrane potentials (DeltaPsimt and DeltaPsip) and an increase in reactive oxygen species (ROS) generation in methicillin-resistant S. aureus (MRSA), C. albicans and human embryonic kidney cells. We postulate that these multiplexed wavelengths cause an optically mediated mechano-transduction of cellular redox pathways, decreasing DeltaPsi and increasing ROS. The cellular energetics of prokaryotic and fungal pathogens, along with mammalian cells, are affected in a similar manner when treated with these multiplexed wavelengths at the power densities employed. Following live porcine thermal tolerance skin experiments, we then performed human pilot studies, examining photodamage to MRSA in the nose and fungi in onychomycosis. No observable damage to the nares or the nail matrix was observed, yet photodamage to the pathogens was achieved at physiologic temperatures. The selective aspect of this near-infrared photodamage presents the possibility for its future utilization in human cutaneous antimicrobial therapy.
 

We have applied to the FDA for a 510(k) approval for the Noveon Laser for the treatment of onychomycosis, and are awaiting approval.

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies

Hmm....not sure if I just read an advertisement for Noveon? 

Mr. Borstein, thank you for laser lesson.  However, with this "newfound" advent of phototherapy, I agree with Dr. Suzuki.  Until we address the onychomycosis, ANY laser therapy is just window dressings.



 

The last post was not meant as an advertisement, as the Noveon is not yet for sale, pending FDA approval.

My intention is to present science and peer-reviewed research into the discussion of treating this Podiatric infectious disease. Any device worthy of being used on patients to treat an infectious disease must have such data behind the therapy.

The Noveon device is photo-biologically treating the onychomycosis by inactivating the dermatophytes.

Here are some specifics on the Pivotal FDA study.

There were 36 subjects (53 Toes) enrolled in the study.

Starting after the completion of the second of the four laser 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.

The control subjects were again handled identically in all respects to those who were treated, except for, of course, sham “treatment” with 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 also followed and data taken for the balance of the study that lasted 180 days.

The top-line preliminary 120-day data analysis that I presented at the Council for Nail Disorders 13th Annual Scientific Meeting demonstrated that after Noveon treatment, 76.3 percent of the treated toes showed evidence of clinical improvement (p<0.02), and a significant drop in positive culture was seen in 74 percent of the treated toes after only two treatments (before the introduction of the tinea pedis cream.)

This data was based on at least 120 days of follow-up on all enrolled patients. Additionally, no significant adverse events were reported.

I must hold out on discussing the final 180 day data, as it is currently under review by the FDA, and we are also under agreement with a peer-review podiatric journal that has agreed to publish the final results.

Thank you for your interest and the questions.

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies