Laser treatment for nail fungus

Hamish - the reason for the reactions that this product/technique is purely to do with the way it is being promoted. And after seeing the pattern so many times before, the cynicism comes in.

It is a new piece of equipment, that is expensive to provide the treatment.

Those touting it on YouTube and other places it claim FDA approval (when its not approved for onychomycosis).

Those touting it claim remarkable success rates, yet as its a new piece of equipment none of them would have owned the device long enough to see these results.

There is a small uncontrolled study from the company that makes some remarkable claims - but it appears to be uncontrolled and its unplublished, so we not going to accept that blindly.

The pattern of the way it is being marketed, we have seen many times in the past. We been there done that. Guess what happen to the other techniques that followed this pattern?

Can you understand why the skepticism? There is huge interest in this topic (its already made it on to the most viewed list)

There is what appears to be a reasonable clinical trial underway, but it is funded by the company, (PinPointe / Patholase) so does lack a certain amount of independence (link to trial). Why is it being marketed and adopted without the data from this study. We will eagerly wait to see if the study gets published (its scheduled for completion in August 2010).

As always, I will always be the first to go where the evidence takes me. I will be urging the University to get one if the data supports its use.

 

Craig,
Your last posting was more the standard of reply I was expecting when I first stepped in.
I do understand the skepticism and am adept at cynicism.
You put your thoughts this time in a well drafted form, that one post says it all about the reservations many have. It is cogent and the best written piece of counter point.
One College of Podiatry in the Sates has one for trials already so I was led to believe, quite what the project is I am unaware. So I am sure they would be very satisfied if your educational establishment were interested in due time.

Hamish

 

What fun!

I had'nt checked this thread, not being dermatologically minded. I've missed out!

I struggle to follow the in depth science of lasers. How a laser can pass through opaque tissue or attack pathogens whilst leaving healthy cells undamaged is a closed book to me and not one I have a particular interest in opening. I suspect few who talk of wavelengths, growth factors etc actually know what these things mean.

What I DO know a little about is outcome measures and cognitive psychology.

So, Hamish. In an honest and open handed attempt to elevate this thread back to the matter in hand I have a simple question.

You said

Fair enough. You can't show us positive or negative outcomes where you've not been doing it long enough for the TX to have worked. All new treatments must go through this period of uncertainty. So from this I can infer that you've as yet had insufficient numbers through to provide positive case studies yourself.

I can also infer, through its absence here, that there is no controlled trial.

My question then, and please take it in the spirit in which it is asked, ie sincerely, is this.

Why do you beleive this treatment is effective.

What made you sufficiently sure that this treatment worked to make the substantial cash outlay?

Regards

 

Robert,
in the spirit of sincerity in which you ask, and replying honestly in the same manner to someone who is knowledgeable in cognitive matters, you already know my answer.

I chose to.
We always choose, whether we do so actively or passively, consciously or unconsciuosly.

So it is largely irrelevant to anyone but me. But thank you far asking, beyond that I have nothing more to say.
The bigger question would be why did I choose to bother and persist? but the answer is the same I chose to.

I will have to reflect on that to consider the value of the exercise to me and to absorb what has been revealed to me during the exchange. I am sure it is most enriching.
I have contributed my part and it is now at an end.

 

Your stock just went up a few points hamish. That's a good answer. You are more honest with yourself than most.

You say you're done here but I'll continue anyway.

The next question is why did you decide to? There are always reasons although they are rarely the ones we think they are.

Was it because it's nice to have a solution when others don't? Hope is a powerful motivator. That certainly predisposed me to believe in dry needling (at least enough to try it)!

The reason this is a relevant line of enquiry is that presuming we start from a baseline of unbeleif there must be something to convince. And whatever made you believe may also convince others... But only if you can identify it.

The mistake that many who bring their new ideas to the arena make is to think that their belief will make others believe. Usually we are inclined to belief, then we seek evidence and rationale to support it.

So my advice to anyone in that situation is to carefully examine why they chose to believe what they do. This required a significant degree of self examination and more honesty than most people can apply to themselves.

Regards

 

Hamish,

I agree, that was a candid reply. Funny, I was just musing over the psychology/similarity of your choosing to "believe this treatment is effective" to the choice that many of us have made in trying Falknor`s needling technique, since observing the great pictures on this forum (although there does not appear to be any robust, repeatable evidenced based research carried out), when Robert piped up!

Let`s hope the Multi-Center Trial by Patholase produces some meaningful data, I will be watching with interest.

Cheers,
Bel

 

It is perhaps more honest of me to say I am done with my rehashing of that which has been done.
This is curious though, is this a philosophy thread now?. That anyone would be interested in my internal processing mechanism. I am not sure we are in the right forum but until we are invited to take it elsewhere I will see what I can do to help you a little.

I have lost the point of why did I decide to? Decide to what Robert? I am genuinely not sure what you mean specifically.
Your wish to offer hope, no doubt with integrity of belief is in my book laudable. What else do we do what we do, if not to offer help in ways we believe we can?

Like the Dow Jones I am sure my stock, as you put it, went up with some and down with others, it is of little consequence really.

The presupposition of starting from a state of unbelief may effect all thought that flows from it. As to would starting from a point of openness, trust, honesty and positivity. This does not constitute absolute acceptance, and being a doormat. Far from it, but it puts oneself in a good state for confidence to survive and possibly one might be more likely to leave the world a better place than it was we arrived in it. If one can leave a legacy when one goes perhaps this is an honourable one. Is this what you wanted to know of me? My convictions?
It is not my intention to sway anyone to my life style or beliefs I am just answering what I thought was being asked of me. So please accept it as such.

As for convincing others with my beliefs so that they might believe too? It is not my place, I must respect they have their own thinking processes to negotiate. Robert Diltz, Vaginia Satir, Fritz Pearls, Milton Ericson and probably even Bandler and Grinder could better explain how we form our beliefs and maintain them better than I could anyway.

What I recognized with my belief system was congruity in the communication with those I met and spoke to. In my dealings with them I continue to find them helpful, open and quite willing to answer questions. If they are unable, as would be expected with scientific issues, they willingly go to source or will put anyone in touch with the reputable scientists involved.

I have no real interest in seeking approval on this site nor do I wish to insult. What I thought, and still see in what I wrote, was a fresh view and it was contrary to some thought but it held information that was missing.
I can offer the following as information, what one does with it depends entirely what is in the reader’s heart, and possibly if they are in a good place or not:

The further study being conducted is not a short-term thing. One of the studies being done in Canada is a five-year study that will include many different treatment variations from one treatment to many over a period of a year, looking for the best efficacy by treatment regimen.

They believe it is their duty, knowing that the laser works as intended to be sure that the protocols followed are the best possible in every possible case.
Remember this is their view. If specific questions require answering they will be the best ones to supply an answer. No one hear will actually be able to answer it in all probability. Not me, I can be a conduit but what is the point of having a telephone and computer if one does not use it to help get answers from where the best source is. I read the promotional information then started speaking to them.
I understand more about light now than I did before but only to a point. I had forgotten about it being merely a component of the entire electromagnetic spectrum for a start. No doubt to some a shocking admission.

Yes they are funding the study just as major drug manufacturers do but, they have no say in the outcomes. It is my understanding that when a drug manufacturer needs a new drug tested, they hire the companies to test them. This is also done in a manner where the company has no say in the proceedings as to how the tests are conducted etc and they have no say on the final outcome.

They would be rather foolish to submit to this kind of testing if they had any doubt that the end result would not be advantageous to them, their business plan, partners and most of all, the patients.

As for the laser that is in New York at the Podiatric College, I understand the following to be true; it is being used to treat inner city people (Harlem) who would otherwise not be able to afford treatment. The deal made with the college was that they could use the donated machine to treat the poor, as long as they kept careful records of every procedure so that we could use results later and so that the up and coming new generation of podiatric professional would understand and use this new modality.
I suggest that this would need verification to some and I suggest they find it for themselves.

To finish, this has been out there to be found by anyone who cares to look since February of this year, and it is permissible to use it in its entirety. Again remember this is what someone else wrote and I would suggest if anyone has issue with it contact the individual directly firs as it would be the most grown up thing to do

“02/25/2009 John Strisower

WI Podiatrist Among First to Use PinPointe FootLaser

I would first like to take this opportunity to 
say thanks to Barry Block and PM News for 
providing this very efficient communication 
channel for our industry. I have been in 
numerous industries in my career and I can say 
as a matter of fact that this is one of the best 
there is.

There are and have been many misquotes in the 
press and I cannot speak to whether or not Chris 
Milkie, DPM, was misquoted as stating “88% cure 
rate” or not. Our first clinical trial showed 
88% of patients improved with a single treatment 
followed for 6 months. The results of that trial 
have now been published and is available by e-mailing me at: John@patholase.com

We have never claimed that this device and 
procedure provides a “cure.” The PinPointe 
FootLaser is a safe and effective way to treat 
onychomycosis and its use results in clear nail 
growth for patients in most cases. It has to be 
used correctly and consistently to achieve best 
results. Most patients will see a noticeable 
improvement with a single or small number of 
treatments. All providers and patients should 
have the expectation that one or a small number 
of procedures will be required to achieve best 
clear nail growth. Obviously, as with any 
medical device, the provider will exercise their 
best medical discretion and obtain patient 
consent to the procedure and cost in advance of 
service provision.

Our clinical data is still being developed and 
it is early. We have formally studied a small 
patient population, though those familiar with 
statistical power analysis will appreciate that 
a small patient population (n-value) is needed 
where the efficacy is very high. Where the 
efficacy is very low (i.e. treated not very 
distinguishable from untreated) a large n is 
required. Most drug studies require very large n 
numbers because their effects are low and due to 
their systemic nature require a large n to 
demonstrate safety.

Our power analysis showed that 19 subjects was 
far more than adequate to demonstrate a p-value 
< 0.0001 which is incredibly small, meaning that 
the effect caused by the FootLaser procedure had 
very high efficacy. One letter to PM News 
stated that our research showed no 
discrimination between treatment and no 
treatment for culture results and notch 
measurement which is true. Our culture results 
were very mixed (as are all culture results 
published in all studies done before us). This 
demonstrates why we are using new analytical 
techniques in our new trial, we will set a new 
trial standard. The notch measurement was nearly 
equal in treated vs. untreated which 
demonstrates no significant change to the nail 
growth between treated and untreated which is a 
critical safety measure.

This is the first published study. We are now 
embarking upon a very ambitious multi-site, 100+ 
patient, long-term follow-up study to 
unequivocally demonstrate the safety and 
efficacy of this revolutionary new technology. 
The sites involved each have specific expertise 
and offer unparalleled quality in clinical 
research and respected publication. Two sites 
have principal investigators who are very well 
respected and published dermatologists with long 
term clinical study expertise. Another site’s 
principal investigator is a world renowned 
general surgeon who has developed published 
expertise in clinical trials in photomedicine. 
Our final site principal investigator is one of 
the most prolific onychomycosis clinical trial 
podiatrists.

This new clinical trial is about to begin 
recruiting patients across the country and 
internationally (one site is in Canada). The 
level of scientific rigor and methods of 
analysis embodied in this trial will set the bar 
for future Onychomycosis trials.

The PinPointe FootLaser in addition to being 
cleared by the FDA, has the first and only 
European equivalent medical device clearance for 
the safe and effective treatment of 
Onychomycosis (CE Mark) based upon the same 
published study attached. Despite the solid 
science upon which everything PinPointe (and its 
parent company PathoLase, Inc.) base its 
business decisions, we are all looking for and 
requiring a higher level of evidence and quality 
of clinical trial data.

Given the state of current evidence available to 
providers, the PinPointe FootLaser is only 
appropriate for those that are visionary 
leaders in the podiatric community. We fully 
expect that providers who are interested and 
become involved today are those that understand 
where the science and data are and where it is 
going. They are the visionary pioneers of the 
industry that are taking advantage of 
technological developments to propel their 
practices to new heights while leading the 
industry.

We are planning long-term on having only the top 
10% of podiatric practices as contracted 
providers. In the near-term we are limiting this 
number much further and are already close to 
closing out numerous major metro markets for 
2009. With better than 50 providers in 18 
states, we are seeing a groundswell of provider 
feedback for those that have been practicing 
this procedure long enough. As you all know, it 
takes a few months for even a small distal 
lesion to grow out due to toenail growth rates. 
For some, it may take as long as 18 months to 
see a fully involved toenail grow out. At 3 and 
4 months, our providers have documented evidence 
of unsurpassed efficacy with no adverse events.

Most of our providers are finding this to be 
podiatry’s best new technology with the biggest 
potential for increasing value, differentiating 
practices and simultaneously satisfying 
patients. Additionally, as a cash paid 
procedure, this is proving to be very profitable 
for providers while greatly enhancing cash 
flow.

While not all providers have succeeded (less 
than a handful have not) the rest are thriving 
even in the current economic state. Currently, 
we are limiting our marketing to podiatry for 
numerous reasons, one of which is that it is the 
specialty that deals with this disease. We also 
feel that since dentists have teeth whitening 
and veneers, ophthalmologists have LASIK, 
plastic surgeons have breast Implants and 
liposuction and dermatologists have hair removal 
and Botox, podiatrists can now have and will 
enthusiastically develop their PinPointe 
FootLaser practices.

John Strisower, Chief Executive Officer, 
PathoLase, Inc./PinPointe FootLaser, 
John@patholase.com

 

Hamish
Thanks for joining this discussion. I am following it with interest and will be facinated with the long term results. I understand there are only a few practioners at present in the UK using this system, are you all joining forces to compare your results?
There are always those who are suspicious of new ideas and concepts but on the other hand there are always those like yourself who are brave and will give new techniques a go. Good luck with the new technique and please keep us posted on success rate.
Wendy

 

I'll go back a step

.

I said

You replied

Hence the question why did you choose to?

Its relevant because as I said what made you choose too might inspire others to.

Regards
Robert

 

To get back a little on the science of the thing, I did my graduate dissertation on low level laser use. Whilst I have probably forgotten much of what I learned at the time, there is evidence to support its penetration through tissue depth. There is a great deal of evidence showing effects on pathogens (bacterial not fungal though) with no negative effect on tissue.


When I first received an email about this system I was very interested, but the construction, data and photos of the attached trial did not give convincing support. I'm fairly sure from all my literature searching that there has been little or nothing looking at lasers and effect on fungal pathogens.
The other thing that immeditely struck me system was how there are probably other commercially available lasers that operate at a similar wavelength, power and pulse rates available, for a much lower cost (without the marketing though).

I remain interested but I'll wait for some more convincing data before I jump in.

 

Hi
Having just caught up with this thread, I have to thank Hamish for his complete honesty and openess- I know nothing about lasers especially in this field,and I suspect those who have posted so vociferously against it know little more than me, but I would be interested to know the outcome. I fear that the doubters would be left with egg on their face if the treatment worked, became cheaper and more widely available and was taken up by the beauty industry!!

At the end of the day, if patients want the treatment who is to say they shouldnt have it? I have a patient that is desperate for me to try needling his VP- even though the evidence is not there!

Cornmerchant

 

Hamish

You have earned my deepest respect in your courtesy shown towards some of the well established inner circle of this forum.

You may have noticed that there is one rule for the established and another for the likes of you but this seems to be the pattern on all forums. It appears that Dr Kirby's opinion is a substitute for evidence and engages admiration, whilst your opinion and conviction elicits a typical Pod A "experts" attack. You dealt with it well.

I applaud post number 45. I think your interpretation may encourage others not so well established to discuss treatment modalities that don't yet have a robust evidence base attached to them. Perhaps your erudite response does expose a touch of someone's self promotion?

I honestly find compliance is a great problem with topical fungal nail treatments due to the length of treatment time required to resolution. No amount of evidence base is going to alter this one human failing - its continued application. I therefore look forward to the long term results of the Pinpointe Laser coming through in the months years to come and will be discussing, with patients, the use of laser in the treatment of fungal nail infection. After all some patients do have the intellect to work out for themselves that this may or may not be a successful method of treatment based on cost, risk and the evidence available to date when an effective clinician is prepared to communicate with them.

GB

 

Hamish:

I want to offer you my apologies for some of my postings, which, now in reading them along with your responses again, I realize that I came across as being far too harsh and condescending than I should have. I guess I do play the "bad boy" here on Podiatry Arena on many occasions, but certainly, in retrospect, I made a mistake with you. In other words, I feel you deserve much better from me. I am sorry for that.

My only thoughts that may explain my response to you is that I am currently living and practicing at the "center of laser nail fungus treatment" for the United States. As a result of the continual barrage of newspaper ads and magazine ads proclaiming how great laser fungal toenail treatment is, myself, and many of my fellow podiatrists here in Sacramento, get lots of phone calls and questions from patients and ask us if we think the laser fungal toenail treatment is worth the $900.00 that is being charged (i.e. cash, credit, but no insurance accepted). If there were any research studies from independent sources that showed it actually worked well and/or had long lasting results, then I would have no problems with the treatment. However, I can't ethically recommend anyone, except the wealthy, spending that kind of money on basically a cosmetic procedure unless I have some data that showed it gave significant and long-lasting therapeutic results.

Good luck with your laser treatment procedures. I am hopeful you will stay a contributor on Podiatry Arena, even after my remarks, so that you can provide us with some follow-up on your patients and posting of photos of your patients as they come available.:drinks

 

Kevin, not sure if I agree here that the potential of laser in the treatment of fungal nails should be condemed to the realms of cosmesis. Personally I have no problem with treating patients who wish to look normal. I am going to assume that you do not either as you have also stated your reasons (perfectly acceptable) for not recommending Pinpointe Laser. For the same reasons I cannot recommend dry needling VPs - costs, unsure of the risk to patient and no evidence base to support the treatment. This doesn't mean though that I will not discuss with the patient the avaliability of such treatment.

But the main reason I will not condem this treatment to the realms of cosmesis is a worrying trend here in the UK and that is the refusal for orthopaedic surgery (knee/hip replacement) if a patient presents with fungal nail infection. Discussing this with colleagues we set about trying to find an evidence base to support this trend. Other than for the immunosuppressed/compromised we haven't been able to find anything. There seems to be no evidence to support refusal in the otherwise healthy patient and certainly my post on Pod A did not uncover any edvidence on the international scene either.

We did wonder if the reason for refusal was more likely a waiting list dodge.

So one of the reasons I will not join in any criticism of the treatment of fungus by laser is that it may hold a lifeline to those being refused surgery who have between 1 and 10 chronically infected toenails, unsuitable for oral meds, unable to persevere with a topical application and in need of orthopaedic surgery.

I hope that one day Hamish and his colleagues do deliver the goods as an alternative therapy for fungal nails. After all this is patient choice.

GB

 

Thank you poster for suggesting I review Ciclopirox. I had thought it was something clever and entirely different to types of paints like, Amorolfine and Tioconazole.
On closer inspection they actually seem about the same.
I have garnered the following information from the website an thought that those who read for sport but do not wade in might like to know the following and gauge it against what has gone before.

The respective proprietary websites make very modest claims and generally advises @12 months of treatment which must be maintained. Perhaps they should update their webpages.

The company states a figure of 36 million sufferers for the USA, and warns of the dangers of oral medication for their potential for serious side effects in cases of immuno-suppressed patients and patients taking other medications as well as the need for periodic blood tests.

The Ciclopirox site is very forthcoming. It states that it works best only for mild to moderate infections, requiring regular (possibly monthly) professional debridement, and an expectation that the treatment program will last 48 weeks. It is advised as a component of management in immuno-competent patient with mild to moderate involvement of the nails without involvement of the lunula due to T.Rubrum.

It warns of caution with diabetes and lactating mothers and application during pregnancy.

This company too has reported that even patients who have been successfully treated have had a recurrence. Advising the continuance of application even when the nails look improved.
They agree that without treatment, the mycosis will continue to infect the nail and untreated nail fungus usually gets worse. One study they quote says that patients with diabetes and onychomycosis have an increased risk of secondary infection and that onychomycosis is associated with a 2- to 4-fold increase in diabetic foot infections.

The very reputable Dr. A K Gupta is one of the doctors they used in their “pivotal studies” (no doubt these studies were in fact paid for by the company as is the norm for any pharmaceutical company) the outcome is out of the hands of the company or at least it is meant to be and has to be taken on trust unless one is implicating the scientists integrity as being erroneous.

If one accepts that Ciclopirox studies were conducted well and honorably by Dr. Gupta and his colleagues, then one can be equally reassured he is doing a good job with the PinPointe as he is also involved in their secondary trials.

An astute observation is that if the manufacturers of Ciclopirox thought that the agent they had developed was efficacious enough to get Dr, Gupta among others to test then they pretty much new it worked before they did so. I have it on trust a key figure in the production of Ciclopirox is actually impressed by the laser and what it does. But this is merely hearsay but I trust the source as a friend.

The Ciclopirox trials excluded insulin dependant patients and patients with diabetic neuropathy, did not trial subjects under 12 years of age, trials have not been conducted in the pediatric population. In its pivotal study the complete cure rate was 5.5% and its “almost clear rate” was 6.5%.
In pivotal study 1 (which was their own I remind you) it managed a mycological cure rate of 29%.
No study has been done to evaluate if it adversely affects the efficiency of systemic medication taken concomitantly, and so it advised to not do so.
Nail plate thickness adversely affected the function of the dose.

The effect on ovine hoof contamination was found to be minimally effective and the elimination of moulds from the hoof material was not achieved. So disappointing for cows with mycosis then. All very thorough because the mice, rat, rabbits, monkey’s and dogs all had a go with it too.


According to the information (if I read it right) Ciclopirox with the following groups were excluded, patients who:
Were pregnant or nursing (or planned to become pregnant).
Had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex).
Were HIV seropositive.
Had received organ transplant.
Required medication to control epilepsy.
Were insulin dependent diabetics or had diabetic neuropathy .
Patients presenting with severe plantar (moccasin) tinea pedis were also excluded.
I gather that the safety and efficacy of using Ciclopirox daily for periods greater than 48 weeks have not been established

A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a completely clear or almost clear toenail.


A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a clear or almost clear toenail.


So I leap back into the swirling void again, to convey the notion that by the company’s own admission the results are about 12%.
So I implore the poster who achieves 60% to contact the company with their data because the scientists conducting the trial got considerably poorer outcomes. One must be duty bound to report this breakthrough for the greater good.
It really wowed me at 6.5% though

As for anyone else reading this thread with interest, I am talking of treating heavily infected o/m including the matrix not just mild to light cases. And happily do know of topical paint applications and their success better than I thought I did. But it probably explains some of the confusion why a person might actually consider treatment by light amplification by stimulated emission of radiation excessive if one is just after treating mild and moderate conditions with mild paint applications. Personally I am after the resistant conditions using a single focused wavelength not a pulsed low level physio laser. Trust me you really do not want to look down the “sharp end” when it is on. It weighs about 50 pounds and is not like a laser pointer for lectures, well only in that it operates in the red end of the spectrum.

If I figure out how I will find a picture of what I am trying to treat from my images I am collecting. Paint aint going to work with these because it has been tried already… for two years or more.
Patients are asking me (I know I said me again) because they have tried all the general current conventional treatments and have had NO success, so THEY wish to explore new treatments.


Out of interest does anyone else get those floating adverts at the top of the page passing by in this website? Or is it only me? I ask simply because the ads for anti-mycosis therapy is “interesting” and who amongst us uses them. If the laser has attracted such derision how have these passed without comment? I guess it must make money for this website somehow.
Another question, who knows about the specific targeting and destruction of pathogens by specific light wavelength? Now there is something to go digging for.
H

 

Hi Hamish

I have been reading the comments on this thread with interest.I have a few questions that I would like to ask
-how many pateints have you treated using this method?
-how many of these treatments have been successful
-what is the regrowth rate,if any?
-are there any clinical trials being currently conducted in the UK? If so,by which institution
- is the laser treatment particularly successful against any specific organisms
-Is there published documented clinical trials/evidence base that demonstrates the efficacy of this modality?

Any insight to these questions would be appreciated

Regards

faye

 

Hello again,
It seems there has been brisk trade on this thread.
As a new visitor to these confines I find it a little confusing. Do some people work as tag teams?
I think it is great to see that passion can be ignited by nail fungus. Who would have thought it?

I would like to thank you all. Some for asking searching questions, some for making me question whether information really is out there, and making me recheck. It is, but you need to look in the right places and it is to be found in cross over research.

I found what I feel is pertinent so I am sure more can do the same. I have limited research capabilities so it shows it is do-able.

Thanks too to those who have found my position worthy of defence purely because I am naive in these waters. I tend to have conversations with people normally and one is able to exchange ideas and information more bloodlessly. Forums are odd places to me, I misjudge them, as they are quite territorial.

The experiential post by ladyfaye was perhaps more relevant than any of mine, I think a great deal of the reasons for "why"? were all in there.
It was from a personal perspective and that of “everyman/woman”.

Research is ongoing. One study is a five year project. I believe anyone could run their own study, all you will need are patients, acceptable protocols/parameters access to the laser and its recommended protocol etc.. and money.

I doubt in all honesty much more can be said.

Previously I stated that specific technological information is proprietary, nothing has changed it still is.
When patents are lodged (pending at present) maybe more can be said. Otherwise exactly what it is doing is their business.
The action of lasers on tissue is well documented otherwise tattoo removing lasers and cutting lasers, eye correction lasers and dental lasers for peridontitis would not be commonplace.
What is happening with this device is simply the redirection of previous knowledge into a specific treatment for the multitude of pathogens involved in nail infection. They often coexist, creating greater resistance to treatment and provide an unpleasant digital reservoir of infection.

Secondary clinical trials are being conducted by reputable scientists in America and Canada, in about 4-5 different sites. Preliminary results will be analysed early next year as part of their longer study.
At present @ 13000 patients in a 12 month cycle are being treated by about 200 Podiatrists, I do not have absolute figures for success rates because I am a practitioner not an employee of the company, and the concept of success depends on what parameters were set to define it and what perspective one is viewing it from.

The laser is effective against a spectrum of pathogens apart from the standard dermatophytes. Again some things you might ask for might make you think the answer to be evasive; but that which is asked for might need proprietary information to answer.
I have said before and I will say again. Professor Harris is a very approachable man and is easily found. Ask the organ grinder if you want the real inside dope. He has been at this for years. He really has.
Check out his cv and his research.
I really am repeating myself though. In dental applications I know laser can vapourise bacteria, and destroy it in tissue without damaging the host. I think you can assume their research has developed further from that point of knowledge. What is actually going on histologically might not be known precisely. But think on this, these are scientists most likely to be found in University positions researching it, not a bunch of podiatrists mucking about with laser pointers.

 

Hi Hamish

Can I check the power rating and other attributes of the pin pointe system- I have looked quite a lot at the effect of lasers which vary significantly with power/dose/pulse shape and rate and a whole heap of other parameters. Generally 'vapourise' would apply at higher levels that would also cause tissue damage, but that's not to say that they do not destroy bacteria (and possibly even fungus) at 'low level'.

Ian

 

Ian,
I can tell you it is restricted to 4 watts and has preset non changeable parameters across wavelength/pulse/time etc. All of the real details that interest people are proprietory and therefore protected.
I understand peoples curiosity but some understanding has to be given to the company so that it may protect its position. I might have misused vapourise as a word but I am not sure. I still may be right as it will depend on the way the beam behaves during lasing which is in itself dependent on a range of parameters including pulse and power that changes output or strength. But at that level the accuracy of my reply comes to pieces.I do not know how most ordinary things actually work, and do not bother to find out. My curiosity level is not that high. And as long as I understand the principles explained to me I can adapt to meet the circumstances.
Contact PinPointe talk to Paul Wolfe or George Bryant or ask to speak with Professor Harris or contact Dr. Gupta

 

Good morning all,

I have read the on going dialogue with interest.

I was very suspicious of this technology when I began using it. It is healthy that you are too.

I have performed almost 850 PinPointe laser procedures over the past 15 months with very good results. Efficacy is 85-90% for patients with moderate infection, i.e. nails with no more than 75% involvement. Those severe cases with 100% involvement, have about a 70 % success rate with 1 treatment and 85% with 2 treatments.

Like so many procedures we perform whether surgical or not, the procedure has evolved and success rates have increased.

We stress prevention following the procedure. We all know that patients will become reinfected if they don't practice daily prevention for the rest of their lives.

The wave length, pulse train etc. is proprietary information.

Hamish, thank you for your kind comments. Kevin Kirby, Your office is just around the corner from mine. Is there some reason you are afraid to come by and see for yourself?

That's it for now. Off to perform laser procedures.

Sincerely,



Michael A. Uro, D.P.M.

 

Oooo Michael, you will have your fun .

Glad you could come talk to us. I have some questions if you'll indulge me?

1. Does one have to debride the bulk of infected tissue back? If so, whats the regime, how often, how far etc.

2. Presumably the laser deactivates the fungus but does not repair the damaged nail. Is the method then to kill the fungus and have a healthy nail grow through?

3. What are your criteria for "success"? I ask because I saw a nice graph from a rep selling a laquer once which talked of high "success" but when pressed it turned out the criteria for success was "noticable change". Are we talking resolution? Throughgrowth of fungal free nail? What?

4. Do YOU have any before / after photos? I know its not evidence but its nice to see some pictures.

5. Does the treatment involve anything besides the laser (topicals, debridement etc)

And most of all :-

6. What is the Daily prevention they must practice and when do they commence it?

Thanks again. I wish I lived up the road from Kevin, you lucky sausage!

Regards

 

Dr. Uro:

I'm not sure I would use the word "afraid" to describe why I haven't taken time from my busy life to talk to you about laser fungus toenail treatment. Let's just say that I am, and have always been, somewhat of a skeptic, and would like to see more evidence in peer-reviewed medical journals (that is not funded by Pin-Pointe) that this treatment is any more effective than using the many other treatments available for onychomycosis before I can recommend it to my patients. Can you please provide us with published medical references of the therapeutic effectiveness of Pin-Pointe Footlaser since Hamish has, so far, been unable to do so? I am anxious to read them.

Also, Dr. Uro, don't you also have a financial interest in Pin-Pointe Footlaser?

Have a nice weekend.

http://local.yahoo.com/info-21784195-uro-michael-foot-doctor-laser-center-sacramento

http://www.pinpointefootlaser.com/reference

 

Press Release:
Nomir Medical Announces Publication of Mechanism-of-Action Data for its Noveon® Dual-Wavelength Device

 

Apparently, according to sources that I cannot confirm, the Noveon device is about to get FDA approval.
From the companies website:

 

I wanted to post my experience with the laser (patholase) treatment. I had my treatment in San Jose over 18 months ago. They told me to use clortirmzole cream every day for 2 weeks and then wait for the miraculous clean nail to emerge....it never did - my nails got worse. I went back about 8 months later and they were shocked that I had no improvement and told me I must have been reinfected from going to the pool. Meanwhile the infection was not distal but closer to the matirx - so that made no sense. The second followup treatment, they charged me $300 (the first treatment cost $1000) and it was performed by some hungover technician....the doctor would not even come in to talk to me...pathetic. 3 months after the followup....no improvement whatsoever...

 

Thankyou for sharing your experiance.

This, of course, proves nothing whatsoever about the efficacy, or not, of the laser. However it does illustrate the need for the "evidence" some of us keep banging on about.

So the protocol is to first use the laser, then apply an anti fungal every day!

This obviously makes it impossible to tell, from experiance, whether the laser actually does anything! It would be like saying "I've discovered a light which kills weeds. We just shine the light on, sprinkle it with weedkiller, and hey presto!"

Frustrating, because if this treatment DOES work we'll never know!

A double blind trial would be SO EASY to do! Treat two groups, one with a dummy laser, then take scrapings a week later. Why has this not been done? If this was my invention that would be the first thing I'd do!

Regards

 

The particular case is a single data unit and pretty meaningless. The protocol, however, is significant. Do you use long term chemical antifungals alongside the laser? That would seem sensible practice in terms of outcome but it completely screws any kind of outcome measure!

Studies have shown that people have better outcomes on medications where the study group was told the drug cost more. I read somewhere else that there is research showing people will be more inclined to follow advice they paid more for. I bet compliance with daily anti fungal regimes could be improved no end with a modest amount of theatre! Nothing wrong with that, the patients are still getting better. But without knowing all the elements we can't assess a treatment!

What's the post laser protocol?

 

Interesting point about compliance. I saw a documentary one time about contraception in India. When they gave condoms away they were not really used, when they asked for a couple of rupees the condoms got used.
Now it occurs to me that if we wish for better compliance we need to possibly offer rupees or condoms.

Remuneration now that would be lovely. I think it is an entirely grand idea, perhaps I could hold out for repeat fees (like actors when their show goes into syndication) too. There are quite a few out there aren't there? Pages of PR blub not actors, well actually there are a few actors out there too come to think of it.

 

Good evening everyone,

Sorry I haven't responded. Long clinic hours on Friday and out of town for the weekend.

Someone asked if I have financial ties to PathoLase. My association is that I train doctors from all over the U.S., U.K., Guam and soon Canada on the use of the PinPointe FootLaser for which I am paid.

The prevention that I recommend to my patients following the PinPointe FootLaser treatment for onychomycosis is as follows; 1-apply an antifungal cream bid interdigitally and in a moccasin distribution for 2 weeks following the procedure, 2-always spray inside the shoes at the end of the day with an antifungal spray and avoid wearing the shoes for 2 days or use the Steri-Shoe ultraviolet shoe sanitizers, 3-after 2 weeks, spray the feet bid with an anti-fungal spray (forever), 4-change the sheets the 1st night after treatment, 5-cleanse the floor of the shower before next use with a cleanser that includes bleach, 6-cleanse all nail instruments with bleach before using them again,7-throw out any nail polish previously used on toenails,8-avoid nail salons or use extreme caution if they insist on using them,9- excercise caution in public areas like hotel rooms and gymnasium showers.

I liken prevention for this condition to caring for the mouth. We brush our teeth at least twice daily and floss daily to prevent tooth decay and gum disease. This should be no different. I think we would all agree that these patients are prone to this condition and that without prevention, they are doomed to re-infection. In fact some may become re-infected even if they do practice prevention just as some people develop cavities despite brushing.

The PinPointe FootLaser initial study included 19 patients and accepted even the worst cases. This study, although small, demonstrated 88% efficacy. The Lamisil study and other similar studies included only nails that had 25% to 75% involvement. As we know, Lamisil at best has an efficacy rate of 60%.

In an effort to increase efficacy, PathoLase has 4 new studies underway. 3 in the U.S. and 1 in Canada.

In regards to Noveon, my understanding is that they are running out of funds and that FDA approval is a way off. We'll see. David Harris, the scientist behind the PinPointe FootLaser technology, has already worked with their wave lengths and found them to be less effective.

In any case gentelmen, I am confident in this technology. I live it almost everyday and have for the past 15 months. Patients are happy to have a treatment such as this that does not pose the risks that the oral anti-fungals do. I advise them that it's not perfect. We know that no surgery, medication or treatment regimen works 100% of the time. As I tell my patients, if a surgeon garantees a 100 % outcome RUN!

I do have pictures to share but the hour is late and I will therefore pass them on another time.

I know that there will be skeptics out there no matter what I say or show them. Oh well, I guess they will just have to wait for the results of the new studies. In the meantime, I will continue to provide this much needed service. Yes, at a price just like my opthomology, dermatology and plastic surgery colleagues.

Fraternally,




Michael A. Uro, D.P.M.

 

Any reason why this is not published in a peer reviewed journal and put out there for scrutiny? Extraordinary claims are being made based on this research, so why is it not publically available?

 

http://www.podiatrytoday.com/emerging-concepts-in-treating-onychomycosis

saw this in Podiatry today mentions laser treatment etc

 

Hello to all:

I am the Chief Science Officer of Nomir Medical Technologies, and would like the opportunity to respond to a few issues that are being presented.


The Noveon®, is a near-infrared diode laser system that is specifically designed to use only the 870nm and 930nm wavelengths. This device, combining the 870nm and 930nm energies in a multiplexed beam, has shown a unique antimicrobial action spectrum in-vitro, in vivo, and in 6 human IRB controlled studies. (1-4)

The device has also finished a 4-site blinded, randomized and IRB approved pivotal study, where the data has been submitted to the FDA for the treatment of Onychomycosis. Apon FDA approval, the Noveon will be available to treat the disease "hands free", up to 4 toes simultaneously, and is catagorized as a non-significant risk, meaing that in 43 states trained ancillary staff will be able to run the device, and not the Dr.

The photobiological mechanism of action has recently been published in the prestigious Journal Photochemistry and Photobiology. (1)

A full review of all possible photo-therapy systems currently being tested to treat onychomycosis has recently been published in JAPMA. (2)


1. Bornstein E., Hermans W., Gridley S., and Manni J. Near infrared Photo-inactivation of bacteria and fungi at physiologic temperatures. Photochemistry and Photobiology, Published Online 26 Aug 2009

2. 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

3. Bornstein, E.S., Y.P. Krespi, A. Robbins, J. Wlassich, E. Sinofsky (2008) Antimicrobial resistance reversal at physiologic temperatures in MRSA in the nares with an 870 nm and 930 nm dual wavelength noveon laser. 2008 Tissue Engineering and Regenerative Medicaine International Society North America Meeting Abstracts.

4. 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.


The other device being discussed (Nd:YAG laser) works via ablation. The ablation interaction has been modified, to act as a laser antiseptic treatment in vitro, with a reported method designed to eliminate only the microorganisms that cause disease.

There are three publications that describe in vitro studies only, where the Nd:YAG laser was used for an antisepsis procedure, lethal to the pigmented dental pathogen P. gingivalis. (1, 2, 3)

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

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

3. 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.

If one were to employ Nd:YAG technology for the antisepsis of T. rubrum, a better choice of wavelength would most likely be the frequency doubled Nd:YAG (532nm –visible green) laser as there is an endogenous red pigment in T. rubrum (Xanthomegnin) that would be a candidate pigment for green light. (1, 2)

1. Gupta AK, Ahmad I, Borst I, Summerbell RC: Detection of xanthomegnin in epidermal materials infected with Trichophyton rubrum. J Invest Dermatol 115:901–905, 2000.

2. Vural E, et al: The effects of laser irradiation on Trichophyton rubrum growth. Lasers Med Sci 23:349–353, 2008.


If there is even one IRB controlled study, with independent data analysis that has been finished and reported in the peer-review literature with an Nd:YAG laser, treating onychomycosis, I would like to see it. Please educate me.

Otherwise, the data is all simple anectdotal evidence.

Sincerely,

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies

 

Please excuse me for not cutting and pasting ad nauseum.

An altogether excellent post. And quite brave considering the vociferous challenge that will no doubt be comming from Kevin, because there is apparenly a concern when a company funds its own research for its pivotal studies. But good that the head researcher (as Kevin likes to call you Chief Science Officers) from the company has popped in; because Kevin and Craig and a few others do not believe that these sorts of technologies actually work. I take it you are saying it does, and like many other interventions yours works differently to (your competitor) the Pinpointe device. In one word are you saying that the PinPointe device does not work?
One word should do it. Or are you saying your device which you wish to sell works in a different way to your competitor?

One could not have picked a more opportune time, nor a better site to tout ones own product. I tried to suggest that your colleagues in research, David Harris and AK Gupta were in fact reputable scientists too, but that was not believed in certain quarters so it is good to see you happy to show some elements of their research to show that they conduct peer reviewed research. I presume you consider them to be of good standing and reputable? You are not suggesting that because they are conducting research for Patholase that they are to be mistrusted are you? I thought not. If otherwise please put me straight.

I am confused does the poster expect to find education on laser research to be found amongst podiatrists? Would it not be best to have a chat with the likes of Dr. Gupta?
Personally I would not ask this lot to educate me on laser and its action, I would ask a scientist like yourself who works in that field. Just as I would not ask a dentist to explain the effects of poor gait mechanics on tib post failure.

I presume that all of the posters own research has been peer reviewed by those in that field, not podiatrists. So likely Dr. Harris has not been reviewed by podiatrists either, but by his peers.
Mighty as some are in this arena, probably not his peers really.
There is a deal of suspicision (I have to warn you) regarding companies who use their own research to substantiate their claims. Kevin will want to know who exactly paid for the research for example, because it has to be independantly confirmed. It will not count in their eyes if the company had to pay for it itself. Right Guys?


Like other laser technologies the product is still waiting for its FDA approval, but you belive it is a technology that works despite what the FDA might say.
Being a Brit the finer details do get lost on me because I gather that the much vaunted FDA does indeed get things crashingly wrong, giving approval to drugs for instance that are then withdrawn because people commit sucide after taking them or end up with debilitating side effects.

I understand the FDA is a mechanism similar to that which we have in the UK of GB (technically there is no such thing as the UK in itself in needs to be of GB to be meaningful, and worth noting that the "UK" does not have a flag. England, Scotland, Ireland and Wales do; as does Great Britain but sadly not the "UK"). I presume it sets a nominal standard but am I correct that Botox was not granted FDA approval for 10 years but was indeed used quite safely by those following treatment protocols during all that time?

What is indeed gratifying to note is that what I had said before has been backed up by this post, that much of the research is in fact cross over research from dentistry, and that laser has in fact been tested by researchers on mycotic samples, effectively. Different laser technologies accomplish the task in different ways it seems, and that dental laser treatment of pathogens has been shown to be highly successful for many years.

 

Hi Hamish:

You are correct on many of your statements. Let me further introduce myself.

I am at a unique cross-roads in the laser/medical community:

1) I have degrees in biochemistry and dental medicine,

2) I have written 10+ publications in the Laser/Dental/Medical literature (including the Journal of the American Podiatric Medical Association)

3) I have Co-authored 3 FDA laser applications that have been approved for laser devices and therapy, including the only "contact bone ablation" approval for Er:YAG lasers, in a device that is also approved for Podiatry.

4) I have designed and completed 6 different IRB approved human studies in laser medicine across the 3 different medical disciplines of Dentistry, Podiatry and Infectious Disease.

5) I have been granted 2 US and 2 Foreign Patents describing Dental/Laser devices

6) I have 30 Patents pending describing Laser/Medical devices and photobiological mechanisms.

These are my Publications in the medical field:

1. Bornstein, E.S., Y.P. Krespi, A. Robbins, J. Wlassich, E. Sinofsky (2008) Antimicrobial resistance reversal at physiologic temperatures in MRSA in the nares with an 870 nm and 930 nm dual wavelength noveon laser. 2008 Tissue Engineering and Regenerative Medicaine International Society North America Meeting Abstracts.

2. 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.

3. Bornstein ES, Michelon M: Examining the antibacterial action spectrum in vitro of the Noveon® dual wavelength laser system through photo-inactivation of E. coli at physiologic temperatures. Abstract presented at ASLMS, National Harbor, Maryland, 2009.

4. Bornstein ES: Treatment of Onychomycosis Using the Noveon® Dual-Wavelength Laser. FDA Pivotal Study data presented at Council for Nail Disorders 13th Annual Meeting, San Francisco, CA, 2009.

5. 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

6. Bornstein E., Hermans W., Gridley S., and Manni J. Near infrared Photo-inactivation of bacteria and fungi at physiologic temperatures. Photochemistry and Photobiology (Published on-line Aug 2009).

Disclaimer:

All of the above research (with our laser device) to date has been financed by investors in Nomir Medical Technologies. I am the Chief Science Officer and one of the founders of the company.

In the last 5 years, I have conducted 100's of laser experiments with the Noveon device on:

1) Lasers
2) Lasers and bacteria
3) Lasers and fungus
4) Lasers and live humans
5) Lasers and mice
6) Lasers and pigs
7) Lasers and human cadavers

All of the research and data collection that I took part in was done in a blinded fashion with an independent CRO, and with certified Animal Review Boards approving the animal studies and Human Investigational Review Boards approving the Human studies. The statistical analysis for each study was accomplished by an additional (and different) independent CRO from the laboratory that we conducted the experiments in.

My issues with any Nd:YAG laser in the Onychomycosis space is this:

Without independent research and data collection, "clinitian case studies on human onychomycosis therapy with an Nd:YAG laser" done outside of a certified Human Investigational Review Board and without an independent CRO is simply interesting anectdotal information.

I cannot adequately comment on the validity of any Nd:YAG onychomycosis study, or if the device works as advertised, because (1) the results have not been peer-reviewed, (2) the procedure has not been approved by; and the data has not been collected under; the auspices of a certified human IRB, and (3) the data has not been statistically analyzed by an independent CRO after meeting the requirements (1 and 2) above.

If someone can produce a journal article that meets these 3 criteria, discussing an Nd:YAG laser treating onychomycosis in human subjects, I would be more than happy to comment.

I am not taking an elitist attitude, it is simply good science and good medicine.

The data from our pivotal human studies in treating onychomycosis with the Noveon device meets all the criteria set above, has been accepted by a peer-review committee, and will be published in a major medical journal in the coming months. This is the data that we presented to the FDA in our 510(k) application.

Finally, we will not advertise or sell a device until the FDA approval, according to US federal law. We are looking into the CE mark and European distribution in the future.

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies

 

Where have I said it does not actually work?

All I challenge is the way its being touted and the extraordinary claims being when we have no studies on its clinical efficacy. I think I said (sorry its late and I don't have time to check what I actually said), that I will be lining up to get one if the clinical efficacy data supports its use.

BTW - the majority of the profession believe its does not work. 63% of those responding to Podiatry Today's online survery answered NO to the question: "In your opinion, can laser care be a viable option for treating onychomycosis?", Thats hardly a "few others"
http://www.podiatrytoday.com/in-you...are-be-a-viable-option-treating-onychomycosis

 

Hello Craig,

We'll"In your opinion, can laser care be a viable option for treating onychomycosis?" see about that claim and how true it is and for long it lasts, if it ever occurs in many patients. My advice.....?......don't hold your breath.

How often have we seen this pattern? (eg ESWT; MIS; etc)

don't figure? Should this be in the snake oil category?

We been there done that. Guess what happen to the other techniques that followed this pattern?

Admittedly one of the quotes is not yours but I obviously mistook your position for one of greater scepticism considering the general tone and flow. Obviously my it was my mistake.
As for the survey on opinion I applaud its scientific reason.

Dr. Bernstein’s response is a stout one and is one I am very pleased to see in this forum. It is open and honest. These are qualities I like to see, and I do not consider the remarks elitist in the slightest.
I am thankful for Dr. Bernstein for his opening statement too.
I am glad that you must have stumbled onto this site when he did.

I see little doubt that the device will garner its CE approval, as the other device has already.

One of the points I have been suggesting is that this new science to podiatry has come from cross over research (which this posting backs up) and that assumptions initiated into viability of efficacy in one are will transfer to another with slight modifications.
Sadly it indicates it already indicates it will not stay with us for very long but will find its way rapidly into the hands of others. But that is a completely different debate for another time
Often the concerns of those at research level are not the same as those at a more grass roots level, but we thank them for their tireless work all the same.

 

i've had a search through pinpointe's website and it doesn't provide any reference to scientific literature on it.
i'd like to have read about it, but i can't find anything except for press releases and patient brochures. most sources quote a 85-88% success rate on treated patients, but i don't have a clue where this came from.

 

Golly did I say that? how daft of me I should have said contact them, any of them I bet a good researcher will soon find the contact details required.
No wonder people keep asking me!

Not me.... them.

 

I never said they did not work either. It was just they way they were promoted and touted before the data came in; the overuse and overabuse of the method. Now, they are now be used appropriately with appropriate claims made for them. They have stopped being touted in they way they used to be (ie YouTube video's; full page adverts in papers and Yellow Pages; and extraordinary and unsubstanted claims being made for them)

 

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) 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.

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies