Laser treatment for nail fungus

Thank you Dr. Bernstein, Eric... if I may be so bold.

Your post is perhaps the best I have seen and most educational and dignified. You have set a new standard for us all to try to maintain.

I am gratified that you have shared your knowledge on this subject and presented it in a thoroughly understandable manner.

You make the case for advanced technology treatment posibilities very eloquently.
Once again thank you for your valuable time and input.

 

Thank you Hamish:

Robert Noyce who co-founded the Intel Corporation in 1968 once said, "Knowledge is power. Knowledge shared is power multiplied."

His words were prescient, whether we are talking micro-chips (in his case), or treating Podiatric infectious diseases.

The more information that a clinitian has about any technology, the better his/her decision making process for patient care.

The internet makes it easier to share knowledge with collegues, and I hope that these discussions ultimately improve patient outcomes.

Best of luck in your therapies.

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies

 

Just thought that those of you who have been lying awake at night wondering who is "North America's Leading Expert in Laser Therapy" could finally find their answer from an ad in our local Sacramento newspaper.

http://shopping.sacbee.com/ROP/ads.aspx?advid=1157133&adid=8344601

 

Collegues:

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.

Eric Bornstein
Chief Science officer
Nomir Medicaal Technologies
ebornstein@nomirmedical.com



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.

 

Forgive me if I've missed this and if it has been discussed already as I only scanned the previous posts in this thread, I'm interested in the dual wave-length laser approach (870nm and 930nm). Why do we need two different wavelengths? Are these applied simultaneously? Pulsed between the two, or what? For how long are these applied? Equal duration on both wavelengths? While wave length is interesting the power of the lasers is too, what are the powers of the laser diodes used? How many diodes of each wavelength? What kind of lenses?

Thanks in advance.

 

is there anyone that is performing the pin pointefootlaser treatment in the Texas or Louisiana area or is it still waiting on approval from FDA? Saw a podiatrist today that said he was thinking about buying one of the lasers from Hawii if enough patients wanted to try it. Take it he has no training on the use of it, he also doesn't give out prescriptions for any type of treatment because he said he says success rate is so small that he quit prescriping anything years ago. All this Dr did was sell me a creme that he makes and sells on his own, so he basically told me there is nothing I can do to resolve my possible toenail fungus from foot injury few years ago(he did say there could be some bacteria under the nail causing blackness because it could get under the damaged nail). He performed no test or did anything except basically look at it and check to see if I had blood flow and feelings in my feet. I plan to see another podiatrist later this week for another opinion but have asked around to see if they knew of anyone who did laser treatment and they did not know. Shouldn't this Dr have taken some kind of sample or checked to see if there was a fungus or bacteria or what is actually under my toenail? Just found it odd that all his diagnosis was, probably fungus and maybe bacteria growing but nothinig tested to show for sure and no thing to try except his creme, even if I was 1 n 100 that medication worked for think he should have given me some option instead od telling me that nothing works at all.

 

Dr. Spooner:

I will attempt to answer your questions below.


Why do we need two different wavelengths?

In Neuman et al. (1) discovered only two distinctive near infrared wavelengths (870 nm and 930 nm) are capable of causing photo-damage in prokaryotic and eukaryotic cells in vitro, during confocal laser microscopy.

1) Neuman, K.C., E.H. Chadd, G. Liou, K. Bergman, S Block (1999) Characterization of photodamage to Escherichia coli in optical traps. Biophys J. 77:2856-2863.

In Neuman’s experiments, he hypothesized that the high cell death curves he was observing were the result of the generation of endogenous radical oxygen species. Our research indicates that 870 nm, is absorbed in Cytochrome C and Cytochrome C oxidase, and 930 nm is absorbed in cell and mitochondrial membranes. Therefore in non-thermal interactions, the Noveon has been shown to photo-biologically perturb the bioenergetics of bacteria and fungi, creating photo-damage and death. (2)

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

Both wavelengths carry photo-damage properties, and using them together allows us to titrate the dose to physiologic temperatures.

We have received 2 US and 2 Foriegn patents on this technology, and have approximately 20 patents pending on this technology including the unique mechanism of action.


Are these applied simultaneously?

Yes. Please see the following link describing our peer-reviewed action spectrum studies that show that 870nm/930nm combined are by far the most photo-damaging, confirming Neuman’s findings in 1999.

Bornstein, E.S., and M. Michelon (2009) Examining the antibacterial action spectrum in vitro of the noveon dual wavelength laser system through photo-inactivation of E. coli at physiologic temperatures. 2009 American Society of Laser Medicine and Surgery Meeting Abstracts.

http://www.nomirmedical.com/pdf/Action_Spectrum_ASLMS_Abstract_09-15-08.pdf


Pulsed between the two, or what? / For how long are these applied? /Equal duration on both wavelengths?

Please see the following link for the peer-reviewed in vitro and in vivo human IRB controlled dose protocols that will answer the above and other dosimetry questions.

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.

http://www.nomirmedical.com/pdf/NCH_Abstract_Presentation_FINAL_08-26-08.pdf


What kind of lenses?

Large Flat-top lenses for uniform dose profiles.

Gaussian profiles (hot spot in the middle) are delivered through fibers used with micro-pulsed lasers.

The Noveon’s large flat-top projections in continuous wave mode prevent “pulse-stacking” interactions.


Eric Bornstein
Chief Science Officer
Nomir Medical Technologies

 

Thanks for you responses and the links, most helpful. Again, forgive me for not wading through all of the other postings, are there any double blind placebo controlled trials of this technology yet?

The patents are interesting, presumably they prevent me or anyone else from buying some laser diodes and using them to treat onychomycosis?

 

Dr. Spooner:

We have completed 3 pilot studies (data from the second pilot in the link below) and a Pivotal FDA trial for a 510(k) application.

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.

http://www.nomirmedical.com/pdf/NCH_...L_08-26-08.pdf


The FDA pivotal study that was:

1)4-different sites site;
2)Bllinded,
3)Randomized
4)IRB approved

The preliminary data from this trial was presented at the Council for Nail Disorders at the Dermatology meeting in San Franciso earlier this year.

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.


This pivotal trial has been completed, and the data has been accepted for publication in a major medical journal to publish in the next couple of months.

Given that the FDA is currently analyzing the data, and the medical journal has peer-reviewed the data for publication and deemed it worthy for presentation in thier journal, I believe that it will "open some eyes" as to the possibility of adding this system into the onychomycosis armamentrium of a Podiatric or Dermatologic practice.

With our two pilots completed with positive MRSA data, we are hoping to start a bioburden reduction study in diabetic pressure ulcers in Q4 of this year.

http://www.nomirmedical.com/pdf/Termis_Poster_FINAL.pdf


Apon FDA approval for onychomycosis, the Noveon will be available to treat onychomycosis "hands free", up to 4 toes simultaneously, and is catagorized as a non-significant risk device, meaing that in 43 states trained ancillary staff will be able to run the device.

The patents are important and necessary in this world, to protect intellectual property rights, and are part of the innovation game for any industry.

As I mentioned before, we have tested 5 other combinations of near-IR energy, and as Neuman reported in 1999, 870nm/930nm are far and away the combination for photodamage at physiologic temperatures.


Eric Bornstein
Chief Science Officer
Nomir Medical Technologies

 

Once again, thanks. Just to be clear I'll ask again, has their been any placebo controlled trials yet?

 

Dr. Spooner:

I apologize for missing the placebo part of the question the first time. My mistake.

Let my expand on the study parameters to address your question directly.

The control subjects in the pivotal FDA onychomycosis study were treated identically in all respects to subjects that were actually treated with the laser, with the exception that when a sham (placebo) “laser treatment” was delivered, the device put forth no energy output, (that is the laser power was set to zero).

The study was single blinded (the patient did not know if they were being treated or not). It was not “double blinded” as the technician running the device did know whether the machine was delivering energy or not.

The device “beeped” in the exact same manner as the real treatment during placebo, the time was the same, and the set-up was the same. The patients had no idea if they were in the treatment phase or the control phase. This is possible because of the minimal heat produced from the procedure at low power densities (discussed in a prior post)

Further, there was an independent expert panel of podiatrists (to evaluate the results) that used baseline (Day 0) photographs to classify each toe in the study as either mild, moderate or severe involvement at the outset. The members of the panel were blinded as to which photographs came from treated patients or control patients.

Follow-up photographs were used by the same panel to subjectively grade clinical improvement, and sophisticated computer software was used to measure outlines that the panel members made of improvement, no-improvement, or regression.The members were again blinded as to which photographs came from treated patients or control.

The data was statistically analyzed and produced by an independent CRO that is certified to perform this function for the FDA.

I hope that this further explanation answers your questions.

Eric Bornstein
Chief Science Officer
Nmir Medical Technologies

 

Thanks. Just a couple more questions: how many subjects were employed in the study? Did they just receive either laser / no laser or was adjunctive therapy employed? Was expert grading of photographs the only outcome or were cultures performed?

 

Dr. Spooner:

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

Starting after the completion of the second of the four treatments, all subjects were required to use a non-prescriptive topical agent: 1% topical terbinafine cream applied only between the toes to control or prevent tinea interdigitalis.

Patients were instructed to not get any cream on the nails.

Use of this topical between the toes only, was in accordance with the current listed product information and is neither FDA indicated, nor FDA cleared as a treatment for onychomycosis. Other adjunctive actions that are "standard of care", such as nail debridement or nail trimming, were allowed at each investigator’s discretion.

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 the peer-review journal that has decided to publish the final results.

Thank you for your interest and the questions.

Eric Bornstein
Chif Science Officer
Nomir Medical Technologies

 

I look forward to reading this. Thanks for your answers. One final question: how much would it cost for me to have one of these systems in my practice?

 

Dr. Spooner:

Thank you for your interest in the Noveon system.

I would like to direct you to the nomirmedical.com web site, and ask you to use the “contact us” page to inquire about the Noveon Academy.

http://www.nomirmedical.com/contact.htm


Due to FDA regulations prohibiting the sale of a medical device in the United States for an uncleared indication, the Noveon system is currently not for sale for the treatment of onychomycosis.

As we have completed our IRB controlled pivotal study, a 510(k) clearance has been applied for from the Center for Devices and Radiological Health (CDRH), the branch of the FDA that oversees the 510(k) process.

http://www.fda.gov/medicaldevices/d...issions/premarketnotification510k/default.htm


However, in the interim, the Noveon Academy can provide you with more information on the Noveon therapy, its practice and clinical implementation.

If you wish to contact me directly, please feel free to do so by email.

It has been a pleasure sharing our science and data with you in the Podiatry Arena.


Eric Bornstein
Chief Science Officer
Nomir Medical Technologies
ebornstein@nomirmedical.com
(P) (781) 893-1000

 

I see there is yet another video clip up on You Tube touting this treatment. They also claim it has FDA approval - why do they that?

 

Hello Dr Payne:

Here (below) is an excellent article about the perils of a doctor teaching and/or using medical devices on patients, off label from thier intended FDA indication in the United States.

http://www.aaos.org/news/aaosnow/may09/clinical3.asp

Any DPM, MD or Dentist in the United States, that is using a device "off label" for any reason, should give this article a thorough read.

A few of the more important points (in my opinion) that the article makes regarding US medical device law are:

1) Using any devices or off-label products is prohibited if your primary objective is to test a hypothesis or obtain general knowledge. Those situations require that you conduct a study under Human Subjects Protection, Institutional Review Board (IRB), or other oversight.

2) Off-label use can be justified when convincing clinical data and research support off-label use (conducted under an IRB, peer-reviewed and published) and when those data are available ahead of regulatory approval.

These laws of course apply to all lasers and onychomycosis therapy. Hence, the Noveon has only been used to conducted IRB approved MRSA and Onychomycosis studies, that have then been peer-reviewed and published as such.

I am admitedly not as familiar with European and Australian laws.

Eric Bornstein
Chief Science Officer
Nomir Medical Technologies

 

My issue (as I have stated many times) is the way its being touted. Here is a cut and paste from message 2 at the start of this thread from the New York Times:

I just do not get why the claims that FDA have approved it for onychomycosis are being made on You Tube (...actually I do sort of know, and thats why they using You Tube ... and Google owns You Tube .... and Google have a corporate motto of 'Do no evil'... so if its on You Tube, then it must be correct) :santa:

 

Craig, Simon and Eric:

When podiatrists are making $1,000+ cash for a procedure that takes them less than an hour (more like 30 minutes) to perform in their offices, it doesn't take a rocket scientist to figure out why it is being advertised so heavily by many podaitrists even though it doesn't have FDA approval or any published studies regarding its efficacy.

 

I stand to be corrected on this, but my understanding is that the business model for the PinPointe device is that they have to pay the company (Patholase) $250 every time they use it....:dizzy: ... there were several DPM's at the PFOLA mtg talking about this.

 

Dr. Spooner:

I wanted to further bring the Podiatric community up to date on current laser studies approaching the Onychomycosis disease paradigm.

Here is a very nice modern in vitro study (2008) describing pulsed laser effects on T. rubrum in vitro.

Vural E. et al. The effects of laser irradiation on trichophyton rubrum growth. Lasers Med Sci 2008 Oct;23(4):349-53

Abstract:

The effects of various laser wavelengths and fluences on the fungal isolate, Trichophyton rubrum, were examined in vitro. Standard-size isolates of T. rubrum were irradiated by using various laser systems. Colony areas were compared for growth inhibition on days 1, 3, and 6 after laser irradiation. Statistically significant growth inhibition of T. rubrum was detected in colonies treated with the 1,064-nm Q-switched Nd:YAG laser at 4 and 8 J/cm(2) and 532-nm Q-switched Nd:YAG laser at 8 J/cm(2). Q-switched Nd:YAG laser at 532- and 1,064-nm wavelengths produced significant inhibitory effect upon the fungal isolate T. rubrum in this in vitro study. However, more in vitro and in vivo studies are necessary to investigate if lasers would have a potential use in the treatment of fungal infections of skin and its adnexa.


These are the wavelengths, and fluences used during the initial phase of the study

Wavelength (nm) ----- Fluence (J/cm2)
695 to 1,000 ---------- 38, 45, 57
755 to 1,000 ---------- 38, 45, 57
585 ---------------------- 8, 11, 14
532 ---------------------- 8, 10
1,064 --------------------- 6, 8, 10, 12
2,940 -------------------- 25
532 ---------------------- 2, 4, 6, 8

In this well done study in vitro study, the Q-switched 532 nm light (visible green), in the Nd:YAG family, was superior to all other systems in T. rubrum inhibition. This Q-switched system pulses in nano-seconds, A nanosecond (ns) is one billionth of a second (10-9 s).

The only problem is, that 532 nm also has less than half the penetration value through the nail (i.e. to the bed and matrix) of near-infrared wavelengths, because of a very high protein absorption coefficient in the keratin.

The study authors concluded with this statement:

“In addition to more in vitro studies, in-vivo studies are necessary to investigate the possible therapeutic effects of various laser systems on various dermatopathogens, as laser–fungus interaction might be different when these microorganisms are embedded within the skin and its adnexa.”

Very nice science.

Eric Bornstein
Chief Science officer
Nomir Medical Technologies

 

Eric:

Thanks for being so helpful to all of us regarding the photo-physiology of lasers. Your knowledge is impressive.

My question to you is this. Why couldn't the scientists involved with the other laser fungal toenail treatment system also come onto Podiatry Arena to give us their opinions of why patients should be spending $1,000+ to have their toenails treated with a technology that has not received FDA approval for onychomycosis and does not have any published studies regarding its clinical efficacy?

 

Dr. Kirby:

This may also be of interest to you.

Researchers are also attempting other light-based modalities in the Dermatophyte/Onychomycosis arena.

Here is a list of references in the photodynamic therapy realm (i.e. light plus active chemical).

Any approvals for these systems is considered a "combinatorial" device by the FDA, and would require much larger safety studies, than a device alone.


Propst, C. and L. Lubin (1978) In vitro and in vivo photosensitized inactivation of dermatophyte fungi by heterotricyclic dyes. Infect. Immun. 20, 136-141.

Calzavara-Pinton, P. G., M. Venturini, R. Capezzera, R. Sala, and C. Zane (2004) Photodynamic therapy of interdigital mycoses of the feet with topical application of 5-aminolevulinic acid. Photodermatol. Photoimmunol. Photomed. 20, 144-147.

Kamp, H., H. J. Tietz, M. Lutz, H. Piazena, P. Sowyrda, J. Lademann, and U. Blume-Peytavi (2005) Antifungal effect of 5-aminolevulinic acid PDT in Trichophyton rubrum. Mycoses 48, 101-107.

Calzavara-Pinton, P. G., M. Venturini, and R. Sala (2005) A comprehensive overview of photodynamic therapy in the treatment of superficial fungal infections of the skin. J. Photochem. Photobiol. B 78, 1-6.

Donnelly, R. F., P. A. McCarron, M. M. Tunney, and W. A. David (2007) Potential of photodynamic therapy in treatment of fungal infections of the mouth. Design and characterisation of a mucoadhesive patch containing toluidine blue O. J. Photochem. Photobiol. B 86, 59-69.

Calzavara-Pinton, P., M. Venturini, and R. Sala (2007) Photodynamic therapy: update 2006 Part 1: Photochemistry and photobiology. J. Eur. Acad. Dermatol. Venereol. 21, 293-302.

Gad, F., T. Zahra, K. P. Francis, T. Hasan, and M. R. Hamblin (2004) Targeted photodynamic therapy of established soft-tissue infections in mice. Photochem. Photobiol. Sci. 3, 451-458.

Altenburg, B. and G. M. T. Smijs (2006) Use of a porphyrin compound for the treatment of skin fungi. PCT patent application.


Eric Bornstein
Chief science Officer
Nomir Medical Technologies

 

Then; what would you say to these photos? If I may be able to attach them)


Mmmm I could not. I may send it to your mail if you want. One of my patients. She had 2 fingers in each hand and feet with fungus, but spreaded to all during pregnancy. And I cannot treat it((

 

Sorry for the big sizes of photos.

 

CBS Atlanta are reporting:
Tough Questions About Foot Fungus Laser Treatment
CBS Atlanta Questions Local Podiatrist About PinPointe Laser Treatment

Full story

Watch the video.

 

That is funny! Isn't the contrast between this media clip and the others earlier in this thread amazing? Good to see the media asking hard questions compared to giving others a free ride to promote the tool.

 

I see they still have the claim on their website:

http://www.piedmontpodiatry.com/
Will the FDA act?

 

Collegues:

I just returned from Phoenix, where I gave a presentation at the 6th Annual High Risk Diabetic Foot Conference. http://www.desertfoot.org/

I was thoroughly impressed with the presentations that I saw from Allen Jacobs, DPM, and Jeff Robbins, DPM (among others) about how Podiatry is currently treaing Diabetic Foot Ulcers.

My lecture was entitled: Optical bioburden reduction: a component of diabetic foot ulcer therapy.

I presented data from the Noveon Pivotal trial for Onychomycosis that will be published in the Journal of the American Podiatric Medical Association around the first of the year (lead author and the PI is Adam Landsman DPM, PhD. - Adam is an Assistant Professor in the department of Surgery at Harvard University School of Medicine)

I also presented the Noveon MRSA Bioburden Reduction in vitro and human in vivo data, that we have collected thus far in our trials, and has been peer-reviewed and provisionally accepted for publication in Q1 2010. We hope to begin Optical Bioburden Reduction IRB human trials for Diabetic Foot ulcers in Q1 2010.

We are still awaiting the FDA 510 (k) approval for the treatment of Onychomycosis, and hope to receive it any day.

For those that are interested, I will continue to keep you posted.

Eric Bornstein DMD
Chief Science Officer
Nomir Medical Technologies

 

Press Release:
Dr. Brian McDowell Presents Clinical Study Results At Society Of Chiropodists And Podiatrists Annual Conference 2009

 

What is the point of comparing this to no treatment?

If they want to be taken seriously then they have to stop making this silly claim. The 85% efficacy was in 16people and compared it to no treatment, not drug therapy. Drug therapy may well have 85% efficacy on onychomycosis of the same severity of onychomycosis used the the laser study, or it may not have. Its not considered acceptable to compare efficay results from other studies, as the trial conditions, severity of the condition and other factors would not be equal (I have never done a clinical trial, but even I learnt enough to know this much)

I suppse there is nothing like the truth to get in the way of a good press release

 

sooo ahmm does it work?

 

At presentation. No meaningful nail tissue, tinea present widely on the skin & obvious fungal infection.



At review: Meaningful growth of near normal nail proportions, dry throughout nail & vastly improved skin condition

 

Following debridement.

 

Hamish:

And how much did the patient pay you to get these results?

 

There is a fixation on these costs. Almost to the point of Asbergers syndrome and tempting as it is to speculate on Asberger’s syndrome, at this point I will not.
It is tiresome, somewhat impertinent, and repetitive as the general costs are already stated several times.

Before I go further let me put this forward:
All those fixated on the costs of this; state your annual income, gross profit and your hourly rate and justify it.
Then state the income of your spouse and their hourly rate and then justify it.
Or if you prefer list the cost of all your procedures and justify them, because I am sure you could do them cheaper.
Then declare if you perform what is euphemistically called dry needling (or puncturing patients warts with large needles to create injuries) state your price to the patient and while you are at it present the ratified peer reviewed data that shows it works along with the reference in US medical procedures that shows it is a viable clinical treatment modality and is specifically covered by US insurance. Because I am struggling to find it. Or is it just experimental and unproven? No doubt if it does not work you refund the entire cost too.
Dry needling was the original phrase developed to make acupuncture acceptable to the medical profession at large not optomistically punch hole in a patient in the hope it might work. Talk about double standards.

Do this before you raise the cost issue again, in general what a person charges is no one else’s business but theirs and their patients.

Because some people might not have followed this from the start I will explain something, because too many people who should know better are going off half-cocked with their poorly researched and ill-informed opinions.
There is a basic, monthly rental cost for the unit to be paid whether it is used or not.
There are increased insurance costings to house a £100,000 laser in your premises.
There are promotional costs and monthly advertising costs, it is not cheap.
The patient has to be administratively processed.
The patient must be assessed and the treatment explained.
The nails need to be professionally extensively, skillfully and elegantly debrided prior to lasing. This may easily take 20 minutes or more.
The patient needs to be lased using an effective protocol. This may easily take 45-50 minutes or more.
The patient must have after care explained to them.
There needs to be two follow-ups and debridements at 4 and 8-10 months. These may take (collectively another half hour).
All this takes @ 3 hours. Once deductions are made one has ones fee, this is no different from anything else. And it is about time some people were more rational.

The pictures I posted were of a patient who has had his unpleasant condition (he phrased it far more earthily) and he wanted it gone. He has tried a year of terbinafine, orally. No effect. He has tried copious topical applications. No effect. He does not want to take medication again. He said it made him feel generally unwell. He does not think it will go away by itself.
Now this is the really important thing one has to understand so pay attention because I will use the next few words very deliberately because they are psycho-linguistically very important. He chose to try the treatment, and was satisfied with the information I gave to him and understanding that this form of treatment is still in its infancy. When I last saw him he was ecstatic with the way his nail looked and the way his feet felt. He was the patient and he was happy with the way it is currently looking. He is happy to feel optimistic about it. He chose to spend his money in this way in an effort to improve (the way he sees it) his health.

Having been away from this topic is amazes me that the same questions are being asked despite having previously been answered. It seems there are still some who arrogantly think that the Mountain should come to Mohammed. Anyone who is reading this has Internet and email. Specific questions can be asked directly to all key players as email addresses are all there, as too are telephone numbers.
Not only that but the PathoLase founder (John Strisower), the CEO Bob Katz), the first Podiatric Surgeon in the world to use one (Brian McDowell) and the Lead scientist behind it (Professor David Harris) were all at the SCP Annual Conference in Harrogate in the UK in November. All were available to talk to. It is not as if they are hiding. Considering the clarion of calls to answer questions I do not remember seeing many people approach them, despite tham being totally approachable.
Their information has been submitted for FDA approval, both retrospective and perspectives are there to be used the latter in maybe March. In the UK and Europe it has approval for use in OM. In parts of the planet outside of America the FDA is not an issue that is something for the Americans to continue to whinge, or gripe, on about. Europe has decided it is safe and fit for purpose.

Finally it has been several months since "any day now" for the other device. There is a word on the street. Is it true that it has all gone pear shaped? or is it any day now?

 

Hamish

Thank you for posting the comparison pictures- to a grunt at the coal face like myself, they look pretty good- There is an obvious improvement not only in the nail but also in the definition of the nail folds. I am sure the patient is delighted.

I cant think of any other probing questions to ask

All the best for a very successful New Year

Cornmerchant

 

Hamish
I will join cornmerchant in thanking you for the comparison pics......:drinks
I do have one genuine question, is this improvement after 1 or a course of treatments?
Thanks again as I am watching your progress with interest as I don't beleive we should stick to the same old stuff (although some of is is invaluable).
Wendy

 

Wendy, Cornmerchant thank you for the polite remarks.
This was treated by prior and extensive debridement and then lased across all nails in a spcecific protocol. So it is to be considered one theraputic intervention. There then followed a post lase protocol of antifungal treatment , for good reason. His return for this next treatment was 4 months post lase. Wha tis intereresting is that it revealed that his visually unaffected R fifth toe was in fact extensively infected and had been positively affected by the laser.
The device is a 4 watt laser using a crystal, it is not a diode. the max power a diode laser can produce is 6 watts. so you could be mistakent hat it is more potent than a PinPointe. You would be wrong. The 4 watt crystal laser is many, many, many hundreds more powerful because of what the flashlamp excitation does to the photons in the crystal. Peak power delivery which takes place in a fraction of a second is considerable.
It is possible it might need a second application (the patient accepts this) but I seriously doubt it. Seeing it in situ more revealing than the just the photo's ablity to demonstrate. the texture is changed into a healthier nature too.

 

Happy New Year All,

Are there any pictures of these lasers and do they have the capability to vary the wattage. I have a Sharp Plan Laser CO 2 with microscope attachment that can be adjusted from 1W to 25W.

At what temperature are the fungal spores classified as being destroyed and once the laser treatment is applied, is an anti-fungal agent administered to clear up any missed spores.


Don Scott