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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
The Following User Says Thank You to Dr. Eric Bornstein For This Useful Post:
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?
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 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.
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?
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.
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.
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?
__________________ Craig Payne
__________________________________________________ ___________________________________ Follow me on Twitter | Run Junkie God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
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.
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:
Quote:
Another company developing a laser, PathoLase, is so eager to get a piece of the billion-dollar-plus market for antifungal nail treatments that it has not waited for federal permission to begin marketing its device, the PinPointe Footlaser, for use on toenail fungus. Nearly 70 podiatrists in 21 states already offer PinPointe, according to PathoLase. The treatment, which is not covered by health insurance, costs $1,000 or more.
The F.D.A. requires manufacturers to wait for federal clearance before marketing a medical device for specific uses. But PathoLase appears to have jumped the gun in the war on spores.
Last week, a news broadcast by a Fox affiliate in Manhattan featured PinPointe as the latest thing for nail disorders. Dr. Stuart J. Mogul, a podiatrist in Manhattan who demonstrated the laser during the broadcast, said he had recently treated four patients with PinPointe at a cost of $1,200 each. He said it was too soon to tell whether the treatment had worked.
“I explain to patients that the only risk is financial,” Dr. Mogul said in an interview last week.
He added that representatives of PathoLase had told him that the F.D.A. had approved the laser as being safe.
Up until Tuesday, PinPointe’s Web site promoted the toenail laser as “F.D.A. cleared” and included an endorsement from a podiatrist in California saying he had used the device for six months on 225 patients.
Because the F.D.A. cleared the device in 2001 for use in dentistry, doctors are free to use it for other purposes, John Strisower, the chief executive of PathoLase, said in an interview on Monday.
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)
__________________ Craig Payne
__________________________________________________ ___________________________________ Follow me on Twitter | Run Junkie God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
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.
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
When podiatrists are making $1,000+ cash for a procedure
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.... ... there were several DPM's at the PFOLA mtg talking about this.
__________________ Craig Payne
__________________________________________________ ___________________________________ Follow me on Twitter | Run Junkie God put me on this earth to accomplish a certain number of things - right now I am so far behind, I will never die.
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.
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
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
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
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
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?
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
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
Usually fungal nails are due to a weakness in the toenail caused by Trauma. the most common trauma is tight shoes. That's why most women develop fungal or damaged nails on their 1st and especially 5th toenails. This damage is permanent and no medication or laser can reverse matrix cells that have been killed by ischemia caused by tight shoes. The fungus can be cured with lamasil but the damaged nails will still show this damage be more porous and prone to fungus. Seldom does fungus spread from a damaged nail to an adjacent normal nail so the fear of fungus on locker room floors is silly. Fungus is everywhere in our environment. In nail salons frequently the "technicians" (using sterile equipment) push back cuticles opening them up allowing a perfect bed for yeast infections. Again this is not due to dirty equipment but opening up the cuticle. The cuticle is a seal between the skin and the nail and should not be opened.
Lets all get real when it comes to fungus how many patients have you seen with one or two fungal nails and never had seen it spread for ten or twenty years to adjacent nails. You know it is not contagious. You know the true reason for nail fungus.
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:(((
CBS Atlanta are reporting: Tough Questions About Foot Fungus Laser Treatment
CBS Atlanta Questions Local Podiatrist About PinPointe Laser Treatment
Quote:
The Ankle and Foot Centers of Georgia has been promoting a foot fungus laser treatment on its Web site.
Mary Long with the FDA said, "The PinPointe Laser has been cleared for marketing by the FDA for soft tissue cutting. It has not been cleared or approved by the FDA for the treatment of toenail fungus."
However, the Ankle and Foot Centers of Georgia is advertising the foot fungus laser treatment online and it even claims it's 88 percent effective. CBS Atlanta questioned the Piedmont Podiatry about the promotion at their Atlanta practice and they shut the door on us.
The FDA said that doctors can use the laser for any type of treatment, but they are not able to advertise treatments that are not FDA approved.
"Promotion of medical devices for unapproved or uncleared uses violates FDA regulation," said Long.
The Ankle and Foot Centers of Georgia told CBS Atlanta Tuesday that the FDA guidelines for promotion of the PinPointe Laser only apply to the manufacturer.
The FDA responded with this statement, "No, it does not only apply to manufacturers. Section 906 of the Food, Drug and Cosmetic Act refers to our authority over promotion of unapproved uses of legally marketed devices by practitioners."
If the FDA decides to take action, the Ankle and Foot Centers of Georgia could lose its laser.
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.
The FDA approved PinPointe FootLaser is a specially designed laser beam that goes through the toenail and safely kills the organisms embedded in the nail bed that cause Onychomycosis
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
Quote:
PinPointe USA, Inc., a privately held emerging medical technology company which introduced the breakthrough PinPointe FootLaser treatment for toenail fungus in Europe, announced that Dr. Brian McDowell presented the results of his pilot clinical study "Laser Treatment for Toenail Fungus" (Harris, McDowell and Strisower, Proc. SPIE 7161A, 2009) at the Society of Chiropodists and Podiatrists Annual Conference 2009 at Harrogate International Centre on November 19. Dr. McDowell, lead author of the study, presented the results at the poster session of the conference, which is the largest event in the UK focusing solely on podiatry.
The PinPointe FootLaser uses proprietary laser technology that is designed to target the pathogens that cause toenail fungus (onychomycosis), a fungal infection that afflicts an estimated 900 million people. PinPointe's laser treatment passes through the toenail without causing damage to the nail itself or surrounding tissue, providing for the ability to treat toenail fungus patients without drugs or anesthesia.
The "Laser Treatment for Toenail Fungus" pilot clinical study recruited 16 subjects from podiatrist offices, all with both great toes afflicted with toenail fungus. Toes with visible signs of fungus were randomized to receive either a single PinPointe FootLaser treatment or no treatment. Notably, 14 out of 16 (88%) toenails that were treated showed significant improvement after a single session. All subjects tolerated the treatment without anesthesia and there were no occurrences of serious adverse effects.
Noted Dr. McDowell: "The results of this study represent truly significant findings for the millions of people who suffer from this nagging, painful and often embarrassing affliction. Most importantly, we found that a single treatment with PinPointe FootLaser resulted in nail clearing for the majority of subjects that was similar in clinical appearance to the results of the leading pharmacological treatment, which can be toxic and can induce pathogen resistance. In addition to superior safety over drug therapies, the PinPointe FootLaser treatment promises to be much more effective. The efficacy of drug therapy is in the range of 15-30% versus the over 85% efficacy we observed in this study."
The results of this pilot clinical study demonstrated better than 85% of the patients had significant clear nail growth after just one in-office treatment. Dr. McDowell added that the study results are preliminary, and data from a much larger sample in a well-controlled, multi-center trial is essential to substantiate the findings. Currently, a major multi-site clinical trial entitled "Multi-Center Trial: Evaluation of PinPointe FootLaser Treatment for Infected Toenails (Onychomycosis)" is underway at four separate research centers across North America.
"Dr. McDowell's study is the first of several clinical studies that the company is pursuing in order to expand our knowledge-base with regards to the potential for this PinPointe FootLaser treatment," added Bob H. Katz, Chief Executive Officer of PinPointe USA, Inc. "We expect our on-going studies to add additional insight based on treating larger patient series in a prospective, randomized and controlled manner."
The PinPointe FootLaser was introduced to Europe in the UK in May 2009 after receiving CE Mark approval. Since then, the PinPointe FootLaser has continued to expand its reach in Europe, certifying podiatrists in the United Kingdom and Germany to administer this revolutionary new laser treatment for toenail fungus.
Toes with visible signs of fungus were randomized to receive either a single PinPointe FootLaser treatment or no treatment. Notably, 14 out of 16 (88%) toenails that were treated showed significant improvement after a single session
What is the point of comparing this to no treatment?
Quote:
The efficacy of drug therapy is in the range of 15-30% versus the over 85% efficacy we observed in this study."
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
And how much did the patient pay you to get these results?
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
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?
The Following User Says Thank You to hamish dow For This Useful Post:
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 :-)
Hamish
I will join cornmerchant in thanking you for the comparison pics......
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.
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.
Re: Laser treatment for nail fungus
... there were several DPM's at the PFOLA mtg talking about this.
Linear Mode
