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Laser treatment for nail fungus

Discussion in 'General Issues and Discussion Forum' started by Cameron, Jan 4, 2009.

  1. Hells bells. Now thats just funny !!
     
  2. Paul Bowles

    Paul Bowles Well-Known Member

    Mac keyboards are just not up to their PC equivalents. Thanks Michael.....

    ...and thanks Kevin for watching my back!
     
  3. NobigDeal

    NobigDeal Welcome New Poster

    Disclaimer: I'm not a professional in podiatry. I became interested in the Patholase/PinPointe laser fungus removal topic only because of problems my wife was having. However, I hope I can add something - at least questions - to this discussion. I'm a retired University of California chemistry professor with a B.S. from Caltech, Ph.D. from Stanford, postdoctoral work in neurochemistry at Columbia P&S, research in biochemical and physical chemistry, publications, grants and grant reviewing, Yada, Yada, Yada. So I have experience reading and evaluating scientific publications and arguments.

    As I read through this forum and other discussions, here are some questions I hope someone can answer. Sorry this post is so long; I thought it would be better to put everything in one place.

    1. I was impressed with the Harris, McDowell, and Strisower article "Laser treatment for toenail fungus" (available in the "Science" tab at the Patholase web site). As a preliminary study, that study appeared to be very well done. They said, "We predict that complete clearing of a totally involved great toe should take up to 12-18 months and we continue to follow those patients." What have been the follow-up results?

    2. My impression is that patient compliance and vigilance after the treatment is absolutely critical to prevent new fungal infection. Given that typical patients are neither compliant nor vigilant, what is the real-world rate of re-infections? And in the real world, what fraction of patients require a second treatment?

    3. In a Consumer Reports forum, Laura Uro said, "A newer study was submitted to the FDA the end of last year. The study results are very promising." Is this study available? Can this study be posted on the Patholase or the Uro web site?

    4. I may have taught Michael Uro (a principal in the Barefoot Laser Centers) freshman chemistry at UCR. I don't have records that go back that far, so I can't look up his grades! I am concerned that one of the Barefoot center newspaper ads printed on March 16 says, "Kill your fungus NOW and have clear nail growth in time for summer." Isn't that deceptive? There may be 4-5 mm of clear nail growth between now and the beginning of summer, but that's hardly going to be a pristine nail.

    5. Along the same lines, Michael Uro is obviously an upright citizen since he is a UCR graduate (and a search showed that his license is in good standing). But some of the people associated with laser treatments aren't in his league. For example, the "board licensed physician" at a local laser center at one point apparently surrendered his M.D. license after accusations of "gross negligence, repeated acts of negligence, incompetence, failure to maintain accurate records, and excessive treatment." Another local podiatrist with a laser facility has had two reported "Administrative Disciplinary Actions" and consequent probations. (Disclaimer: I found these after simple internet searches, and do not know anything about the legal issues.) Laser fungus treatments may not be snake oil (as some people in this forum have suggested), but shouldn't Patholase screen its practitioners to make sure no snake oil salesmen are doing them?

    6. What's happened with the Nomir/Noveon IR laser treatment? When this thread started, they were "hoping to receive clearance to market Noveon by this fall" [2009]. Apparently this hasn't happened.

    7. What I find most surprising about the laser treatment is the dog that isn't barking. If I had treated 1000 or so patients using a novel treatment (as Uro said he has), I would have had my office call them or mail follow-up cards to all of them at regular intervals, would have asked them about their compliance, and would have asked them about their degree of satisfaction with the treatment. I probably would even have offered them a no-cost follow-up appointment (or this could be done by a sample of 50-100 patients for a detailed follow-up). And if the results were what I advertised in advance (>80% cure rate), I would have posted them on my web site in 72-point bold font. Why isn't that dog barking with joy?

    Again, I apologize for the length of this post, especially since it comes from a non-professional in the field. I hope somebody can answer some of these questions.
     
  4. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    To NoBigDeal:

    Let me answer your question that relates to Nomir.

    Our status with the FDA has not changed. We are still seeking to get specific FDA clearance for the Noveon treatment of onychomycosis, based on the pivotal randomized study data previously sent to the FDA, and soon to be published in JAPMA (May/June) issue. The Ref is below.

    Landsman, A. et al. (2010) Treatment of Mild, Moderate and Severe Onychomycosis Using 870nm and 930nm Light Exposure J. of the Am. Pod. Med. Assoc. Publication in May/June

    This will allow the greater Podiatric community to have full disclosure of our study, statistics, results, and all related issues in the Podiatric profession's priemere peer-reviewed scientific journal. It should generate much discussion.

    We have requested a face-to-face meeting with appropriate agency representatives to further consider the onychomycosis clearance. That meeting should be scheduled sometime in the next 60 days.

    In the mean time however, we are beginning to move the system into the marketplace using our existing 510k clearance for use in podiatry and dermatology in the US, and are currently weighing options for world-wide distribution with multiple potential partners. Here is our 510(k) approval.

    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=29577


    For the purposes of clarity in the US market, it is important to understand that the current system is approved for general podiatric use. It was and still is our intent to get the additional level of clearance for the specific indication of onychomycosis, which we are agressively persuing.

    With the general 510K approval, Podiatric and Dermatology Clinicians will be able to elect to use the Noveon within FDA guidelines based on the practitioner’s conclusion from familiarity with peer-reviewed published data. This will include The following peer-reviewed publications.

    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 Medicine 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. In Proceedings of the 9th Annual New Cardiovascular Horizons, p.72, New Orleans, LA, September 10–13, 2008. New Cardiovascular Horizons, Lafayette, LA.

    3) Bornstein E.S. (2009) A Review of current research in light-based technologies for treatment of podiatric infectious disease states. J. of the Am. Pod. Med. Assoc. 99 (4), 348-352.

    4) Bornstein E.S. (2009) 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, March 5, 2009.

    5) Bornstein E., W. Hermans, S. Gridley, and J. Manni (2009) Near infrared Photo-inactivation of bacteria and fungi at physiologic temperatures. Photochem. and Photobiol. 85, 1364–1374

    6) Landsman, A. et al. (2010) Treatment of Mild, Moderate and Severe Onychomycosis Using 870nm and 930nm Light Exposure J. of the Am. Pod. Med. Assoc. Publication in May/June

    7) Bornstein E., S. Gridley, and P. Wegender (2010) Photodamage to Multidrug-resistant Gram-positive and Gram-negative Bacteria by 870 nm/930 nm Light Potentiates Erythromycin, Tetracycline and Ciprofloxacin. Photochem. and Photobiol Publication in April

    Regards,

    Eric

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

    Dr. Eric Bornstein Active Member

    For colleagues that are interested, here is our latest research with Noveon system. This paper is now available for early view on-line.

    Photodamage to Multidrug-resistant Gram-positive and Gram-negative Bacteria by 870 nm/930 nm Light Potentiates Erythromycin, Tetracycline and Ciprofloxacin

    Eric Bornstein*1, Scott Gridley 2 , Paul Wengender 2 and Alan Robbins 1
    1 Nomir Medical Technologies, Waltham, MA
    2 Blue Sky Biotech, Inc., Worcester, MA
    *Corresponding author email: ebornstein@nomirmedical.com (Eric Bornstein)
    Copyright Journal compilation © 2010 American Society for Photobiology

    ABSTRACT
    We have previously shown that 870 nm/930 nm wavelengths cause photodamage at physiologic temperatures in methicillin-resistant Staphylococcus aureus (MRSA) and Escherichia coli via generation of endogenous radical oxygen species (ROS) and decreased plasma membrane potentials (ΔΨp). We tested MRSA (Strain HSJ216) in vitro with sublethal 870 nm/930 nm laser energy and subinhibitory concentrations of erythromycin, tetracycline, penicillin, rifampin and trimethoprim to surmise whether photodamage could potentiate these antimicrobials. We also tested patient isolates of fluoroquinolone-resistant MRSA and E. coli with subinhibitory concentrations of ciprofloxacin. In MRSA (Strain HSJ216) we observed 97% potentiation (a 1.5 log10 CFU decrease) with erythromycin and tetracycline. In patient isolates of E. coli, we observed 100% potentiation (>3 log10 CFU decrease) in all irradiated samples with ciprofloxacin. To assess whether staphyloxanthin pigment conferred protection against the generated ROS, we created an isogenic carotenoid-deficient mutant of S. aureus that was significantly less tolerant of 870 nm/930 nm exposure than the wild type strain (P < 0.0001). We suggest that antibiotic potentiation results from a photobiological attenuation of ATP-dependent macromolecular synthetic pathways, similar to that observed with daptomycin, via disruption of ΔΨp and endogenous generation of ROS. With erythromycin, tetracycline and ciprofloxacin, attenuation of energy-dependent efflux systems is also a possibility.


    --------------------------------------------------------------------------------

    Received 16 October 2009, accepted 12 February 2010

    http://www3.interscience.wiley.com/journal/123342137/abstract

    We intend to begin an IRB approved Bio-burden reduction study in DFU patients within the next 60 days.


    Regards,

    Eric

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

    Dr. Eric Bornstein Active Member

    Pivotal Onychomycosis Study now in JAPMA

    http://www.japmaonline.org/cgi/content/abstract/100/3/166


    Journal of the American Podiatric Medical Association
    Volume 100 Number 3 166-177 2010
    Copyright © 2010 American Podiatric Medical Association

    Treatment of Mild, Moderate, and Severe Onychomycosis Using 870- and 930-nm Light Exposure

    Adam S. Landsman, DPM, PhD *, Alan H. Robbins, MD , Paula F. Angelini, DPM , Catherine C. Wu, DPM , Jeremy Cook, DPM *, Mary Oster, BS and Eric S. Bornstein, DMD

    * Division of Podiatric Surgery, Beth Israel Deaconess Medical Center, Boston, MA.
    Nomir Medical Technologies Inc, Waltham, MA.
    Southboro Medical Group, Southboro, MA.
    Private practice, Revere, MA.
    Corresponding author: Alan H. Robbins, MD, Nomir Medical Technologies Inc, 307 Waverley Oaks Rd, Ste 109, Waltham, MA 02452. (E-mail: cfolster@nomirmedical.com )

    Abstract

    Background: The Noveon is a unique dual-wavelength near-infrared diode laser used to treat onychomycosis. The device operates at physiologic temperatures that are thermally safe for human tissue. It uses only 870- and 930-nm near-infrared light, wavelengths that have unique photolethal effects on fungal pathogens. These wavelengths lack the teratogenic danger presented by ultraviolet light and the photoablation toxic plume associated with pulsed Nd:YAG lasers.

    Methods: In this randomized controlled study, treatments followed a predefined protocol and laser parameters and occurred on days 1, 14, 42, and 120. Toes were cultured and evaluated, and measurements were taken from standardized photographs obtained periodically during the 180 day follow-up period.

    Results: We treated mycologically confirmed onychomycosis in 26 eligible toes (ten mild, seven moderate, and nine severe). All of the patients were followed-up for 180 days. An independent expert panel, blinded regarding treatment versus control, found that at 180 days, 85% of the eligible treated toenails were improved by clear nail linear extent (P = .0015); 65% showed at least 3 mm and 26% showed at least 4 mm of clear nail growth. Of the 16 toes with moderate to severe involvement, ten (63%) improved, as shown by clear nail growth of at least 3 mm (P = .0112). Simultaneous negative culture and periodic acid–Schiff was noted in 30% at 180 days.

    Conclusions: These results indicate a role for this laser in the treatment of onychomycosis, regardless of degree of severity. Ease of delivery and the lack of a need to monitor blood chemistry are attractive attributes. (J Am Podiatr Med Assoc 100(3): 166–177, 2010)
     
  7. :eek:

    Laser in well designed RCT shock!

    Nice work!:drinks
     
  8. For those that want to read the full text........
     
  9. MDeSoto

    MDeSoto Member

    I have a question for Dr. Bornstein. The article refers to the protocol for the study being four treatments (at days 1, 14, 42 and 120). I assume then that would be the recommended protocol in practice as well. Is that correct?
     
  10. MDeSoto

    MDeSoto Member

    I see that in a press release dated March 5, 2009, Nomir stated that "a significant drop in positive culture was seen in 74 percent of the toes after only two treatments." Was that mid-treatment (i.e., 2 of the 4 treatments) or is the company still refining the recommended course of treatment?
     
  11. Kelly Cox

    Kelly Cox Welcome New Poster

    This is a fascinating thread, and thank you for letting the lay public post to this forum. I especially appreciate the information provided on the Noveon laser treatment, including specific information about the laser wavelength and fluency.

    I'm interested in this topic for two reasons--the first being the obvious one, that I have OM infections on 6 toenails. I only had one infected toenail as a teenager, but through my forties it has spread to other toes on both feet (I am now 48).

    The other reason is that I designed lasers for much of my first career, including lasers for various medical treatments, so I'm quite interested in reading about the specifics of the laser treatment used, including the photobiology of the treatment. That is why I especially appreciate the Noveon information that has been provided.

    That is also why I'm canceling the appointment I have scheduled for next week for a treatment with a Pinpointe laser system. I may have missed it, but I've seen no specifics mentioned about this laser, and a great deal of what appears to be propaganda. Hamish Dow has said quite specifically that the wavelength and other information are proprietary. I also have seen no clear answer from him, in spite of repeated requests, as to how the 88% efficacy figure is supported by peer-reviewed studies.

    OTOH, Dr. Borstein has been completely forthcoming about his background and expertise in multiple disciplines related to this treatment, and has provided a wealth of clear information about the treatment modality of the Noveon laser, studies supporting the efficacy of the treatment, and the current FDA status of the Noveon treatment.

    I especially appreciate Kevin Kirby's conservative advice about treatment modalities. Based on this, I will ask my PCP to refer me to a podiatrist who can prescribe a nail lacquer treatment. But I expect that treatment with the Noveon laser will be available fairly soon in my area (Madison, Wisconsin) and I’m looking forward to taking advantage of that treatment too.

    Best regards,

    Kelly Cox
    Madison, WI
     
  12. Kelly:

    Welcome to Podiatry Arena.:welcome:

    Good idea. Save your hard earned money and have your doctor prescribe Penlac nail lacquer for you. It is only about $22.00 a bottle at Costco and Walmart and have him/her give you five refills. Word has it that one of the podiatrists in my area that uses laser fungal toenail treatment with PinPointe charges $1,200.00 for a 30 minute treatment, offers no guarantees and according to one of his former patients, this podiatrist has quit doing surgery otherwise because "he is making too much money doing laser toenail treatments."

    I am looking forward to a laser treatment for fungal toenails that does have peer-reviewed research that document its efficacy.

    Like you, I am also a long time competetive distance runner and my nails aren't in the best shape....but I'm five years older than you. Penlac worked great for me and generally works well for my patients and has no side effects that I know of.
     
  13. RiverRider

    RiverRider Member

    I absolutely agree! So much useful information here and fun to watch the debate unfold.

    A big thanks to all the experts that took their time to discuss this topic in a public forum. Well done! :drinks
     
  14. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member



    For colleagues that are interested, I will be presenting our new research with the Noveon system at the at The 9th International Mycological Congress, Future strategies for the control of fungal diseases, Edinburgh Uk. Aug 1-6 2010.

    The Presentation is entitled:

    Antifungal Synergy Produced in Candida Albicans with 870nm/930nm Near Infrared Photodamage

    This presentation will detail similar positive photobiological interactions with sub MIC levels of Terbinafine and Itraconazole against Candida, as we have previously published with (1) MRSA and genreic Erythromycin, and (2) Ciprofloxacin and resistant E. coli.

    Regards,

    Eric

    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
     
  15. hamish dow

    hamish dow Active Member

    PinPointe have had a positive meeting with FDA. Landsman is presenting for PinPointe In Bournemouth sponsored by PinPointe I believe.
    If my grasp on this website has worked. There will be images attached of a presenting infection pre-lase, followed by two images at 4 month presentation and then in its post-debrided state.
     

    Attached Files:

  16. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Dear colleagues:

    I would like to report that Nomir Medical Technologies has delivered its first three Noveon systems in the greater New York Tri-State area this week. My team has planned for another 10 deliveries by the end of August.

    We are meeting with the FDA on August 19th (in person) to discuss any further issues that need to be resolved with our Onychomycosis 510(k) application, and Dr. Landsman (the PI on Nomir's pivotal OM study) will be meeting with the FDA approximately 10 days later.

    We are hopeful that this will clear the way for the 510(k) approval for OM sometime before the end of the year, if not sooner. I will keep you informed as to our progress.

    Further interest in the Noveon laser should please be directed to nomirsales@gmail.com

    Regards,

    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
    Cell: 508-380-9866
     
  17. Paul Bowles

    Paul Bowles Well-Known Member

    Thanks Eric and Hamish for keeping us updated.......
     
  18. cwardnm

    cwardnm Welcome New Poster

    Thank you for allowing posts from the general public - I have poured over these threads for a couple of hours because laser therapy is all over the radio here in New Mexico.

    I finally struck gold with the following..... [apologies in advance if my jaded view of medical practicioners paints with too broad a brush]

    "Word has it that one of the podiatrists in my area that uses laser fungal toenail treatment with PinPointe charges $1,200.00 for a 30 minute treatment, offers no guarantees and according to one of his former patients, this podiatrist has quit doing surgery otherwise because "he is making too much money doing laser toenail treatments."

    PURE GOLD --

    Most of my contact with physicians has been social - and perhaps that's the best way to view the profession [together with enough Crown Royal to put everybody on the same page]

    I've had a mild case of toe fungus for a couple of years. My sister told me there's no cure - so I decided to have a look at the discussions within the 'industry'.

    I'm an athiest who was raised a Christian Scientist. I have either extraordinary genetic programming - or there is some metaphysical reasons for the good health in my extended family.

    I've always considered the medical profession to be filled with opportunists and charlatans - again... I've known too many doctors socially .... oncologists whose false positives grow with each discarded trophy wife - dermatologists who crow that certain insurance policies will allow 5 to 10 worthless treatments for common warts before they have to actually remove them.

    So the above quote was particularly meaningful to me. It's all about the Benjamins after all, in an industry of highly compensated poseurs.

    thank what ever gods there be for my genetic material.... What would I do if I were a hostage to such assorted monsters.

    By the way... I've had limited success with vinegar in a home made big toe condom.... made from the thumb of a surgical glove. I leave it on over night and I've been amazed at the change in my big toe nail! Or maybe it's all in the mind after all.

    My apologies to the forum mods... I suspect you have little patience for patients like me.
     
  19. hamish dow

    hamish dow Active Member

    can't help but notice:
    "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."

    But now I notice:

    "Nomir Medical Technologies has delivered its first three Noveon systems.
    My team has planned for another 10 deliveries by the end of August.
    We are meeting with the FDA on August 19th......and Dr. Landsman (the PI on Nomir's pivotal OM study) will be meeting with the FDA approximately 10 days later."
    Will he really? I thought he has met with them already perhaps the details could be clarified.

    "We are hopeful that this will clear the way for the 510(k) approval for OM sometime before the end of the year."
    Eric Bornstein
    So what changed? I am sure there are others with far storonger views than mine that sure will be keen to remark on the change of heart. Or is it possible that the promotion on this site and that they are not retail but lease not counted as selling nor advertising?
    "Further interest in the Noveon laser should please be directed to nomirsales@gmail.com"
    Looks like advertising and sales to me and prior to FDA approval to me. And what happens to the devices if FDA bumps the 510 (k)?
     
  20. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Hamish:

    I find it remarkable, that in all of my data driven and scientific posting during the last year, that this is the one or two sentences that seem to now be causing a chafe in your undies.

    There are many companies that are currently advertising and selling in the American market to treat onychomycosis. None of them are FDA approved to do so.

    My group is not advertising as such at all, and we have begun selling our laser, that has twice been FDA approved for Podiartic, Dermatologic, ENT and Plastics general use on Label, and in full compliance with regulations.

    No other company has anywhere close to the years and years of lab, animal, cadaver and human clinical data that my team has presented and published in the areas we have been discussing on this board. Yet we are still not advertising as such to fully comply with the FDA.

    Our meeting on the 19th of August with the FDA is to continue our discussions for our third FDA approval, which we hope will be the "disease specific" treatment of Onychomycosis. Possibly you missed that nuance in the prior postings.

    I do not know what representatives from other companies have been telling you about Nomir, or what other issues you may have with what my group is doing, but they certainly seem to be causing you some angst.

    Might the angst come from the fact that it is harder to argue with publications and data, than with salesmen and advertising?

    Regards,

    Eric

    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
    Cell: 508-380-9866
     
  21. Eric:

    I think you, at least, have been very upfront and forthcoming with your laser technology to all of us here on Podiatry Arena. I can't say that for the PinPointe Laser company who is still marketing a technology without FDA approval and with no peer-reviewed literature to back up their claims.
     
  22. hamish dow

    hamish dow Active Member

    Thanks guys, my trollies ar just fine
     
  23. MDeSoto

    MDeSoto Member

    And what were the results of the meeting with the FDA?
     
  24. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member


    MDeSoto:

    We had an excellent meeting with the FDA, and are continuing to work with them on the approval process for an onychomycosis indication. I will further update, as I receive more information in the future.

    On another front, the Abstract of our latest research that was peer-reviewed for the 9th International Mycological Congress, Future strategies for the control of fungal diseases, Edinburgh Uk. Aug 1-6 2010, has been published, for thoes that are interested.

    I unfortunately did not make the meeting in Scotland, but present the published abstract below.

    [P2.245]
    Antifungal synergy produced in Candida albicans with 870nm/930nm near infrared photodamage

    E. Bornstein*1, S. Gridley2

    1Nomir Medical Technologies, United States, 2Blue Sky Biotech, United States

    We have previously determined that 870nm/930nm near infrared energy will cause photo-damage at physiologic temperatures to the fungal pathogens Candida albicans and Trichophyton rubrum. This was measured as decreased trans-membrane potentials (∆Ψ mt and ∆Ψ p) and increased radical oxygen species. Herein, we tested Candida albicans ATCC 14053 in vitro, with a sub-lethal dose of 870nm/930nm laser energy and less than the minimum inhibitory concentrations of terbinafine (0.5 ug/ml) and itraconazole (0.5 ug/ml), to surmise whether photo-damage would synergistically lower the MIC of these antifungals. Irradiation consisted of 8640 J/cm2 over 30 minutes in saline, and samples were plated in quintuplicate. With both molecules, the combination of sub-inhibitory 870nm/930nm energy and sub-MIC antifungal concentrations killed ~ 85% more colony forming units than the sum of the individual activities of each treatment alone, confirming synergy of the antifungal molecules with the light therapy. There was a statistically significant difference in CFU distribution between Control and Experimental colonies (terbinafine P=0.0143, and itraconazole P=0.0090). We suggest that this antifungal synergy results from a photobiological attenuation of ATP-dependent macromolecular synthetic pathways, via disruption of ∆Ψ mt and endogenous generation of ROS, and could potentially be exploited in cutaneous antifungal therapy.

    Keywords: Candida, Infrared, Itraconazole, Terbinafine

    Regards,

    Eric

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

    MDeSoto Member

    Dr. Bornstein, thank you for the update.
     
  26. Bennepod

    Bennepod Active Member

    Greetings.

    I have to admit I have not trolled through all the postings, but does anyone have any experience/opinions information on the Coolbreeze Cooltouch laser system for toenail fungus?

    Brendan
     
  27. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Bennepod:

    Here is a repeat of a previous post on Free-running pulsed Nd:YAG laser technology and T. rubrum. It deals with a good "in vitro" study conducted by Vural et al 2 years ago.

    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.

    Today, if one were to go to PubMed http://www.ncbi.nlm.nih.gov/pubmed, and search Laser and T. Rubrum, the only relevent study, other than the multiple Human, Animal, Cadaver and Bench studies completed by my team in the last 5 years, would be this one (below).

    Manevitch et al, Direct antifungal effect of femtosecond laser on Trichophyton rubrum onychomycosis. Photochem Photobiol. 2010 Mar-Apr;86(2):476-9. Epub 2009 Dec 7

    This study, was conducted with a femtosecond infrared titanium sapphire laser that pulses at 10-15 of a second, (Free running pulsed and diode lasers cannot pulse this way) and did successfully inhibit growth in vitro of T. rubrum.

    I can find no IRB controlled, blinded, peer-reviewed and published human studies, with independent statistical analysis, using any laser other than the Noveon, for the human treatment of Onychomycosis.

    Eric Bornstein
    Chief Science officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
     
  28. pearlyshells

    pearlyshells Welcome New Poster

    I read alot of things in Podiatry Arena and have not felt the need to reply to anything. This thread has interested me alot due to the fact that I work for a company who advertises and uses Pinpointe. I was hoping to get some clarification and justification of its use but have the same feeling I had when I first started reading it. I want to be satisfied that the outcome justifies the cost ..... thats all.
     
  29. Frederick George

    Frederick George Active Member

    I have been using a CO2 laser to treat onychomycosis since the mid 1980's. Success has been about 75-80%.

    There is no magic to this. Adjusting the wattage for the thickness of the nail, many perforations are made through the nail plate without going through to the nail bed. The patient feels nothing. If they feel a zing, you back off on the wattage. The patient applies a couple of drops of 10% ciclopirox olamine solution TID.

    The laser of course kills the fungus where the perforations are, and the holes dry out the underlying fungus, but mostly the med can penetrate into the fungus, killing, or inhibiting it. As the nail grows out the fungus is inhibited from advancing proximally, and finally disappears off the end of the nail.

    You have to redo the holes at 4wk intervals, because they start to close up, and the med can't penetrate.

    I charge about twice a normal office visit rate, and tell patients it normally takes about 4-6 treatments.

    I think that success is primarily dependent on patient compliance (applying the med TID).

    It seems silly to worry about what wavelength kills various fungi. Are we really expected to believe that one treatment will kill it for all time? And that the patients shoes, etc. won't simply continue to provide a source of fungus?

    Come on . . .

    CO2 lasers are relatively cheap direct from China, and can also be used for matrixectomies and verrucae.

    Cheers
     
  30. and what sort of long term damage occurs - or is it better not to think about it?
     
  31. Frederick George

    Frederick George Active Member

    Dear Michael

    Long term damage?? We're talking about dead toenails. Don't you cut toenails in Sweden?

    Cheers
     
  32. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    For thoes interested, here is the basics of the C02 Laser.

    C02 Lasers are generally used for the surgical treatment or removal of mycotic toenails.


    Rothermel E, Apfelberg DB.
    Clin Podiatr Med Surg. 1987 Oct;4(4):809-21

    McInnes BD, Dockery GL
    J Am Podiatr Med Assoc. 1997 Dec;87(12):557-64

    Onychoplasty with carbon dioxide laser matrixectomy for treatment of ingrown toenails.
    Farley-Sakevich T, Grady JF, Zager E, Axe TM.
    J Am Podiatr Med Assoc. 2005 Mar-Apr;95(2):175-9.

    The CO 2 laser used for matrixectomy.
    Karpen M.
    J Clin Laser Med Surg. 1992 Dec;10(6):454-6. No abstract available.


    A C02 laser is a surgical laser, with a mechanism of action that works via vaporization of tissues with high water content. A C02 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) that cause safe and rapid ablation of tissues. Exploiting this laser-tissue interaction, a podiatric clinician using a CO2 laser has the ability to apply an intense burst of laser energy, for a very short time interval, to effect a desired surgical outcome.

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


    This ability will cause quick, safe and precise ablation of the tissues irradiated, as long as the physician performing the procedure is particularly careful not to employ pulse stacking.

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

    This is where clinitian skill and patience must come into play with these lasers.

    I have purchased 3 different C02 lasers over the last 15 years, and successfully used them in thousands of surgical procedures.

    Eric Bornstein DMD
    Chief Science Officer
    Nomir Medical Technologies
     
  33. Frederick George

    Frederick George Active Member

    Eric

    Exactly, and since the patient is not anaesthetised during an onychomycotic perforation procedure, he can immediately tell you if there is any heat or discomfort. The nail bed is a well innervated place.

    Cheers
     
  34. Toehealth

    Toehealth Welcome New Poster

    I have heard recently that Normir has sold the laser to Podiatrists throughout the United States for the treatment of Onychomycosis. What happened to waiting for specific FDA approval before marketing and selling it for an indication that is not FDA approved? How many have been sold for Onychomycosis in the US? Rather how many are being used in the US by Poditrists who now market it for Onychomycosis?
     
  35. hamish dow

    hamish dow Active Member

    I have no knowledge of other systems other than through conversation with other podiatrists. What I know is that my work with PinPointe shows no need to cause injure to any tissue. the wavelength and output work on the pathogens not the tissue. I think the FDA will be looking very hard at anything that is not approved with use, at a practitioner level fairly soon. That is to say they are going to get interested in the podiatrists not just the companies.
    I have a question though. If a company in the States gets its FDA approval. what would be the mood of the forum? accepting? or would there be a consensus that it is not enough and that it would still need approval from some vague professional group with little knowledge of lasers? ok that is really 3 questions.
    Lets face it a huge number of podiatrists think diode lasers are potent, and yet have no idea of the capability a crystal based laser.
     
  36. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

  37. hamish dow

    hamish dow Active Member

    Thanks Eric but I am not sure if it answers my question. I suspect that if you get your K number or whatever it is called most podiatrists, and I do mean most, and a very large number of the general public will see that as enough. It is more often how we all make choices. A few will go out and read to the nth degree about a doctor, dentist or perhaps podiatrist. but most will ask a few friends if they are any good and make a decision whether to go to them or the next one because they are far nicer.
    As an aside, doctors are far more likely to get sued if their communication skills suck, no matter how good they are.
    I am sure that a good many people who pop in on this forum have a head full of beliefs that would not stand up to close examination, but the point I wish to stay with is this. Will an FDA approval for a device such as these units mean that the far greater number will find that is acceptable enough. My personal choice for "pain relief"is Solpadeine (strange how many call it Solfadeine) I know it has regulatory approval I have no idea what level of peer review it has it, but it has been deemed safe (then again I did not check) and I take it on trust that the Governing powers in the Country that I live in has done its job in checking it out.
    I know it is bad of me, but I largely do not care what another Country's regulations (or lack of them) does for its own inhabitants. This (laser) stuff is largely cross over technology and been around for years, and it is not like one is reinventing the wheel but figuring out how to refine it to purpose. Hence all that blurb in the FDA application that allows these units to exist and be used but just as long as you don't talk about it being a fungal intervention in toenails it would seem. I use one, most people know that by now, it works, and sometimes it even amazes me in the manner it does so, sometimes it is less astonishing and it is not a magic wand. It requires skilled preparation and application, like most cases operator ability is a massive factor in success/failure. Now I suppose I sit and wait to see who is going to be the rudest to reply, there are about 1/2 a dozen or so vying for top slot it seems.
     
  38. Frederick George

    Frederick George Active Member

    A laser is a surgical instrument. As long as the instrument isn't dangerous to use, it is up to the surgeon to use it properly, as he sees fit. Or else, how would the profession progress?

    The problem I have with the PinPointe laser is that two basic things about it don't make sense. (I have no problem with a certain wavelength of light killing fungus.)

    1. The layer of fungus between the nail plate and the nail bed is often quite thick. Since the wavelength is presumably not in the X band, how does the laser beam kill the fungus that can't be seen under the top layer that is bathed in the laser beam. How does the laser beam penetrate to the deeper fungus?

    2. How can one treatment cure the fungus for all time? Doesn't it simply come back from the surviving fungus, especially the deeper layers? Or the fungus on the skin, in shoes, etc.?

    I suppose because there is a kick back to the PinPointe company every time the machine is used, there has to be a high price. But the rumoured $1500 for one treatment seems a bit high, don't you think? As a case fee, until the nails are cleared, would be a different story.

    So, it smells like a scam. But the proof will be in the pudding.

    Cheers
     
  39. Fred:

    Nice posting.:good:

    It would be nice to have an independent source do a good research study on the efficacy of the PinPointe laser at "curing" nail fungus infections of different degrees and report it in the scientific literature. The device has been around now for a few years but the lack of published peer-reviewed research on this device certainly raises my suspicions that the results with this device are not near as good as the podiatrists claim in their radio and newspaper advertisements. One patient told me that the leading "laser fungal podiatrist" here in town has quit doing regular surgery in the surgery center and hospital since laser fungus nail treatment is so much more lucrative ($$$$) for him. I guess it's all about the money.

    Regardless, it seems like a whole lot of hard-earned money in difficult economic times for treating a largely cosmetic issue....with a non-FDA approved device.....and with no guarantee.:confused: At least Dr. Bornstein is very up front with us and hopefully will provide us all with an effective treatment for our patients that also is supported by good research data that we can comfortably hang our hat on.
     
  40. hamish dow

    hamish dow Active Member

    I charge about $1,100 US for a prep, lase and 2 follow ups with full relevant debridement when it involves all ten nails. Which as I have stated before may take 30-40 mins to prep to the standard I feel the lase should be administered at, folloed by about one hour to lase all nails, follow-ups can easily take another 30 mins to an hour each. So I guess that works aout at @ a little under $400 per hour. I have no idea what you guys charge per hour or how much you earn so what do you charge per hour and how much do you earn. It would be helpful for me and someother folks to know so we can understand where you are coming from. I think it would be right that severe infections will need more than one lase, I deal with that as it arrises case by case. It is a question of trying to figure out variables. One patient was poor to respod in the arly days but then I figured his shoes that he liked to wear were 2 sizes smaller than he measured. So moderate relase at a modest fee and now we are 65% clear growth from the eponychium.
    I have posted images from my work on this thread so one can see for ones self. Yes smoke and mirrors were involved because sometimes there is a little sparking and what would a laser be without some mirrors to create a coherent beam.
    But coming bac to my question; Does it mean from the last two replies from Kevin and Frederick that the FDA is actually of no value and lacks credibility? Can a company actually get their approval by submitting papers that are meaningless? So Eric can bang in any application he likes and they are going to rubber stamp it? Surely not? Surely he has to submit something of value. I looked at teh Penlac website and they were granted FDA approval and I think the best they could manage was less than 9% improvement and it is very popular over in The States.
    Question: who pays for independant research? a competitor? that would be poor would it not? My guess one ought not trust that either. Can't be someone who uses one either could it? they would have a vested interst in it too. So who is volunteering to do it and how much would it cost? I ask that last one because i was told by someone at a UK University and he implied if they were to conduct a meaningful research program it would be @ $1,000,000 US.
     
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