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Kevin Kirby, Your office is just around the corner from mine. Is there some reason you are afraid to come by and see for yourself?
Oooo Michael, you will have your fun .
Glad you could come talk to us. I have some questions if you'll indulge me?
1. Does one have to debride the bulk of infected tissue back? If so, whats the regime, how often, how far etc.
2. Presumably the laser deactivates the fungus but does not repair the damaged nail. Is the method then to kill the fungus and have a healthy nail grow through?
3. What are your criteria for "success"? I ask because I saw a nice graph from a rep selling a laquer once which talked of high "success" but when pressed it turned out the criteria for success was "noticable change". Are we talking resolution? Throughgrowth of fungal free nail? What?
4. Do YOU have any before / after photos? I know its not evidence but its nice to see some pictures.
5. Does the treatment involve anything besides the laser (topicals, debridement etc)
And most of all :-
6. What is the Daily prevention they must practice and when do they commence it?
Thanks again. I wish I lived up the road from Kevin, you lucky sausage!
Kevin Kirby, Your office is just around the corner from mine. Is there some reason you are afraid to come by and see for yourself?
Dr. Uro:
I'm not sure I would use the word "afraid" to describe why I haven't taken time from my busy life to talk to you about laser fungus toenail treatment. Let's just say that I am, and have always been, somewhat of a skeptic, and would like to see more evidence in peer-reviewed medical journals (that is not funded by Pin-Pointe) that this treatment is any more effective than using the many other treatments available for onychomycosis before I can recommend it to my patients. Can you please provide us with published medical references of the therapeutic effectiveness of Pin-Pointe Footlaser since Hamish has, so far, been unable to do so? I am anxious to read them.
Also, Dr. Uro, don't you also have a financial interest in Pin-Pointe Footlaser?
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
Press Release:
Nomir Medical Announces Publication of Mechanism-of-Action Data for its Noveon® Dual-Wavelength Device
Quote:
Nomir Medical Technologies, a leader in the development of optical energy technologies for medical applications, announced today the publication of a scientific paper in the journal Photochemistry and Photobiology that details in vitro and human data demonstrating the unique and patented mechanism-of-action for its Noveon® dual-wavelength device, as well as positive efficacy and safety data. Noveon is a light-based system that photo-biologically targets the elimination of bacterial and fungal infections through a unique, near-infrared, photo-inactivation effect, while preserving healthy tissue and promoting recovery.
“This publication provides important information about the efficacy and side-effect profile of Noveon in multiple classes of infectious disease pathogens, as well as the underlying mechanism-of-action that produces its photo-inactivation effect,” said Eric Bornstein, D.M.D., Chief Scientist of Nomir and lead author on the paper. “It is essential that potential light-based therapies for infectious disease be nontoxic to surrounding healthy human tissue. In the past, UV wavelengths have been used to photo-damage pathogens, but unfortunately, UV light is also photo-carcinogenic to human cells, necessitating the study of other phototherapy-based treatments for infectious disease. We believe the selective aspect of near-infrared photo-inactivation provided by Noveon highlights its potential for the treatment of a broad range of infectious diseases. The Noveon is the first system to produce statistical evidence of safe photo-damage to resistant bacterial pathogens like MRSA and fungal pathogens such as C. albicans and T. rubrum, all at physiologic temperatures.”
Quote:
In the detailed onychomycosis (toenail fungus) human pilot study, all seven patients reached a mycological negative culture at 60 days following treatment. No negative sequelae or adverse events were observed, and experimental temperatures were again well within accepted safety levels.
Apparently, according to sources that I cannot confirm, the Noveon device is about to get FDA approval.
From the companies website:
Quote:
In vitro and in vivo human studies demonstrated that Noveon therapy treatments resulted in complete photo-inactivation of the fungi that cause OM at safe energy densities and temperatures. Additionally, Noveon therapy treatments resulted in 87 percent clinical improvement in a human pilot study. Based on these positive data, Nomir is currently testing Noveon in a pivotal FDA registration trial, the objective of which is to demonstrate the efficacy and safety of Noveon in treating patients with OM.
I wanted to post my experience with the laser (patholase) treatment. I had my treatment in San Jose over 18 months ago. They told me to use clortirmzole cream every day for 2 weeks and then wait for the miraculous clean nail to emerge....it never did - my nails got worse. I went back about 8 months later and they were shocked that I had no improvement and told me I must have been reinfected from going to the pool. Meanwhile the infection was not distal but closer to the matirx - so that made no sense. The second followup treatment, they charged me $300 (the first treatment cost $1000) and it was performed by some hungover technician....the doctor would not even come in to talk to me...pathetic. 3 months after the followup....no improvement whatsoever...
This, of course, proves nothing whatsoever about the efficacy, or not, of the laser. However it does illustrate the need for the "evidence" some of us keep banging on about.
So the protocol is to first use the laser, then apply an anti fungal every day!
This obviously makes it impossible to tell, from experiance, whether the laser actually does anything! It would be like saying "I've discovered a light which kills weeds. We just shine the light on, sprinkle it with weedkiller, and hey presto!"
Frustrating, because if this treatment DOES work we'll never know!
A double blind trial would be SO EASY to do! Treat two groups, one with a dummy laser, then take scrapings a week later. Why has this not been done? If this was my invention that would be the first thing I'd do!
The particular case is a single data unit and pretty meaningless. The protocol, however, is significant. Do you use long term chemical antifungals alongside the laser? That would seem sensible practice in terms of outcome but it completely screws any kind of outcome measure!
Studies have shown that people have better outcomes on medications where the study group was told the drug cost more. I read somewhere else that there is research showing people will be more inclined to follow advice they paid more for. I bet compliance with daily anti fungal regimes could be improved no end with a modest amount of theatre! Nothing wrong with that, the patients are still getting better. But without knowing all the elements we can't assess a treatment!
Interesting point about compliance. I saw a documentary one time about contraception in India. When they gave condoms away they were not really used, when they asked for a couple of rupees the condoms got used.
Now it occurs to me that if we wish for better compliance we need to possibly offer rupees or condoms.
Remuneration now that would be lovely. I think it is an entirely grand idea, perhaps I could hold out for repeat fees (like actors when their show goes into syndication) too. There are quite a few out there aren't there? Pages of PR blub not actors, well actually there are a few actors out there too come to think of it.
Sorry I haven't responded. Long clinic hours on Friday and out of town for the weekend.
Someone asked if I have financial ties to PathoLase. My association is that I train doctors from all over the U.S., U.K., Guam and soon Canada on the use of the PinPointe FootLaser for which I am paid.
The prevention that I recommend to my patients following the PinPointe FootLaser treatment for onychomycosis is as follows; 1-apply an antifungal cream bid interdigitally and in a moccasin distribution for 2 weeks following the procedure, 2-always spray inside the shoes at the end of the day with an antifungal spray and avoid wearing the shoes for 2 days or use the Steri-Shoe ultraviolet shoe sanitizers, 3-after 2 weeks, spray the feet bid with an anti-fungal spray (forever), 4-change the sheets the 1st night after treatment, 5-cleanse the floor of the shower before next use with a cleanser that includes bleach, 6-cleanse all nail instruments with bleach before using them again,7-throw out any nail polish previously used on toenails,8-avoid nail salons or use extreme caution if they insist on using them,9- excercise caution in public areas like hotel rooms and gymnasium showers.
I liken prevention for this condition to caring for the mouth. We brush our teeth at least twice daily and floss daily to prevent tooth decay and gum disease. This should be no different. I think we would all agree that these patients are prone to this condition and that without prevention, they are doomed to re-infection. In fact some may become re-infected even if they do practice prevention just as some people develop cavities despite brushing.
The PinPointe FootLaser initial study included 19 patients and accepted even the worst cases. This study, although small, demonstrated 88% efficacy. The Lamisil study and other similar studies included only nails that had 25% to 75% involvement. As we know, Lamisil at best has an efficacy rate of 60%.
In an effort to increase efficacy, PathoLase has 4 new studies underway. 3 in the U.S. and 1 in Canada.
In regards to Noveon, my understanding is that they are running out of funds and that FDA approval is a way off. We'll see. David Harris, the scientist behind the PinPointe FootLaser technology, has already worked with their wave lengths and found them to be less effective.
In any case gentelmen, I am confident in this technology. I live it almost everyday and have for the past 15 months. Patients are happy to have a treatment such as this that does not pose the risks that the oral anti-fungals do. I advise them that it's not perfect. We know that no surgery, medication or treatment regimen works 100% of the time. As I tell my patients, if a surgeon garantees a 100 % outcome RUN!
I do have pictures to share but the hour is late and I will therefore pass them on another time.
I know that there will be skeptics out there no matter what I say or show them. Oh well, I guess they will just have to wait for the results of the new studies. In the meantime, I will continue to provide this much needed service. Yes, at a price just like my opthomology, dermatology and plastic surgery colleagues.
The PinPointe FootLaser initial study included 19 patients and accepted even the worst cases. This study, although small, demonstrated 88% efficacy.
Any reason why this is not published in a peer reviewed journal and put out there for scrutiny? Extraordinary claims are being made based on this research, so why is it not publically available?
Sorry I haven't responded. Long clinic hours on Friday and out of town for the weekend.
Someone asked if I have financial ties to PathoLase. My association is that I train doctors from all over the U.S., U.K., Guam and soon Canada on the use of the PinPointe FootLaser for which I am paid.
The prevention that I recommend to my patients following the PinPointe FootLaser treatment for onychomycosis is as follows; 1-apply an antifungal cream bid interdigitally and in a moccasin distribution for 2 weeks following the procedure, 2-always spray inside the shoes at the end of the day with an antifungal spray and avoid wearing the shoes for 2 days or use the Steri-Shoe ultraviolet shoe sanitizers, 3-after 2 weeks, spray the feet bid with an anti-fungal spray (forever), 4-change the sheets the 1st night after treatment, 5-cleanse the floor of the shower before next use with a cleanser that includes bleach, 6-cleanse all nail instruments with bleach before using them again,7-throw out any nail polish previously used on toenails,8-avoid nail salons or use extreme caution if they insist on using them,9- excercise caution in public areas like hotel rooms and gymnasium showers.
I liken prevention for this condition to caring for the mouth. We brush our teeth at least twice daily and floss daily to prevent tooth decay and gum disease. This should be no different. I think we would all agree that these patients are prone to this condition and that without prevention, they are doomed to re-infection. In fact some may become re-infected even if they do practice prevention just as some people develop cavities despite brushing.
The PinPointe FootLaser initial study included 19 patients and accepted even the worst cases. This study, although small, demonstrated 88% efficacy. The Lamisil study and other similar studies included only nails that had 25% to 75% involvement. As we know, Lamisil at best has an efficacy rate of 60%.
In an effort to increase efficacy, PathoLase has 4 new studies underway. 3 in the U.S. and 1 in Canada.
In regards to Noveon, my understanding is that they are running out of funds and that FDA approval is a way off. We'll see. David Harris, the scientist behind the PinPointe FootLaser technology, has already worked with their wave lengths and found them to be less effective.
In any case gentelmen, I am confident in this technology. I live it almost everyday and have for the past 15 months. Patients are happy to have a treatment such as this that does not pose the risks that the oral anti-fungals do. I advise them that it's not perfect. We know that no surgery, medication or treatment regimen works 100% of the time. As I tell my patients, if a surgeon garantees a 100 % outcome RUN!
I do have pictures to share but the hour is late and I will therefore pass them on another time.
I know that there will be skeptics out there no matter what I say or show them. Oh well, I guess they will just have to wait for the results of the new studies. In the meantime, I will continue to provide this much needed service. Yes, at a price just like my opthomology, dermatology and plastic surgery colleagues.
Fraternally,
Michael A. Uro, D.P.M.
Hello to all:
I am the Chief Science Officer of Nomir Medical Technologies, and would like the opportunity to respond to a few issues that are being presented.
The Noveon®, is a near-infrared diode laser system that is specifically designed to use only the 870nm and 930nm wavelengths. This device, combining the 870nm and 930nm energies in a multiplexed beam, has shown a unique antimicrobial action spectrum in-vitro, in vivo, and in 6 human IRB controlled studies. (1-4)
The device has also finished a 4-site blinded, randomized and IRB approved pivotal study, where the data has been submitted to the FDA for the treatment of Onychomycosis. Apon FDA approval, the Noveon will be available to treat the disease "hands free", up to 4 toes simultaneously, and is catagorized as a non-significant risk, meaing that in 43 states trained ancillary staff will be able to run the device, and not the Dr.
The photobiological mechanism of action has recently been published in the prestigious Journal Photochemistry and Photobiology. (1)
A full review of all possible photo-therapy systems currently being tested to treat onychomycosis has recently been published in JAPMA. (2)
1. Bornstein E., Hermans W., Gridley S., and Manni J. Near infrared Photo-inactivation of bacteria and fungi at physiologic temperatures. Photochemistry and Photobiology, Published Online 26 Aug 2009
2. Bornstein ES: A Review of Current Research in Light-Based Technologies for Treatment of Podiatric Infectious Disease States. Journal of the American Podiatric Medical Association Volume 99 Number 4 348-352 2009
3. Bornstein, E.S., Y.P. Krespi, A. Robbins, J. Wlassich, E. Sinofsky (2008) Antimicrobial resistance reversal at physiologic temperatures in MRSA in the nares with an 870 nm and 930 nm dual wavelength noveon laser. 2008 Tissue Engineering and Regenerative Medicaine International Society North America Meeting Abstracts.
4. Bornstein, E.S., A.H. Robbins, M. Michelon (2008) Photo-inactivation of fungal pathogens that cause onychomycosis in vitro and in vivo with the noveon dual wavelength laser system. 2008 New Cardiovascular Horizons Meeting Abstracts.
The other device being discussed (Nd:YAG laser) works via ablation. The ablation interaction has been modified, to act as a laser antiseptic treatment in vitro, with a reported method designed to eliminate only the microorganisms that cause disease.
There are three publications that describe in vitro studies only, where the Nd:YAG laser was used for an antisepsis procedure, lethal to the pigmented dental pathogen P. gingivalis. (1, 2, 3)
1. Harris DM and M Yessik: Therapeutic ratio quantifies laser antisepsis: Ablation of Porphyromonas gingivalis with dental lasers. Lasers Surg Med 35:206-213, 2004.
2. Harris DM: Laser antisepsis of Phorphyromonas gingivalis in vitro with dental lasers. SPIE Proceedings 5313-22, 2004.
3. Harris DM, SE Jacques: Monte Carlo Simulation of depth of kill of P. gingivalis in dentin based on experimental damage threshold. Abstract presented at ASLMS, Orlando, FL, April 2005.
If one were to employ Nd:YAG technology for the antisepsis of T. rubrum, a better choice of wavelength would most likely be the frequency doubled Nd:YAG (532nm –visible green) laser as there is an endogenous red pigment in T. rubrum (Xanthomegnin) that would be a candidate pigment for green light. (1, 2)
1. Gupta AK, Ahmad I, Borst I, Summerbell RC: Detection of xanthomegnin in epidermal materials infected with Trichophyton rubrum. J Invest Dermatol 115:901–905, 2000.
2. Vural E, et al: The effects of laser irradiation on Trichophyton rubrum growth. Lasers Med Sci 23:349–353, 2008.
If there is even one IRB controlled study, with independent data analysis that has been finished and reported in the peer-review literature with an Nd:YAG laser, treating onychomycosis, I would like to see it. Please educate me.
Otherwise, the data is all simple anectdotal evidence.
Sincerely,
Eric Bornstein
Chief Science Officer
Nomir Medical Technologies
The Following 3 Users Say Thank You to Dr. Eric Bornstein For This Useful Post:
Admin (29th September 2009),
Kevin Kirby (29th September 2009),
Wendy (30th September 2009)
Please excuse me for not cutting and pasting ad nauseum.
An altogether excellent post. And quite brave considering the vociferous challenge that will no doubt be comming from Kevin, because there is apparenly a concern when a company funds its own research for its pivotal studies. But good that the head researcher (as Kevin likes to call you Chief Science Officers) from the company has popped in; because Kevin and Craig and a few others do not believe that these sorts of technologies actually work. I take it you are saying it does, and like many other interventions yours works differently to (your competitor) the Pinpointe device. In one word are you saying that the PinPointe device does not work?
One word should do it. Or are you saying your device which you wish to sell works in a different way to your competitor?
One could not have picked a more opportune time, nor a better site to tout ones own product. I tried to suggest that your colleagues in research, David Harris and AK Gupta were in fact reputable scientists too, but that was not believed in certain quarters so it is good to see you happy to show some elements of their research to show that they conduct peer reviewed research. I presume you consider them to be of good standing and reputable? You are not suggesting that because they are conducting research for Patholase that they are to be mistrusted are you? I thought not. If otherwise please put me straight.
I am confused does the poster expect to find education on laser research to be found amongst podiatrists? Would it not be best to have a chat with the likes of Dr. Gupta?
Personally I would not ask this lot to educate me on laser and its action, I would ask a scientist like yourself who works in that field. Just as I would not ask a dentist to explain the effects of poor gait mechanics on tib post failure.
I presume that all of the posters own research has been peer reviewed by those in that field, not podiatrists. So likely Dr. Harris has not been reviewed by podiatrists either, but by his peers.
Mighty as some are in this arena, probably not his peers really.
There is a deal of suspicision (I have to warn you) regarding companies who use their own research to substantiate their claims. Kevin will want to know who exactly paid for the research for example, because it has to be independantly confirmed. It will not count in their eyes if the company had to pay for it itself. Right Guys?
Like other laser technologies the product is still waiting for its FDA approval, but you belive it is a technology that works despite what the FDA might say.
Being a Brit the finer details do get lost on me because I gather that the much vaunted FDA does indeed get things crashingly wrong, giving approval to drugs for instance that are then withdrawn because people commit sucide after taking them or end up with debilitating side effects.
I understand the FDA is a mechanism similar to that which we have in the UK of GB (technically there is no such thing as the UK in itself in needs to be of GB to be meaningful, and worth noting that the "UK" does not have a flag. England, Scotland, Ireland and Wales do; as does Great Britain but sadly not the "UK"). I presume it sets a nominal standard but am I correct that Botox was not granted FDA approval for 10 years but was indeed used quite safely by those following treatment protocols during all that time?
What is indeed gratifying to note is that what I had said before has been backed up by this post, that much of the research is in fact cross over research from dentistry, and that laser has in fact been tested by researchers on mycotic samples, effectively. Different laser technologies accomplish the task in different ways it seems, and that dental laser treatment of pathogens has been shown to be highly successful for many years.
You are correct on many of your statements. Let me further introduce myself.
I am at a unique cross-roads in the laser/medical community:
1) I have degrees in biochemistry and dental medicine,
2) I have written 10+ publications in the Laser/Dental/Medical literature (including the Journal of the American Podiatric Medical Association)
3) I have Co-authored 3 FDA laser applications that have been approved for laser devices and therapy, including the only "contact bone ablation" approval for Er:YAG lasers, in a device that is also approved for Podiatry.
4) I have designed and completed 6 different IRB approved human studies in laser medicine across the 3 different medical disciplines of Dentistry, Podiatry and Infectious Disease.
5) I have been granted 2 US and 2 Foreign Patents describing Dental/Laser devices
6) I have 30 Patents pending describing Laser/Medical devices and photobiological mechanisms.
These are my Publications in the medical field:
1. Bornstein, E.S., Y.P. Krespi, A. Robbins, J. Wlassich, E. Sinofsky (2008) Antimicrobial resistance reversal at physiologic temperatures in MRSA in the nares with an 870 nm and 930 nm dual wavelength noveon laser. 2008 Tissue Engineering and Regenerative Medicaine International Society North America Meeting Abstracts.
2. Bornstein, E.S., A.H. Robbins, M. Michelon (2008) Photo-inactivation of fungal pathogens that cause onychomycosis in vitro and in vivo with the noveon dual wavelength laser system. 2008 New Cardiovascular Horizons Meeting Abstracts.
3. Bornstein ES, Michelon M: Examining the antibacterial action spectrum in vitro of the Noveon® dual wavelength laser system through photo-inactivation of E. coli at physiologic temperatures. Abstract presented at ASLMS, National Harbor, Maryland, 2009.
4. Bornstein ES: Treatment of Onychomycosis Using the Noveon® Dual-Wavelength Laser. FDA Pivotal Study data presented at Council for Nail Disorders 13th Annual Meeting, San Francisco, CA, 2009.
5. Bornstein ES: A Review of Current Research in Light-Based Technologies for Treatment of Podiatric Infectious Disease States, Journal of the American Podiatric Medical Association Volume 99 Number 4 348-352 2009
6. Bornstein E., Hermans W., Gridley S., and Manni J. Near infrared Photo-inactivation of bacteria and fungi at physiologic temperatures. Photochemistry and Photobiology (Published on-line Aug 2009).
Disclaimer:
All of the above research (with our laser device) to date has been financed by investors in Nomir Medical Technologies. I am the Chief Science Officer and one of the founders of the company.
In the last 5 years, I have conducted 100's of laser experiments with the Noveon device on:
1) Lasers
2) Lasers and bacteria
3) Lasers and fungus
4) Lasers and live humans
5) Lasers and mice
6) Lasers and pigs
7) Lasers and human cadavers
All of the research and data collection that I took part in was done in a blinded fashion with an independent CRO, and with certified Animal Review Boards approving the animal studies and Human Investigational Review Boards approving the Human studies. The statistical analysis for each study was accomplished by an additional (and different) independent CRO from the laboratory that we conducted the experiments in.
My issues with any Nd:YAG laser in the Onychomycosis space is this:
Without independent research and data collection, "clinitian case studies on human onychomycosis therapy with an Nd:YAG laser" done outside of a certified Human Investigational Review Board and without an independent CRO is simply interesting anectdotal information.
I cannot adequately comment on the validity of any Nd:YAG onychomycosis study, or if the device works as advertised, because (1) the results have not been peer-reviewed, (2) the procedure has not been approved by; and the data has not been collected under; the auspices of a certified human IRB, and (3) the data has not been statistically analyzed by an independent CRO after meeting the requirements (1 and 2) above.
If someone can produce a journal article that meets these 3 criteria, discussing an Nd:YAG laser treating onychomycosis in human subjects, I would be more than happy to comment.
I am not taking an elitist attitude, it is simply good science and good medicine.
The data from our pivotal human studies in treating onychomycosis with the Noveon device meets all the criteria set above, has been accepted by a peer-review committee, and will be published in a major medical journal in the coming months. This is the data that we presented to the FDA in our 510(k) application.
Finally, we will not advertise or sell a device until the FDA approval, according to US federal law. We are looking into the CE mark and European distribution in the future.
Eric Bornstein
Chief Science Officer
Nomir Medical Technologies
because Kevin and Craig and a few others do not believe that these sorts of technologies actually work. .
Where have I said it does not actually work?
All I challenge is the way its being touted and the extraordinary claims being when we have no studies on its clinical efficacy. I think I said (sorry its late and I don't have time to check what I actually said), that I will be lining up to get one if the clinical efficacy data supports its use.
BTW - the majority of the profession believe its does not work. 63% of those responding to Podiatry Today's online survery answered NO to the question: "In your opinion, can laser care be a viable option for treating onychomycosis?", Thats hardly a "few others" http://www.podiatrytoday.com/in-your...-onychomycosis
__________________ 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.
We'll"In your opinion, can laser care be a viable option for treating onychomycosis?" see about that claim and how true it is and for long it lasts, if it ever occurs in many patients. My advice.....?......don't hold your breath.
How often have we seen this pattern? (eg ESWT; MIS; etc)
don't figure? Should this be in the snake oil category?
We been there done that. Guess what happen to the other techniques that followed this pattern?
Admittedly one of the quotes is not yours but I obviously mistook your position for one of greater scepticism considering the general tone and flow. Obviously my it was my mistake.
As for the survey on opinion I applaud its scientific reason.
Dr. Bernstein’s response is a stout one and is one I am very pleased to see in this forum. It is open and honest. These are qualities I like to see, and I do not consider the remarks elitist in the slightest.
I am thankful for Dr. Bernstein for his opening statement too.
I am glad that you must have stumbled onto this site when he did.
I see little doubt that the device will garner its CE approval, as the other device has already.
One of the points I have been suggesting is that this new science to podiatry has come from cross over research (which this posting backs up) and that assumptions initiated into viability of efficacy in one are will transfer to another with slight modifications.
Sadly it indicates it already indicates it will not stay with us for very long but will find its way rapidly into the hands of others. But that is a completely different debate for another time
Often the concerns of those at research level are not the same as those at a more grass roots level, but we thank them for their tireless work all the same.
If anyone would like contact details of the principals involved, contact me.
i've had a search through pinpointe's website and it doesn't provide any reference to scientific literature on it.
i'd like to have read about it, but i can't find anything except for press releases and patient brochures. most sources quote a 85-88% success rate on treated patients, but i don't have a clue where this came from.
__________________
-------------------------
"Try not.
Do, or do not.
There is no try"
Golly did I say that? how daft of me I should have said contact them, any of them I bet a good researcher will soon find the contact details required.
No wonder people keep asking me!
How often have we seen this pattern? (eg ESWT; MIS; etc)
We been there done that. Guess what happen to the other techniques that followed this pattern?
I never said they did not work either. It was just they way they were promoted and touted before the data came in; the overuse and overabuse of the method. Now, they are now be used appropriately with appropriate claims made for them. They have stopped being touted in they way they used to be (ie YouTube video's; full page adverts in papers and Yellow Pages; and extraordinary and unsubstanted claims being made for them)
__________________ 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.
i've had a search through pinpointe's website and it doesn't provide any reference to scientific literature on it.
i'd like to have read about it, but i can't find anything except for press releases and patient brochures. most sources quote a 85-88% success rate on treated patients, but i don't have a clue where this came from.
Collegues:
I would like to take the opportunity to present some basics in laser/tissue interctions, so that Podiatric Physicians can read and better understand some of the photobiology involved in the issues being discussed, with potential onychomycosis therapy with lasers.
A free running pulsed (FRP) Nd:YAG laser is capable of pulse durations in the millionths of a second (10-6 sec), that allow for very high peak powers (1-2 thousand watts/pulse) for safe and rapid ablation of tissues.
Exploiting this laser-tissue interaction, a clinician using a FRP Nd:YAG has the ability to apply an intense burst of laser energy, for a very short time interval, to effect a desired outcome. As previously described, this has been successfully peer-reviewed and applied in vitro for photo-disinfection experiments, (2, 3, 4) and in humans for periodontal therapy. (1)
1) Harris, D., Gregg, RH., McCarthy DK. et al, Laser-assisted new attachment
procedure in private practice, General Dentistry, Sept-Oct 2004, Vol52 No 5,
pp396-403
2) Harris DM and M Yessik: Therapeutic ratio quantifies laser antisepsis: Ablation of Porphyromonas gingivalis with dental lasers. Lasers Surg Med 35:206-213, 2004.
3) Harris DM: Laser antisepsis of Phorphyromonas gingivalis in vitro with dental lasers. SPIE Proceedings 5313-22, 2004.
4) Harris DM, SE Jacques: Monte Carlo Simulation of depth of kill of P. gingivalis in dentin based on experimental damage threshold. Abstract presented at ASLMS, Orlando, FL, April 2005.
A continuous wave (CW) or gated diode laser (such as the Noveon device) does not have the high peak power or microsecond pulse abilities of the FRP Nd:YAG. A CW Diode laser has far longer pulse durations in milliseconds (10-3 sec or thousandths of a sec), with far less peak power, that will not reach the ablation threshold in soft tissues. (5, 6)
5) ALD (The Academy of Laser Dentistry). Featured wavelength: diode – the diode
Laser in dentistry (Academy report) Wavelengths 2000: 8: 13.
6) Bornstein E, Near-infrared dental diode lasers. Scientific and photobiologic
principles and applications, Dent Today. 2004 Mar;23(3):102-8
The abilities of the FRP: Nd:YAG can cause quick, safe and precise ablation of soft tissues involved, (7, 8) as long as the physician performing the procedure is particularly careful not to employ a manual method called pulse stacking.
Pulse stacking is an overlapping localization of laser pulses (going over the same small spot more than once) that occurs from the inconsistent manual aiming of small to medium laser spot sizes over large areas of tissue. This can lead to excessive heating of areas of treatment, and potentially ablate healthy tissues.(9).
In careful hands, this can be avoided and pulse stacking is not partial to the Nd:YAG laser, but is a phenomenon associated with all micro-pulsed lasers such as the Er:YAG, CO2, Homium:YAG and Nd:YAG (9)
This issue is the same universally based on Photo-physics with micro-pulsed lasers.
I am not knocking Nd:YAG lasers.
7) Marjaron B, Plestenjak P, Luka CM: Thermo-mechanical laser ablation of soft biological tissue: modeling the micro-explosions. Applied Physics B 69:71-80, 1999.
8) Venugopalan V, Nishioka NS, Mikic BB: The thermodynamic response of soft biological tissues to pulsed infrared-laser irradiation. Biophysical Journal 70:2981-2993, 1996.
9) Dawson E, Willey A, LEE K: Adverse events associated with nonablative cutaneous laser, radiofrequency, and light-based devices. Semin Cutan Med Surg 26:15-21, 2007.
The Noveon (Diode laser) works on a completely different mechanism of action. This device expands the laser/spot size to 1.5 cm diameter (vs 1mm for most FRP systems through a fiber), to cover the entire nail area simultaneously, in a hands free manner, vs a spot by spot manual procedure with a FRP laser.
With the Noveon, the device can make use of the non-ablative ability, to stay below the Thermal Threshold in the treatment of skin and nail.
The Thermal Threshold Power Density for near-IR laser energy (W/cm2), that will produce Thermal Interactions with tissues and will permanently alter the tissues, is about 10 W/cm 2 (This is 2-3 Log less than ablative lasers).
According to Henriques (10) and Eichler and Seiler (11) and Dewhirst (12) producing voluminous data, it can be deduced that as long as the tissue temperature being irradiated (with any system) is at or below about 45 C (113 F), there is little chance of Irreversible Tissue Damage. The Noveon therapy, in peer-reviewed publications and under IRB guideance does not go over 101 F when treating human nails. (13, 14)
Hence, to separate out (non thermal) unique photo-biological effects of 870nm/930nm, the Noveon has a Power Density that is below the 10 W/cm2 threshold, so that the photobiology of the wavelength can be the dominant interaction, instead of thermal tissue changes. This is the basis for the noveon therapy. (13, 14)
10) Henriques and Moritz, Am. J. Path., 23,. 531-549 (1947)
11) Eichler and Sieler, Lasertichnik in der Medizin, Springer, Berlin (1991)
12) Dewhirst MW, et al. Basic principles of thermal dosimetry and thermal thresholds for tissue damage from hyperthermia. Int J Hyperthermia. 2003 May-Jun;19(3):267-94. Review.
13) Bornstein E., Hermans W., Gridley S., and Manni J. Near infrared Photo-inactivation of bacteria and fungi at physiologic temperatures. Photochemistry and Photobiology
14) Bornstein ES: A Review of Current Research in Light-Based Technologies for Treatment of Podiatric Infectious Disease States Journal of the American Podiatric Medical Association Volume 99 Number 4 348-352 2009
With the Noveon device, there is:
1) no ablation,
2) no manual moving of a fiber handpiece or holding an individual toe,
3) no worry of pulse stacking,
4) and no skill involved.
The device delivers the same therapy every time, at the same dose, to four toes simultaneously, independent of the user.
Eric Bornstein
Chief Science Officer
Nomir Medical Technologies
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.
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
Here are the most recent published abstracts for the material we have been discussing. These are directly from from PubMed, for thoes intrested.
The JAPMA article is available at their web site for $12 US, and the Photobiology article should be available soon, when the next journal is published.
J Am Podiatr Med Assoc. 2009 Jul-Aug;99(4):348-52. Links
A review of current research in light-based technologies for treatment of podiatric infectious disease states.Bornstein E.
Nomir Medical Technologies, Inc, 307 Waverley Oaks Road, Suite 109, Waltham, MA 02452, USA. ebornstein@nomirmedical.com
Recently, there has been a resurgence of interest in potential phototherapy technologies for the local treatment of bacterial and fungal infection. Currently, onychomycosis is the principle disease that is the target of these phototherapies in podiatric medicine. Some of these technologies are currently undergoing in vitro and in vivo trials approved by institutional review boards. The three light-based technologies are ultraviolet light therapy, near infrared photo-inactivation therapy, and photothermal ablative antisepsis. Each of these technologies have markedly dissimilar mechanisms of action. In this review, each technology will be discussed from the perspectives of history, photobiology, individual mechanism of action, safety, and potential clinical efficacy, with data presented from published material. This review is intended to give podiatric physicians detailed information on state-of-the-art infectious disease phototherapy.
Photochem Photobiol. 2009 Aug 26. [Epub ahead of print]Links
Near-infrared Photoinactivation of Bacteria and Fungi at Physiologic Temperatures.Bornstein E, Hermans W, Gridley S, Manni J.
Nomir Medical Technologies, Waltham, MA.
Abstract We examined a laser system (870 and 930 nm), employing wavelengths that have exhibited cellular photodamage properties in optical traps. In vitro, with 1.5 cm diameter flat-top projections (power density of 5.66 W cm(-2)), at physiologic temperatures, we achieved photoinactivation of Staphylococcus aureus, Escherichia coli, Candida albicans and Trichophyton rubrum. Using nonlethal dosimetry, we measured a decrease in trans-membrane potentials (DeltaPsimt and DeltaPsip) and an increase in reactive oxygen species (ROS) generation in methicillin-resistant S. aureus (MRSA), C. albicans and human embryonic kidney cells. We postulate that these multiplexed wavelengths cause an optically mediated mechano-transduction of cellular redox pathways, decreasing DeltaPsi and increasing ROS. The cellular energetics of prokaryotic and fungal pathogens, along with mammalian cells, are affected in a similar manner when treated with these multiplexed wavelengths at the power densities employed. Following live porcine thermal tolerance skin experiments, we then performed human pilot studies, examining photodamage to MRSA in the nose and fungi in onychomycosis. No observable damage to the nares or the nail matrix was observed, yet photodamage to the pathogens was achieved at physiologic temperatures. The selective aspect of this near-infrared photodamage presents the possibility for its future utilization in human cutaneous antimicrobial therapy.
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.
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?
I thought it about time that I presented myself as one of the practitioners, in this country, operating the PinPointe FootLaser.
I have read through the posts a couple of times and find it a little odd or disappointing that so many people would want to remain anonymous. I have the courage of my own conviction to be happy to be named; and it is surprising what you can dig up on the medical effects of laser if you try. Even contacting the company directly will get you a professional and warm reception.
Currently @ 198 + Doctors of Podiatry in America are using this device. A bold move in itself; considering the litigious nature of the country.
Researching the principal characters involved would be a revelation to many because of their backgrounds in medical research.
Professor Harris would no doubt be happy to give anyone the benefit of his years in medical research and his involved work with the use of lasers in Otolaryngology; he has a considerable reputation and has much peer review to his credit.
There is a board of advisors and scientists involved and a serious amount of financial investment, even interest from the American Cystic Fibrosis organisation. I presume that people do not know of any of this, but a simple rudimentary search of the PathoLase site would reveal traces for contact and further research and would even reveal contact details for many of them. John Strisower the man behind this has deeply personal reasons to develop a range of laser technologies to treat many medical diseases, and he has passion and vision. He has made fortunes off his other business interests and committed many of his own millions to the project.
I consider John to be a serious intellect with a wide vision capable of gathering around him the expertise to make things happen. He certainly seems to demonstrate a level of greater intellect and humility than I see in evidence in close quarter. His CV is of seriously substantial proportions and was an invited participant of the Milken Institute Global Conference in 2009. I could go on about each and everyone involved but I think it better to invite those who have so far demonstrated a a little laziness in their own research to dig a bit more. A short walk for some might be all that is needed. There is even one operating on Scripps Drive.
So what is it? It is a serious technological variety of medical laser set to operate at 4 watts using a single beam width, fired in measured pulses to target the sensitivity range of the pathogens involved in mycotic nail infections, using a specified treatment protocol.
More in depth technical details are proprietary and therefore kept by the company. One certainly should not consider using just any old laser in the belief that it is going to do the same thing.
Elegant debridement is a useful skill to demonstrate prior to delivery. It is designed to penetrate both nail and soft tissue without damage to host tissue but harmful to the range of pathogens involved; Viral, bacterial, mould and fungal.
The treatment is mainly without discomfort and has no systemic side effects reported at all.
Perhaps anyone interested could call Dr. Michael Uro in Sacramento he has performed perhaps close to 800 procedures to date, and could be considered the pre-eminent authority on the subject.
Up to now, when presented with a patient asking for treatment our profession in the UK has only been able to administer remedial palliative care and suggested a range of medications either close to useless or capable of serious side effects. The most serious of all being fatal.
Patients now have a viable physical treatment to consider, but will be unable to make an informed choice if the podiatrist they have sought to consult omits to mention it.
The cost seems high but it is a serious piece of cutting edge technology and is not cheap to operate and promote. Is the real problem that our profession has always undersold its skills and when a high tarrif treatment is offered to it, there is a collective lack of self belief that we deserve to have it?
What would our profession prefer? Perhaps the company deciding that it should be placed with the beauty industry or the dermatologists? Thus removing us again from the chain of real treatment.
If anyone would like contact details of the principals involved, contact me. They are astonishingly easy to come by. In fact I know one poster already has had contact but seems to not have updated the forum.
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.
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.
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.
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.
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?
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.
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.
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
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.
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.
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?
Re: Laser treatment for nail fungus
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