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I like George have no financial interest in the pin point laser or the Dow clinic. I have met Hamish and I only work in Private practice in the UK.
I believe that we Brits have almost nothing in common with our Colonial cousins. My daughter is married to an American and lives there. I find it easier to operate in Spain, and I speak very little Spanish than the US where even buying bread is difficult. The UK health system is completely different to anywhere else and the route by which patients approach a PP Pod is almost never via NHS referral. Our education system is also far different from the US, our BSc is a valued qualification, the US is more akin to our A levels. It is only at PhD level they equate and even then the route is very different. Even out professional titles differ.
The point I am trying to make is we are different, and many of the non UK posts on this thread reflect that difference. It seems people are ascribing their national attributes rather than trusting that Hamish is not using this forum as an advertising platform but trying to share his ‘experience’ with what he thought was an ‘interested audience’.
So to specifics.
Paul as far as I can tell the $AUD is about half the value of the British £. Hamish charges £650 therefore £1300 AUD not $13350 AUD (ten times more, no wonder you are appalled.) With respect the rest of your contributions seem just as inaccurate.
Kevin, again with respect your screed on OM is your choice. I found it incredibly biased towards your treatment of choice, certainly any Brit would see through it (difference again?).
At the end of the day what are you offering ‘a significant improvement in nail appearance’. Not a cure and you do not explain if this applies to all OM cases irrespective of the extent of the infection.
75%, it appears you outperform any published data. Finally what do you do with the 25% failures, do you refund their treatment costs?
Graham, I found your first post quite confusing, you agree with Kevin’s assessment of Laser therapy, although he has no experience of the treatment, then point out the 40% cure rate for his treatment of choice and the 40% you point out is ‘clinical trials’ not the RBCs the big boys are baying for.
Crazy.
The UK do not run TV and Radio ads and to imply Hamish is unethical is unfair.
If I could understand it I may agree with your double posted Asshole post, there is a delete option. Is it true Canadians and Americans do not get on, is it because of a humour gap?
Finally Paul.
Yes Hamish is ‘nice to chat to’. He is always prepared to be lengthy in his postings and in the main is very thorough in his ‘research’.
So taking a theme from Roberts last post can we all agree that in the main Podiatry is all smoke and mirrors, it’s theory is heavily based in practice not research, and yes it does need to move forward. However unless forward thinking Pods are allowed to extrapolate from other discipline’s research and then try it out we will stagnate.
Last point I studied 15 years ago when force plates were very new and primitive and computers had almost no memory. Now they abound, but I do not see the RBCs to support their use in foot orthotic design.
Correct me if I am wrong but I assume they all use an algorithm that is proprietary to the manufacturer. I had a spinal bend following an algorithm. I became sceptical.
Hamish’s work is still early days, we really need to be looking at cure rates as defined by no reoccurrence after what 1, 2 years? He and his clients are taking the commercial risk. I’m sure if it fails Hamish is big enough to come and tell us the truth.
Bob
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Maybe I didn't make myself clear when I stated that I tell my patients "My experience with treating about 100 patients, including myself, with this therapy is that it provides significant improvement in nail appearance in 75% of patients after about 10 months of treatment."
I don't even suggest topical Penlac solution treatment for those patients with the worst mycotic infections and my 75% does not indicate a cure, it only represents a significant improvement in nail appearance in the approximately 100 patients I have treated with Penlac Nail Lacquer (daily application). Maybe when PinPointe Laser finally publishes a study in a peer-reviewed journal on what their "cure rate" is, then we can finally see how it compares to the ciclopirox nail lacquer treatment which has now, for about a decade, had literature published in peer-reviewed journals on its "cure rate".
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
The product you refer to is not available in the UK.
Please remember we are different.
The only American I have discussed OM with, a relative by marriage who lives in Virginia, was well disillusioned with her Foot doctor and his OM treatment, and fees.
I also examined my daughters mother in laws 'plantar fasciitis' on a visit , resolved when we treated it as 'policeman's heel'.
The product you refer to is not available in the UK.
Please remember we are different.
The only American I have discussed OM with, a relative by marriage who lives in Virginia, was well disillusioned with her Foot doctor and his OM treatment, and fees.
I also examined my daughters mother in laws 'plantar fasciitis' on a visit , resolved when we treated it as 'policeman's heel'.
Funny old world is it not?
Bob
Bob:
Not trying to confuse...honest.
Speaking of being confused.....what does OM mean?
In addition, why is ciclopirox not available in the UK? It is very popular here and seems quite safe. Is it available in other countries???
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
I'll be in the UK in April. Will check and see if there is anything comparable available. When I left many moons ago there was a topical terbinafine solution which showed some potential.
__________________
Graham Curryer
None of us know what we are doing, but some of us know more about what we are not doing than others!::
Antifungal nail paints. If only the end of the nail is affected, and the nail is not too thick, and the cause is a Trichophyton fungus, your doctor may prescribe a nail paint. There are various types of nail paint.
* 28% tioconazole is applied twice a day for 6 months.
* Amorolfine is applied once a week for 9–12 months. # Ciclopirox is used in the USA, but is not available in the UK.
Quote:
You need a doctor’s prescription for these nail paints – you cannot buy them over the counter. They are inconvenient and it is important to use them continually because if you stop, even for a short period, the new nail that has grown will become infected by the fungus, and you are back to square one. These antifungal paints are not suitable if you are pregnant. Success rates are not very high – about 22% for tioconazole, possibly 40% for amorolfine and about 12% for ciclopirox. However, they do have an important plus point; you apply the drug only to the part of the body where it is needed, rather than taking a tablet that could have side effects.
Unsure if this sheds much light although does appear Ciclopirox is not available in the United Kingdom.
Regards,
Mandy.
__________________
:)
twirly
Mandy Brooks
Brooks Podiatry
S64 0DE
Suffering a fondness for odd things.
“ Though the mills of God grind slowly;
Yet they grind exceeding small;
Though with patience he stands waiting,
With exactness grinds he all. ”
Paul as far as I can tell the $AUD is about half the value of the British £. Hamish charges £650 therefore £1300 AUD not $13350 AUD (ten times more, no wonder you are appalled.) With respect the rest of your contributions seem just as inaccurate.
Apologies an obvious typo - was meant to be $1335 (I used an online conversion tool to do it and cut and past leaving the zero in).
Please point out my other inaccuracies and I would be happy to talk you through them. It would appear that your post is simply inflammatory in nature and not getting to the real point of the issue "peer reviewed evidenced based medicine". I personally don't agree with your assumption that Podiatry is mainly "smoke and mirrors" and not evidenced based. I am sure most people on these boards would disagree strongly. Is there more research to be done? Absolutely.
REG does it strike you as odd that the least researched practices seem the most expensive?
Anyways REG lets let by-gones be by-gones, as I have stated previously nothing will come out of this thread until the peer reviewed, independent, double blind, randomized evidence is presented.
Apologies an obvious typo - was meant to be $1335 (I used an online conversion tool to do it and cut and past leaving the zero in).
Please point out my other inaccuracies and I would be happy to talk you through them. It would appear that your ost is simply inflammatory in nature and not getting to the real point of the issue "peer reviewed evidenced based medicine".
You missed a P in you last sentance, which is the same word as cheese in Swedish .
Just trying to lighten the mood a little !!
Edit and you just fixed up you post got to be quick around here !!
....and you missed the second "e" in "sentence"......
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
By the way, everyone following along, this thread, "Laser Treatment for Nail Fungus" has now become the most popular thread ever in the history of Podiatry Arena....33,000+ views.....and growing every day! I am amazed at the interest in this subject!
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.
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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.
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
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
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.
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)
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?
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?
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.
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.
Kelly:
Welcome to Podiatry Arena.
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.
__________________
Sincerely,
Kevin
**************************************************
Kevin A. Kirby, DPM
Adjunct Associate Professor
Department of Applied Biomechanics
California School of Podiatric Medicine at Samuel Merritt College
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!
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.
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.
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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
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.
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)?
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
Re: Laser treatment for nail fungus
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