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Nomir Medical Announces FDA Clearance for Noveon NaiLaser

Discussion in 'General Issues and Discussion Forum' started by NewsBot, Mar 20, 2014.

  1. NewsBot

    NewsBot The Admin that posts the news.

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    Press release:
    Nomir Medical Announces FDA Clearance for Noveon NaiLaser
     
  2. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    The new FDA approval language is an evolution in now treating OM with lasers as an infectious disease.

    Noveon NaiLaser – FDA Clearance

    The Noveon® is indicated for the temporary increase in clear nail in patients with onychomycosis (e.g., dermatophytes - Trichophyton rubrum and T mentagrophytes) only when used together with topical antifungal drug therapies approved to treat the accompanying tinea pedis and/or approved to treat onychomycosis.

    This is based on our Peer-reviewed studies published 3 times in JAPMA:

    First JAPMA article: (J Am Podiatr Med Assoc
    99(4): 348-352, 2009)

    · Temperatures observed during a human pilot study
    of onychomycosis with the Noveon laser never
    reached higher than 100.4°F.

    Second JAPMA article: (J Am Podiatr Med Assoc
    100(3): 166-177, 2010)

    · 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);

    Third JAPMA article: (J Am Podiatr Med Assoc
    102(2): 169-171, 2012)

    · Review of 270-day mycological data, con?rmed
    that 38% of the treated population, 150 days after
    final laser therapy, had negative culture and
    microscopy, qualifying as "mycological cures."


    A series of video’s describing the Noveon can be viewed here:

    1. For doctors seeking to understand how the Noveon works: Noveon Technology http://www.noveoninternational.com/physician/science-video

    2. For doctors who would like to hear from podiatrists using the Noveon Naillaser: Physicians’ Video – http://www.noveoninternational.com/physician/physician-video

    3. For more patient information about the Noveon technology: Patient Video - http://www.noveoninternational.com/physician/patient-video

    I welcome contact and discussion.

    Best regards,

    Dr. Eric Bornstein
    ebornstein@nomirmedical.com
     
  3. AnnetteJoyceDPM

    AnnetteJoyceDPM Welcome New Poster

    This is one of the most exciting dermatological controversies of our time in Podiatry. For those us of who have purchased and treated thousands of patients with ND: YAG lasers, do we actually believe it is heat that is eradicating fungus? Most in vitro studies suggest a level of 50 C to be fungicidal, there is simply no way this can be reproduced in human studies without thermal events and PAIN! The idea of a photobiological laser with no thermal effect is a revolution for the nail laser industry. It's nice to see the FDA finally "catching up" with evidenced based medicine and peer reviewed literature. As for the tinea language, every podiatrist who uses lasers knows you have to treat the skin first if you are going to have success with treating nail fungus. It makes perfect sense.
     
  4. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Here are the references for the true high temperature issues with an Nd:YAG systems for OM treatment.

    2009

    "Measurement of temperature on the nails during and after 1064 nm Nd:YAG scanning suggest that the nail is fully covered in approximately 15 sec, reaching 50°C and the cooling down phase below 40°C is usually longer than 1 minute"

    Kozarev, J., and Sremska Mitrovica. "Laser treatment of nail fungal infection." Proceedings of the Berlin Conference of the European Academy of Dermatology and Venereology. 2009.

    2012

    New Results Challenge Nd:YAG Laser Effectiveness for Onychomycosis - EXPERT ANALYSIS FROM THE ANNUAL MEETING OF THE AMERICAN ACADEMY OF DERMATOLOGY (2012)

    Boni Elewski MD, funded by Cutera, (maker of the Genesis Toenail laser) conducted in vitro temperature studies, and then treated 10 patients with an Nd:YAG laser, and found that to kill three different types of fungus with an Nd:YAG Laser, the following temperatures and times had to be met.

    - T rubrum 50° C for 15
    - E. floccosum 50° C for 10 minutes
    - Scytalidium 55° C for 5 minutes.


    This is compared to Nomir's photo-biologic system that does not raise the temperature above 39.5 ° C.

    Bornstein, Eric. "A review of current research in light-based technologies for treatment of podiatric infectious disease states." Journal of the American Podiatric Medical Association 99.4 (2009): 348-352.


    Best regards,

    Dr. Eric Bornstein
    Chief Science Officer
    Nomir Medical Technologies
    www.noveoninternational.com
    ebornstein@nomirmedical.com
     
  5. Lab Guy

    Lab Guy Well-Known Member

    There is no laser that will be effective for our geriatric patients with thick onychomycotic nails. Lasers have no effect on the cellular mediated response which to me is an important causative factor in the development of onychomycosis and the reason for recurrence.

    My treatment is to simply debride them every 2-3 months or permanently remove the nail and problem solved. For what purpose do toenails serve us anyway?

    Steven
     
  6. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Dear Lab Guy:

    I must disagree.

    We have successfully treated dystrophic onychomycosis, endonyx onychomycosis, hypertrophic and pigmented onychomycosis, and geriatric patients with onychomycosis.

    Some of these can be seen at the following link, which is our 199 patient (not yet published) retrospective study: http://qa.noveoninternational.com/sites/default/files/Noveon_Trade_Study_White_Paper_Final.pdf


    For a geriatric patient, the nails will grow out more slowly for sure, but they will also end up thinner and more manageable for the patient, with far less shedding of fungi than simple debridement.

    Please take a look at the following statements regarding any placebo effect that may come from simple debridement alone, without some type of true OM intervention and therapy:

    Onychomycosis Placebo Effect and Rate of Spontaneous remission

    “The open design was deemed appropriate because spontaneous improvement of the disease is not part of the known natural history of onychomycosis and there have been no published trials demonstrating any significant placebo or vehicle effect in onychomycosis.”

    Alley, Michael RK, et al. "Recent progress on the topical therapy of onychomycosis." (2007): 157-167.



    “no spontaneous clearing is known to occur”


    Singal, Archana, and Deepshikha Khanna. "Onychomycosis: Diagnosis and management." Indian Journal of Dermatology, Venereology, and Leprology 77.6 (2011): 659.



    “the absence of spontaneous remission precludes any policy based on expectation of cure without treatment.”

    Salo, Heini, and Markku Pekurinen. "Cost effectiveness of oral terbinafine (Lamisil®) compared with oral fluconazole (Diflucan®) in the treatment of patients with toenail onychomycosis." Pharmacoeconomics 20.5 (2002): 319-324.


    “Fungal infections of the nail are very difficult to treat, spontaneous remission is rare”

    Scher, Richard K., et al. "Once-weekly fluconazole (150, 300, or 450 mg) in the treatment of distal subungual onychomycosis of the toenail." Journal of the American Academy of Dermatology 38.6 (1998): S77-S86.


    “Cure rates of onychomycoses in those on placebo treatment participating in clinical trials of antifungals suggest that spontaneous cure occurs in from 0 to 5% at the most”

    Williams, H. C. "The epidemiology of onychomycosis in Britain." British Journal of Dermatology 129.2 (1993): 101-109.


    “The absence of spontaneous remission means that infection will not resolve of its own accord”

    Fonzo, Di. "LI ON. Study: efficacy and tolerability of continuous terbinafine (Lamisil®) compared to intermittent itraconazole in the treatment of toenail onychomycosis." British journal of dermatology 141.s56 (1999): 5-14.


    With modern technology, we can do better than simple serial debridement or nail removal.

    Best regards,

    Dr. Eric Bornstein
    Chief Science Officer
    Nomir Medical Technologies
    www.noveoninternational.com
    ebornstein@nomirmedical.com
     
  7. Lab Guy

    Lab Guy Well-Known Member

    What are the top reasons why people develop onychomycosis? The laser is not a vaccine. How can any laser prevent recurrence of onychomycosis or are patients to have laser treatments once a year?

    If we can help boost up the patient's cellular immunity, we can help treat as well as prevent recurrence of onychomycosis. This would be very difficult of course in those patients with diabetes and PVD, patients at risk for subungual ulcerations and bacteria infections.

    Steven
     
  8. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Lab Guy:

    Onychomycosis is a complicated infectious disease.

    Complicating the disease and treatment outcomes are patients who have a genetic predisposition to onychomycosis, or who belong to a susceptible population (i.e., the elderly, diabetic, immuno-compromised, etc.) and are likely to experience recurrence of disease.

    In these patients, onychomycosis is a progressive and recurring condition for whom therapy (any therapy) is intended to manage rather than cure disease.

    These patients in particular are prone to onychomycosis and often not permanently cured with any therapy. (1, 2)

    The frequency of recurrence of onychomycosis varies considerably among patients, probably due to varying levels of susceptibility. Although the overall rate of recurrence is not known, recurrence rates between 6.5% and 53% have been reported, despite successful treatment with oral antifungal drugs. (3)

    With lasers, onychomycosis in many susceptible patients should be considered a controllable disease rather than a permanently curable disease.

    In these patients, since treatment may be administered almost indefinitely (at periodic intervals), physicians should take into account potential long-term adverse effects and drug-drug interactions of other available treatment regimens when they make decisions for their patients. (4)

    In addition, patients presenting with both onychomycosis and tinea pedis will also require a topical antifungal medication to resolve the tinea pedis. This is exactly how the Noveon pivotal study was conducted. http://www.alnc.com.au/uploads/1/3/3/4/13341286/japma_ii.pdf

    Treating tinea pedis is vitally important for preventing recurrence of onychomycosis, because the fungal pathogens infecting the skin may act as a reservoir for reinfection of the nail, as the FDA has now codified, with the Noveon's new approval. (5, 6)

    Given that there is a fundamental genetic predisposition to onychomycosis in many individuals, simple ongoing topical treatment modalities with the expectation of inevitable recurrence, may be the most appropriate course of management.

    Therefore, it is not unreasonable to suggest that what might be most important from the perspective of the patient is that the infection be managed in a low risk, more effective, way than is currently provided by systemic and currently available topical treatments. (7-10) Most recently (2012), Gupta found that up to 47% of patients with onychomycosis relapse because of under-treatment, reinfection, or other factors. (11)

    Best regards,

    Dr. Eric Bornstein
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
    www.noveoninternational.com

    1) Tosti A, Piraccini BM, Stinchi C, Colombo MD. Relapses of onychomycosis after successful treatment with systematic antifungals: a three-year follow-up. Dermatology. 1998;197:162-166.

    2) Sigurgeirsson B, Ólafsson JH, Steinsson JB, Paul C, Billstein S, Evans EG. Long-term effectiveness of treatment with terbinafine vs itraconazole in onychomycosis: a 5-year blinded prospective follow-up study. Arch Dermatol. 2002;138:353-357.

    3) Tosti A, Piraccini BM, Stinchi C, Colombo MD. Relapses of onychomycosis after successful treatment with systematic antifungals: a three-year follow-up. Dermatology. 1998;197:162-166.

    4) Sigurgeirsson B, Ólafsson JH, Steinsson JB, Paul C, Billstein S, Evans EG. Long-term effectiveness of treatment with terbinafine vs itraconazole in onychomycosis: a 5-year blinded prospective follow-up study. Arch Dermatol. 2002;138:353-357.

    5) Ingber A. Intermittent low dose itraconazole treatment for onychomycosis -- long term follow-up. Med Mycol. 2001;39:471-473.

    6) http://www.noveoninternational.com/...ser-FDA-Clearance-Press Release_3-12-14_0.pdf

    7) Sigurgeirsson B et al, Long-term effectiveness of treatment with terbinafine vs itraconazole in onychomycosis: a 5-year blinded prospective follow-up study. Arch Dermatol. 2002 Mar;138(3):353-7.

    8) Tosti A, Piraccini BM, Stinchi C, Colombo MD: Relapses of onychomycosis after successful treatment with systemic antifungals: a three-year follow-up. Dermatology 1998, 197(2):162-6.

    9) Sobera JO, Elewski BE: Chapter.76 Fungal infections. In Dermatology 2nd edition. Edited by: Bolognia JL, Jorizzo JL, Rapini RP. Elsevier; 2008.

    10) Warshaw EM, St Clair KR: Prevention of onychomycosis reinfection for patients with complete cure of all 10 toenails: results of a double-blind, placebo-controlled, pilot study of prophylactic miconazole powder 2%. J Am Acad Dermatol 2005, 53(4):717-20.

    11) Gupta AK, Examination of Cure and Relapse of Dermatophyte Toenail Onychomycosis During Long-Term Follow-up After Oral Therapy. Abstract 5643
     
  9. Lab Guy

    Lab Guy Well-Known Member

    Eric,

    Excellent reply.


    Complicating the disease and treatment outcomes are patients who have a genetic predisposition to onychomycosis, or who belong to a susceptible population (i.e., the elderly, diabetic, immuno-compromised, etc.) and are likely to experience recurrence of disease.

    Yes, it is those types of patients that Podiatrists most commonly see in their practice with mycotic nails where they are likely to experience recurrence.

    I do wish you well on your laser although I would have expected you to invent a laser to whiten teeth since your a Dentist. :D

    Steven
     
  10. Bennepod

    Bennepod Active Member

    Greetings.
    Some interesting background information on onychomycosis (OM) gleaned from the NY Podiatry conference in Jan 2014. Dr. Joseph Warren presenter.

    OM relatively rare 100 yrs ago.
    Genetic predisposition, autosomal dominant
    Estimated incidence in US. 35 million.
    Distribution by age. 20.5% 30 -45 yrs old 11.2% 46 - 54 yrs old 13% 55 - 64 yrs old
    21.9% 65 - 74 yrs old 24.2% 75 + yrs old.
    OM most common nail disease representing approx 50% of nail problems.
    Study of 258 pts (Drake et al J ASm Acad Dermatol 1998:38 (5 Pt 1): 702-704): pain in 48% Pressure 40% Embarrasment 74% Shoe discomfort 38%
    Almost always presents as a secondary infection following Tinea Pedis.
    2.8 times more prevalent among diabetics.
    Diabetes without OM rate of gangrene 1%, with OM 5%
    Diabetes without OM rate of foot ulceration 2% with OM 6%.

    Of the estimated 35million infected wtih OM only 6.3 million have been diagnosed and of these only 2.5 million receive treatment (33 million untreated).

    Brendan
     
  11. Lab Guy

    Lab Guy Well-Known Member

    :good:

    Until the underlying etiology of OM can be addressed to prevent recurrence, laser is no more than highly expensive snake oil (and not covered by insurance) for the vast majority of patients with OM that seek treatment by their Podiatrist.

    Steven
     
  12. Bennepod

    Bennepod Active Member

    Steven

    Diabetes is an incurable disease.
    Hypertension is an incurable disease.
    Depression is an incurable disease.
    Etc. etc.
    I'm glad there is snake oil to manage these diseases.
    Given your description, is not podiatric management of OM by debridement another form of snake oil, its certainly not a cure. And what about hyperkeratosis management in the absence of a cure?

    Insurance companies are always slow to accept newer therapies ( I used to be an insurance underwriter), and for the first time (to my knowledge) there are some more robust studies in support of laser treatment. You are right the cost needs to come down as do some of the claims of practitioners.

    To Eric I would ask, is there a pattern or common feature of the failed treatments in the studies or in clinical application?

    Brendan
     
  13. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Dear Bennepod:

    Your question is a good one: "Is there a pattern or common feature of the failed treatments in the studies or in clinical application?"

    In our retrospective study, we collected data on all of the six following parameters for the 199 patients: (a) Clear nail length, (b) Clear nail area, (c) Paronycheal disease, (d) Dermatophytoma, (e) Nail color, (f) Sub-unguanal hyperkeratosis.

    It is logical to assume that the majority of these criteria should continually trend in a positive direction with any successful and efficacious therapy.

    When looking at OM studies, simple evaluation of clear versus non-clear nail does not take into account the presence of dystrophic onychomycosis. In many patients, damage to nails, in particular to the nail bed and the nail plate, occurs before or during, rather than as a result of, mycological infection.

    Also, repeated trauma, psoriasis, lichen planus, local tumors, vascular disorders, and inflammatory diseases can all exert a continued effect on the nail plate and its color, even after successful onychomycosis therapy.

    This can leave a discolored nail which could be assessed as a poor response, even though the fungal disease has been well-treated.

    In addition, dermatophytomas (thick masses of fungal hyphae and necrotic keratin between the nail plate and the nail bed) can present a major diagnostic challenge in terms of interpreting response to therapy. Also, recurrence and regression can occur not as a function of failed therapy, but as a function of the large fungal in an individual patients environment such as the tinea pedis on his/her feet, and live residual fungus in the shoes. We found all of these issues to influence our results in our retrospective study, even with excellent treatment results. http://qa.noveoninternational.com/sites/default/files/Noveon_Trade_Study_White_Paper_Final.pdf

    With all of that being said, in our pivotal study, the best data clearly came from "Mycologic negative culture" readings in the following very interesting manner.

    Below, is s series of non-published data from Nomir’s pivotal onychomycosis trial, where the majority of the data (clinical and mycology) was published in two separate JAPMA articles in 2010 and 2012. (1,2)

    When assessing the anti-fungal nature of the Noveon laser wavelengths, (i.e. if the 870nm/930nm light is treating the fungal infection itself) we compared the Noveon trial nail growth rate data to a landmark study by Yu et al (2004) (3) In this study in Clinical and Experimental Dermatology, Yu et al measured growth rates of nails that had different levels of onychomycosis involvement, and the growth rates of these same nails after oral/systemic onychomycosis therapy. He compared them to control (non-infected) great toes in the same patient.

    Yu, et al. determined two different important additions to the body of onychomycosis and nail growth knowledge:

    1) The degree of difference between fungally affected and unaffected great toenails was determined by the amount of fungally affected area, i.e. the larger the fungally affected area, the slower the nail growth rate.

    2) Yu, et al then showed that there were no differences in growth rate between the healed great toenail with a history of onychomycosis, and the other great toenail without a history of onychomycosis (same patient), after the fungus was killed.

    When this data is examined in relation to the Noveon “Growth Speed” data (below and non-published from the pivotal trial), it shows that the increased linear growth and area seen with the Noveon laser therapy (even in the most severe cases of disease), only increases and returns to normal with inactivation of the fungus (negative culture).

    Noveon Pivotal Trial Growth Sped Data:

    At Day 180 in the pivotal trial, in patients that had moderate to severe disease, we looked specifically at patients that attained “Negative Culture” after the second Noveon treatment (Day 14). {All patients had to be mycologically positive to be included in the study}

    For these patients in the treatment arm, the average Negative Culture at 14 days was:

    · 50% for mild OM cases
    · 43% for moderate OM cases
    · 57% for severe OM cases.

    For these patients in the control arm, the average Negative Culture at 14 days was:

    · 25% for mild OM cases
    · 17% for moderate cases
    · 0% for severe cases.

    When these patients were looked at for Clear Area Growth at day 180 (last treatment occurred at day 120) the breakdown of Clear Area Growth (from baseline) was the following:

    Mild OM Control arm: + 11mm2
    Mild OM Treatment arm: + 12mm2

    Moderate OM Control arm: - .07mm2
    Moderate OM Treatment arm: + 6.7mm2

    Severe OM Control arm: - 133mm2
    Severe OM Treatment arm: + 16mm2

    It was clearly seen that not only did the control OM cases get worse (positive mycology) and the treatment OM cases get better (negative mycology), but ONLY in the “Mild Disease” patients was there NO increase over control in growth speed of the clear nail area.

    These data when looked at through the prism of Yu, et al (3), speak against any Bio-stimulation for nail growth, and on behalf of negative mycology as the key to onychomycosis therapy, independent of the method used to achieve it.

    This is most likely true because the enzyme Keratinase (produced by live fungi) is a proteolytic enzyme that will attack the disulfide (-S-S-) bond of the keratin amino acids and digest the nail and nail bed. (4) When the Noveon laser
    photo-inactivates the fungus with ROS, the fungi (in the nail and nail bed) stop producing keratinase, and the nail begins to grow out clean.

    Our in vitro (non-thermal) anti-fungal data was also published in the peer-reviewed journal of Photochemistry and Photobiology in 2009 (5) and our
    antifungal drug potentiation data (with itraconazole and terbinafine) was published in 2010. (6)

    It is most likely a failure to inactivate the pathogen that most likely results in failure, next issue would be (inadequately debrided) thick dermatophytoma and genetic predisposition. I hope this answers your question.

    1. Landsman, A. et al. "Treatment of mild, moderate, and severe onychomycosis using 870-and 930-nm light exposure." Journal of the American Podiatric Medical Association 100.3 (2010): 166-177.

    2. Landsman, A and Robbins, A. "Treatment of Mild, Moderate, and Severe Onychomycosis Using 870-and 930-nm Light Exposure Some Follow-up Observations at 270 Days." Journal of the American Podiatric Medical Association 102.2 (2012): 169-171.

    3. Yu, H. et al, Is slow nail growth a risk factor for onychomycosis. Clinical and Experimental Dermatology, 29, 415-418, 2004

    4. Takasuka, Tsuyoshi. "Amino acid-or protein-dependent growth of Trichophyton mentagrophytes and Trichophyton rubrum." FEMS Immunology & Medical Microbiology 29.4 (2000): 241-245.

    5. Bornstein, Eric, et al. "Near-infrared Photoinactivation of Bacteria and Fungi at
    Physiologic Temperatures." Photochemistry and photobiology 85.6 (2009): 1364-1374.

    6. Bornstein E., and Gridley S. , Antifungal synergy produced in Candida albicans with 870nm/930nm Near Infrared Photo-damage, 9th International Mycological, Congress, Future strategies for the control of fungal diseases, Edinburgh Uk. Aug 1-6 2010.

    Dr. Eric Bornstein
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
     
  14. citychiropody

    citychiropody Member

    The Noveon® is indicated for the temporary increase in clear nail in patients with onychomycosis

    TEMPOARY ?!! whats the point then ???
     
  15. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member


    Dear Citychiropody:

    Let me take this in two parts.

    First, every Toenail laser FDA approval has the word “temporary” in it. This is not new, and not detrimental.

    Second, unless a device (any device) categorically fixes or cures something, it gets the word “Temporary” put in its indication by the FDA.

    A cursory look at the FDA web site for 510(k) approvals will find the following examples with the word “Temporary”:

    Laser Hair Reduction:
    “The GentleMAX Family of Laser Systems is indicated for temporary hair reduction.”
    http://www.accessdata.fda.gov/cdrh_docs/pdf13/k133283.pdf

    Light based pain reduction:
    “The Clear lOO………………………….infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.”
    http://www.accessdata.fda.gov/cdrh_docs/pdf4/k041569.pdf

    Blue light Acne Vulgaris treatment:
    “The blue light spectrum is intended to reduce mild to moderate acne vulgaris.”
    http://www.accessdata.fda.gov/cdrh_docs/pdf13/k131113.pdf

    Laser cellulite treatment:
    Temporary improvement in the appearance of cellulite”
    http://www.accessdata.fda.gov/cdrh_docs/pdf13/k132431.pdf

    As can also be seen (above) acne vulgaris is an infectious disease like Onychomycosis, and gets the language "reduce" not "cure" in its indication. It is ridiculous on its face to suggest that if you treat acne vulgaris with a laser, tetracycline or benzoyl peroxide, that it is anything but temporary, as it will most likely return at some point. Does that mean that the Blue Light therapy is useless? Hardly. Ask anyone that has ever reduced their acne with a device.

    This is the same issue with onychomycosis, whether treating with Lamisil or a laser based system.

    What differentiates the Noveon from other lasers is a couple of very important points:

    1) It is a photo-biologic system and not thermal

    2) It is completely “Hands Free” so the DPM does not need to bend over, hold a hand piece, wear a mask, or worry about smoke and plume.

    3) Once the device is turned on, the computer takes over and the DPM can be seeing other patients, and making revenue with other patients at the same time. Think of the Noveon as a mechanical Dental Hygienist for podiatry.

    4) The Noveon can treat 4 toes simultaneously.

    5) It is the only system with evolved FDA language recognizing the Tinea Pedis component of the disease.

    As I have said earlier, with lasers, onychomycosis in many susceptible patients should be considered a controllable disease rather than a permanently curable disease.

    Since treatment may be administered almost indefinitely (at periodic intervals), physicians should take into account potential long-term adverse effects and drug-drug interactions of other available treatment regimens when they make decisions for their patients.

    The (1) logic, (2) benefit to the patient, and (3) benefit to the DPM business model is no different from that seen with my 4 examples above of: Temporary hair removal, Temporary pain reduction, reduction of mild to moderate acne vulgaris and Temporary improvement of cellulite.

    Best regards,

    Dr. Eric Bornstein
    Chief Science Officer
    Nomir Medical Technologies
    ebornstein@nomirmedical.com
     
  16. Lab Guy

    Lab Guy Well-Known Member

    You hit the nail on the head. Whats the point of spending $1000 plus out of pocket plus money every month for topical medication for a treatment that is indicated for a temporary increase in clear nail? When the water in my pool starts turning green, I know that when I pour chlorine in, it will kill the algae and my pool will be clear and blue. The chlorine does kill the algae but it is temporary.

    OM is an infectious disease so a patient would have to know up front that he or she may have to pay every year for additional treatment to prevent recurrence and purchase and apply their topical medication to their nails.

    Most people believe the laser treatment is going to be a cure and those patients that have spent the money and time applying topicals are not going to be happy campers with recurrence and be upset at their Podiatrist. In turn, this could potentially put a black mark on our profession when we have worked hard to gain the respect that we so deserve.

    One solution is for practitioners offering Laser treatment for OM is that they must state in their marketing as well as consent form that it is a treatment that offers not a permanent cure but temporary clearness of the nail as that is what the FDA cleared the laser device for. If this is done, then patients cannot blame the Podiatrist when their OM returns. People can choose to spend their money any way they wish, they just must be properly informed to make the appropriate decision for themselves since their insurance is not paying for the service.

    With that being said, I would still bet that the Noveon nail laser will be a financial success as it clearly has advantages over the competition and is indeed a much better alternative than prescribing oral anti-fungal medication. If it is priced well, it will certainly make a big impact in the marketplace.


    Steven
     
  17. Dr. Eric Bornstein

    Dr. Eric Bornstein Active Member

    Two very good papers that speak to the necessity of actively treating chronic onychomycosis.


    One:

    "Disease of the fingernails can cause impaired or lost tactile function, whereas disease of the toenails can interfere with walking, exercise, and how shoes fit. Untreated patients can act as source of infection for family members and potentially contaminate communal areas."

    "Infection may be chronic and resistant to treatment, with 16-25% of patients not achieving cure by current treatments. No spontaneous clearing is known to occur."

    Eisman, Samantha, and Rodney Sinclair. "Fungal nail infection: diagnosis and management." BMJ: British Medical Journal 348 (2014).


    Two:

    We found high levels of interleukin 6 and interleukin 10 positive cells in the nail bed and in the bloodstream. Interleukin 1, however, was not a part of any of the functional units of any of the nails. Significant amount of fibres containing human beta defensin-2 were found in the bed and plate of the nail. Therefore one can conclude that as regards the nails affected by onychomycosis, the most effective morphopathogenical processes include cytokine and defensin excretion occurrence in the nail bed.

    Zaikovska, Olga, Mara Pilmane, and Janis Kisis. "Morphopathological aspects of healthy nails and nails affected by onychomycosis." Mycoses (2014).


    This second paper is particularly interesting, as it highlights the chronic inflammatory nature of the disease.

    IL-6 is secreted by T cells and macrophages and stimulates an immune response because of infection, that leads to inflammation. http://en.wikipedia.org/wiki/Interleukin_6

    Much as in the chronic treatment of periodontal disease, to keep the inflammation at bay, the same holds true for onychomycosis. Look for more papers in the future describing the inflammatory destructive nature of chronically fighting these keratinolytic fungi.

    Dr. Eric Bornstein
    Chief Science Officer
    Nomir Medical Technologies
    www.noveoninternational.com
    ebornstein@nomirmedical.com
     
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