SPECIFICATION

• Configuration: 2 Line Generated Class 2 Laser Diode Modules
• Wavelength: 635nm & 405nm
• Modulation: Constant Wave (CW)
• Display: Full Color TFT Touch Screen Control Center
• Power Source: 100-240VAC 50-60Hz
• Chassis: Powder Coated Aircraft Aluminum
• Treatment Area:  304 Stainless Steel for Anti-Microbial Properties
• Housing: Injection Molded Process with Non-Allergen Material/Plastic
• Weight: 23lbs. (10.43kg)
• Accessories: 2-Keys, Power Cord & Laser Safety Glasses
• Complaint to: ISO 13485 Medical Device Quality, IEC 60825-1 Laser Safety, IEC 60601-1-2 EMC, IEC 60601-1 MEE Safety, CE Mark, CB Cert, CMDCAS
• Laser Class 2 / Device Class II (USA); 2a(EU)

TREATMENTS

Lunula Laser® is the revolutionary low-level laser therapy bringing new hope to people suffering from the painful, discolored and disfigured toenails associated with onychomycosis, or nail fungus. Unlike other treatments, Lunula Laser® promises no pain, no risk and no downtime and is the easy, convenient way to experience healthy, clear nails again.

The Lunula Laser® laser targets fungus that lives in and under the toenail. The laser light passes through the nail without causing damage to it or the surrounding skin. Effective, the Lunula Laser® poses none of the risk and harmful side effects of oral anti-fungal medications. Plus, this convenient in-office procedure typically takes only minutes to perform, with absolutely no recovery time required. In fact, as little as four 12-minute sessions are needed to treat the affected area.

Stop suffering the pain and embarrassment of unsightly nail fungus, and enjoy clear, beautiful nails today.

CLINICAL STUDIES

Science Behind Lunula laser

• • FDA Submitted study summary

• • Shanks EFFECTIVENESS OF LOW-LEVEL LASER THERAPY FOR TREATMENT OF TOENAIL

• Sullivan Erchonia Laser Therapy in the Treatment of Onychomycosis Preliminary Report_Podiatry Review
• Clinical Innovations in Onychomycosis – Clearing Onychomycosis through Low-Level Laser Therapy.  This article was recently presented in the January 2017 Podiatry Management Magazine.

THE COMMITMENT TO RESEARCH

Since 1996, Erchonia, the manufacturer of Lunula, has been committed to fully elucidating the medical utility of low-level laser therapy through rigorous clinical studies. For over a decade, Erchonia has studied the clinical utility of low-level laser devices for the treatment of numerous medical ailments, and their recent device, Lunula, looks to revolutionise the way clear and healthy nails are restored following infection by fungus.

Lunula has been markedly studied “ from the early in-vitro analysis to the extensive in-vivo studies “ and its clinical utility to enable unsightly toenails to grow clear and healthy has been substantiated. The unique dual-diode approach of Lunula fortifies the body™s natural defense mechanisms against any infectious agent, and accelerates the growth of the nail. This multifaceted approach is the first of its kind, providing a truly effective, yet safe, way to enable the growth of strong, clear and healthy nails even when they may have previously been infected with fungal spores.

As you will quickly learn, Lunula is supported by an unwavering clinical foundation of both histological and clinical evidence that upholds the viability of this approach and ensures an effective procedure.

DID YOU KNOW? Lunula has been studied both in-vitro and in-vivo.

Lunula™s effectiveness at growing clear and healthy nails has been substantiated by three independent clinical investigations. It is important to mention that no topical/oral antifungals were administered during the studies. The first study evaluated 168 toes with an average baseline affected nail involvement of 81.15%. After a single Lunula application, affected nail involvement was reduced to 31.32% at study endpoint, an improvement in nail clarity of 63.58%. The second study, evaluated 105 toes, or 75 subjects, after two Lunula applications separated by a single week. Subjects reported an average clear nail of 73.79% and 79.75% at post-procedure months 3 and 6, respectively. This was a statistically significant change compared with the average 43.4% clear nail measured at baseline. The third study consisted of 109 patients (139 toes) subject to laser irradiation at 405nm and 635nm for twelve minutes at weekly intervals for four weeks. The interim results from this Lunula Laser study show extremely high levels of efficacy over 48 weeks. Equally important, the responses observed in all three trials were achieved without a single adverse event.

DID YOU KNOW? More than 10% of the general population has onychomycosis.

ORAL MEDICATIONS

The limitations and risks of oral antifungal medications have been well documented. First, treatment of the body™s most distal region “ the toes “ with an oral antifungal medication is often greeted with non-response or high rate of recurrence due to limited drug bioavailability routinely caused by insufficient blood flow. Next, the infectious agent is a eukaryote, and therefore, shares structural and biochemical similarities with our body™s eukaryotic cell. As a result, our own important biochemical pathways can be negatively affected by oral antifungals. Although quite rare, hepatotoxicity has been reported in patients taking oral antifungal medication. To mitigate the risk of liver complications, patients with specific pre-existing medical conditions cannot be prescribed oral antifungal medications, but for those patients who are taking antifungals they must undergo routine liver function tests throughout the treatment course. Non-response, high-rate of recurrence, limited to certain patients, and serious risk of adverse events “ these represent the drawback of oral antifungal medications.

In addition to the serious side effects, the results are not impressive. Below is a chart that details reported results for common oral therapies.

*Patients must undergo liver function tests at baseline and weeks 4 or 6 to ensure there are no complications.

DID YOU KNOW?

The Lunula device requires very little set-up and no operator.

DID YOU KNOW?

Patients in a 168-toe study reported a 73.89% improvement in nail clarity in 3.5 months.

LUNULA™S PROVEN APPROACH

Lunula combines two beneficial low level laser wavelengths: 405nm and 635nm. Each wavelength is capable of stimulating a specific cascade to help the body grow strong, clear and healthy nails. Both wavelengths are enriched by a proprietary, rotating line-generated beam; a unique delivery mechanism that maximises photon concentration and application surface area” ensuring that all toes received adequate stimulation. As a result, the Lunula provides a completely safe procedure absent of any adverse events while inducing key pathways to effectively address unsightly nails.

The 635nm wavelength stimulates Cytochrome C Oxidsase (CCO), an important enzyme necessary for the production of Adenosine Triphosphate (ATP) and Reactive Oxygen Species (ROS). Increased ATP activates PI3 kinase/eNOS signaling pathways, which increases Nitric Oxide (NO) production. NO is critical for new blood vessel formation increasing nutrient delivery and infiltration of immunological cells. For resident macrophages and neutrophils, two types of immune cells, the increased production of ROS is quickly converted into cytotoxic hydrogen peroxide (H2O2), which enhances the performance of the immune cells.

The 405 nm wavelength targets NADPH oxidase (NOX), a membrane bound enzyme, and increases NOX™s production of ROS, which can be converted into H2O2. The increase in the production of H2O2 that is enabled, helps to increase the fungal spore susceptibility to the body™s immune response

.

When applied concurrently, the two wavelengths represent a truly multifaceted procedure.

FIRST “ By increasing fungal spore susceptibility to the body™s immune response.

• SECOND “ By fortifying the body™s endogenous immune system.

HISTOLOGY

The application of 405 nm has been reported to significantly increase the production of ROS and activate key secondary cascades. When compared to other wavelengths, 405 nm yields the highest production of ROS (Figure 1).

FIGURE 1. ROS generation following laser therapy at ~405 nm and Red Laser Courtesy of Lavi et al. (2012)

Peripheral blood flow impairment can affect the body™s endogenous immune response to any infectious agent. Without the infiltration of leukocytes, monocytes, and macrophage, the infectious agent is able to spread along the nail plate and bed. The 635nm wavelength has been proven to increase peripheral blood by stimulating key pathways responsible for angiogenesis (new blood vessel formation). Increased blood flow provides greater nutrient delivery to tissues for rejuvenation, accelerating nail growth and enabling a more effective immune response. The images below demonstrate the improved blood flow benefit of the 635nm wavelength.

BLOOD FLOW OF GREATER TOE PRE AND POST PROCEDURE

Baseline                                                                                   Post-Procedure

FAQ

1. To begin, what are the advantages of the Erchonia Lunula onychomycosis laser device?

This device is unique in that it is the only true, dual diode, Class 2 laser that offers multiple benefits. The Lunula combines the anti-fungal effects of the 405 nm wavelength with the regenerative outcomes of a 635 nm wavelength.

The Lunula produces two wavelengths, 635 nm and 405 nm, both of which have been enriched by a proprietary rotating line-generated laser beam. The Lunula™s specially designed delivery mechanism maximizes both photon concentration and treatment surface area.

The Lunula™s patented delivery system ensures that all infected tissue, nail bed and most importantly, the proximal germinal/matrix tissue are properly targeted and treated.

2. Are all laser wavelengths the same?

No. The higher wavelengths produce more heat. Wavelengths of 900nm or higher are considered Class 4 devices and produce an increase in temperature in the tissue being treated.

The lower wavelength lasers, Class 2, do not rely on heat production. Cold lasers initiate true physiologic responses, photo modulation. The Class 2 lasers have wavelengths 700 nm or lower.

3. Is the tissue response the same with the lower wavelengths?

No, the lower the wavelength the greater the anti-microbial/antifungal effect and as the wavelength decreases the power increases.

4. Do you feel there is an advantage utilizing a multiple diode approach in the treatment of onychomycosis?

Yes. The 635 nm wavelength stimulates endogenous mechanisms, which enhances the immunological function of resident neutrophil and macrophage function to further degrade the infectious agent. This wavelength also induces tissue rejuvenation, increased vascularization, which enables the dual diode approach to accelerate the growth of a clearer, healthier nail.

The 405 nm wavelength provides anti-microbial, antibacterial and anti-fungal effects.

The dual diode approach provided by the Lunula Onychomycosis Device provides symbiotic wavelengths that enhance the eradication of the infectious agent.

5. What kind of response have you seen when utilizing the dual diode lower wavelength approach in the treatment of onychomycosis?

I have participated in a preliminary study involving over 100 patients and we had an average clearance of 73.89% in as little as 3.5 months following two treatments. In this study neither concurrent systemic nor topical therapy was utilized.

I am currently involved in a multi-site study which includes four treatments over a four-week period, again with no adjunct systemic or topical therapy. It appears that the increased number of treatments, four treatments as opposed to two treatments, will result in a significantly increased success rate.

6. Have you seen any complications with this form of therapy?

No complications have been reported.

7. Why do you feel that cold laser therapy for onychomycosis is gaining acceptance in both the medical community and patient community?

Laser therapy is gaining in popularity because mainstay onychomycosis therapies have continuously provided inconsistent outcomes combined with potentially significant adverse events while low-level laser therapy provides a safe and subtle, yet effective approach to the treatment of onychomycosis.

Whether it is the clinical validation, the effectiveness or the safety, the Lunula is providing patients with a non-invasive and painless treatment solution for their fungal toenails. This therapy has emerged as the alternative treatment of choice.

8. What is your feeling regarding obtaining fungal cultures prior to low-level laser therapy?

Onychomycosis can be a clinical impression. Fungal cultures can be utilized however false negatives are often present. I used to obtain cultures prior to systemic therapy because of the risks of liver toxicity and therefore definitive diagnosis was necessary prior to treatment. Because of the high percentage of false negative culture results, many patients were not treated. I now provide treatment based on clinical evaluation as low-level laser therapy is without risks and the worst thing that can happen is essentially nothing. This is explained in full to the patient.

9. Overall the Lunula is an effective device, providing a painless treatment option for the treatment of onychomycosis.

Pinpoint and other Class IV heat-based lasers can be an issue in patients with peripheral neuropathy or sensation issues as pain may not be sensed and heat damage can be incurred. The heat generating lasers are also unable to treat to germinal matrix area where fungi are often harbored. Please comment.

I believe this is significant. The heat based and spot delivery systems cannot treat the germinal/matrix layer and in my opinion present other concerns. The Lunula laser treats the entire nail complex: nail plate, nail bed and germinal/matrix complex. The Lunula leaves no area untreated, not so with the other lasers. Safety is another issue. The heat-based lasers have the potential to burn tissue and thereby create areas of sub-ungual necrosis, a significant issue in a patient with medical co-morbidities such as diabetes and peripheral vascular disease.

10. Do you have any other concerns regarding the heat-based lasers as opposed to a true cold laser?

Another concern would be the fact that the heat based lasers create a foul smelling plume which places the patient, the treating physician and any ancillary staff in the room at risk for inhaling active mycosis, potentially exposing any individual in the room at risk for pulmonary ingestion and infection. In my opinion heat based lasers should have a sophisticated air evacuation system and adequate masks for filtration for all people in the room and in fact should have an air filtration system that purifies the air to help prevent the risk of airborne transmitted infection. Common remarks from all users of the heat based laser systems are that they ask their patients to tell them when they feel pain, that™s already too late. They also state that they can smell laser plume, again too late.

11. You mentioned laser plume. What is it?

The Class IV and higher wavelength heat generating lasers are used to
increase temperature, vaporize, coagulate and cut tissue. The vapors, smoke and
particulate debris produced during the procedures are laser plumes.

12. What does laser plume contain?

Its my understanding that laser plume can contain carcinogens, irritants, mutagens and dust. Plumes may also contain viruses, bacteria, fungal spores, blood fragments and even cancer cells. The contents may also contain carbon monoxide, hydrocarbons and various toxic gases. Plumes may also contain chemicals such as formaldehyde, hydrogen cyanide and benzene, especially if nail polish and nail polish removers have been utilized.

13. You seem concerned about laser plume, why?

Both patients and medical staff can be at risk from exposure to laser plumes.
14. What do you feel are the risks with using a heat-based Class 4 laser as opposed to a true cold laser?
The heat-based lasers are not without risk. When using heat-based lasers to treat nail fungus, there are risks: thermal burning, necrosis, pain, threat of airborne mycosis with the potential of pulmonary ingestion with resultant long-term infection and disease.
When utilizing true cold laser therapy, such as the Lunula device, there is virtually no risk, either to the patient or the treating physician. The worst thing that can happen with true cold laser therapy for onychomycosis is nothing.
15. Is debridement of the toenail necessary when utilizing laser therapy to treat onychomycosis?
In my practice no debridement is being performed except on extremely hypertrophic and thickened nails. Occasionally it may be necessary to completely remove the nail plate and then directly irradiate the nail bed. This preserves the nail matrix to allow the nail to regrow. Removal of the nail plate is generally reserved for severe cases were conventional treatments have been ineffective. The Lunula generally yields very good results.
16. Can you comment as to whether or not there is a difference in response when treating Candida versus Dermatophytes?
The response to clinical onychomycosis appears to be the same for both Candida and Dermatophytes. I am not aware of any specific study that has been done to show a differentiation in response to treatment. I am currently involved in a study whereby we have taken cultures of all patients and we will be able to see if there is any difference in response to treatment. That information should be available in approximately five months. However, I might add that the cultures were only positive in 60% of the patients.
17. It is my understanding that you have modified your treatment protocol that now employs four treatments over four weeks. Please comment.
I do believe that the four treatment protocol will be the most effective protocol that we will use. Again this treatment is noninvasive and painless and is administered without risk. The current study that we are employing indicates that the results will be significantly superior to the prior two treatment protocol. This is because this therapy increases microcirculation which results in accelerated nail growth and increased nutrition to the nail.
18. Have you noticed a clinical advantage of the four treatment protocol as opposed to the two treatment protocol?
Yes and I believe this advantage to be most significant. With preliminary studies we know that with treatment from the low- level laser, it increases the vascular supply to the toe. However the effects last for a short period of time. With repeated treatments such as once a week for four weeks the results remain for the long-term and an increase in vascularity promotes more rapid nail growth and growth of healthier nail tissue.
19. The Lunula appears to be an effective solution to onychomycosis in the vast majority of individuals (~75%) however in some situations or where faster results are sought then there are alternative options such as the four treatment protocol or complete nail avulsion. What are your thoughts?
Our success rate with two treatments was approximately 73%. It is becoming clear that the success rate will be significantly greater with four treatments. I will have a clearer picture in six months. Again, there are no alternative treatments that offer any measure of success that do not have negative effects.
20. What are the Advantages of Lunula Low Level Laser for the Treatment of Onychomycosis?
no chance of developing microbial resistance to this form of treatment
does not interfere nor interact with any systemic medicine
no chance for liver toxicity
treatment protocol is painless, ensuring good patient compliance
no pain during treatment
21. What are your thoughts regarding the mechanism of action in the destruction of the invading fungal organism?
Peroxynitrite is a compound that has potent anti-microbial effects. This compound is formed when Nitric Oxide (NO) reacts with Reactive Oxygen Species (ROS). The Lunula Laser by Erchonia, the only true Low Level Laser used to treat onychomycosis, uniquely has two different laser diodes; a 635nm and a 405nm. This combination of wavelengths is crucial in that the 635nm diode produces NO and the 405nm diode is the best producer of ROS, both within the visible light spectrum. Cell destruction is triggered by the cytotoxic effects of peroxynitrite.
*NO + ROS = peroxynitrite destroys fungal pathogens*
The 635nm laser enhances mitochondrial energy metabolism, which generates NO, and this is combined with the 405nm laser, which generates ROS, produces peroxynitrite. This by-product is cytotoxic and destroys pathogenic bacteria, fungi and protozoa.
22. As we wind down the questioning it occurred to me that we have not spoken about the chance for re-infection. Is this a concern and if so how do you deal with the risk?
Yes, this is a real concern. People that have had nail fungus are always susceptible to re-infection. However I have a post treatment regimen that can minimize the risk.
I ask all patients before treatment if their spouse or significant other has nail fungus. If so, I will not administer Lunula laser treatment without treating their partner and treatment is postponed until it can be administered at the same time.
The patient is advised to spray the shower with an anti-microbial agent before using after their laser treatment.
All closed toe shoes are to be sanitized. I have a gas sterilizing device that is used to treat the patient™s shoes. This devise is located in the same room as the Lunula so patients can be treated at the same time as their shoes. They can see that we are serious about reducing their risk for recurrence.
All patients are sent home with an antifungal spray and they are advised to get into the habit of spraying their shoes every time they take them off so that they remain fungus free and ready for the next use.
Patients are asked to scrub their toes daily while showering.
I also advise patients that when they get a pedicure they should seek out a reputable salon or spa that uses sterile instruments. They are further advised to bring their own nail polish and remover, both of which should be newly purchased after the Lunula treatment. I inform the patients that at a nail salon when they are picking out a color they are really picking out a fungus.
In conclusion I remind patients that fungus is everywhere in our environment and that their risk of re-infection is ever present. In order to control fungus, they must practice daily foot hygiene.
23. What kind of clinical results have you experienced with the Lunula Laser?
The results have been quite impressive. I will share some of the results of our study. The results that you will see are the state of the toenail on the day of the first treatment and again at six moths. Each on of the following patients was given four treatments, one week apart. No other adjunctive therapies were used in any of theses patients.
Lunula Clinical Results Summary for Press Release_Page_7

Lunula Laser – What is the ROI for my clinic?

We’re pleased to share with you the results of our market research on the Lunula Laser’s typical ROI (return on investment) for podiatry clinics within Australia and New Zealand.

If you’ve been interested in the Lunula for some time, but not sure if it fits your clinic, you will find it informative to print and read through the full, 5-page PDF report.

View or download the full 5-page PDF report for free here, entitled “Lunula Laser: What’s the ROI, and is it worth the investment for your clinic?”