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Low-Level Laser Therapy Creating Photochemical Effects to Treat Fat Loss CEOCFO Magazine Interview

Low-Level Laser Therapy Creating Photochemical Effects to Treat Fat Loss, Onychomycosis, Pain, Toenail Fungus and
Plantar Fasciits

Steven C. Shanks
President

 
ERCHONIA CORPORATION
 
Interview conducted by:  Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – August 29, 2016
BIO:
Steven Shanks, the President of Erchonia Corporation; stands at the forefront of medical innovation and the growth of low level laser technology. He has spent the last 20 years advocating and promoting bio-modulation as an alternative modality to invasive procedures and primary treatment. A calculated risk taker, with profound understanding of clinical research, he has devoted his knowledge to researching applications that advance safe, effective and non-invasive medical technology. Even with the numerous FDA issued market clearances to his credit, all awarded based on FDA IRB approved Level 1 clinical trials and the creation of a new product code OLI, Steven Shanks continues to look for opportunities where low level laser as a medical modality can improve healthcare and the quality of life.

CEOCFO:
 What is the idea behind ERCHONIA?
Mr. Shanks: We are a research development company. Our core technology is low-level laser therapy. We conduct research to determine the effect of low level lasers on the body and develop treatment protocols based on the research. From there, we do clinical trials on human subjects, similar to what drug companies do; in order to obtain new indications for use from the FDA.
CEOCFO: Would you tell us about laser therapy?
Mr. Shanks: Erchonia promotes low-level therapy or non-thermal laser therapy. Most people are familiar with heat lasers that obliterate tissue. Low-level or non-thermal laser therapy stimulates the tissue without causing damage. The effects on the cells are similar to the basis of a medication. With a drug, you are going to get a biochemical effect and many side effects. With non-thermal lasers, you will obtain a photochemical effect and depending on the wavelength, usually red, green or violet, different photochemical effects will happen. The benefit of non-thermal laser therapy photochemical effects are you can go directly to the site. You can get phenomenal results, and there are no known side effects.
CEOCFO: What are some of the areas you are tackling?
Mr. Shanks: We have a number of FDA clearances, each obtained through clinical research. We obtained our first FDA clearance in 2002 on chronic neck and shoulder pain; then in 2004 and 2008 we received post-surgical pain indications from the FDA. Erchonia has seven indications for non-invasive fat reduction that we received from the FDA from 2010 to present day. The most recent indication for use was FDA cleared in June of this year for Onychomycosis or toenail fungus.
 
CEOCFO: Would you tell us about that product?
Mr. Shanks: The Lunula Laser is FDA market cleared to treat toenail fungus. We use two different wavelengths with this laser in order to target the fungus and obtain clear nail growth. To prove efficacy in our clinical trial we measured “clear nail” growth. Erchonia submitted clinical data three times to the FDA and finally received this new indication in June 2016. It took us about seven years of clinical research to get one indication for toenail fungus, but the final results were worth it — The FDA success criteria was a minimum of 3 millimeters of new clear nail growth at 6 months in 60% of the patients. Our results were an average of 5.18 millimeters of new growth in 67% of the patients in 6 months so we easily obtained the FDA success criteria.
CEOCFO: Why does low laser treatment work and what do you understand that others may not?
Mr. Shanks: When developing a treatment protocol, whether by a drug or a low-level laser, we focus on the photochemical effect of the body. We have done research at several universities where we identified the photochemical effect three different wavelengths have on mitochondria production, TNF-alpha (Tissue Factor-alpha), which is inflammation into the tissue. We have looked at laser Doppler, where we can get blood to the area.  We then apply the cellular effects from each wavelength based on this research; we then select the wavelengths that will result in the desired affect for the condition to be treated. For instance, we just started a clinical trial on Alzheimer’s disease based on a completed pilot study. Knowing that I can reduce inflammation and stimulate neuron function with red lasers, we will then mimic the pulsing of what a normal brain operates at (alpha, theta, beta waves, etc.) and that is how we develop protocols. From there we perform research and compare the laser to placebo LED to see if our theory is correct.
CEOCFO: You mentioned a wide range of medical areas. How do you decide what to look at next?
Mr. Shanks: We consider market, medical need, doctor request and building upon and following what was learned from previous research. At present, fat loss as an indication, is as viable as its application is extremely widespread. It is also a natural progression for the research we have conducted since 1999, when attempting to make liposuction less intrusive. In the fat reduction industry is probably one of the largest markets out there, and it is one where there is a possibility for return on investment. We try to go into those markets where we have the best chance of success.
For medical needs such as brain diseases, even being new to us, we have done pilot studies on Parkinson’s disease and Autism. Typically for new a medical area, we conduct pilot studies in order to observe the results and determine viability. Once successful results are obtained, we take those to clinical trial. Application will depend on some of our basic research, what we have looked at in the past and as we get through a pilot study, we will look at what the results are. We will then take those results and go through a process with the FDA called Pre-IDE where we say we figured out what it will take to get FDA clearance for an indication. We work out the protocol with the FDA and from there, we to go to clinical trial.
Erchonia is extremely fortunate. We have many brilliant doctors come to Erchonia with requests to explore a diverse number of research projects. We usually have anywhere from six to eight research projects going on at any time.
CEOCFO: There are many people in the non-invasive fat loss arena with many claims. Why is the ERCHONIA approach valid?
Mr. Shanks: In non-invasive fat loss, there are two different kinds of science. Everyone has heard of Cool Sculpting by Zeltiq. It is one of the bigger players in the market. It is a publically traded company. Their indications are to affect appearance of fat loss. Affecting appearance is the lowest form of science that you can prove. To get an appearance claim is simple; basically you have someone say they treated one flank and did not treat the other. Then you ask, “Can you tell which one was treated?” This is how success is measured. It is not compared to a placebo which is the gold standard. If you look at the Zeltiq research, it is based on what they say is a 22% fat reduction, but what they do not tell the consumer is that the 22% is a 1.8 millimeter fat reduction off a fat pad according to Dover on their website, which is not much. The clinical trials that we do are Level 1, blinded and controlled. We have a treated group and we have a placebo group. Our fat loss laser can take 3 ½ inches off your waist, hips and thighs with the red laser in two weeks, compared to placebo. Those are reduction claims. We have seven different indications for reduction claims with the FDA for fat loss. My latest device, I took over the counter (OTC). When you look at science, what is the difference between fat loss and affecting appearance? Some of that stuff gets lost in marketing. What people do not understand with the FDA is 90% of all devices, when they get their 510(k) marketing clearance, they have submitted no data. Of the remaining 10% that due submit data, virtually none of it is blinded and controlled. Depending on what the FDA requires, most all of our clinical trials are blinded and controlled. We do the same clinical trials that drug companies perform, but have a smaller sample size. To date, we have reported no side effects.
 
CEOCFO: Do providers want an ERCHONIA product? Do they know the company?
Mr. Shanks: We have been in business since 1996. We were the first company to get a low-level laser through the FDA in 2002. Now we have thirteen different indications through blinded and controlled clinical trials. We are a small research development company. We are known in the pain management market, but we are getting more and more known for our research. We have been published in over 20 peer review journals and textbooks.
CEOCFO: Are all the products something that a provider would use as opposed to something a person could use at home?
Mr. Shanks: Most of our devices are by order of physician through the FDA except our Zerona Z6® device. The Zerona Z6 is over the counter, which does not require a doctor’s supervision. We decided to take this device OTC to go after the tanning market which is kind of getting beat up because of the carcinogen effects that the FDA has claimed for tanning. We are working with some of the tanning chains to put our Zerona Z6 in them to give another form of income. We market to Plastic Surgeons, Dermatologists, Physical Therapists, Podiatrists, Chiropractors and Obesity doctors.
 
CEOCFO: With the toenail fungus product, would people anticipate this being a first line treatment or might people eventually turn to a provider because they have tried other methods?
Mr. Shanks: Yes. Currently high powered lasers are being used to treat toenail fungus and many of the patients are diabetic and cannot feel their toes. If you apply a hot laser to a diabetic foot, you do not know if you are burning the patient, and there is an increased risk of getting an infected wound. Hot lasers also vaporize tissue, making fungus spores airborne. When you can smell the smoke you are breathing in some of the fungus.
 
With most of the drugs used to treat this condition, you have to do liver tests, before, during and after treatment. We have a patent on the process of using low-level laser to treat toenail fungus. The results are very good, and there are no known side effects. Additionally, if you used a Laser Doppler, which measures blood flow, directly after the Onychomycosis treatment, you would see the blood being delivered to the foot. Erchonia sees this as a two phase treatment which not only kills the fungus but makes the toenail grow out clearer. The treatment is unique in its application, and it is a different way of looking at toenail fungus treatments. Since we just received the market clearance from the FDA, we are going to start educating doctors on the efficacy and safety of the Lunula Laser for toenail fungus. We think this will be a huge success. We have sold probably over a hundred devices in Europe this year so we think this indication will be a front line treatment.
 
CEOCFO: How do you reach potential customers?
Mr. Shanks: We do many of our own trade shows. We are also present at most of the medical conferences, whether they are in dermatology, plastic surgery or podiatry and we have our own general pain management seminars where we reach out to the chiropractic market.
 
CEOCFO: Would there be a one-time treatment or an ongoing series of treatments?
Mr. Shanks: Most of them are a series of treatments. Typically for fat reduction, it is six treatments over 2 weeks or you can treat 1 time a week for 6 weeks. The toenail fungus is one treatment a week for four weeks. For plantar fasciitis, it is six treatments over three weeks. For post-surgical pain, we usually just do a pre-treatment, a post-treatment and follow the pain over a month. Laser treatment times are influenced by acute and chronic conditions. Acute treatments like post-surgical pain respond quicker, so there are fewer treatments. Chronic conditions such as toenail fungus, plantar fasciitis and low back pain require more treatments over time and are harder to treat so our clinical trial follow up is much longer.
 
CEOCFO: Is the device easy to use in general for the providers?
Mr. Shanks: With the newer laser devices like Zerona Z6 OTC, Verju, Lunula and FX 635, we are using many scanning techniques that are unattended. The doctor positions the laser on the treatment area, then presses a button and the treatment is performed. This saves time and money.
 
CEOCFO: Your site indicates ERCHONIA is the world leader in low level laser technology. What is your geographic range, and where do you see growth?
Mr. Shanks: We are in most countries except for China, which we hope will happen later this year. We have sold in Europe, Brazil, Canada, Australia and North America. We are working on several other countries, which have to go through the regulatory process to begin marketing.
 
CEOCFO: What is next?
Mr. Shanks: We are getting heavily involved in brain diseases. Currently we are in the process of performing clinical trials for Alzheimer’s disease, Autism, post-surgical pain following neck and low back surgery and peripheral neuropathy pain in diabetic patients.
 
CEOCFO: How have you maintained the cultural and principles of a small family business?
Mr. Shanks: My business partners are my brothers John, Charlie, Mark and Kevin Tucek. We have been in business for 20 years. This is a family business with many of the employees’ last names being Shanks or Tucek. My Dad when he was alive really kept all of us close. It is the only way we know how to do business and work together.  It helps that we have each other to rely on when things get tough.
CEOCFO: Why pay attention to ERCHONIA?
Mr. Shanks: We believe low-level laser is the future of medicine. We feel that we can accomplish as good or better results than pharmaceutical intervention without side effects. That is why we tag ourselves as the world leader in low-lever laser technology. There are 15 indications for low-level laser right now, and ERCHONIA has 13 of them. We have a history of science publications and FDA indications, so people need to start paying more attention to this technology. The problem we face right now is doctors were not taught this in school, and it is really hard for them to wrap their minds around this technology. They don’t know how shining a laser that you cannot feel works. In my opinion, this requires lots of cellular research and many Level 1 clinical trials trying to get new FDA indications.

We believe low-level laser is the future of medicine.”- Steven C. Shanks

ERCHONIA CORPORATION

ERCHONIA CORPORATION
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Erchonia Expands Presence in Europe with Erchonia Laser Ltd.

Erchonia, the global leader in low level laser healthcareapplications, today announces the company is expanding with a London-based team, Erchonia Laser Ltd.

This experienced management and sales team will handle European sales for all of Erchonia’s laser products including ZeronaLunulaVerju, and the new XLR8 handheld device.

Steven Shanks, president of Erchonia, comments, “We are excited to expand the Erchonia brand in Europe. The research supporting Erchonia’s lasers and their level of technological advancement make them exceptionally-suited to the European market. The added focus of a dedicated direct sales staff will help fuel an even stronger growth projection for Erchonia in 2014.”

For more information, please visit www.erchonia.com.

About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years, Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent level 1 clinical trials. Erchonia has garnered eight FDA 510 (k) market clearances and has several other products in research and development for new applications. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, and treat acne. For additional information, visit www.erchonia.com.

Contact: Katie Cycan
Crier Communications
310-274-1072 x 207
katie@crierpr.com

Erchonia receives patent for noninvasive fat reduction.

Patent no. US 8, 932,338B2- a noninvasive method of reducing fat from targeted regions of a patient’s body by applying low-level laser energy externally through the skin of the patient to the targeted areas. The laser works by applying sufficient energy to release intracellular fat into the interstitial space. The released intra-cellular fat is removed through the body’s natural functions.

Erchonia has a long list of patents on processes and devices on this technology along with 20 publications. Erchonia created the non-invasive method for site specific fat reduction category with the US FDA when they were the first device to get a 510k market clearance for the Zerona device which proved a 3.5 inch reduction from the waist, hips and thighs in 2 weeks.

Erchonia has gone onto to get an additional 6 non-invasive fat loss claims from the FDA and is now submitting for its eighth indication.

Steven Shanks, President of Erchonia and one of the inventors on the patent stated, “We are very pleased with the issuance of this latest patent as we have devoted a lot of time and passion creating this category and feel this will give us a huge competitive advantage in this emerging market.

The FDA has previously cleared Erchonia’s low level lasers for: non-invasive reduction of cellulite; the non-invasive circumference reduction of the arms; for liposuction and breast augmentation assistance and the reduction of associated pain; the reduction of chronic neck, shoulder and heel pain.

About Erchonia

Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat and cellulite, eliminate pain, and treat acne.

For additional information, visit https://www.erchonia.com.

Read the full story at http://www.prweb.com/releases/2015/03/prweb12585992.htm

ChiroEco, Erchonia partner to offer PL3000 Laser in September giveaway

ChiroEco, Erchonia partner to offer PL3000 Laser in September giveaway

Continuing to generate excitement online, Chiropractic Economics magazine’s monthly Facebook giveaway program features a new prize each month from a vendor of chiropractic products.

“This is how you engage readers,” says Daniel Sosnoski, editor-in-chief of Chiropractic Economics. “The monthly Facebook sweepstakes connect our industry partners and fans together, thanks to the power of social-media marketing. Chiropractors win when they discover new technology and products for their practices.”

This month’s giveaway, from Erchonia Corporation, is Erchonia’s PL3000 laser, which has FDA 510(k) market clearance for the treatment of chronic neck and shoulder pain. This variable frequency, single diode, 3LT 635 nm wavelength laser is valued at $7,000. “Erchonia is happy to partner with Chiropractic Economics,” says Charlie Shanks, vice president of sales and marketing for Erchonia. “We want to help chiropractors learn about and experience the wide array of benefits that therapeutic laser treatments can add to a practice. We support doctors who want the best in science and technology for their patients.”

The September giveaway ends Sept. 28 at 4 p.m. EST. This particular giveaway is only offered to Facebook fans of Chiropractic Economics magazine (facebook.com/ChiroEcoMag) and Erchonia (facebook.com/pages/Erchonia), and participants must be licensed doctors of chiropractic. To enter into the giveaway, go to Chiropractic EconomicsFacebook page and click on the “Enter” tab.

About Chiropractic Economics magazine

Founded in 1954, Chiropractic Economics (ChiroEco.com) is the leading magazine in the chiropractic industry. The Doyle Group, publisher of Chiropractic Economics and MASSAGE (MASSSAGEmag.com) magazines, offers a wide range of products and services designed to generate qualified sales leads for business in the chiropractic and massage market places.

Connect with Chiropractic Economics magazine on Facebook at facebook.com/ChiroEcoMag, and follow Chiropractic Economics magazine on Twitter at twitter.com/chiroecomag.

About Erchonia Corporation

Erchonia Corporation’s commitment to the advancement of Low Level Laser Therapy (3LT) through scientific and clinical research has transformed the company into a world leader in the field of LLLT technology. The integrity, diligence, quality, and commitment of the company are evident in the rigorous processes it follows in taking a research hypothesis from concept to viable, agency-approved product and treatment method.

Erchonia provides laser training around the country and throughout the year by sponsoring numerous seminars and webinars. A complete listing of these seminars can be found at erchonia.com/seminars.

For more information, visit erchonia.com.

Connect with Erchonia on Facebook at facebook.com/pages/Erchonia.

Inside-Out Health: A Revolutionary Approach to Your Body (Advanced Seminar)

Presented by: Dr. Robert Silverman
November 19th-20th, 2016 –
Indianapolis, IN

Co-sponsored by: Erchonia Corporation & Northwestern Health Sciences University

~12 CE Hours Applied~

 About the Seminar

Join Dr. Silverman as he explores the process of implementing advanced laser protocols into your practice. He will share in-office tools, hands-on laser protocols, nutrition protocols and proven rehab programs. In this exciting presentation, you will gain insight into a simple methodology to incorporate these protocols into a clinically effective system. This seminar is ideal for any practitioner who wants to get the health performance edge in their community.

Register Here!

Nail Fungus Sufferers Find Relief in New Laser Treatment

Lunula receives FDA approval, launches

With the summer fun and flip flop season in full swing, those suffering from discolored toenails start to worry about wh

at others think of their feet. Toenail fungus sufferers can now enjoy clear nail beds with the FDA 510(k) approval of the Lunula Laser, an Erchonia Corporation low-level laser.

Photo – http://photos.prnewswire.com/prnh/20160701/385717 

Photo – http://photos.prnewswire.com/prnh/20160701/385718

The Lunula device increases the amount of clear nail in patients infected with onychomycosis, or nail fungus. In the clinical trial, 67 percent of patients met the success criteria of three millimeters of clear nail growth. By six months after the initial treatment, these pa

tients average more than five millimeters of new growth.

This is the first and only low-level laser to receive FDA 510(k)

marketing clearance for onychomycosis.

“Lunula is the future of treating onychomycosis,” said Dr. Kerry Zang, founder of the Arizona Institute of Footcare. “The results seen in the clinical trial are spectacular and we are eager to provide Americans with the opportunity to treat this nail fungus with an effective product.”

The portable Lunula device applies a laser to the area infected by onychomycosis. During the study, patients between 18 and 70 years old received treatments once a week for four weeks.

Previously, treatment for nail fungus included prescription oral antifungal medication, which increased potential for liver toxicity issues, or else called for ineffective, over-the-counter topical creams.

“Nail fungus is a big problem and the toxicity of the available drugs is almost as bad,” said Dr. Robert Sullivan. “Lunula gives doctors a viable treatment option: no blood tests, no pain and no mess.”

Zang and Sullivan lead the research behind Lunula. Prior to FDA 510(k) approval, the product went through four clinical trials which recorded no known side effects.

Preorders begin June 30, with delivery scheduled for mid-July.

The 510(k) is a premarketing submission to the FDA that demonstrates that the device marketed is safe and effective. The premarket approval for the 510(k) is the most rigorous type of device marketing application accepted by the FDA.

Founded in 1996, Erchonia Corporation is the world leader in low-level laser technology. The company created the low-level laser category in 2002 when it received an FDA 510(k) market clearance for low-level lasers. Erchonia was the first company to receive this FDA 510(k) distinction. For more information, visitwww.erchonia.com or call 888-242-0571.

Watch the Lunula Laser Treatment Here

For additional information, image and interview requests, contact Marjorie ComerAxia Public Relations at 888-PR-FIRM-8, ext. 700.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nail-fungus-sufferers-find-relief-in-new-laser-treatment-300293487.html

SOURCE Erchonia Corporation

 

Related Links

https://www.erchonia.com

Erchonia Receives 7th FDA Market Clearance for Non Invasive Fat Loss

Erchonia Receives 7th FDA Market Clearance for Non Invasive Fat Loss New once a week protocol allows for more treatment flexibility

Erchonia announces today that they have received their 7th 510(k) market clearance and the 2nd in 2015 from the US FDA for non-invasive fat loss which is measured by circumference reduction. Erchonia has also been published 20 times in journals and text books with our patented laser processes.

Erchonia has been researching fat loss since 1998 and has performed several level 1 blinded and controlled clinical trials on circumference reduction. “We have more 510(k) market clearances on non-invasive fat loss than all other companies combined” stated Steven Shanks President of Erchonia Corp.
The new study was performed on 54 subjects who participated in a once a week treatment for (6) weeks; the results showed that patients continued to see a reduction 2 weeks post treatment which is believed to be due to the process of fat metabolism. What this study demonstrated was that patients with a 25 to 40 BMI should expect to lose 6 inches from their waist, hips, thighs, and upper abdomen.
“I would implore consumers seeking such treatments to compare this to other body contouring device’s that have FDA market clearance, such as those that freeze fat which can only claim according to their 510(k) statements to effect appearance of fat  in 2 to 4 months”.
“After considering all the data potential patients should contemplate if they would like to lose 6 inches of fat in 6 weeks with no known side effects with the New Zerona Z6 laser protocol or be able to affect the appearance of fat in 2 to 4 months with a risk of pain, and side effects associated with other devices” says Charlie Shanks, Vice President of Marketing.
We would like to thank Carl Thornfeldt M.D and Paul Thaxton M.D for their dedication to research and helping Erchonia with its latest achievement.
The FDA has previously cleared Erchonia’s low level lasers for non-invasive reduction of cellulite; the non-invasive circumference reduction of the arms; for liposuction and breast augmentation assistance and the reduction of associated pain; the reduction of chronic neck and shoulder pain; and for the treatment of acne.
For more information, please visit www.erchonia.com.
About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat and cellulite, eliminate pain, and treat acne. For additional information, visit www.erchonia.com.

FDA Clears Erchonia’s New FX635 Laser for Chronic Heel Pain from Plantar Fasciitis

“This new technology is a breakthrough for chronic heel pain sufferers, because it offers pain-free treatment with no known side effects or contraindications. “

 

Erchonia today announces the U.S. Food and Drug Administration (FDA) has granted the company 510 (k) clearance to market FX635, its new low level laser for the relief of chronic heel pain from plantar fasciitis.

Erchonia received FDA clearance based on a double-blind, randomized, multi-site and placebo-controlled clinical trial. In order to participate in the study, patients had to have self-reported pain of greater than 50 on a visual analog scale (VAS) of 0 to 100 and be unresponsive to conservative measures.
“This new technology is a breakthrough for chronic heel pain sufferers, because it offers pain-free treatment with no known side effects or contraindications. “

After just two FX635 treatments a week for three weeks, patients treated with the FX635 Laser reported reduced pain on the VAS scale at 2 weeks, 6 months and 12 months post-treatment. On average, patients went from a 68 on the VAS scale down to 8 at the 12-month mark. Those patients who received a placebo laser did a not achieve a statistically-significant reduction in pain at any time during the clinical trial.

Michael Coughlin, MD, the clinical investigator, stated, “Erchonia’s FX635 low level laser for chronic plantar fasciitis demonstrated exceptional results with a marked reduction in almost all of the 30 treated patients. They had suffered from plantar fasciitis for an average of almost a year—one patient had pain for 5 years. All had undergone a variety of non-operative treatments which had all been unsuccessful. At the year follow-up point, almost all patients noted a dramatic reduction in pain and an improvement in function.”

Kerry Zang, DPM, added; “I use the Erchonia FX635 for chronic plantar fasciitis as part of a regenerative medicine protocol. This new technology is a breakthrough for chronic heel pain sufferers, because it offers pain-free treatment with no known side effects or contraindications. Low level laser technology works by stimulating a physiological response which is necessary to healing—whereas other treatments such as cortisone, suppresses inflammation which delays or even stops the healing process.”

Charlie Shanks, vice president of Erchonia, comments, “This FDA-clearance for the FX635 laser is Erchonia’s latest example of our ongoing commitment to low level laser technology research. Not only can it provide non-invasive relief to those who suffer from this type of chronic heel pain, the FX635 laser itself is extremely simple to operate and doesn’t require manual operation like all other pain management devices.”

The FDA has previously cleared Erchonia’s low level lasers for the reduction of chronic neck and shoulder pain; non-invasive reduction of cellulite, the non-invasive circumference reduction of the arms and the waist, hips and thighs; for liposuction and breast augmentation assistance and the reduction of associated pain; and for the treatment of acne.
For more information, please visit https://www.erchonia.com.
About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years, Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Erchonia created the low level laser category after the company was granted the first low level laser FDA clearance for any indication in 2002. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat and cellulite, eliminate pain, and treat acne. For additional information, visit https://www.erchonia.com

Results of Erchonia’s Lunula Laser’s Clinical Trial for the Noninvasive Treatment of Nail Fungus Published in Podiatry Review

Erchonia today announces that the preliminary results of an ongoing clinical trial testing its Lunula laser for the noninvasive treatment of nail fungus have been published in the latest issue of the medical journal Podiatry Review.

 “I am pleased to say the current data we are obtaining substantiates the Lunula laser as a safe and effective treatment for onychomycosis. Furthermore, the data demonstrates that Lunula is effective at treating varying degrees of infection.”

Erchonia today announces that the preliminary results of an ongoing clinical trial testing its Lunula laser for the noninvasive treatment of nail fungus have been published in the latest issue of the medical journal Podiatry Review (Vol. 71 No 2 pgs 6-9).

The technical article entitled, “Erchonia Laser Therapy in the Treatment of Onychomycosis,” summarizes the 48-week interim results of an 18-month study in which data for 323 patients has already been successfully recorded.

According to the results of the study, the Lunula laser validated percentages of nail clearance, specific to varying levels of nail inclusion. Post 4 treatments, the fungal infection was eradicated on 99% of study participants, and clear nail growth was also recorded on all these participants. It was also observed at the 48 week stage that only 4 patients were found to have suffered re-infection.

Unlike conventional hot lasers used for the treatment of fungal nail infections, the Lunula laser is reported to cause no pain to the patient and no temperature change in the treated area. Further results will be published at the close of the study.

Erchonia’s Lunula low level laser therapy is administered non-invasively and efficiently in just four treatments. Using low level laser light, it effectively eradicates fungus from the nail, nail bed and surrounding tissue — without pain and without adverse effects. All ten toes are treated at the same time in a 24-minute treatment unlike more conventional lasers where each toe is treated individually.

The primary author of the study, Robert Sullivan, states, “After reading the existing study data presented to me by Erchonia, I initiated a new, independent study to scientifically question this data. I am pleased to say the current data we are obtaining substantiates the Lunula laser as a safe and effective treatment for onychomycosis. Furthermore, the data demonstrates that Lunula is effective at treating varying degrees of infection. The successful treatment of nails with an initial percent involvement of up to 100% demonstrates the laser’s ability to permeate down to the nail bed.”

“This latest independent study validating the Lunula technology as a new standard to the safe and effective treatment for onychomycosis is a real breakthrough,” says Charlie Shanks, vice president of Erchonia Corp. “We are pleased to be able to share this data with the members of the Institute of Chiropodists and Podiatrists through their Podiatry Review publication and strive to carry on pushing the boundaries of low level laser therapy treatments.”

For more information, please visit https://www.erchonia.com.

About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years, Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent level 1 clinical trials. Erchonia has garnered eight FDA 510 (k) market clearances and has several other products in research and development for new applications. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, and treat acne. For additional information, visithttps://www.erchonia.com.

Erchonia XLR8 Laser Granted FDA Clearance for Pain Treatment

Erchonia XLR8 Laser Granted FDA Clearance for Pain Treatment

McKinney, TX – October 21, 2013 – Erchonia, the global leader in low level laser healthcare applications, today announces the company has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) to market its new XLR8 Laser for pain treatment.
Depending on the settings selected, the Erchonia XLR8 laser can provide temporary relief of chronic neck and shoulder pain; reduce pain after liposuction of the thighs, hips and stomach; or reduce post-surgery pain after breast augmentation.
The Erchonia XLR8 laser is a handheld device that uses low level laser technology to speed the recovery process following liposuction and breast augmentation by encouraging cell regeneration. The XLR8 laser is a noninvasive, safe way to manage pain—without negative side effects.
Steven Shanks, president of Erchonia comments, “The Erchonia XLR8 laser combines three FDA 510(k) market clearances into one device. With user-definable channels, an easy-to-use interface, and preset protocols, cold laser technology is now more flexible than ever before.”
For more information on the Erchonia XLR8 laser, please visit www.erchonia.com.
About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years, Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, and treat acne. For additional information, visit www.erchonia.com.