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.
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 Comer, Axia 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
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.
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.“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
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.
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.
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.
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, visitwww.erchonia.com
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