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Erchonia’s Lunula Laser Gains Traction in Korean Market

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“It’s very helpful for patients to have a non-thermal, painless treatment, covered by insurance. Doctors also save time with an effective and comfortable procedure for patients. The mutual needs of both doctors and patients are met with Lunula.”

 

Melbourne, Fla., May 21, 2019 — Erchonia Corporation, the global leader in low-level laser technology (“3LT”), is announcing new strides in the Korean market, particularly with its Lunula Laser, which targets foot fungus non-thermally and non-invasively with low-level laser technology. Since bringing its first Lunula unit to Korea back in 2015, Erchonia has continued to grow its stake there, placing a total of 277 units to date throughout the country.

 

The Lunula Laser is backed by extensive clinical data that led to the U.S. FDA market-clearing the laser to provide clear nail growth in patients with onychomycosis. In a placebo-controlled, randomized, double-blind clinical trial, 89 percent of patients responded to treatment, seeing clear, healthy nail growth in as little as four, 12-minute treatments per foot.

After Erchonia secured U.S. market clearance for the Lunula Laser, Erchonia’s international partner, C.M. Blue, registered the Lunula in Korea as the first device to improve onychomycosis with a non-thermal, low-level laser. Thanks to Lunula’s clinical results and Erchonia’s patent, C.M. Blue received approval from the Ministry of Food and Drug Safety (MFDS) on July 24, 2017, and Lunula has been growing in popularity in Korea ever since.

“The Lunula has been a great success among our product lines,” says Hoon Cheol Kim, CEO & President of C.M. Blue. “It’s very helpful for patients to have a non-thermal, painless treatment, covered by insurance. Doctors also save time with an effective and comfortable procedure for patients. The mutual needs of both doctors and patients are met with Lunula.”

C.M. Blue Sales & Marketing Director Joo Ho Park is also continuing this momentum by securing the most influential doctors to speak at medical conferences in Korea, targeting major clinics, and supporting Lunula’s expansion with various marketing activities including blogging and advertising.

 

About Erchonia Corporation
Based in Melbourne, Florida, family-owned Erchonia is the global leader in the manufacturing and development of low-level laser therapy technology (“3LT”). From humble beginnings in a garage in 1996, Erchonia today develops and sells the most advanced, non-invasive 3LT medical equipment on the market in over 50 countries. With more than 15 clearances from the FDA, Erchonia remains passionately committed to effective, research-based 3LT solutions for a wide variety of conditions — from managing chronic pain to promoting fat loss. For more information, please visit www.erchonia.com.

 

 

Opioid Alternative: Doctor Using Laser to Treat Lower Back Pain & Heel Pain

Fox

KRIV

May 13th, 2019 Aired

 

Medical treatment of pain has typically involved NSAIDs, opioids or even surgery.  Issues with effectiveness, side effects and addiction have fueled the demand for better pain management solutions.  Dr. John Codwell, DPM of Houston, TX is a provider of the Erchonia FX 635 Laser.  There are more than 3 million cases diagnosed in the U.S. per year who experience chronic heel pain or plantar fasciitis.  Treatments for this pain usually include physical therapy, shoe inserts, steroid injections or surgery. However, these treatments are not always effective long-term.

Erchonia’s FX 635 is the first and only low-level laser to receive FDA market clearance for relief of chronic, musculoskeletal lower back pain and is also FDA-market cleared for chronic heel pain related to plantar fasciitis

The FX 635 low level laser treatments are pain-free, and you can immediately resume normal activities afterwards.  When Erchonia says non-invasive, they mean it. Patients can’t even feel the laser.

Erchonia to Exhibit at 2019 Arab Health Conference in Dubai

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“We are very excited by the growth that we are achieving across the world and are very much looking forward to Arab Health.”

 

Melbourne, Fla., January 10, 2019 — Erchonia Corporation, the global leader in low level laser therapy technology (“3LT”), today announces the company will be exhibiting at the upcoming 2019 Arab Health Conference at the Dubai World Trade Centre from January 28 to January 31.

 

Erchonia will share the latest from its non-invasive laser line including the FX 635, FDA market-cleared for chronic lower back pain and chronic heel pain from plantar fasciitis; the Verjú laser, FDA market-cleared for the circumferential reduction of the waist, hips and thighs, and the appearance of cellulite; and the LunulaLaser, FDA market-cleared for clear nail growth in patients with onychomycosis.

 

“We are very excited by the growth that we are achieving across the world and are very much looking forward to Arab Health,” says Charlie Shanks, VP of Erchonia Corporation.

 

“After a very successful 2018, we are delighted to continue our expansion,” adds Simon Ramshaw, managing director of UK-based Erchonia Lasers Ltd. “We now have representation in many new European markets and are looking to continue our rapid growth in 2019 and beyond.”

 

The low level laser technology Erchonia will be exhibiting at Arab Health is backed by extensive clinical data. In the placebo-controlled, randomized, double-blind clinical trial that led to the FX 635’s FDA market clearance, 72.4 percent reported at least a 30 percent decrease in their lower back pain with the laser treatment. Clinical trial data proved average pain reduction in patients of 58 percent. And Erchonia’s Verjú low level laser is the only device proven effective in a double-blind, multi-site, placebo-controlled study that delivered an average four-inch loss after two weeks of treatment. The FDA also cleared LunulaLaser when 89 percent of patients responded to treatment in a clinical trial, seeing clear, healthy nail growth in as little as four, 12-minute treatments per foot.

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

 

About Erchonia Corporation

Based in Melbourne, Florida, family-owned Erchonia is the global leader in the manufacturing and development of low level laser therapy technology (“3LT”). From humble beginnings in a garage in 1996, Erchonia today develops and sells the most advanced, non-invasive 3LT medical equipment on the market in over 50 countries. With more than 15 clearances from the FDA, Erchonia remains passionately committed to effective, research-based 3LT solutions for a wide variety of conditions — from managing chronic pain to promoting fat loss. For more information, please visit www.erchonia.com.

 

Good Day Bring Feet Out Of Hiding – Good Day Sacramento

Good Day Sacramento

Tina talks with Dr. Michael A. Uro the podiatrist and he has some tips on getting your feet in tip top shape for the summer!

Click Here to Play Video

 

Pain Infographic: Chronic Pain in Numbers

Chronic Pain is a major issue in society today that affects over 1.5 billion people around the world. This pain has proven to have detrimental effects on the overall quality of life.Erchonia also broke down some opioid epidemic stats in hopes to spread awareness and end the Opioid Epidemic with alternative methods, such as Erchonia Low Level Laser technology.

 

Erchonia & InnerScope Hearing Technologies to Conduct FDA Clinical Trial to Treat Tinnitus with Low Level Laser Technology

Erchonia Corporation today announces a joint development agreement with InnerScope Hearing Technologies to conduct clinical research and trials for the purpose of obtaining 510(k) clearances from the FDA for 3LT devices to treat hearing-related conditions, including tinnitus.

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“We’re hopeful our partnership with InnerScope can make a real difference in patients’ lives and eventually provide a scientifically-proven, non-invasive option.”

Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology (“3LT”), today announces a joint development agreement with InnerScope Hearing Technologies. Under the agreement, Erchonia and InnerScope will conduct clinical research and trials for the purpose of obtaining 510(k) clearances from the FDA for 3LT devices to treat hearing-related conditions, including tinnitus.

Erchonia and InnerScope expect to be the first to receive 510(k) clearance from the FDA for a treatment protocol for relief of tinnitus symptoms — not tinnitus “maskers” or management devices which are the only currently available options for patients. The companies have already received approval under FDA regulations from the Institutional Review Board for their initial clinical trial.

Commonly referred to as “ringing in the ears,” tinnitus is the perception of sound when no actual external noise is present. Approximately 20 percent of the world’s population suffers from tinnitus, experiencing buzzing, hissing, whistling, swooshing, or clicking. Those with intolerable tinnitus also often suffer from higher rates of anxiety, depression, low self-esteem, and poor quality of life.

“We’re looking forward to exploring low level laser’s impact on hearing disorders, especially on tinnitus, which can be debilitating,” says Steve Shanks, president of Erchonia Corporation. “We’re hopeful our partnership with InnerScope can make a real difference in patients’ lives and eventually provide a scientifically-proven, non-invasive option.”

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

About Erchonia Corporation
Based in Melbourne, Florida, family-owned Erchonia is the global leader in the manufacturing and development of low level laser therapy technology (“3LT”). From humble beginnings in a garage in 1996, Erchonia today develops and sells the most advanced, non-invasive 3LT medical equipment on the market in over 50 countries. With more than 15 clearances from the FDA, Erchonia remains passionately committed to effective, research-based 3LT solutions for a wide variety of conditions — from managing chronic pain to promoting fat loss. For more information, please visit https://www.erchonia.com.

About InnerScope Hearing Technologies
InnerScope Hearing Technologies (INND) is a rapidly expanding consolidator of the hearing aid industry. Management is applying decades of profitable industry experience and technology to an antiquated and disjointed industry, unlocking scale and efficiency, which will serve all of InnerScope’s stakeholders. Its direct-to-consumer model is revolutionizing the industry with its Walmart.com relationship representing a paramount shift in the consumption of hearing aids by the hearing impaired. In addition InnerScope plans to continue to open, acquire, and operate a physical chain of audiological and retail hearing device clinics. InnerScope’s mission is to serve approximately 1.2 billion people around the globe that are suffering with 25 db or greater hearing loss across the entire hearing impaired vertical from R&D and manufacturing through direct consumer sales and services. For more information, please visit http://www.innd.com.

CBS’s “The Doctors” Showcases the Remarkable Lunula Laser as a Solution for Nail Fungus

Top-Rated Daytime Talk Show Features a Confident and Dramatic Patient Result

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“We know our Lunula Laser can help so many people achieve healthy, clear nail growth without experiencing any harmful side-effects”

Erchonia, the leading low-level laser technology manufacturer in the world today announces the company’s Lunula Laser was featured on an episode of CBS’s hit show “The Doctors” which aired on Friday, October 19th, 2018.

Board-certified dermatologist, Dr. Glynis R. Ablon, MD, discusses and demonstrates the Lunula Laser’s unique capacity to zap away toe nail fungus. While other treatment options provide unsuccessful, painful or harmful results in comparison to the FDA Market Cleared Lunula Laser. Toe nail fungus is not only a U.S. problem, but a world-wide problem. It is estimated that 10% of the world is plagued by this condition.

In contrast to high-power, high-heat lasers which have been used to treat toe nail fungus, the new Lunula Laser produces a low-level or cold output that is non-thermal with no effect on the body’s tissue or nail bed. Instead, the non-invasive Lunula Laser offers impressive clinical response stemming from its two therapeutic wavelengths: 405 nm (violet) and 635 nm (red). Each wavelength performs a very specific function to provide a comprehensive solution for toe nail fungus.

“We were so pleased with the patient’s results and think “The Doctors” segment is the perfect way to introduce the Lunula Laser to a national audience,” says Charlie Shanks, VP of Erchonia Corporation. “We know our Lunula Laser can help so many people achieve healthy, clear nail growth without experiencing any harmful side-effects.”

About Erchonia
A small family company is changing the world with the most advanced non-invasive lasers on the market. Erchonia went from starting in a small garage in 1996 to selling their products in over 50 different countries around the world in 2018. Erchonia has been passionate about researching and developing low level lasers since the beginning with over (14) FDA clearances for treating chronic pain and promoting fat loss. As this family has grown so has the world of non-invasive drug-free healthcare solutions

Erchonia Submits Data to US FDA to Support Low-Level Laser 510(k) Market Clearance for Autism

Quadruple-Blind laser study proves success in treating Autism in children and adolescents.

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“The results are so strong, nobody can argue them.”

Erchonia, the World Leader in Low Level Laser technology, announces today that they have submitted data to the US FDA to support a 510(k) market clearance for Autism.

The clinical trial was a quadruple-blind (Participant, Care Provider, Investigator and Outcome Assessor), randomized, placebo-controlled, and crossover clinical trial. The study was designed to treat autistic children with the 640nm Erchonia Spectrum Laser as the active device or a 640nm LED or light emitting diode as a placebo device, which had the same power output. FDA input was obtained prior to clinical trial and implemented into the protocol.

Both test and placebo patients were treated twice a week for 4 weeks. Post-treatment follow-up on both sets of patients was performed after 4 weeks, 8 weeks, and 6 months. At the end of 6 months, patients from the LED placebo group were crossed over and then given Erchonia’s Spectrum Laser treatment protocol. The results were documented and submitted to the US FDA for a 510(k) market clearance De Novo Application.

The inclusion criteria consisted of autistic children between the ages of 5 to 17 years old, and progress was measured by using the ABC or Aberrant Behavior Checklist as the primary diagnosis. The ABC 58-point symptom checklist was used to assess and classify behaviors of irritability and agitation; lethargy and social withdrawal, stereotypic behavior, hyperactivity and noncompliance, and inappropriate speech in children with developmental disorders. The ABC tests were performed at baseline, 2 weeks, and 4 weeks during the treatments phase, and 4 weeks, 8 weeks, and 6 months post-treatment in both the treated and placebo groups.

“This is a well-designed trial that shows evidence supporting the use of Low Level Laser Therapy in children and adolescents with autism,” said Dr. Morales-Quezada, Associate Research Director at Spaulding-Labushagne Neuromodulation Center. “Moreover, the technique proved to be safe and well tolerated by the study participants. The active intervention showed to be more effective than the placebo (sham) device in treating symptoms of autistic disorder, and this statistically significant treatment effect was observed for all clinical outcomes, by the end of the intervention period and after the 6 months follow-up. This evidence offers a new treatment option to be considered for children and adolescents with autism.”

Calixto Machado, MD, PhD, FAAN, President of the Cuban Society of the Clinical Neurophysiology Institute of Neurology and Neurosurgery agreed, “Results are so strong, nobody can argue them.”

Steven Shanks, President of Erchonia stated, “This study from a scientific perspective is one of the most stringent ways to perform a clinical trial. The original placebo patients have now acted as their own control group. The LED that was used as a placebo showed no results even though we used the same wavelength and power output.”

The Erchonia Spectrum Laser implemented in this clinical trial was a prototype laser and is not currently sold. While waiting for the 510(k) market clearance, Erchonia will start the development process for the new Erchonia Spectrum Laser.

Erchonia would like to thank Calixto Machado, MD, PhD, FAAN, Mauricio Chinchilla, MD, Yanin Ferrer, MD, and the University of Havana for their dedication to research and helping Erchonia with its latest achievement.

About Erchonia. Erchonia created the low-level laser category in January 2002 when the FDA granted Erchonia the very 1st 510(k) market clearance for any low-level laser. This new study further sets Erchonia apart from its competitors based on their commitment to research and numerous 510(k) market clearances obtained through blind and controlled clinical trials.

The Back Pain Solution

 
 

 

Dynamic Chiropractic August 2018

 

Low back pain will affect some 80 percent of all adult Americans at some point.(1) However, it’s not just an American problem. Low back pain is becoming more prevalent around the world. Worldwide, disability from low back pain has risen by more than 50 percent since 1990.(2)

As low back pain becomes a more international problem, the costs to patients, health care systems, and society escalates. In the U.S. alone, total costs associated with LBP exceed $100 billion per year, two-thirds of which are a result of lost wages and reduced productivity.(3)

 

Drugs Don’t Help

 

Traditional medical treatment of low back pain often involves prescription painkillers, particularly opioids. The risk of abuse and addiction with these drugs is well known. In 2016, the CDC issued revised prescribing guidelines that recommend sharply cutting the duration of any pain-killer prescription.(4) Most importantly, these drugs fail to be effective in the long term.

A 2016 meta-analysis of 20 studies of opioids for low back pain, published in JAMA Internal Medicine, found that opioid analgesics for chronic low back pain provided only modest short-term pain relief, and only for some patients. In many of the studies analyzed, more than half of the participants in the trial dropped out due to adverse side effects of these dangerous drugs. None of the studies showed clinically important pain relief (defined as more than 20 points improvement on a 100-point scale). Those who did get some relief from pain took doses that were much higher than recommended.

The meta-analysis brought out an important point about opioid studies: almost all are short term. Very few high-quality studies have looked at the long-term effects of opioid use for patients with chronic low back pain. A recent study that did look at a 12-month period found that treatment with opioids was no better than treatment with nonopioid medications such as ibuprofen for improving pain-related function.(5)

In addition to offering little help to patients, opioid drugs can make chronic pain worse. For some patients, using opioids can induce hyperalgesia, or a paradoxical response whereby patients who take these drugs become more sensitive to painful stimuli. The mechanisms behind hyperalgesia are still unclear, but the risk that painkilling drugs could make a patient more sensitive to pain is clear.6 Hyperalgesia is another potential harm to add to the long list of bad side effects of opioid use.

 

Better Solutions

 

The evidence is very clear: opioids not only aren’t a solution to low back pain, they’re harmful to patients and may make the pain worse. Nondrug treatments, such as nonthermal low-level laser therapy led by chiropractors, are far preferable. They’re safe, they’re supported by research, they work, and they’re cost effective.

 

A Breakthrough Tool For Chronic Low Back Pain

 

In July 2018, the Erchonia FX 635 low-level laser received official FDA clearance for relief of chronic low back pain—the first and only laser to be cleared for this purpose. Chiropractors now have a powerful new tool to help their patients relieve chronic low back pain and get back to work and normal activity.

Founded in 1996, Erchonia is the first company in the world to gain an FDA market clearance for the use of low level laser therapy. The company has 16 FDA 510(k) approvals for their equipment and more Level 1 clinical trials than all other therapeutic laser manufacturers combined.

The clinical trial conducted to obtain FDA clearance was designed to test the effectiveness of the Erchonia FX-635 in providing relief of chronic low back pain of musculoskeletal origin. The study was a placebo-controlled, randomized, double-blind parallel group multi-center design.

Fifty-eight people completed the study; half were treated with the laser and half were treated with a placebo (sham laser 635nm LED). All the participants rated their pain as 40 or greater on the 0 to 100 Visual Analog Pain Scale (VAS). The average duration of low back pain for the participants was 97.8 months (approximately eight years). The majority of the participants had had bilateral low back pain with an average pain rating of 59.10 on the VAS.

All the participants received eight 20-minute procedure administrations across the lower back region with the Erchonia FX-635 laser (active or sham) across a four-week period: two procedures per week, each procedure three to four days apart.

Of those who received the active laser treatment, 72.4 percent attained a 30 percent or greater decrease in chronic low back pain VAS rating from baseline to endpoint (see chart).

Chart 1 shows the response to laser treatment among the test group and those who received placebo treatment (635 nm LED, not a laser). Among the actual treatment group, VAS ratings dropped precipitously from 59 to 23 over eight weeks. Among the placebo group, the drop was only about 10 points and the improvement quickly leveled out.

No adverse events were reported during the study duration. At the end of three months, the reduction in pain was sustained, even though no additional treatment was administered after the first month.7 Low level laser treatment (LLLT) works by stimulating cell activation processes which, in turn, intensify physiologic activity. The light energy from the laser initiates a cascade of reactions that stimulate the mitochondria to increase the production of ATP. The laser light stimulates the release of natural healing chemicals that lead to rapid cell growth, increased metabolic activity, increased angiogenesis, improved vascular activity, suppression of the COX-2 inflammatory pathway, and decreased inflammation.

The specific wavelength (color) of the laser light is responsible for influencing the biochemical cascades. Research has shown that a wavelength of 635 nm is ideal for accelerating healing and reducing post-injury inflammation. The coherent, pulsed light delivered by the Erchonia laser insures deep tissue stimulation and absorption.

Laser treatment is painless. There’s no sensation of heat and the skin and tissue aren’t damaged in any way. The patient lies prone; the laser light is provided by the FX-635 using three diodes on an adjustable stand. The laser light is delivered to the lower back area in a moving circular pattern for twenty minutes. The patient does not need to be attended during this time.

The clearance of the FX-635 is a watershed moment for the chiropractic profession for treating low back pain.

(Erchonia Corporation www.Erchonia.com)

 

 

Rob Silverman, DC, DABCO

https://www.drrobertsilverman.com/

REFERENCES:

1. Lemeunier, N, Leboeuf-Yde, C, and Gagey, O. The natural course of low back pain: a systematic critical literature review. Chiropract Man Ther. 2012; 20: 33

2. Stephanie Clark, Richard Horton. Low back pain: a major global challenge. The Lancet. Volume 391, No. 10137, p2302, 9 June 2018. DOI: https://doi.org /10.1016/S0140- 6736(18)30725-6 |

3. William Thomas Crow, DO; David R. Willis, DO, MBA. Estimating Cost of Care for Patients with Acute Low Back Pain: A Retrospective Review of Patient Records. The Journal of the American Osteopathic Association, April 2009, Vol. 109, 229-233.

4. Deborah Dowell, MD; Tamara M. Haegerich, PhD; Roger Chou, MD. Morbidity and Mortality Weekly Report (MMWR), CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016; March 18, 2016, 65(1);1–49.

5. Krebs EE et al. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients with Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA. 2018 Mar 6;319(9):872-882. doi: 10.1001/ jama.2018.0899.

6. Lee M et al. A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011 Mar-Apr;14(2):145-61.

7. Market Clearance to Treat Chronic Low Back Pain.(FX 635) – 2018 – A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Multi-Center

 

 

 

 

 

Erchonia Donates One Hundred and Fifty Thousand Dollars’ worth of Low-Level Lasers to the New York College of Podiatric Medicine & Foot Center of New York

Pain-Free, Non-Surgical Laser Treatment Options

 

MELBOURNE, Fla. (PRWEB) July 25, 2018

We are pleased to announce New York College of Podiatric Medicine (NYCPM) & Foot Center of New York’s (FCNY) acquisition of several Erchonia low-level lasers, including both Lunula Lasers and FX 635 Lasers.  NYCPM provides unrivaled excellence in podiatric medical education and clinical experience.  Their students receive comprehensive academic training and directly-supervised clinical experiences that are second to none.

The Lunula and the FX 635 low-level lasers are non-invasive, pain-free, non-thermal, non-surgical and backed by clinical trials proving their safety and effectiveness.  The Lunula Laser is the 1st and only non-thermal FDA Market Cleared laser device for the temporary increase of clear nail for patients with onychomycosis, while the FX 635 is a low-level laser for the relief of chronic heel pain from plantar fasciitis.  These laser technologies are breakthroughs for pain-free treatments with no known side effects or contraindications.

The donated lasers will be used by doctors and their students at the New York College of Podiatric Medicine & Foot Center of New York as solutions for conditions common in the field of podiatry, such as acute and chronic heel pain and onychomycosis (toe nail fungus).

“We at NYCPM are excited to include this technology in the care of our patients with inflammatory heel pain or onychomycosis and in the education of our students” said Michael J. Trepal, Professor of Surgery, Vice President of Academic Affairs and Academic Dean of the New York College of Podiatric Medicine.

Vice President of Erchonia Charlie Shanks said, “The Dean of New York College of Podiatric Medicine & Foot Center of New York, his staff, and students have created an environment that encourages a high standard of education.  We are proud that NYCPM and FCNY have trusted us to be a part of their ongoing education and help us bring awareness of low level laser therapy (3LT®) treatment options to the podiatry field.  This is a joyous occasion for the Erchonia family to be able to give back to those who have supported us and continue to help us reach our goal of being the world leaders in low level laser applications.”

 

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

 

About Erchonia
A small family company is changing the world with the most advanced non-invasive lasers on the market. Erchonia went from starting in a small garage in 1996 to selling their product in over 50 different countries around the world in 2018. Erchonia has been passionate about researching and developing low level lasers since the beginning with over (15) FDA clearances for treating chronic pain and promoting fat loss. As this family has grown so has the world of non-invasive drug-free healthcare solutions.