September 23, 2019 Issue
Erchonia Low Level Laser, the Future of Medicine
Interview conducted by:
Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – September 23, 2019
CEOCFO: Mr. Shanks, we spoke almost three years ago and at that time you told us you believe low-level laser is the future of medicine. How has that developed over the last three years at Erchonia?
Mr. Shanks: Since the last time we spoke, we have obtained several new indications or FDA 510k market clearances. In 2018 we were cleared for lower back pain. The clearance was obtained through a blind and controlled clinical trial; In June of this year we received another indication from the FDA for overall neuromuscular pain, and last week for chronic neck and shoulder pain.
CEOCFO: How does low-level laser work?
Mr. Shanks: A simple analogy would be if you look at Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), such as Advil® and Tylenol®, NSAIDs reduce pain by reducing inflammation. They are Cyclooxygenase-2 (COX-2) inhibitors or they reduce inflammation through a process called, TNF-alpha. These drugs are designed to suppress immune function and reduce inflammation; low level lasers can prove better results without suppressing immune function. Both have similar mechanisms of action, drugs create biochemical affect, low level lasers create a photochemical affect.
CEOCFO: Why has it been so difficult to treat chronic back pain and how have you been so successful in developing the right treatment?
Mr. Shanks: If you are going to take an NSAID or an opioid, all you are really doing is treating the symptom; you are not treating the condition. Therefore, you are going to have to keep taking the drug pretty much forever because you have not dealt with the root cause of the problem. We believe that low-level laser therapy deals with the root cause of the problem and we base this on clinical trial and our long-term follow-up.
CEOCFO: Is this done by a medical professional?
Mr. Shanks: Right now, all of our pain lasers are by order of a physician, so we only market to doctors.
CEOCFO: How often would somebody need a treatment?
Mr. Shanks: It depends on the condition. For instance, we were just FDA cleared for submitted data on a neck and shoulder study that we just completed; we documented pain reduction of about 60% in one treatment. For our low back pain, which is a more complex condition, the protocol was 8 treatments and for plantar fasciitis it was 6 treatments.
CEOCFO: What is the feeling in the medical community?
Mr. Shanks: There is a lot of skepticism based on this technology not being taught in most medical schools and are shining a light on a patient and there is no sensation.
CEOCFO: Regarding the back pain, is your device something an orthopedist, chiropractor or therapist would be able to use? How wide a range of medical professionals do you target?
Mr. Shanks: We market to chiropractors, physical therapists, podiatrists and doctors that are treating pain management. What we are seeing lately is a lot of practitioners have been referring out their pain patients because how strictly opioids are regulated at this point. Medical doctors are becoming more and more open to low level laser, the doctors do not want to turn a pain patient away, so they refer them out. Therefore, we think that is a big market for us in the future.
CEOCFO: How do you reach the market?
Mr. Shanks: We do our own seminars and we advertise to doctors to come to a specific location where we teach them over a weekend how to treat based on our research. We do about ten to twelve seminars a month. We will also do national trade shows such as PAIN Week, Physical Therapy, Obesity tradeshows along with Chiropractic and Podiatry tradeshows.
CEOCFO: What is the physical equipment?
Mr. Shanks: We market mechanically scanning and handheld devices; these lasers are designed to go right to the area of pain. Most of our research lately is with mechanically scanning lasers for lower back pain, plantar fasciitis and overall muscular skeletal pain, we try to build devices which are as simple as targeting the area to be treated and pushing a button.
CEOCFO: Is there any potential downside with low-level laser treated?
Mr. Shanks: There are no known side-effects. The worse thing is you are not going to respond to treatment. There was a great article published in JAMA last year where they looked at chronic pain for over a year and they showed NSAIDs reduce pain by 26% and opioid reduce pain about 20% and stated based on the side effects they did not recommend treating chronic pain with drugs. Whereas, we have been able to document about a 50% pain reduction without side effects.
CEOCFO: Do you reach out to the public, to patients to encourage them to ask their doctors and chiropractors about your low-laser therapy as an alternative treatment for their pain?
Mr. Shanks: That would be effective, but we are a small family business, so we do not have the money like the drug companies to start paying for TV advertising to market directly to patients.
CEOCFO: What are you looking at next?
Mr. Shanks: We are now looking at autism and Alzheimer’s disease and peripheral neuropathy. Then sometime in the late fall we will be looking at tinnitus or ringing in the ears.
CEOCFO: Would you tell us about the autism and Alzheimer’s treatment you are working on now?
Mr. Shanks: We have already completed a blinded and controlled clinical train on autism, and the results were phenomenal. The FDA did not accept that data, so I am meeting with them again in September to start the project again. However, this is not unusual, as many of our clinical trials go through the same process. With Alzheimer’s, we are in the middle of it and hopefully by the end of the year I will know what the results are. With peripheral neuropathy we are starting our second clinical trial and it will hopefully be completed in 2020.
CEOCFO: Where in the body are you targeting with autism?
Mr. Shanks: We are targeting the brain itself. Based on we PUBLISHED measuring connectivity in the brain with Quantitative Electroencephalogram (QEEG) or EEG, looking at pre and post treatments and documenting that the laser seems to be connecting the brain activity. Basically, in autistic kids the connectivity might not be what should be a normal child. This research is going to help explain scientifically what we are seeing clinically.
CEOCFO: It seems there is no condition a low-level laser might not help!
My opinion is that any condition you can treat with a drug, you can treat
with a low-level laser. I think the laser is more effective and there is no
downside. If you go on PubMed, you are going to find over nine thousand
articles published on low level laser and there are no known side-effects.
CEOCFO: Is cost a big factor for the clinicians that are using your equipment or do they realize the value?
Mr. Shanks: Cost is always a factor but once the doctors purchase the device, the cost of the device completely goes away, because of the value they are seeing based on the results the patients and seeing.
CEOCFO: No disposables to be purchased along with the equipment?
Mr. Shanks: There are no disposables. We warranty our devices for two years.
CEOCFO: What is your geographic range today?
Mr. Shanks: We just kicked off in Japan today for another one of our devices for toenail fungus, and we have distributors in most countries in the world.
CEOCFO: What should we expect a year from now at Erchonia?
Mr. Shanks: Hopefully, we are going to be talking about my 510(k) for autism and Alzheimer’s disease. Those will be my next big ones out, and I hope will be cleared by sometime in 2020.
CEOCFO: How do you deal with some of the frustration when you know in your heart it is going to work but there is so much proof that goes into approval?
Mr. Shanks: I can remember the day that I got my first 510(k) clearance in 2002 for chronic neck and shoulder pain, I think the struggle is worth it once we obtain the FDA 510k letter. You just have to keep your eyes focused on the prize and if you look at all the negativity and all the naysayers, I would probably never been in this business.
CEOCFO: Final thoughts?
Mr. Shanks: If you have not heard of low-level laser therapy, I think in twenty years everybody will be exploring this technology. It is the future of medicine. If you look at the results just on pain, and measure low level laser compared to drugs I believe that we have demonstrated a more cost effective and efficacious treatment.
“If you have not heard of low-level laser therapy, I think in twenty years everybody will be exploring this technology. It is the future of medicine. If you look at the results just on pain, and measure low level laser compared to drugs I believe that we have demonstrated a more cost effective and efficacious treatment.”- Steven Shanks
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