Chiropractic + Naturopathic Doctor • September 2018 • New Light Shed On Laser Therapy

The North American Association for Photobiomodulation defines light therapy as the use of “non-ionizing forms of light sources, including LASERS, Light Emitting Diodes (LEDs), and broad-band light, in the visible and infrared spectrum. It is a non-thermal process involving endogenous chromophores eliciting photophysical (i.e. linear and non-linear) and photochemical events at various biological scales. This process results in beneficial therapeutic outcomes including but not limited to the alleviation of pain or inflammation, immunomodulation, and promotion of wound healing and tissue regeneration.”

The operative word in the above definition is “non-thermal.” However, out of the hundreds of companies that sell therapeutic lasers around the world, almost all have been cleared for use in the US by the FDA and classified under the product code “ILY.” The FDA describes ILY as an infrared heating lamp that has the labeling claims that are the same as any product that produces heat (heat packs, heating pads, etc.). Heat is good, by the way, but heat from a laser may not be; in fact it may be harmful. While the marketing materials produced by laser manufacturers promote laser “Hazard Classification” (i.e. Class IV) as an advantage, the more important consideration is the laser “Product Classification.”

It is interesting to note that out of the hundreds of companies that have come to market under the easy-to-attain ILY product code, only a limited few have achieved the FDA product classification of “NHN,” whose first two initials stand for “non-heating.” There is an obvious explanation for this discrepancy, but also a subtle one.

To be granted the FDA’s NHN product code clearance, a manufacturer must conduct and submit results from a double-blinded, randomized clinical trial to support not only the claim with clinical data but the method of action of the laser. This process is very costly and takes a great deal of clinical and regulatory expertise.

The subtle reason most companies, particularly higher powered or Class IV Laser manufacturers, do not pursue NHN clearance is simply because they cannot mask the heat their lasers produce. In the case of cryotherapy, if it’s cold you can feel it. Similarly, with lasers, if it’s hot you can feel it. As such they will never be able to produce studies that would be included in a meta-analysis or systematic review, the highest forms of research.

Most ILY-cleared laser companies fail to produce peer-reviewed research with their own devices. The biggest oenders of this again are Class IV laser vendors that cite or reference Class IM or Class 3b papers when research on their own products is lacking, banking on the fact that the casual reader will not follow through and read the referenced studies.

Not only is Multi Radiance Medical among the few companies in the world that have received both the FDA’s ILY and NHN product classification clearances, but Multi Radiance has also conducted research that has been published in peer reviewed journals 12 times in just the last two years. Ironically, one Class IV Laser company actually cited one of Multi Radiance’s studies as proof that their lasers worked. Unfortunately, this is all too common in the therapeutic laser industry. Many companies tout the fact that “laser therapy is efficacious because there are thousands of research papers and hundreds of randomized clinical trials.” While that is true, they try to use someone else’s studies to “prove” their own technology works, when they have no evidence validating their own specific technology. In most circles that is disingenuous at best and outright misleading at worst.

In contrast, Multi Radiance is conducting over 30 research projects around the world to advance the field of laser therapy. It is the only company to publish its dosimetry optimization curve, thermal time profile, depth of penetration profile and cytochrome c oxidase peak activation prole, investing millions of dollars in studies that were conducted in vitro and in vivo, in controlled laboratory studies and in field studies.

Beyond proving that its technology is the safest and most powerful therapeutic laser on the market, Multi Radiance has also solved the imbalance between light energy produced and light energy absorbed. The First Law of Thermodynamics states that energy is neither created nor destroyed, it just changes forms. Most lasers create heat due to the poor penetration of the light through the skin. So, surprisingly, if your laser creates heat, you know it’s not delivering much light energy to “deep” tissue or providing light therapy. Multi Radiance solved this imbalance of light produced to light absorbed and eliminating dangerous heat by starting with its proprietary multiple wavelength technology. This technology has been proven in The Pillars Paper to have a “Cascade Eect” that doubles the amount of light that passes the skin barrier compared to individual wavelengths alone.

Pulsing and super pulsing, by nature, have a clean distinctive advantage: their operation, by design, is to minimize heat. Super pulsed laser creates the desired higher peak power; however, due to the ultrashort pulses, there is little resulting heat accumulating within the target tissue. The patented combination of wavelengths in the Multi Radiance Medical device helps to improve the percentage of available light at greater tissue depths. This resolves any issues with the inefficient use of higher powered outputs in continuous wave devices and a poor penetration profile.

It should be noted that in addition to the super pulsed lasers, each Multi Radiance Medical device contains several infrared emitting diodes (IREDs) and LEDs. The addition of visible and infrared wavelengths and light sources provided by both spectrums allows broader coverage of the therapeutic window. To work in concert with the super pulsing laser, both IREDs and LEDs are pulsed to reduce photothermal eects on tissue.

Solving the imbalance between light produced and light absorbed continues with LaserSweep™ technology which will constantly change the pulse duration time in nanoseconds to prevent tissue adaptation. It culminates in arguably the most novel concept in laser therapy, LaserStim: which comes with the unique TARGET and DOSE technology.

Previously, this technology was only available in a corded emitter that attached to the MR4 Console. Now it is available in a battery-operated, cordless model: the ACTIV PRO with LaserStim.

Research, Innovation, Validation, Optimization, Clinical Outcomes. These are the hallmarks of Multi Radiance technology. They are known as not just a laser therapy company, but also as one of the few who can claim NHN clearance (non-heating) as classified by the FDA. Multi Radiance Super Pulsed Lasers are peer reviewed, and practice proven. Want proof? Download the research at: bit.ly/researchMRM