“Smart Laser” is newly developed advanced medical technology. This technology is designed to treat musculoskeletal pain and resides in a category termed low-level laser therapy (LLLT). It is a three-module medical device. Module I has digital sensory capture features that capture data at and below the skin surface. Module I transmits captured sensory data to Module II consisting of a central processing unit (CPU). There the CPU, using proprietary bio-algorithms, calculates and generates a customized digital prescription. The digital prescription primarily uses dual energies (Dynamic Photonic and Dynamic Thermal Kinetic) blended in concert with the sensory data information. The device’s energies reside in the category of low-level laser therapy.
The Dynamic Photonic Energy utilizes photons that cover a wide spectrum of wavelengths residing in both the visible and invisible categories. This digital prescription has multiple parameters that can change thousands of times a second. The customized digital prescription is delivered to the body surface by Module III, the Therapeutic Module. The curvilinear surface of this module, also using proprietary algorithms, delivers the customized digital prescription at the skin surface. Because of the characteristics of this digital prescription, the therapy tends to overcome adaptation (tachyphylaxis), which is the body’s natural mechanism to blunt the response to repeated stimuli. This is a feature that contributes to successful treatment outcomes in this setting. Additionally, this device has the capacity to reduce inflammation and carries the tag, “Digital Anti-inflammatory® Medical Device.”
This “Smart Laser” Device Is Marketed under the Brand Name Willow Curve®
A controlled, double blind, randomized medical study confirmed its efficacy. Physicians and patients observe and report favorable responses using the Curve in over 90% of treatments. These favorable responses include pain relief, reduced stiffness and muscle spasm, increased mobility, enhanced performance, and faster return to activities. To date, there have been over one million treatments administered by over 50,000 patients with no adverse side effects when properly using the device. This is not surprising given that the safety of LLLT is well-established. Indeed, with diodes such as those imbedded in the Willow Curve, the photonic power is lower than that needed to produce anything more than safe minimal heating of tissue.
For example, Nakaji assessed the long-term effects of LLLT in 1,087 patients who were treated by LLLT at a Japanese clinic from April 1992 to August 1995. Questionnaires were sent to subjects in the fall of 1996, thus demonstrating a significant amount of time had passed since treatment. After reviewing the 662 replies, the study concluded that LLLT could be “considered safe, effective, and side-effect-free.”
Similarly, the Abrisham 2011 study evaluated the effect of LLLT on subacromial syndrome shoulder pain in 80 patients. The study noted that none of the participants reported any adverse reaction or side effects. Furthermore, Willow Labs LLC has not received any reports of serious adverse events related to the proper use of the product.
Low-Level Laser Therapy (LLLT) Background Information
LLLT involves exposing cells or tissue to low levels of red and near infrared (“NIR”) light. It is referred to as “low level” because of its use of light at lower energy levels as compared to other forms of laser therapy (e.g., those that are used for ablation, cutting, and thermally coagulating tissue). With LLLT, the energy levels used are lower than those needed to produce significant heating of tissue. Essentially, light is packets of electromagnetic energy, which also have a wave-like property. Wavelength is measured in nanometers and is visible in the 400–700 nm range and also determines how the light will be absorbed. Typically, LLLT devices use wavelengths in the 600–1000 nm range. All LLLT devices work in a similar manner, namely by inducing photo-biomodulation.
LLLT’s benefits were first discovered inadvertently in 1967 by researcher Endre Mester of Semmelweis University in Budapest, Hungary. LLLT has been used for years to reduce neurogenic pain, reduce inflammation, treat hair loss, promote wound healing, and treat acne among other therapeutic treatments.
LLLT has been the subject of numerous studies demonstrating its many health and cosmetic benefits. LLLT came into being in its modern form soon after the invention of the ruby laser in 1960 and the helium-neon laser in 1961. In a study conducted to determine whether laser radiation causes cancer in mice, Mester divided the mice into two groups, shaved the hair from the mice’s backs, and administered low-powered ruby laser treatment to one of the groups. The mice treated with lasers did not develop cancer, but their hair grew back more quickly than mice in the untreated group. He then demonstrated the laser’s ability to stimulate wound healing in mice and then to stimulate healing in non-healing skin ulcers.
Since then, LLLT has developed into a therapeutic procedure that is used to reduce inflammation, edema, and pain in chronic joint disorders and to promote healing of wounds, deeper tissues, and nerves. LLLT is also used to treat painful neurological disorders such as neuropathy and shingles.
There are multiple biochemical mechanisms underlying the therapeutic effects of LLLT. Past and current research and literature are defining these mechanisms. According to Chung9, it appears that LLLT has a wide range of effects at the molecular, cellular, and tissue levels. In addition, its specific modes of action may vary among different applications. Within the cell, there is strong evidence to suggest that LLLT acts on the mitochondria to increase adenosine triphosphate (“ATP”) production (which generates cellular energy), modulation of reactive oxygen species (“ROS”), and induction of transcription factors. Several transcription factors are regulated by changes in cellular redox state. These transcription factors then cause protein synthesis that triggers further effects downstream, such as increased cell proliferation and migration, modulation in the levels of cytokines, growth factors and inflammatory mediators, and increased tissue oxygenation. There is also evidence from Levinson and others that suggests there is likely modification of the sodium ion channels, which modify pain perception.
At the most basic level, LLLT acts by inducing a photochemical reaction in the cell, a process referred to as bio-stimulation or photobiomodulation. When a photon of light is absorbed by a chromophore in the treated cells, an electron in the chromophore can become excited and jump from a low-energy orbit to a higher-energy orbit; various cellular tasks can then use this stored energy. There are several pieces of evidence that point to a chromophore within mitochondria being the initial target of LLLT. Radiation of tissue with light causes an increase in mitochondrial products such as ATP, nicotinamide adenine dinucleotide + hydrogen (“NADH”), protein, and ribonucleic acid (“RNA”) as well as a reciprocal augmentation in oxygen consumption, and various in vitro experiments have confirmed that cellular respiration is upregulated when mitochondria are exposed to a helium-neon (“HeNe”) laser, a recognized form of LLLT, or other forms of illumination.
Immune cells appear to be strongly affected by LLLT. Mast cells, which play a crucial role in the movement of leukocytes, are of great importance in inflammation. LLLT is able to trigger mast cell degranulation, which results in the release of the pro-inflammatory cytokine TNF-a from the cells. This leads to increased infiltration of the tissues by leukocytes. LLLT also enhances the proliferation, maturation, and motility of fibroblasts and increases the production of basic fibroblast growth factor. Collagen deposition is also promoted. Lymphocytes become activated and proliferate more rapidly, and epithelial cells become more motile, allowing wound sites to close more quickly. The ability of macrophages to act as phagocytes is also enhanced under the application of LLLT.
Additionally, LLLT has been shown to cause vasodilation by triggering the relaxation of smooth muscle endothelium, which is highly relevant to the treatment of joint inflammation. LLLT is well known to generate local production of Nitric Oxide (“NO”), which is a potent vasodilator via its effect on cyclic guanine monophosphate production, and it has been hypothesized that LLLT may cause photodissociation of NO, not only from cytochrome c oxidase (“CCO”) but also from intracellular stores such as nitrosylated forms of both hemoglobin and myoglobin, all promoting vasodilation. This vasodilation increases blood circulation, the availability of oxygen to treated cells, and allows for greater traffic of immune cells into tissue. Importantly, these events promote the removal of toxic inflammatory debris, all which contribute to accelerated healing.
The Willow Curve® has passed Federal Communications Commission (“FCC”) testing (47 C.F.R. § 15.109(a) and 47 C.F.R. § 15.107(a)) for radio frequency devices conducted limits and radiation emission limits. It has also passed testing for Canada’s ICES-003, Issue 5 (technical l requirements relative to radio noise generated by Information Technology Equipment).
The Willow Curve® is FDA registered, 510K exempt, and recognized as a low risk medical device to reduce minor musculoskeletal pain, stiffness, and muscle spasm and temporarily increases local blood circulation due to the local release of nitric oxide from LLLT treatment. Willow Curve has been issued a U.S. Federal Government (GSA) Contract (Contract number V797D-70038) to provide Willow Curve devices, paid for by the government, to government employees and veterans. The Department of Health & Human Services Centers for Medicare and Medicaid Services has assigned DME code E0221 to the Willow Curve for Medicare payment. Additionally, the American Medical Association (AMA) CPT Editorial Panel has created a unique CPT code, described as Low-level laser therapy, dynamic photonic and dynamic thermokinetic energies, provided by a physician or other qualified health care professional. This Code will be published in the CPT coding manual in 2019 and available for billing in July 2019.
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