© Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

© Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

LIGHT THERAPY USING POLARIZED, POLYCHROMATIC, LOW ENERGY LIGHT: CLINICAL APPLICATIONS (Title side for slideshow) Presentation entitled ‘Light therapy using polarized, polychromatic, low energy light: clinical applications’. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

CONTENTS INTRODUCTION TO LIGHT THERAPY CHARACTERISTICS OF EMITTED LIGHT TARGET AREAS THERAPEUTIC EFFECTS CLINICAL APPLICATIONS LIGHT THERAPY SYSTEM (Contents page for slideshow) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

INTRODUCTION TO LIGHT THERAPY
(Chapter title slide) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Ultraviolet radiation Electromagnetic spectrum
WHAT IS LIGHT? Light is a form of energy Light has wave-like properties Light is part of the electromagnetic spectrum This is a range of types of radiation from low energy radio waves to high energy gamma rays Energy Wavelength Visible light Ultraviolet radiation Infra-red radiation Microwaves X-rays Gamma-rays Radio waves Electromagnetic spectrum What is light? Light is a form of energy; the ‘packets’ of light energy are called photons. We are familiar with the rainbow and what we call ‘light’ is that spread of colors. The difference between the various colors is defined by their wavelength. Light is part of the electromagnetic spectrum, which also includes gamma rays, X-rays, ultraviolet radiation, infrared radiation, microwaves, and radio waves. The major difference between these different types of radiation is their wavelength and energy content. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

LIGHT THERAPY: HISTORY
Light has been used to treat various medical conditions since ancient times Modern light therapy was pioneered by Niels Ryberg Finsen*, a Danish physician Recent developments in light therapy have used low-power lasers & other sources of polarized light Light therapy: history The use of light therapy in medicine stretches back to the very earliest civilisations known to human-kind. It is known that ancient Greek, Roman and Arabic physicians harnessed natural light for the treatment of different diseases. In the last century, Dr Niels Ryberg Finsen developed the first device to generate synthesized ‘sunlight’. Finsen was awarded the Nobel Prize for Medicine in 1903 for this ground-breaking work. In 1981, a team of Hungarian research physicists created a light source that was originally based on low level laser therapy, but which worked with visible light and a small portion of infrared radiation. The team considered that polarization of light was an important parameter in the induction of photo-biostimulation (active effects of light on the cell). This technology was later used to create the BIOPTRON Light Therapy Systems. * Nobel Prize winner (Medicine) 1903 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

CHARACTERISTICS OF EMITED LIGHT (Chapter title slide) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

CHARACTERISTICS OF EMITTED LIGHT
The light emitted by this light therapy system has specific characteristics Polarized Light waves move in parallel Polychromatic Light emitted from visible & part of infra-red regions of the spectrum Characteristics of emitted light These four crucial parameters are identical in this light therapy system; Polarization Polychromatic Incoherency Low energy Incoherent Light waves are ‘out-of-phase’ Low energy Optimal tissue penetration with minimal heat effects © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

POLARIZED LIGHT Non-polarized light waves move (oscillate) in all directions (planes) Polarized light waves are restricted to oscillate in parallel planes Highly efficient polarization process used (degree of polarization ~95%) Achieved using a system of multi-layered mirrors Polarization Light polarization is generated using a sophisticated multi-layered mirror system, which produces linear polarization by reflection. Polarization is very efficient in this form of light therapy system, and the light emitted by the device reaches a polarization degree of 95%. Non-polarized Polarized © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

POLYCHROMATIC LIGHT Light emitted contains a range of wavelengths (480nm  3400nm) This includes visible light & part of the infra-red region Polychromatic Light Light emitted is polychromatic. This means it contains a wide range of wavelengths including visible light and a part of the infrared range (unlike laser light, which contains just one wavelength). In fact, the wavelength of BIOPTRON Light ranges from 480 nm to 3400 nm. Importantly, the light emitted by these devices does not contain UV radiation. Thus, it cannot cause any damage to the cells’ genetic material. BIOPTRON light 480nm 3400nm No ultraviolet radiation is emitted   safety © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

INCOHERENT LIGHT Light waves emitted by this system are not synchronized, i.e. they are ‘out-of-phase’ BIOPTRON Light Unlike laser light in which all the light waves are synchronized Incoherency As opposed to laser light, the light emitted by the device is incoherent or ‘out-of-phase’ (i.e. the light waves are not synchronized). Laser light © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

LOW ENERGY LIGHT Light waves emitted have low energy density* This provides optimal tissue penetration with minimal heating effect Low energy Light emitted by the device has a low energy density or ‘fluency’. The energy density is approx. 2.4J/cm2 per minute, given that the power density is approx. 40mW/cm2. The energy density/fluency is the same for all three types of the BIOPTRON Light Therapy devices (BIOPTRON Compact III, BIOPTRON Pro 1 and BIOPTRON 2). This energy density has biostimulative effects, which allow the emitted light to induce various beneficial biological processes in the body. HEAT MINIMAL HEAT High energy Low energy *Energy density ~ 2.4 Joules/cm2 per minute *Power density ~ 40 mW/cm2 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

LIGHT CHARACTERISTICS: BENEFITS
This combination of light characteristics confers several benefits; Optimal tissue penetration Minimal heating effects No damage to the skin or underlying tissue No known side effects Light characteristics: benefits This combination of characteristics in the emitted light provides optimal beneficial effects with minimal negative effects to the patient. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

TARGET AREA (Chapter title slide) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

LIGHT PENETRATION INTO TISSUES
When the light therapy device is held over the skin, energy from emitted light penetrates the underlying tissues This produces a biological response (called ‘photo-biostimulation’) Different wavelengths of light can affect different tissues Both visible light & infra-red radiation have been reported to stimulate changes at the cellular level Penetration of light through skin Light emitted by the device has photo-biostimulative effects, which, when applied to the skin, stimulates light-sensitive intracellular structures and molecules. This then initiates cellular chain-reactions and triggers secondary responses; these are not necessarily limited to the treated skin area and may involve the whole body. The different tissues and cell types in the body have their own particular light absorption values and characteristics, and will only absorb light at specific wavelengths. Although both visible and infrared wavelengths penetrate the tissue to different depths and affect the tissues differently, their therapeutic effects are considered to be similar. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

LIGHT PENETRATION INTO TISSUES
Wavelength λ [nm] >1350 Epidermis 0.5 Dermis Penetration of light through skin The figure shows a cross-section of the skin and underlying tissues, and shows the penetration of emitted light through these layers according to the specific wavelength. The penetration of visible light and the infrared portion of the spectrum are slightly different; infrared light penetrates deeper into the tissues. 1.0 ~ Subcutaneous tissue ~ 3.0 Cross-section of human skin & underlying tissues UV Visible Infra-red Penetration depth mm (approx.) BIOPTRON Light © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

POSSIBLE CELULAR TARGETS
Basic science 1 The exact mechanism of action of photo-biostimulation is still under investigation Proposed targets within the cell include Cell membrane Acting on polar heads of phospholipid bi-layer1 Acting on calcium channels2 Mitochondria3 Changes to the local peripheral blood supply may also be involved4 Possible cellular targets Although the exact mechanism of action of photo-biostimulation is still not fully understood, several research groups have suggested various parts of the cell that are likely to be involved. These currently include the cell membrane (i. polar heads of the lipid bilayer [1] and ii. calcium channels [2]) and the mitochondria [3]. Changes to the local blood supply are also likely to be important [4]. 1. Karu T. Health Physics 1989; 56: 2. Smith KC. Laser Therapy 1991; 3: 19-24 3. Kertesz I. Optics & Laser Technology 1982; 16: 31-32 4. Medenica L. J. Wound Care 2003;12: 37-40 1Karu T. Health Physics 1989; 56: Smith KC. Laser Therapy 1991; 3: Kertesz I. Optics & Laser Technology 1982; 16: Medenica L. J. Wound Care 2003;12: 37-40 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

POSSIBLE CELULAR TARGETS OF LIGHT THERAPY
Mitochondrion Cell membrane Human cell Possible cellular targets of light therapy This figure shows the areas of the human cell that are currently believed to play a part in photo-biostimulation, namely the parts of the cell membrane and the mitochondria. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Basic science - #1 The body’s organs (e.g. heart, liver, skin) are made up from different types of tissue A tissue is a collection of cells that are similar in structure & function (e.g. muscle, nerve, bone) A cell is the basic structural unit of the body & each person is made of billions of cells Each cell has an outer layer (cell membrane) & contains specialized structures (organelles) A mitochondrion is one type of organelle; mitochondria are the cell’s ‘powerhouses’ & release energy to power the cell’s activities (Basic science detail aid) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

EFFECTS ON CELL MEMBRANE
Basic science 2 Light therapy may cause structural changes in the cell membrane & alter lipid-protein interactions1 This could reduce the activation energy required for certain enzymatic reactions1 Infra-red radiation has been shown to stimulate the cell membrane, probably via activation of Ca2+ channels2 Membrane protein Lipid bilayer; Head Tail Inside cell Structural changes in cell membrane Effects on the cell membrane This figure shows the possible ways in which light therapy may affect the cell membrane. Light may alter the structure of the cell membrane by interacting with the heads of the lipid bilayer (which carry an electrical charge). This may then affect the proteins situated within the cell membrane, possibly reducing the amount of energy that is then required for certain enzymes to activate. This would make some cell reactions more likely to occur [1]. Furthermore, infra-red radiation has been shown to have a stimulatory effect on the cell membrane, possibly by activating calcium channels [2]. 1. Kertesz I. Optics & Laser Technology 1982; 16; 31-32 2. Smith KC. Laser Therapy 1991; 3: 19-24 Alteration in lipid-protein interactions Decreased activation energy for enzyme reactions 1Kertesz I. Optics & Laser Technology 1982; 16: Smith KC. Laser Therapy 1991; 3: 19-24 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Basic science - #2 The outer layer of the cell is called the cell membrane It is made from a double layer of special fat molecules (phospholipids); sitting in this layer are protein molecules These proteins have various specialized functions; some (called enzymes) act as catalysts for cell reactions Other proteins form ‘channels’ that allow the controlled entry/exit of salts, sugars & other molecules in & out of the cell; one type of channel is the calcium channel Calcium (Ca2+) plays an vital role in passing messages within & between cells (Basic science detail aid) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

EFFECTS ON MITOCHONDRIA
Basic science Outer membrane Absorption of visible light energy by the mitochondria is postulated to activate a chain of molecular events1 This results in an increase in available cell energy & the activation of nucleic acid synthesis (DNA & RNA) This is essential for repairing tissue damage Inner membrane Respiratory chain reactions ADP ATP Effect on mitochondria This figure shows the possible ways in which light therapy might affect mitochondria. It is postulated energy from visible light is absorbed by the mitochondria and stimulates a chain of molecular reactions involving respiratory enzymes. This then results in increased synthesis of ATP, higher cell energy and the activation of nucleic acid synthesis, which is vital for tissue repair processes [1]. 1. Karu T. Health Physics 1989; 56: ATP synthase  Cell energy  Nucleic acid synthesis, etc. 1Karu T. Health Physics 1989; 56: © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Basic science - #3 There are numerous ‘sausage-shaped’ mitochondria within each cell Inside each mitochondrion, various molecular reactions are carried out that release energy This energy is stored in chemical ‘packets’ called ATP molecules Energy released from ATP is required for cellular functions & all cells require a constant supply of ATP Copying the cell’s genetic material (nucleic acids; DNA, RNA) is one process that requires large amounts of ATP (Basic science detail aid) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

OTHER TARGETS Light therapy also causes dilatation of blood vessels in the area treated1 This has several beneficial effects; Improved local blood flow Increased delivery of oxygen Other targets of light therapy Research from other groups has shown that light therapy also causes local blood vessel dilatation in the area treated [1]. This has several potentially beneficial effects on wound healing, including increased local blood flow and increased delivery of oxygen and nutrients [2]. 1. Lievens P. Laser 1988; 1: 6-12 2. Medenica L. J. Wound Care 2003;12: 37-40 Increased delivery of nutrients Promotion of healing 1Lievens P. Laser 1988; 1: 6-12 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

OTHER TARGETS Light therapy may also improve the drainage of extra-cellular fluid into lymphatic vessels This reduces edema (tissue swelling) Reduction of edema helps to decrease pain & improve mobility of the affected area (e.g. a swollen joint) Light therapy may increase the activity of the lymphatic system Light therapy may also increase the activity of the lymphatic system by improving the flow of the lymph (extra cellular fluid) through the lymph vessels. Thus, light therapy could reduce edema (swelling of the tissue). © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

TARGET PROCESS Click on box to launch animation
Animation of possible effects of light therapy on cellular targets, as outlined in previous slides. Click on box to launch animation © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

THERAPEUTIC EFFECTS (Chapter title slide) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

THERAPEUTIC EFFECTS The main therapeutic effects of polarized light therapy are Stimulation of tissue repair Stimulation of body defense mechanisms Therapeutic effects of light therapy The main therapeutic effects of light therapy can be divided into three groups; i. Stimulation of healing – tissue repair and regeneration ii. Stimulation of body defense (immune) mechanisms iii. Reduction of pain sensation Reduction of pain sensation © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

STIMULATION OF TISSUE REPAIR
Basic science 4 Clinical data Light therapy has a stimulatory effect on healing Stimulation of cell proliferation Enhanced collagen synthesis Release of growth factors Acceleration of wound closure Improved quality of scar tissue Demonstrated by in vitro & in vivo data1-4 Findings confirmed by clinical studies5-8 Stimulation of tissue repair and regeneration Polarized light therapy has been shown to stimulate the complex process of wound healing. The biological effects reported include stimulation of cell proliferation (fibroblasts), release of various growth factors, stimulation of collagen synthesis, acceleration of wound closure, increased wound epithelialization and improved tensile strength of scar tissue [1-8]. 1. Mester E. Lasers Surg. Med. 1985; 5: 31-39 2. Kertesz I. Optics & Laser Technology 1982; 16: 31-32 3. Kubasova T. Photochem. Photobiol. 1988; 48: 4. Bolton P. Laser Therapy 1992; 4: 33-37 5. Depuyt K. Abstract from 10th Annual EURAPS Meeting, Madrid, 1999 6. Medenica L. J. Wound Care 2003;12: 37-40 7. Monstrey S. Br. J. Plastic Surg. 2002; 55: 8. Iordanou P. Int. J. Nurs. Pract. 2002; 8: 49-55 1Mester E. Lasers Surg. Med. 1985; 5: Kertesz I. Optics & Laser Technology 1982; 16: Kubasova T. Photochem. Photobiol. 1988; 48: Bolton P. Laser Therapy 1992; 4: Depuyt K. Abstract 10th Annual EURAPS Meeting, Medenica L. J. Wound Care 2003;12: Monstrey S. Br. J. Plastic Surg. 2002; 55: Iordanou P. Int. J. Nurs. Pract. 2002; 8: 49-55 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

STIMULATION OF TISSUE REPAIR WITH LIGHT THERAPY
This figure illustrates some of the potential mechanisms by which polarized light therapy may help to promote wound healing. These include – Stimulation of fibroblast activity and increased production of collagen - Light therapy can significantly improve fibroblast activity of fibroblasts. Fibroblasts are present in the connective tissue and are responsible for the production of the collagen. Collagen is the essential protein for the repair and regeneration of the damaged and old tissues. Enhanced vascularization- Light therapy can stimulate the formation of new blood vessels (angiogenesis). New blood vessels will increase the supply of oxygen and nutrients to the tissues, which is essential for the complex healing mechanisms to occur. Increased phagocytosis by macrophages - Light therapy can stimulate the activity of the macrophages, which are the key cells in phagocytosis. (Phagocytosis is the ingestion of dead or infected tissues that is carried out by phagocytic cells, such as macrophages.) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Basic science - #4 ‘Connective tissue’ provides a structural framework that supports blood vessels, nerves & other tissues/organs Connective tissue is made from different types of cells plus a mix of protein fibers & complex sugars Collagen is one such type of protein fiber; it is found in several places including the lower layers of the skin (dermis) Collagen is important in repairing damage involving the skin (i.e. from cuts, ulcers, surgical incisions) & is the main component of scar tissue Collagen is made by special cells called fibroblasts (Basic science detail aid) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

USE OF POLARIZED LIGHT THERAPY IN THE MANAGEMENT OF VENOUS ULCERS: A PILOT STUDY Aims To assess the efficacy of polarized light in the treatment of venous leg ulcers Treatment regimen All 25 patients given light therapy x8 minutes daily for 4 weeks Concomitant treatment = saline bath & dry dressing Assessment Ulcer size post-therapy (performed weekly) Management of venous leg ulcers: pilot study data (Medenica & Lens 2003) Objective: The aim of this study was to assess the effectiveness of polarized polychromatic incoherent light therapy in treatment of venous leg ulcers. Methods: Light Source –non-invasive and non-thermal optical device with patented technology based on the biostimulative effects of polarized incoherent light in the visible and infrared spectrum (Bioptron 2TM, Bioptron AG, Switzerland). The physical parameters of the output of this light unit were as follows: wavelength 480 – 3400 nm; spot size 254 cm2, average power density, 40 mW/cm2 (at the distance of 10 cm). At each treatment session a patient received a fluence of 19.2 J/cm2. Intervention: All 25 patients were treated with light only. Phototherapy treatments were given for eight minutes daily for four weeks. The light device was kept at the distance of 10 cm from the skin surface. No other therapies that may enhance healing of the ulcer were permitted during the study. The only concomitant therapy consisted of daily rinsing of ulcers with saline followed by simple sterile dry dressing. Wound Assessment: Wound assessment was performed before the treatment, and weekly thereafter until the end of the study period (week 4). Medenica L & Lens M. J. Wound Care 2003; 12: 37-40 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

USE OF POLARIZED LIGHT THERAPY IN THE MANAGEMENT OF VENOUS ULCERS: A PILOT STUDY Results 99% ulcers showed positive improvement in healing area by end of week 4 Decrease in wound surface area at end of study statistically significant (mean decrease 57%; SD 32%; p<0.01) Mean overall healing rate of 3.5cm2 per week (SD 4.1; range to +19.3) Total number of 73 leg ulcers at beginning of study was reduced to 51 after end of week 4 (p<0.01) No adverse effects observed Conclusions Polarized light therapy used as monotherapy was associated with positive healing rates in patients with venous leg ulcers Results: All ulcers except one (72/73 or 98.6%) had a positive value for the change in healing area at the end of four weeks. Twenty two of the 73 ulcers (30.1%) had completely healed by week four. After four weeks, the decrease in the wound surface area was statistically significant (mean 57.15%, SD 31.87%, p<0.01). The total numbers of 73 ulcers at the beginning of the study was reduced to 51 after four weeks (p< 0.01). Mean overall healing rate was 3.53 cm2/week (SD 4.1, range –0.052 to 19.34). Importantly, no adverse effects were observed. Conclusion: Polarized, polychromatic light therapy applied as a monotherapy enhanced wound healing in patients with venous leg ulcers. It is a simple and non-invasive treatment. However, a larger randomized study is required to provide more evidence about advantages of this treatment and its potential application in the management of chronic leg ulcers in the current clinical practice. Medenica L & Lens M. J. Wound Care 2003;12: 37-40 Medenica L & Lens M. J. Wound Care 2003; 12: 37-40 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

USE OF POLARIZED LIGHT THERAPY IN THE MANAGEMENT OF VENOUS ULCERS: A PILOT STUDY This slide shows an example of the efficacy of light therapy in the treatment of venous ulcers of the leg. The marked improvement in the wound after the treatment period is obvious. Immediately before treatment After 4 weeks of treatment Medenica L & Lens M. J. Wound Care 2003; 12: 37-40 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

STIMULATION OF BODY DEFENSE MECHANISMS
Basic science 5 Light therapy may promote non-specific cellular immune responses1 Activation of neutrophil granulocytes Activation of monocytes / macrophages Stimulation of natural killer cells These activities have general bactericidal & anti-tumor effects Stimulation of body defense mechanisms Polarized light therapy has been shown to induce rapid structural and functional modifications of various types of white blood cell [1]. These include increased phagocytic activity in monocytes, increased anti-tumor cell activity by natural killer cells, and increased anti-bacterial activity by neutrophil granulocytes. 1. Samoilova KA. Proceedings of Low-power Light on Biological Systems 1998; IV: (Part of EUROPTO Conference, Stockholm, 1998) 1Samoilova KA. Proc. Low-Power Light Biol. Syst. 1998; IV: © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

STIMULATION OF NON-SPECIFIC IMMUNE REACTIONS WITH LIGHT THERAPY
Red blood cell White blood cells Stimulation of non-specific immune reactions with light therapy This figure shows the possible types of blood cell that may be activated by light therapy to promote immune function in a non-specific manner. Neutrophil granulocyte Monocyte / macrophage Natural killer cell © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Basic science #5 White blood cells (leukocytes) protect the body against infection from viruses & bacteria or infestation from parasites; they are sub-divided into several types - Neutrophil granulocytes attack bacteria Monocytes are large cells that digest foreign material & dead matter; they can leave the bloodstream & enter the tissues, where they are then called macrophages Natural killer cells* eliminate virus-infected cells & tumor cells (*exact origin of these cells is not yet known) [Lymphocytes are a further type of leukocyte involved in immune function; they recognize specific foreign particles (antigens). Lymphocytes are divided into B-cells (produce antibodies) & T-cells (help B-cells, kill infected cells, etc.)] (Basic science detail aid) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

REDUCTION OF PAIN SENSATION
Basic science 6 Clinical data Light therapy may influence pain sensation in several ways1-4 Improved local blood flow Reduction in muscle spasm Reduction of inflammation Induction of natural pain-killing chemicals Reduction of pain transmission by direct action on peripheral nerves Reduction of pain sensation Pain occurs following injury due to the release of chemical mediators that stimulate local pain receptors. These then activate peripheral sensory nerves that transmit the pain impulse, via specific neural pathways to the higher centers of the brain, where it is converted into the sensation of ‘pain’. Muscle spasm and tissue ischemia are major contributory factors to the generation of pain, via both direct stimulation of mechano-sensitive pain receptors and release of pain mediators. Light therapy may reduce pain sensation in several ways [1-4]; i) it may improve local blood supply & reduce muscle spasm, thus reducing stimulation of pain receptors, ii) it may have an anti-inflammatory effect, again reducing release of chemical mediators, iii) it may induce release of natural pain-killing agents, such as endorphins, enkephalins and/or serotonin, and/or iv) it may act directly on nerve fibers to reduce excitability. 1. Konstantinovic L. Vojnosanit Pregl 1989; 46: 2. Sakurai Y. Eur. J. Oral Science 2000; 108: 29-34 3. Walker JB. Neuroscience Letters 1983; 4: 4. Tam G. J. Clin. Laser Med. Surg. 1999; 17: 29-33 1Konstantinovic L. Vojnosanit Pregl 1989; 46: Sakurai Y. Eur. J. Oral Science 2000; 108: Walker JB. Neurosci. Lett. 1983; 4: Tam G. J. Clin. Laser Med. Surg. 1999; 17: 29-33 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

REDUCTION OF PAIN SENSATION WITH LIGHT THERAPY
Cell damage Muscle spasm Tissue ischemia Release of pain & inflammatory mediators Light therapy: potential effects Stimulation of pain receptors & nerve pathways Sensation of pain Reduction of pain sensation This figure shows the potential ways in which polarized light therapy can reduce pain. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Basic science #6 Pain is an unpleasant sensation that serves to limit or reduce injury to the body Pain is caused by the stimulation of special free nerve endings (pain receptors) that occurs when certain chemicals (mediators) are released following an injury Pain impulses travel up the spinal cord and into the brain, where they are interpreted as the sensation of ‘pain’ (Basic science detail aid) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

USE OF POLARIZED LIGHT THERAPY IN THE TREATMENT OF CHRONIC MUSCULOSKELETAL PAIN Aims To assess the efficacy of polarized light in the treatment of chronic musculoskeletal pain in the neck/shoulders Treatment regimen Patients given light therapy or placebo* x10 minutes daily for 3 days (60 patients in each group) (*’Fake’ light therapy with inactive device) Assessment Self-reported degree of pain (VAS 100mm scale) Linear range of motion Management of chronic musculoskeletal pain (Ballyzek & Rusculic 2004) Objective: The aim of this study was to assess the effectiveness of polarized polychromatic incoherent light therapy in the treatment of chronic musculoskeletal pain in the neck/shoulders. Methods: Light Source –non-invasive and non-thermal optical device with patented technology based on the biostimulative effects of polarized non-coherent light in the visible and infrared spectrum (Bioptron CompactTM, Bioptron AG, Switzerland). The physical parameters of the output of this light unit were as follows: wavelength 480 – 3400 nm, average power density 40 mW/cm2 (at the distance of 10cm from skin). Intervention: Patients (n=120) were randomized (1:1) to receive either active light therapy or fake light therapy with an inactive device. Treatments were given for 10 minutes daily for 3 successive days. Pain medication was not permitted during the study period. Assessment: Self-reported degree of pain was assessed using a 100-point scale where 0=no pain and 100= worst pain imaginable (100mm VAS scale). Linear range of motion was also assessed to determine mobility in the affected areas (neck and/or shoulders). Ballyzek MF & Ruscuklic G. Manuscript in preparation 2004 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

USE OF POLARIZED LIGHT THERAPY IN THE TREATMENT OF CHRONIC MUSCULOSKELETAL PAIN Results Statistically significant improvement in degree of pain (VAS) in active therapy group (83% versus 12% for placebo) Mean improvement in pain score was four times higher in active therapy group (31 versus 8 for placebo; p<0.001) For all locations of pain, improvement in range of motion after study period was greater in active therapy group Light therapy was safe & well-tolerated with no side effects Conclusion Polarized light therapy used as monotherapy was associated with improvements in degree of pain & range of movement in patients with chronic neck/shoulder pain Results: Improvement in degree of pain (>30%) was reported in 83% of patients receiving active light therapy versus only 12% of those on placebo. Mean change in degree of pain was four times greater in the active therapy group than the placebo group; 30.6 versus 7.7, respectively (p<0.001). For all locations of pain, improvements in range of motion over the study period were greater in the active therapy group than the placebo group. In addition, light therapy was found to be safe and well-tolerated; no adverse events were recorded. Conclusion: Polarized light therapy is a safe and effective treatment for musculoskeletal pain in the neck and/or shoulders. A larger scale randomized study is now required to confirm these data. Ballyzek MF & Ruscuklic G. Manuscript in preparation 2004. Ballyzek MF & Ruscuklic G. Manuscript in preparation 2004 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

CLINICAL APPLICATIONS OF LIGHT THERAPY (Chapter title slide) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

CLINICAL APPLICATIONS
WOUND HEALING Treatment of burns Treatment of skin ulcers (ulcus cruris, decubitus) Treatment of post-operative wounds Treatment of traumatic injuries PAIN THERAPY Treatment of musculoskeletal pain in rheumatology, physiotherapy and sports medicine Clinical applications of light therapy Polarized light therapy has multiple uses in medicine. The major current applications include - i. Wound healing Treatment of burns; first degree & some second degree burns Treatment of skin ulcers & sores; venous ulcers, diabetic ulcers, pressure sores Treatment of post-operative wounds; surgical incisions Treatment of traumatic injuries ii. Pain therapy Treatment of musculoskeletal pain in rheumatology, physiotherapy and sports medicine © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

CLINICAL APPLICATIONS
Light therapy can be used in many clinical fields Dermatology Rheumatology Care of the elderly Light therapy Physical therapy Clinical applications of light therapy Light therapy can be used in many fields of medicine, as shown in this figure. Pain management Occupational therapy Surgery Sports medicine © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY in rheumatology: osteoarthritis, rheumatoid arthritis (chronic), arthroses in physiotherapy: low back pain, shoulder and neck pain, carpal tunnel syndrome, scar tissue, musculoskeletal injuries in sports medicine: soft tissue injuries of muscles, tendons & ligaments like muscle spasm, sprains, strains, tendonitis, ligament and muscle tears, dislocations, contusions, tennis elbow Clinical applications of light therapy To ii. Pain therapy in rheumatology: osteoarthritis rheumatoid arthritis (chronic) artroses in physiotherapy: low back pain shoulder and neck pain carpal tunnel syndrome scar tissue musculoskeletal injuries in sports medicine: soft tissue injuries of muscles, tendons & ligaments like muscle spasm, sprains, strains, tendonitis, ligament and muscle tears, dislocations, contusions and tennis elbow © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN MANAGEMENT: MUSCULOSKELETAL PAIN
Example: Lower back pain Example application: Lower back pain Treatment with BIOPTRON 2 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN MANAGEMENT: REHABILITATION
Light therapy can be applied to various parts of the body Example application: Rehabilitation in various chronic musculoskeletal injuries BIOPTRON Pro 1 BIOPTRON Compact III BIOPTRON 2 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Rheumatology: Arthritis ‘Arthritis’ is the inflammation of a joint Main symptoms include – Pain, swelling, stiffness & loss of function in the affected joint(s) Huge costs to society – Major cause of disability & poor quality of life Treatment costs + loss of earnings (time off work &/or unemployment; billions per year) There are many different types of arthritis, including – Osteoarthritis Rheumatoid arthritis Clinical applications of light therapy: Arthritis © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Basic anatomy #1: A joint
Ligament Bone Articular cartilage Synovial membrane Synovial fluid Basic anatomy #1: A joint For non-medical audiences only. Articular cartilage – acts as a shock absorber, protects bone Synovial membrane – lines joint & secretes lubricant (synovial fluid) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Osteoarthritis Commonest joint disorder worldwide
Frequency increases with age Present in most all people aged >60 years Degenerative joint disease Caused by wearing away of protective cartilage lining the joints Risk factors: excess weight, injury to bone/joint, manual occupations, sports Clinical applications of light therapy: Osteoarthritis Affects hip, knee, elbow, joints in hand/foot © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Osteoarthritis Disease affecting synovial joints Characterised by loss of articular cartilage with accompanying periarticular bone response Diagnosis based upon symptoms + x-ray appearance + pathological joint changes Main signs: microfractures, bone cysts, osteophyte formation & narrowing of joint space Variable rate of disease progression; symptoms flare up & remit Clinical applications of light therapy: Osteoarthritis Detail slide for health professionals. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Rheumatoid arthritis Occurs in 0.5-3% of population Usual age of onset years old, although can occur at any age Immune disorder affecting joints (& other parts of the body) Caused by inflammation of the synovial membrane lining the joints Risk factors: female gender, family history, certain immunological/genetic characteristics Clinical applications of light therapy: Rheumatoid arthritis Affects small joints in hands/feet, knee, elbow, shoulder, neck © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Rheumatoid arthritis Chronic, progressive, systemic inflammatory disorder of unknown cause Characterised by inflammatory synovitis; ‘pannus’ blocks nutrient supply to underlying articular cartilage Diagnosis based upon history + x-ray changes + blood tests Rheumatoid factor present in ~70% cases; associated with greater disease severity Non-articular disease affects lungs, blood vessels & heart, nerves, eyes, kidneys, etc. Clinical applications of light therapy: Rheumatoid arthritis Detail slide for health professionals. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY BIOPTRON Light Therapy may help to reduce the symptoms of arthritis Clinical applications of light therapy: Treatment of arthritis © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Basic anatomy: Soft tissues
muscle ligaments tendons (bone*) subcutaneous tissue skin Basic anatomy #2: Soft tissues For non-medical audience only. Tendon – connects a muscle to a bone Ligament – connects a bone to another bone (*not a soft tissue) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Sports medicine: Sprains & strains Strain: injury to a muscle or tendon Sprain: injury to a ligament Both are caused by overstretching or tearing Symptoms: pain, swelling, loss of movement,  bruising Sprains commonly involve ankle, knee & wrist Strains commonly affect upper arm, elbow, thigh, ankle, groin & abdomen Risk factors: playing sports, gardening, lifting heavy objects, etc Clinical applications of light therapy: Sprains & strains © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Sports medicine: Dislocations Dislocation: Displacement of bones at a joint Caused by forces pulling a bone into an abnormal position, or by violent muscle contractions Symptoms: pain, swelling, loss of movement,  fracture,  joint damage Commonly affects shoulder, thumb/finger, jaw Risk factors: any violent collision (car crash, falling, contact sport), electrocution Clinical applications of light therapy: Dislocations © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Sports medicine: Contusions Contusion: Bleeding into the tissue beneath the skin surface (bruise) Caused by blunt trauma to the body Pressure of impact ruptures small blood vessels, causing blood to pool around the injured area Symptoms: swelling, pain Risk factors: playing contact sports (martial arts, football, boxing, etc.) Clinical applications of light therapy: Contusions © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Sports medicine: Tendinitis & tenosynovitis Tendinitis: Inflammation around a tendon Tenosynovitis: Inflammation around a tendon sheath Caused by overuse or overloading of the tendon (e.g. tennis elbow) Symptoms: pain, stiffness, weakness, loss of movement Risk factors: playing sports (patellar tendon, Achilles tendon), repetitive hand movements - typing, packing, sewing (tendons in wrist/hand) Clinical applications of light therapy: Tendinitis & tenosynovitis © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY BIOPTRON Light Therapy may help to reduce the symptoms of sports injuries Clinical applications of light therapy: Treatment of sports injuries © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Physiotherapy: Lower back pain Occurs in >75% of people at some point in their lives Recurrent or persistent lower back pain is a major cause of disability 90% of low back pain is caused by injury to tissues in the back and spine Other (less common) causes include spinal infection/inflammation, bone disease and tumours Symptoms: pain, stiffness, difficulty walking/bending, scoliosis Risk factors: lifting, bad posture, obesity, pregnancy, old age, etc Clinical applications of light therapy: Lower back pain © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Physiotherapy: Carpal tunnel syndrome Carpal tunnel is a narrow anatomical passage in the wrist Median nerve passes through it to supply part of the palm, thumb & certain fingers  Clinical applications of light therapy: Carpal tunnel syndrome Swelling of tissues in the carpal tunnel causes compression of the median nerve  loss of sensation & loss of movement in the hand Occurs in 1-3% of the population, more common in women than men (smaller carpal tunnels) Symptoms: numbness or aching in the hand (often worse at night)  weakness/muscle wasting in the thumb Risk factors: prolonged use of hands (typing, sewing, etc), injury or infection in wrist/hand; also seen in pregnancy, diabetes, obesity, arthritis & hypothyroidism © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY Physiotherapy: Neck & shoulder pain Common problem for many people Often due to minor injury, poor sleep position or prolonged work over a computer keyboard Injury to the soft tissues in the shoulder/neck include muscle strain/tear, tendonitis, and whiplash injury Neck/shoulder pain may also occur with arthritis, bone disease (ankylosing spondylitis), disc prolapse and tumours Symptoms: pain, stiffness, difficulty moving head or upper arm,  headache Clinical applications of light therapy: Neck & shoulder pain © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAIN THERAPY BIOPTRON Light Therapy may help as a treatment in physiotherapy Clinical applications of light therapy: Physiotherapy treatment aid © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

WOUND HEALING Burns therapy: partial thickness burns – superficial & deep Skin ulcers: venous leg ulcers diabetic foot ulcers pressure sores Traumatic wounds: surgical wounds – incisions non-surgical injuries – minor cuts & bruises © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Immediately before treatment
WOUND HEALING: BURNS Example: Burns to face & neck Example application: Burns to neck & face Immediately before treatment After 12 days of treatment After 9 months of treatment Source: Dept. Plastic Surgery, University Hospital Ghent, Belgium © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

WOUND HEALING: PRESSURE SORES
Example: Pressure sore to sacrum After 18 days of treatment After 4 weeks of treatment Immediately before treatment Example application: Pressure sore to sacrum (base of back) Source: Dept. Plastic Surgery, University Hospital Ghent, Belgium © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

WOUND HEALING: POST-OPERATIVE
Example: Cardiothoracic surgery Example application: After major cardiothoracic surgery Immediately before treatment After 25 days of treatment Source: First Surgical Hospital, University of Belgrade, Serbia & Montenegro © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Burns Burns are common injuries Young children & elderly people are particularly vulnerable Burns often occur in the home Examples: spilling hot coffee, steam from cooking, flames/hot coals from a fire, excessively hot bath water, etc. Severity of a burn is classified by the depth of injury Partial thickness burn; superficial or deep Full thickness burn Burns (background slide) Burns are common injuries, particularly among young children and the elderly. Most burns occur in the home and are caused by contact with fire, steam, or hot fluids. The severity of a burn wound is determined by how deeply the skin has been damaged and burns are divided into partial or full thickness. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

BASIC HISTOLOGY: NORMAL SKIN & UNDERLYING TISSUES
Cornified layer Granular layer Epidermis Basal layer Loose connective tissue, blood vessels & sensory cells Basic histology: Structures present in normal skin (epidermis) & the underlying tissue layer (dermis) are shown. Dermis Subcutaneous tissue © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Partial thickness - superficial Partial thickness - deep
TYPES OF BURN Partial thickness - superficial Partial thickness - deep Full thickness Types of burn: These figures illustrate the different depths of tissues damage occurring in the different types of burn. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PARTIAL THICKNESS BURNS: SUPERFICIAL
Tissues affected Outer skin layer (epidermis) only Common causes Sunburn (mild) Any sudden & brief burst of heat Signs & symptoms Burn is red & painful – no blisters Medical treatment Basic first aid – cold compress  pain relief; dressing not required Complications None Burn usually heals within a few days Partial thickness burns – superficial: Superficial burns affect only the outer layer of skin (epidermis). The burn wound is red, painful, dry, and without blisters – e.g. mild sunburn. Most superficial burns only require basic first aid (cold compress, pain relief). They normally heal quickly (~7 days); long-term tissue damage is rare and usually consists of a slight change in skin color only. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PARTIAL THICKNESS BURNS: DEEP
Tissues affected Outer skin layer (epidermis) + part of underlying layer (dermis) Common causes Scalds from hot liquids Flames from fire Contact with hot objects Signs & symptoms Burn is deeply red*, painful, swollen + blistered [*may also appear white or ‘wet’] Medical treatment Hospital treatment – if area affected >10-15% total skin area; burns to face/hands/feet/genital area Outpatient treatment for smaller burns – wound is cleaned & protected with a dressing;  pain relief Complications Infection of wound; scarring Burn usually heals within 3-4 weeks Partial thickness burns- deep: Deep partial thickness burns involve the epidermis and part of the skin layer underneath (dermis). The burn wound is red, swollen and painful - e.g. scald from spilling hot coffee over arm. Blister formation occurs with this type of burn wound. Deep partial thickness burns should be reviewed by a doctor. The burn wound is cleaned and treated with suitable dressings (Vaseline gauze or silver sulfadiazine with absorbent gauze), antibiotics and pain-relieving medicine. Severe deep partial thickness burns should be treated in hospital & may require specialist treatment. Deep partial thickness burns can be more difficult to treat and doctors still do not agree on the best method: some prefer to use skin grafts (i.e. surgery), while others believe conservative treatment (wound dressings, antibiotics, etc.) is better. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

FULL THICKNESS BURNS Tissues affected Outer skin layer (epidermis) + all of underlying layer (dermis)  muscle  bone Common causes Severe scalds from hot liquids Prolonged contact with flames or hot objects Electrical or chemical sources Signs & symptoms Wound is white, dry & swollen; skin may be blackened; wound is painless (nerve endings destroyed) Medical treatment Hospital treatment (burns unit) – cleaning of wound (surgery); skin graft may be needed Complications Infection; scarring; loss of function Burn may take many weeks to heal completely Full thickness burns: Full thickness burns destroy the epidermis & dermis. There may also be damage to the underlying tissues, such as bone & muscle. The burn wound is white or charred but is painless, as the nerve endings in the area have been destroyed – e.g. electrical burn. Patients with full thickness burns require urgent admission to hospital. The exact treatment depends upon how much of the body surface area is affected; a patient with burns covering >30% of their body surface area should be sent to specialist burns unit. Full thickness burns may require surgery, as they will not heal without grafting skin over the wound. Treatment may also include intravenous (iv) fluids, iv antibiotics, special diet (high protein), pain relief, warm & humid environment, and plastic surgery to restore function and cosmetic appearance (e.g. hand burn, facial burn). In severe burns, the increased amount of tissue damage makes healing a slow and difficult process (deep partial thickness burns) or prevents it occurring at all (full thickness burns). The longer a burn wound takes to heal the greater the risk of; 1. Excessive scar tissue formation – this may lead to loss of function, poor cosmetic appearance, and the development of contractures 2. Infection – delayed wound closure may allow bacteria to enter the wound and then to get into the bloodstream (causing septicemia) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

WOUND HEALING: BURNS BIOPTRON Light Therapy may help to stimulate wound healing following a burn injury (& may also help to reduce pain from the wound) BLT & treatment of burns: Possible treatment areas. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

SKIN ULCERS A skin ulcer is an erosion in the surface layer of skin (epidermis) that exposes the underlying tissue (dermis, subdermal tissue) Skin ulcers are often difficult to treat & may take many months to heal Common types of skin ulcer include; Venous ulcer (lower leg) Diabetic ulcer (foot) Pressure sore (lower spine, pelvis, back of head, etc.) Skin ulcers: Background slide © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

VENOUS LEG ULCERS 1 person in 50 will develop a venous leg ulcer during their life Commonly occur in elderly people More common in women than men Caused by ‘pooling’ of blood in the veins in the lower leg Treatment includes Regular wound dressing to keep wound clean Compression bandages Elevation of leg when at rest Regular exercise Venous leg ulcers: Venous ulcers are common in elderly people, particularly women: the life time risk of developing a venous ulcer is 1 in 50 (or 2%). They are caused by abnormal flow of venous blood in the lower leg – see next slide for details. Venous ulcers can be very difficult to treat as they can take many months to heal & often recur. To reduce pooling of blood © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

VENOUS LEG ULCERS: DEVELOPMENT
Valves in veins become damaged  allows blood to flow ‘downhill’ towards the feet (due to gravity) Increased pressure from the blood causes fluid to build up in the tissues around the lower leg/ankle Prevents normal flow of oxygen & nutrients to the tissues  begin to die ‘Venous’ ulcer forms normal valve: closes when leg muscles contract, preventing backflow of blood damaged valve: opens when leg muscles contract, allowing backflow of blood x Development of venous leg ulcers: (Basic version for non-health professionals) Blood in the veins of the leg is pushed back towards the heart by the contraction of the leg muscles. Normally, valves within the veins prevent blood from flowing ‘backwards’ (i.e. towards the feet). However, the valves can become damaged (caused by age-related changes, blood clots, varicose veins) and can stop working properly. When this happens, blood can flow back down the leg, where gravity then causes it to pool around the ankle area. The pooling of venous blood around the lower leg/ankle has two main effects; 1. Disruption to normal blood flow - the circulation of blood (carrying food and oxygen) to the tissues is impaired, so the cells in those tissues are starved of essential nutrients and cannot function normally; they will eventually die 2. Increase in pressure the tissues – fluid leaks out from the veins and collects in the tissues, causing swelling of the ankle/lower leg and further impairment to normal cell/tissue function Eventually, the cells in the outer layer of the skin (epidermis) become so damaged that they die and fall off, exposing the tissue underneath (dermis) and forming an ulcer. This process can continue and damage the underlying tissues as well, making the ulcer deeper and more difficult to heal. Venous blood flow: normal Venous blood flow: abnormal © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

VENOUS LEG ULCERS: DEVELOPMENT
Detail slide The precise mechanism for the pathogenesis of venous ulcer formation remains unclear: various theories have been reported Venous stasis and tissue hypoxia were cited as the main etiological factors Later studies recorded elevated oxygen levels in venous blood samples from patients with chronic venous insufficiency and ulcerations, which led to the development of the theory of tissue hypoxia associated with arteriovenous fistulas More recent publications have included reports of the blockade of capillary exchange of gases/nutrients by pre-capillary accumulation of fibrin (subsequently leading to cell death and formation of venous ulceration), and the role of leucocytes in venous ulcer pathogenesis Venous leg ulcer development: (Detail slide for health professionals) The precise mechanism for the pathogenesis of venous ulcer formation remains unclear: various theories have been reported; Venous stasis and tissue hypoxia were cited as the main etiological factors in early studies Later studies recorded elevated oxygen levels in venous blood samples from patients with chronic venous insufficiency and ulcerations, which led to the development of the theory of tissue hypoxia associated with arteriovenous fistulas More recent publications have included reports of the blockade of capillary exchange of gases/nutrients by pre-capillary accumulation of fibrin (subsequently leading to cell death and formation of venous ulceration), and the role of leucocytes in venous ulcer pathogenesis © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

VENOUS LEG ULCER: PATHOLOGY
B Venous leg ulcer pathology: Zone A = the ulcer [highly inflamed tissue, areas of dead (necrotic) tissue within, underlying tissue exposed where dead tissues has fallen off] Zone B = surrounding abnormal tissue [tissue is discolored and looks like a patch of eczema, it is vulnerable to damage] Venous pooling prevents nutrients/oxygen reaching epidermis & the epidermal cells start to die, areas of dead tissue fall off & expose the dermal tissue underneath [zone A]: this is an ulcer Tissue around the ulcer becomes discoloured & eczematous (i.e. itching, flaking skin) [zone B]: it is very vulnerable to injury © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

WOUND HEALING: VENOUS LEG ULCERS
BIOPTRON Light Therapy may help to stimulate wound healing in a venous leg ulcer BLT & treatment of venous leg ulcers: Possible treatment areas. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

DIABETIC FOOT ULCERS Diabetes is becoming more common in many populations People with long-term diabetes often develop foot injuries caused by ulceration Lifetime risk of diabetic foot ulcer is 1 in 10 (10%) Diabetic foot ulcers can become so severe that amputation of the lower leg is required Risk of amputation x15-46 higher for a diabetic Diabetic foot ulcers account for ~25% of all hospital admissions for diabetes (USA & UK) Treatment options; Prevention via patient education, good foot hygiene, etc. Wound care, infection control, surgery Diabetic foot ulcers (background): Diabetes mellitus (types 1 & 2) is increasing in frequency in many populations. People with long-term diabetes have a lifetime risk of developing a diabetic foot ulcer of 1 in 10 (10%). Diabetic foot ulcers can become infected, which can result in gangrene requiring amputation of the lower leg. A diabetic person has an increased risk of amputation that is times higher than for a non-diabetic. Diabetic foot ulcers and their complications account for around 25% of all hospital admissions for diabetes in USA and UK. Treatment of diabetic foot ulcers consists of preventing their occurrence and stopping an existing ulcer from getting worse. Prevention strategies include educating diabetic patients about foot ulcers and the risk factors, and teaching them to look after their feet and to check them regularly for possible injuries. Once an ulcer is present, the wound should be cleaned regularly, any infection should be treated aggressively and, if necessary, surgery may be required to remove dead/infected tissue. Reference: Armstrong DA & Lavery LA. Diabetic foot ulcers: prevention, diagnosis and classification. Am Fam Physician 1998; 57(6) Information from : Armstrong DG & Lavery LA. Am Fam Physician (online) 1998; 57(6) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

DIABETIC FOOT ULCERS: DEVELOPMENT
There are several reasons why diabetic people develop foot ulcers – Diabetes damages nerves supplying sensory information to the legs & feet Diabetic person may not notice when he/she injures his/her foot (e.g. cuts, blisters, etc.); consequently, an injury may worsen before it is detected Diabetes damages blood vessels (arteries) supplying the legs & feet Cells may be damaged by not receiving sufficient nutrients & oxygen; if this is prolonged & severe, the cells will die Diabetes causes other changes that may contribute to foot ulceration Decreased sweating resulting in dry, broken skin Impaired wound healing Foot joint deformity causing areas of increased pressure Diabetic foot ulcers - development: (Basic slide for non-health professionals) There are several reasons why diabetic people develop foot ulcers; Diabetes damages nerves supplying sensory information to the legs & feet. This means a diabetic person may not notice when they injure their foot (e.g. cuts, blisters, etc.) and, consequently, the original injury may become much worse before it is detected. Diabetes damages blood vessels (called arteries) supplying the legs & feet. If the cells do not receive sufficient nutrients & oxygen they will become damaged and eventually die. Diabetes also causes other changes that may contribute to foot ulceration; diabetes damages nerves controlling the release of sweat, which results in decreased sweating and dry, broken skin; diabetes is associated with impaired wound healing; diabetes also causes deformity in some of the foot joints, which can lead to injury due to unequal distribution of pressure on the foot. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

DIABETIC FOOT ULCERS: DEVELOPMENT
Detail slide Factors contributing to diabetic foot ulcer formation – Peripheral neuropathy (loss of protective sensation) Peripheral arterial occlusive disease Autonomic neuropathy (decreased sweating & dry skin) Structural foot deformity (increased focal pressure & movement limitation) Impaired wound healing (poor glucose control) Diabetic foot ulcers - development: (Detail slide for health professionals) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

DIABETIC FOOT ULCERS: LOCATION
Diabetic ulcers commonly develop in the weight-bearing areas on the sole of the foot Diabetic foot ulcers - location: Figures show the common sites for diabetic ulcers on the foot. Problems are made worse by badly fitting footwear. Diabetic ulcers also develop at other pressure points, such as on the toes (which are often deformed in diabetes due to joint damage) © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

WOUND HEALING: DIABETIC FOOT ULCERS
BIOPTRON Light Therapy may help to stimulate wound healing in a diabetic foot ulcer BLT & treatment of diabetic foot ulcers: Possible treatment areas. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PRESSURE SORES Pressure sores can occur in anyone who is unable to move part of their body Sedation (general anesthetic), severe illness (coma, stroke), splinting (broken limb), severe pain, etc. Pressure sores can develop in a matter of hours Pressure sores are ulcers caused by downward pressure of the body’s weight + friction forces Pressure sores can take many weeks to heal & can become infected Pressure sores – background: Pressure sores can occur in anyone (young or old) who is unable to move part or all of their body. For example, pressure sores can develop in people who have been sedated (general anesthetic), or who have a severe illness (coma, stroke), or who have splints on a broken limb, or in those who cannot move due to severe pain or weakness, etc. Pressure sores are ulcers that occur when the downward pressure of the body’s weight, combined with any friction forces, squashes the tissues and prevents normal blood flow. Pressure sores can develop in a matter of hours and can take many weeks to heal. They are vulnerable to infection, which can be fatal in patients who often already have other (severe) illnesses. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Pressure sores: development
Early stage – skin intact Sore (ulcer) formation Deep sore – into muscle/bone e d s b m Downward force of the body’s weight ‘squashes’ the underlying tissue & prevents normal blood flow Tissues are starved of nutrients & oxygen, cells being to die & an ulcer (or ‘sore’) begins to form Severe sores can extend down into muscle, bone & even joints Bony parts of body are more vulnerable to development of pressure sores Wet skin is more susceptible to damage (e.g. incontinence) Development of pressure sores: Figures showing progression of a pressure sore. e = epidermis d = dermis s = subcutaneous tissue m = muscle b = bone © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Pressure sores: location
Pressure sores develop in bony, weight-bearing parts of the body Location of pressure sores: Figures showing normal position of pressure sores. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

WOUND HEALING: PRESSURE SORES
BIOPTRON Light Therapy may help to stimulate wound healing in a pressure sore BLT & treatment of pressure sores: Possible treatment areas. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

TRAUMATIC WOUNDS: SURGICAL INCISIONS
A surgical incision is a wound made during surgery by a cutting instrument, such as a scalpel There are many different types of surgical incision Chosen by the surgeon depending on the procedure being carried out 2 3 1 Example: Abdominal surgical incisions Traumatic wounds: Traumatic wounds can include those made intentionally during surgical procedures (surgical incisions) and those made ‘accidentally’ (cuts & bruises). 5 1 Midline 2 Paramedian 3 Subcostal 4 McBurney 5 Pararectus 6 Low transverse abdominal 7 Pfannenstiel 4 1 6 7 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

SURGICAL INCISIONS The edges of a surgical incision are sewn or stapled together to close the wound & promote healing Complications include wound infection, delayed healing, & scarring Incision Incision with sutures epidermis dermis blood vessel (cut) Surgical incisions: The edges of a surgical incision are closed using sutures or staples (or sometimes even special glue!). This helps the wound to heal more quickly and with less risk of scarring. Complications include wound infection, delayed healing, & scarring. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

TRAUMATIC WOUNDS: NON-SURGICAL INJURIES
Non-surgical traumatic injuries include incisions + lacerations & contusions Incisions Clean cut from a sharp object (e.g. knife or broken glass) Wound edges are straight May bleed profusely as blood vessels cut Lacerations Rough tear caused by crushing or ripping forces Tissue damage & increased risk of infection Less bleeding Contusions Rupturing of blood vessels beneath skin (bruising) caused by blunt force or punch Fracture to bone or other internal injury may be present Non-surgical injuries: Non-surgical traumatic injuries include incisions + lacerations & contusions Incisions are ‘clean’ cuts from a sharp object (e.g. knife or broken glass). The wound edges are generally straight, which makes healing easier. Incisions may bleed profusely as blood vessels are often cut through when the wound is made. Lacerations are ‘rough’ tears caused by crushing or ripping forces. There is more tissue damage and, therefore, an increased risk of infection. Lacerations tend to bleed less as the blood vessels may not have been cut. Contusions occur when blood vessels beneath skin rupture and blood leaks out (bruising). They are caused by blunt force or punching. Severe contusions may indicate internal injuries beneath, such as a bone fracture. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

NON-SURGICAL INJURIES
Figures show the three types of non-surgical injury previously described. Incision: Clean edges Profuse bleeding Laceration: Rough tear Tissue damage Contusion: Bleeding from small blood vessels under the skin © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

WOUND HEALING: TRAUMATIC WOUNDS
BIOPTRON Light Therapy may help to stimulate wound healing following a traumatic wound BLT & treatment of traumatic wounds: Possible treatment areas. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

NEW INDICATIONS FOR THE USE OF BIOPTRON LIGHT THERAPY
In addition to the existing clinical applications of BIOPTRON Light Therapy, four new sets of indications have been added - Dermatological conditions Paediatric indications Indications in the newborn baby Seasonal affective disorder © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

DERMATOLOGICAL CONDITIONS
Acne Atopic dermatitis Psoriasis Herpes infections Superficial bacterial infections Oral mucosal lesions © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

NORMAL SKIN STRUCTURE Cornified layer Epidermis Granular layer Basal layer Sebaceous gland Dermis Hair follicle Sweat gland Blood vessels Subcutaneous fat © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

DERMATOLOGY: ACNE Acne vulgaris Common rash occurring on the face, back & chest Mainly affects teenagers & young adults More common in males (testosterone dependent) Caused by blockage & inflammation of the sebaceous glands ‘Blackheads’ & inflammatory pustules Often heals with scarring Can cause adverse psychosocial effects Poor self-image, low self-confidence, depression Treatment Topical then systemic - antibiotics, retinoids © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

ACNE: COMEDONE LESIONS
Blackhead (open comedone) Whitehead (closed comedone) Sebum oxidized & darkened Sebaceous gland duct blocked by ‘plug’            Bacteria        Hair follicle © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

BIOPTRON LIGHT THERAPY & ACNE
BIOPTRON Light Therapy may help to treat acne by reducing skin inflammation & promoting healing © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

BLT STUDY DATA: ACNE Patient details 60 juvenile patients with acne & other skin disorders (atopic dermatitis, herpes simplex, boils) BLT regimen Duration: 2-4 minutes per treatment area Frequency: 3 to 12 exposures in total per day (depending upon number of treatment areas) Results Good therapeutic response observed in 91% patients Reduced skin healing time No damage to skin following treatment Conclusions Clinical observations confirm marked benefits & healing effects of BLT Patient tolerance was good Device was easy to use BLT Study Data: Herpes skin infections Institution: Russian Scientific Center of Reconstructive Medicine & Balneotherapy Author: MA Khan Data source: Internal Report, Moscow, 2001 Patients: 60 juvenile patients with acne and other skin disorders (including atopic dermatitis, peri-oral Herpes simplex virus infection, furuncles, etc) BLT: Treatment given for 2-4 minutes per treatment area, 3 to 12 times per day (depending upon number of areas to be treated); total exposure 2 to 10 minutes Results: BLT achieved a good therapeutic effect in 91% of patients. Time taken for skin lesions to heal was reduced. There was no damage to the skin. Conclusions: These clinical observations confirm the marked benefits and healing effects of BLT. In addition, the BLT devices were well tolerated and were easy to use. MA Khan, Russian Scientific Center of Reconstructive Medicine & Balneotherapy, Moscow,2001 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

BIOPTRON LIGHT THERAPY & ACNE
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DERMATOLOGY: ATOPIC DERMATITIS
Atopic dermatitis (‘eczema’) Common condition Occurs in >5% population More common in children (up to 15%) Also called ‘endogenous’ eczema Occurs in people with allergies (hay fever, asthma) Exacerbating factors = detergents, animal fur, some foods, (house dust mites??) Main clinical features Skin reddens & tiny vesicles may form  itching Surface thickens & cracks  bleeding  painful Secondary infection may occur

ATOPIC DERMATITIS (CONTINUED)
Quality of life issues with atopic dermatitis Constant itching/soreness, loss of sleep (child & parents) Embarrassment at skin lesions Treatment of atopic dermatitis General treatment Avoid known irritants Topical therapy Topical steroid cream + barrier cream + bath soap substitute 2nd line agents (severe disease) UV therapy, oral steroids, immunosuppressants Prognosis Children commonly ‘grow out’ of the condition Older children & adults often have chronic disease

ATOPIC DERMATITIS: PATHOLOGY
Normal skin Fully developed atopic dermatitis lesion Hyperkeratosis & parakeratosis (skin scales) Spongiosis (vesicles)

ATOPIC DERMATITIS: COMMON AREAS AFFECTED
adult

BIOPTRON LIGHT THERAPY & ATOPIC DERMATITIS
BIOPTRON Light Therapy may help to treat atopic dermatitis by reducing skin inflammation & promoting healing

BLT STUDY DATA: ATOPIC DERMATITIS
Patient details 36 patients with atopic dermatitis; Males & females aged years IgE levels IU/mL BLT regimen Duration: 10 minutes per session Frequency: 1 session per day Course: ≥10 sessions Results & conclusions 21/36 (58%) patients showed immediate improvement, 6/36 (17%) patients improved with co-application of skin ointment Complete remission observed in several patients Erythema & skin fissuring decreased Itching & excoriation eliminated BLT shows good therapeutic effects in this disease BLT Study Data: Atopic dermatitis Institution: Allergy and Immunology Department, Prague, Czech Republic Author: L Pennigerova Data source: Congress Proceedings, Abstract Book, Prague 2005 Patients: Data was collected from 36 patients with atopic dermatitis. Patient details; ages years, male & female, Immunoglobulin E (IgE) levels in the range 262 to 2345 IU/mL. All patients were stable. Flexural predilection was identified. Medication included antihistamines & topical therapy only. BLT: Given for 10 minutes for 1 session per day; each treatment course lasted for at least 10 sessions. Results: Immediate improvement was observed in 21/36 patients and a further 6 patients improved upon co-application of topical skin ointment. Several patients had complete remission of their lesions. Erythema was reduced, skin fissuring decreased, itching & excoriation were eliminated. Conclusions: BLT provided good therapeutic results in the treatment of atopic dermatitis. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

DERMATOLOGY: PSORIASIS
Psoriasis is an incurable, chronic skin disorder Affects up to 3% of the population Men & women affected equally 25% patients have clinically severe disease 10-15% patients also have destructive arthropathy Aetiology not fully understood Genetic component + environmental factors T-cell disorder Clinical features Well defined, red, scaly patches Commonly on extensor surfaces (knees, elbows) Associated with reduced quality of life issues Low self-confidence/ self-esteem, employment, etc.

PSORIASIS Treatment of psoriasis Prognosis
Concerned with control of disease not cure Topical therapies (mild/moderate disease) Emollients, steroids, retinoid, coal tar extracts Phototherapy Psoralen UV-A, UV-B Systemic therapies (severe/resistant disease) Methotrexate, ciclosporin, acitretin Careful monitoring for toxic side effects Prognosis Relapsing-remitting pattern is common Many patients have the disease for life Disease severity cannot be predicted

Fully developed psoriatic lesion
PSORIASIS: PATHOLOGY Normal skin Fully developed psoriatic lesion Hyperkeratosis & parakeratosis (skin scales) Sterile pustule Inflammatory cells Rete ridges accentuated Dilated blood vessels

BIOPTRON LIGHT THERAPY & PSORIASIS
BIOPTRON Light Therapy may help to treat psoriasis by reducing skin inflammation & promoting healing

DERMATOLOGY: HERPES SKIN INFECTIONS
Herpes viruses Cause a wide range of human disease Characterized by their ability to become latent (silent) & persist within an individual for life Two main types of herpes virus considered here; Herpes simplex virus HSV type 1 – cold sores (HSV type 2 – genital herpes) Varicella zoster virus Chickenpox – children Shingles – older adults

HERPES SKIN INFECTIONS
Treatment Complications Symptoms Entry into body Chickenpox: Aciclovir (adults) Shingles: Aciclovir, valaciclovir, faciclovir Prophylaxis – Zoster immunoglobulin Chickenpox: Pneumonia, CNS involvement (rare) Shingles: Eye complications, persistent pain Chickenpox: days after initial exposure → malaise, fever & rapid development of vesicles Shingles: Reactivation of latent VZV from spinal/cranial nerve → severe dermatomal pain & skin lesions Via upper respiratory tract mucosa Aciclovir – oral, cream Corneal ulceration, acute encephalitis, erythema multiforme (all rare) Primary infection is usually subclinical. Viral reactivation causes ‘cold sore’ around mouth/lips. Recurrence occurs in ~1/3rd of people. Via the mouth (or skin) Herpes simplex 1 Varicella zoster

BIOPTRON LIGHT THERAPY & HERPES SKIN INFECTIONS
BIOPTRON Light Therapy may help to treat herpes skin infections by reducing skin inflammation, stimulating the immune system & promoting healing

BLT STUDY DATA: HERPES SKIN INFECTIONS
Patient details 20 patients with Herpes simplex (HS) lesions 12 patients with Herpes zoster (HZ) lesions (Male & female, aged 15 – 60 years) BLT regimen Duration: 3-4 minutes per session Frequency: 2 sessions per day Results Good therapeutic response observed in 85% patients Pain & itching disappeared after 1-2 days HS group & after 1-3 days HZ group No permanent skin changes after treatment Neurological pain reduced by 50% in HZ patients Conclusions Clinical observations confirm analgesic, anti-inflammatory & healing effects of BLT Device was easy for patients to use at home BLT Study Data: Herpes skin infections Institution: Belarusian Academy of Postgraduate Training Authors: LE Kozlovskaya & VS Ulaschik Data source: Internal Report, Minsk, Belarus, 2001 Patients: 20 patients with peri-oral Herpes simplex virus infection & 12 patients with Herpes zoster infection; patients male & female, aged years old BLT: Treatment given for 3-4 minutes, 2 times per day Results: BLT achieved a good therapeutic effect in 85% of patients. Pain & itching resolved after 1-2 days for H. simplex lesions and after 2-5 treatment sessions (1-3 days) for H. zoster. There was no damage to the skin. Conclusions: These clinical observations confirm the analgesic, anti-inflammatory & healing effects of BLT. In addition, the BLT devices were easy for the patients to use at home. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

DERMATOLOGY: SUPERFICIAL BACTERIAL INFECTIONS
Infection usually prevented by skin’s normal ‘friendly’ bacterial flora Damage to epidermis can allow penetration by pathogens & subsequent skin infection Common pathogens include staphylococcus & streptococcus Bacterial skin infections considered here; Impetigo Boils Erysipelas

SUPERFICIAL BACTERIAL INFECTIONS: IMPERTIGO
Impetigo Staphylococcal skin infection (90% cases) Bacteria penetrate the outer layers of epidermis Pus collects beneath cornified layer Commonly seen in younger children Spread by direct contact → highly infectious! Clinical features Yellow-orange pustules + crusting Pustules rupture easily Treatment Topical antibiotic cream Add oral antibiotics if severe

SUPERFICIAL BACTERIAL INFECTIONS: BOILS
Boils (furuncles) Caused by staphylococcus infection Entry via hair follicle Commonly seen in young adults Associated with local trauma, illness, poor nutrition Clinical features Painful, red swellings with central ‘core’ Often recurrent Large boils = caruncle Treatment Oral antibiotics  incision & drainage

SUPERFICIAL BACTERIAL INFECTIONS: ERYSIPELAS
Superficial infection of dermis Usually caused by streptococcus Entry via trauma site or leg ulcer Commonly affects lower leg or face Clinical features Hot, red area on the skin Well-demarcated edges Overlaps clinically with cellulitis Treatment Antibiotics – oral; iv (severe disease)

BIOPTRON LIGHT THERAPY & SUPERFICIAL BACTERIAL INFECTIONS
BIOPTRON Light Therapy may help to treat superficial bacterial skin infections by reducing skin inflammation, stimulating the immune system & promoting healing

DERMATOLOGY: ORAL MUCOSAL LESIONS
The oral mucosa is affected by various conditions; Stomatitis Inflammation of the lining of the mouth Multiple causes (infection, allergy, illness) Chelitis Fissuring of the corners of the mouth Caused by dentures, infection, deficiency states Aphthous ulcers Small, painful ulcers on tongue or cheeks Occur in ~20% population Normally heal without scarring

BIOPTRON LIGHT THERAPY & ORAL MUCOSAL LESIONS
BIOPTRON Light Therapy may help to treat oral mucosal lesions by reducing inflammation, stimulating the immune system & promoting healing

BLT STUDY DATA: ORAL MUCOSAL LESIONS
Patient details Patients with various types of oral mucosal disease were divided into 2 groups; Test group = conventional medical treatment + BLT Control group = conventional therapy only BLT regimen Details not available Results & conclusions Test group results: Re-epithelialization of the lesions x1.6 faster Superior condition of the mouth & teeth Good improvement in patients with sialosis / gingivitis BLT provides an effective therapy in oral diseases BLT Study Data: Oral mucosal lesions Institution: Ural State Medical Acdemy, Ekaterinburg, Russia Authors: VI Shilko Data source: Report of patient series, Russia, 2000 Patients: Patients with various types of oral mucosal disease, including traumatic injury, stomatitis, chelitis, Vincent’s ulcero-necrotic gingivostomatitis and chronic aphthous ulcers Patients were divided into 2 groups; Test group - treated with BLT + conventional medical treatment Control group - treated with conventional therapy only BLT Treatment: Details were not available Results: Patients receiving BLT showed more rapid re-epithelialization of the lesions (1.6-fold faster than the control group), and exhibited superior conditions of the mouth & teeth. Patients with sialosis or gingival inflammation also showed good improvement following BLT. Conclusions: BLT provides an effective therapy in the treatment of oral mucosal diseases © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAEDIATRIC INDICATIONS
BIOPTRON Light Therapy can be used to treat the following types of condition in children; Paediatric dermatological conditions Allergic eczema, skin infections Paediatric respiratory conditions Upper respiratory tract infections Paediatric musculoskeletal conditions Arthritis, congenital conditions, bone fractures, etc. Paediatric neurological disorders Polio, degenerative conditions, etc.

PAEDIATRIC INDICATIONS: DERMATOLOGY
Allergic eczema Background Affects >15% of children; onset between 2-18 months Often a family history of allergy ~70% cases resolve by age 11 years Clinical features Inflamed, red skin patches  weeping Itching, scratching, loss of sleep Secondary infection common Treatment Topical steroid cream + barrier cream + bath soap substitute Prevent of scratching, cotton underclothes  Mild night sedation  Antibiotics for secondary infection

PAEDIATRIC ALLERGIC ECZEMA: COMMON AREAS AFFECTED

PAEDIATRIC INDICATIONS: DERMATOLOGY
Paediatric skin infections Viral infections Bacterial infections Herpes simplex Eruption of painful blisters around the mouth & nose; oral aciclovir for severe infections only Impetigo Contagious staphlococcal skin infection; small pustules with honey-coloured crusts; topical antibiotic cream Varicella zoster Causes chickenpox – malaise, fever & vesicular rash on trunk/head; lesions resolve spontaneously, usually with complete healing Erysipelas Streptococcal infection of dermis, commonly affects leg or face; affected skin area is hot, red & swollen Molluscum contagiosum Caused by a pox virus; multiple small lesions at any site on body, spread by direct contact, ‘crops’ may continue for 6-12 months; resolves spontaneously

PAEDIATRIC INDICATIONS: RESPIRATORY
Upper respiratory tract infections in children treated with BIOPTRON Light Therapy Commonly caused by viral infections Children <5 years have up to 8 episodes per year Coryza (common cold) Rhinovirus (multiple strains) Nasal discharge, blockage, sneezing, malaise Symptomatic treatment Sinusitis Infection (bacterial) of paranasal sinuses Headache, facial pain, nasal discharge Antibiotic therapy Tonsillitis Adenovirus (50% cases) Sore throat, malaise

BLT STUDY CASE: RESPIRATORY DISEASES (CHILDREN)
Patient details 331 children with various respiratory diseases; Susceptible to frequent illnesses Bronchial asthma 46 Sinusitis Acute respiratory viral infection 85 BLT regimen Duration: 4-6 minutes per treatment area [+ conventional treatment] (Face, submandibular & cervical lymph nodes, pharynx, immune organs & reflexogenous zones) Frequency: 2 sessions per day Course: sessions (bronchial asthma 2-3 courses per year) Results & conclusions Pharynx pain disappeared by Day 2 Reduction of tissue swelling & restored nasal breathing by Day 3 Complete clinical recovery around Day 4 Asthma remission after 2nd treatment course in 58% children Clinical observations support use of BLT in children BLT Study Data: Respiratory diseases in children Institution: Krepysh Regional Children’s Rehabiliation Center, Tyumen, Russia Authors: GA Antonova, NV Demina, EA Komoltseva Data source: Report, Russia, 2003 Patients: Data from 331 children with various respiratory diseases were collected over a 3-year period, including those susceptible to frequent illnesses (n=148), bronchial asthma (n=46), sinusitis (n=52), acute respiratory viral infection (n=85) BLT: Treatment given for 4-6 minutes per treatment area, for 2 sessions per day; each treatment course lasted for sessions. Treatment areas included the face, submandibular & cervical lymph nodes, pharynx, immune organs & reflexogenous zones. Children with bronchial asthma received 2-3 courses of BLT per year. Conventional medical therapy was also given to all patients. Results: Pharynx pain was relieved within 2 days, blocked nose was reduced (normal nose breathing restored) within 3 days and complete clinical recovery was observed by the 4th day. Bronchial asthma remission following 1 and 2 treatment courses was achieved in 32% and 58% patients, respectively. Conclusions: Clinical observations support the use of BLT in children. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

BLT STUDY DATA: EFFECTS OF RADIATION
Patient details Children & adolescents exposed to acute & chronic radiation from the Chernobyl catastrophe BLT regimen Treatment applied to sacrum & sternum; BLT-1 device x6 areas irradiated (30 min exposure) BLT-2 device x2 areas irradiated (20 min exposure) Results Respiratory system; Increased permeability of small/medium bronchi Recovery of bronchial epithelial function Hematology; Increased number of leukocytes, T- & B-lymphocytes Conclusions Both types of BLT devices provided similar efficacy BLT Study Data: Light therapy in victims of the Chernobyl catastrophe Institution: Nuclear Radiation Medicine Center, National Academic Science, Kiev, Ukraine Authors: SA Gulyar, EI Stepanove, IE Koplakov, VY Vdoevenko, VG Kondrashova Data source: AA Bogomoletz Institue for Physiology (at NAS, Kiev) Patients: Children & adolescents exposed to acute & chronic radiation from the Chernobyl catastrophe BLT: Treatment applied to areas in the sacrum & sternum; 6 areas were irradiated using BLT-1 device (30 min exposure) & 2 areas were irradiated using the BLT-2 device (20 min exposure) Results: Main results are summarized as follows – Improved function of respiratory system – increased permeability of small/medium bronchi, recovery of bronchial epithelial function Positive hematology changes– increased number of leukocytes, increased number of T- & B-lymphocytes Conclusions: Both types of BLT device provided similar efficacy in treating young people exposed to radiation © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAEDIATRIC INDICATIONS: MUSCULOSKELETAL
Musculoskeletal conditions in children treated with BIOPTRON Light Therapy Juvenile chronic arthritis Still’s disease, ankylosing spondilitis, rheumatoid arthritis, etc. Chronic pain & swelling of the joints  systemic symptoms Congenital orthopaedic conditions Deformity of spine, leg/foot Traumatic conditions Bone fractures, post-surgical wounds, injury

BLT STUDY DATA: CHRONIC MUSCULOSKELETAL DISORDERS
Patient details 98 children (<1 year to 18 years old) Various musculoskeletal disorders; juvenile rheumatoid arthritis, flaccid paralysis, torticolis, muscular contractures & scoliosis BLT regimen Details not provided Results BLT was effective in; Alleviation of pain Healing of wounds (caused by immobility) Decrease of muscle hypertonia Conclusions BLT was a useful in the treatment & rehabilitation of children with these types of medical problems BLT Study Data: Musculoskeletal disorders in children Institution: MS Curie Hospital, Pediatric & Rehabilitation Sections, Bucharest, Romania Author: L Padure Data source: Congress Proceedings, also presented at BIOPTRON seminar in Bucharest, September 2004 Patients: 98 children aged <1 year to 18 years old with various musculoskeletal disorders, including juvenile rheumatoid arthritis (n=15), flaccid paralysis (n=67) and other conditions, such as torticolis, muscular contractures & scoliosis BLT: Treatment details not given Results: BLT proved its efficiency in the following; Alleviation of pain Healing of wounds (caused by immobility) Decrease of muscle hypertonia Conclusions: BLT has provided a useful tool in the treatment & rehabilitation of children with these types of medical problems © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

BLT STUDY DATA: MUSCULOSKELETAL INJURIES (CHILDREN)
Patient details 78 children with musculoskeletal injuries; Test group (n=48) = conventional medical treatment + BLT Control group (n=30) = conventional therapy only BLT regimen Duration: 4-6 minutes Frequency: 2 sessions per day Results Children receiving BLT (test group) demonstrated - Faster reduction in pain levels Faster recovery time Conclusions Good therapeutic effect with BLT & no side effects observed Children had no negative emotions regarding BLT BLT Study Data: Musculoskeletal injuries in children Institution: Trauma Department, GN Speransky Municipal Children’s Clinical Hospital, Moscow, Russia Authors: IA Burkin, VS Okatyev Data source: Report, Moscow, 2004 Patients: 78 children (aged 1 to 15 years old) receiving treatment for musculoskeletal injuries, including fractured long bones, soft tissue injuries, knee arthroscopy. The children were divided into 2 groups; Test group – 48 children; given conventional medical treatment plus BLT Control group – 30 children; given conventional medical treatment only BLT Treatment: Given for 4-6 minutes per treatment area and for 2 sessions per day. The BLT device was held 15 cm from the treatment area. Results: All children treated with BLT showed positive results, including improvement in general condition, reduced pain, muscular relaxation and improved sleep. Reduction in pain levels occurred earlier in children treated with BLT and their time to recovery was 1.5-fold shorter than children who did not receive BLT. Conclusions: BLT had a good therapeutic effect and no side effects were observed. Importantly, the children were not afraid of BLT because it was quiet, clean and painless. BLT enhances the effects of conventional treatment in traumatic injuries in children. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

PAEDIATRIC INDICATIONS: NEUROLOGY
Neurological conditions in children treated with BIOPTRON Light Therapy Poliomyelitis Peripheral nerve palsies Traumatic injuries to nerves Inflammatory neurological disorders Degenerative neurological disorders Neuromuscular disorders

BLT STUDY DATA: NEUROLOGICAL DISORDERS
Patient details 315 patients with various neurological diseases (affecting PN, CNS, spinal cord, brain) BLT regimen Duration: 10 minutes per session Frequency: 3-4 sessions per day Results & conclusions BLT provided good therapeutic effect BLT had several advantages over other types of treatment; BLT reduced pain levels effectively BLT allowed faster recovery time in some patients BLT could easily be combined with other treatments BLT was simple to use, clean, painless & inexpensive BLT was easy to use in patients who had limited mobility BLT Study Data: Neurological disorders Institution: Spa Pineštany, Liečebny dom Pro Patria, Slovakia Authors: R Čunčikova, M Tóthová Data source: Report, , Slovakia Patients: 315 patients with various neurological diseases, including damage to peripheral nerves, polyneuropathies, CNS disorders, spinal cord disorders, degenerative diseases and states post-cerebrovascular event BLT: Given for 4-6 minutes several times per day, as required Results & conclusions: BLT provided a good therapeutic effect and was noted to have several advantages over other types of treatment; BLT reduced pain levels effectively BLT allowed faster recovery time in some patients BLT could easily be combined with other types of treatment BLT was simple to use, clean, painless & inexpensive BLT was easy to use in patients who had limited mobility © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

BIOPTRON LIGHT THERAPY & PAEDIATRIC INDICATIONS
BIOPTRON Light Therapy may help to treat various conditions in children by reducing pain & inflammation, stimulating the immune system & promoting healing

INDICATIONS IN THE NEW BORN BABY
BIOPTRON Light Therapy can be used to treat the following types of condition in newborn babies Traumatic injuries Lacerations, abrasions, bruises, etc. Nappy / diaper / napkin rash (intertrigo) Caused by Candida infection Phlebitis Caused by intravenous lines/injections Pressure sores In babies that are unable to move normally

BIOPTRON LIGHT THERAPY & INDICATIONS IN THE NEW BORN BABY
BIOPTRON Light Therapy may help to treat various conditions in newborn babies by reducing pain/inflammation, stimulating the immune system & promoting healing

BLT STUDY DATA: CONDITIONS IN NEWBORN INFANTS
Patient details Newborn babies (requiring Life Support & ICU therapy) Various illnesses; phlebitis, skin necrosis, pressure sores & skin infections, etc BLT regimen Duration: 10 minutes per session Frequency: 3-4 sessions per day Results Babies all responded well Best results obtained for treatment of phlebitis Pain reduced within 24 hours Skin problems improved within 2-3 days Conclusions BLT was an effective treatment in newborn babies Parents were very happy with BLT BLT also suitable for low birth weight infants BLT Study Data: Conditions in newborn infants Institution: Department of Pediatrics & Adolescent Medicine, General University Hospital Prague, Czech Republic Authors: O Cerná Data source: Congress Proceedings Abstract Book, Prague 2005 Patients: Newborn babies admitted to the Life Support and Intensive Care Unit with various illnesses, including phlebitis (caused by IV or intra-arterial lines, etc.), skin necrosis (caused by intra-arterial injection), pressure sores & skin infection (intertrigo) BLT: Given for 10 minutes and for 3-4 sessions per day Results: The babies responded well to BLT and no side effects were observed; the best results were achieved for treatment of phlebitis. Pain was reduced within 24 hours; skin problems improved within 2-3 days. Conclusions: BLT was a good treatment in newborn babies and their parents were very happy with the treatment. BLT was also suitable for use in very low birth weight infants. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

SEASONAL AFFECTIVE DISORDER (SAD)
SAD & bright light therapy BIOPTRON 2 13,000 to 14,000 lux BIOPTRON Compact III 10,000 to 22,000 lux BIOPTRON Pro 1 10,000 to 20,000 lux Indoor light <500 lux Outdoor (cloudy) <5000 lux Midday summer sun >50,000 lux

BIOPTRON LIGHT THERAPY & SEASONAL AFFECTIVE DISORDER
BIOPTRON Light Therapy may help to treat seasonal affective disorder by providing a source of bright light therapy

BLT STUDY DATA: LIGHT THERAPY & SAD
>60 studies carried out worldwide Response rates 60% - 90% Light therapy = 1st line treatment for SAD Mild side effects reported after light therapy Eye strain/visual disturbance 19-27% Headache 13-21% Agitation 6-13% No damage to eye or retina Finland study (Lönnqvist) Office workers received light therapy November - February Improvement in mood, energy levels, alertness & productivity Positive effects occurred in people without SAD BLT Study Data: Light therapy & Seasonal Affective Disorder (SAD) In excess of 60 clinical studies have been reported on this subject worldwide. Several qualitative reviews concluded that light therapy was an effective treatment for SAD with observed response rates of 60% to 90% in controlled studies. Clinical consensus guidelines recommend light therapy as 1st line treatment for SAD (Lam & Levitt 1998). Lewy et al (1998) demonstrated that light therapy was more effective when administered in the morning than in the evening. Reported side effects from light therapy in SAD commonly include eye strain/visual disturbance (19-27%), headache (13-21%), agitation (6-13%), nausea (7%), sweating (7%) and sedation (6-7%). However, these side effects are generally mild and subside over time or by reduction in light dose. No damage to the eye or retina has been reported with light therapy in SAD. A study carried out in Finland, where a cohort of office workers was given light therapy daily from November until February, demonstrated improved mood, vitality and productivity following light therapy (Partonen & Lönnqvist 2000). These results were also found in people who did not regard themselves as having SAD. Lam RW & Levitt A, Can J Diagnosis 1998; Supplement 1-15 Lewy AJ, Bauer VK, Cutler NL, et al. Arch Gen Pyschiatry 1998; 55: Partonen T, Lönnqvist J. J Affective Disorders 2000; 57: 55-61 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

LIGHT THERAPY SYSTEM BIOPTRON Light Therapy System Product information – subsidiary slides from Clinical slideshow BIOPTRON Compact III BIOPTRON Pro BIOPTRON 2 © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

BIOPTRON AG: THE COMPANY
Swiss manufacturing company Founded in 1988 Holder of patents for the BIOPTRON Light Therapy System Integrated into Zepter International in 1996 Distribution Using synergies enables us today to distribute the products to more than 50 countries worldwide More than 2,000,000 satisfied users BIOPTRON AG – The company BIOPTRON AG is a traditional Swiss company that manufactures top quality products BIOPTRON AG was founded in 1988 BIOPTRON AG holds the patent for the BIOPTRON Light Therapy System In 1996, 8 years after it was founded, BIOPTRON AG was integrated into ZEPTER International. This has opened up new possibilities, such as the use of distribution channels in more than 50 countries. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

QUALITY ASSURANCE CERTIFICATION
The BIOPTRON Light Therapy System – approved medical devices according to EEC-Directive 93/42/EEC Certificates for BIOPTRON AG Certificates issued by DEKRA (BIOPTRON AG's notified body). These certificates confirm the accordance to the required ISO standards and the EU directive for medical devices. Certificates 1 and 2 - International Quality Assurance Specifications from ISO 9001 and ISO 13485 Certificate 3 - Quality Assurance System Specifications from the European Union Directive for Medical Products 93/42/EEC ISO 13485 ISO 9001 Declaration of Conformity 93/42/EEC with annex © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

MEDICAL DEVICES: TYPE COMPARISON
Identical: Technical characteristics Polarization up to 95% Polychromacy nm Low energy density ~2.4 J/cm2 Incoherency Different: Treatment areas Approximate filter diameters 4 cm BIOPTRON Compact III 11 cm BIOPTRON Pro 1 15 cm BIOPTRON 2 BC BPro B2 BIOPTRON Light Therapy devices - the differences Identical: Technical characteristics - polarization - polychromacy - incoherency - low energy density Different: Size of treatment area (different filter diameters) At the distance of 10 cm from the skin surface, the spot size of the emitted BIOPTRON light beam is approximately: 19 cm2 for BIOPTRON Compact III 154 cm2 for BIOPTRON Pro 1 254 cm2 for BIOPTRON 2 Proportional representation of the filter diameters © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

MEDICAL DEVICES: BIOPTRON 2
The convenient solution for medical use The convenient solution for clinical use BIOPTRON 2 (B2) BIOPTRON 2 is designed for professional use in hospitals, therapeutic centres, spas and other professional environments. B2 - Features: A Digital display allows to preset the length of each treatment session up to 95 minutes, dividable into minute steps and controlled by an integrated soft-start/soft-stop electronic switch. Time effective treatment of large surfaces thanks to the large treatment area (filter diameter approx. 15 cm; treatment area ~ 254 cm2). User friendly for physician and medical staff To assure the best fitting solution for every need, two different types of floor stands are available: Y-Stand and Professional-Stand. Floor Stands - Features : Consumer safety Convenience by low base construction leading to fit unter beds & chairs Flexibility by reaching all body areas High comfort for a relaxing treatment Consumer friendly assembly and adjusting Mobility Domestic Stand Professional Stand © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

MEDICAL DEVICES: BIOPTRON Pro 1 The versatile, ergonomic and elegant solution for professional and home use free adjustable head inclination 360° rotation of the head adjustable stand hight 10 cm distance holder BIOPTRON Pro 1 (BPro1) The BIOPTRON Pro 1 state-of-art designe is suitable for: professional use in hospitals and therapeutic centres as well as for private use at home. The innovative BPro1 can be obtained in 2 combinations: with table stand or with floor stand. BPro1 - Features: Digital display  easy time setting and control Integrated distance rod (10 cm)  facilitates the distance adjustment Device Head can rotate through 360°  allowing the use in any position The filter diameter (approx. 11 cm) permits the treatment of both smaller but also larger surface areas (treatment area ~ 154 cm2) Easily adjustable position of device head Table Stand - Features: Ergonomic table stand Flexibility by free adjustable head inclination and easy adjustment of stand height No assembly necessary Supporting mat for comfortable treatment (desinfectable, exchangable and washable) Protective cover  for storage Floor stand - Features: Consumer friendly assembly and adjusting Convenience by low base construction leading to fit unter beds & chairs Flexibility by reaching all body areas High comfort for a relaxing treatment Table Stand Floor Stand Available with ergonomic table stand or floor stand © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

MEDICAL DEVICES: BIOPTRON Pro 1
BIOPTRON Pro 1 (BPro1) Click on the box to launch a 3D animation of the new BPro1 device. Click on box to launch animation © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

Storage and transport case Optional available stand
MEDICAL DEVICES: BIOPTRON Compact III The versatile, ergonomic and elegant solution for professional and home use BIOPTRON Compact III (BCIII) The BCIII has been designed particularly for home use. However, the BCIII design is suitable for a professional environment in hospitals or therapeutic centres, as well as it qualifies the device perfectly for continuation of treatment at home. BCIII - Features: The device is packed in a handy plastic case for smart storage at home or for travelling It is equipped with a timer that gives an acoustic signal every two minutes The filter diameter (approx. 4 cm) permits to selectively treat small surface areas (treatment area ~ 19 cm2 ) Customer friendly and easy to use Although the BCIII device can be used as a hand-held unit, it is recommended to purchase the optionally (additionally) available floor stand for a comfortable treatment. Floor stand - Features: The appendant floor stand is foldable and takes up little space in either folded or fully assembled position Easy assembly Storage and transport case Optional available stand © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

LIGHT THERAPY SYSTEM – SOME ADVANTAGES AT A GLANCE
Swiss quality Developed & manufactured by BIOPTRON AG, Switzerland Conclusive therapeutic results Clinically proven efficacy & visible results, that encourage patient compliance Versatile Units are mobile, easy to use & maintenance-free Multifunctional Therapy can be applied in medical practice & in the patients home Cost-effective Potential shortening of hospitalization No side effects any negative side effects are not known Wide application area from traumatology to surgery, from rheumatology to sports medicine, from geriatrics to home care and more. Light therapy system Some advantages on a glance: Swiss quality: This method of light therapy was developed by BIOPTRON AG, Switzerland. The company produces various types of light therapy system for distribution world-wide. Conclusive therapeutic results: Clinically proven efficacy and visible results, which encourage the patient compliance. Multifunctional: The therapy can be applied in medical practice and in the patients home. Cost-effective: potential to shorted hospitalization and rehabilitation periods. No side effects: Until today – after more than 18 years – no negative side effects of the therapy has been recognized. Wide application area: Surgery, rehabilitation, reumatology, home care, sports medicine, traumatology, geriatric medicine, dermatology, nursing homes, physiotherapy, … Most importantly, BIOPTRON Light Therapy is safe & effective. BIOPTRON Light Therapy is safe & effective © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

CONVINCING MEDICAL RESULTS … … THE INNOVATIVE SOLUTION FOR YOUR PATIENTS BIOPTRON Compact III BIOPTRON Pro BIOPTRON 2 ONE TECHNOLOGY THREE MODELS Light Therapy System Some advantages on a glance: Swiss quality: This method of light therapy was developed by BIOPTRON AG, Switzerland. The company produces various types of light therapy system for distribution world-wide. Conclusive therapeutic results: Clinically proven efficacy and visible results, which encourage the patient compliance. Multifunctional: The therapy can be applied in medical practice and in the patients home. Cost-effective: potential to shorted hospitalization and rehabilitation periods. No side effects: Until today – after more than 18 years – no negative side effects of the therapy has been recognized. Wide application area: Surgery, rehabilitation, reumatology, home care, sports medicine, traumatology, geriatric medicine, dermatology, nursing homes, physiotherapy, … Most importantly, BIOPTRON Light Therapy is safe & effective. © Copyright by BIOPTRON AG - FOR INTERNAL USE ONLY!

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