Introduction to New�High Power High Dose �Class IV Laser Therapy�

Scott Davis, MD, MA, FASAM Bruce R. Coren, DVM, MS� Founder

Class IV Laser Therapy

HDLT-HPLT �High Dose – High Power Laser Therapy

•  HPLT was first introduced to the medical field in

2002 by then CEO of Avicenna Laser Technology,

Inc, Bruce R. Coren, DVM, MS.

•  The company invented and developed the first

High Power Therapeutic Laser to receive FDA

clearance in 2003.

•  TMA – Technological Medical Advancements is a spin off from Avicenna and was founded not only to advance the field of Laser Medicine but also to bring other innovative medical devices to the market place.

•  TMA offers the most powerful laser platforms in the world and thus allowing physician's of all medical disciplines the capability to heal injuries previously refractive to traditional medical care.

Design of the TMA Laser

•  The TMA laser was

designed from the

ground up to be a

therapeutic medical

laser.

•  It was developed using research

by our own biomedical

engineers and clinicians as

well as collaboration with a major

medical school and university

optics department.

•  We investigated important

criteria such as wavelength,

power and power

density, optics and beam

delivery in order to afford the

greatest penetration and

delivery of a therapeutic dose

capable of stimulating tissue

healing in deep seated

pathologies.

LASER — an acronym for:

Light Amplification by Stimulated Emission of Radiation

•  The TMA Laser is the only laser available on the market that was designed to accomplish both surgical and therapeutic procedures.

Lasers in Medicine •  Therapeutic Lasers are used for the

stimulation of cell function.

•  The biological effect is photochemical not thermal, as is the case with surgical lasers.

Comparison of “Class IV” Surgical and Therapeutic

Lasers •  Surgical lasers collimate

high amounts of laser energy into a beam of high intensity resulting in tissue destruction

•  High Power Therapeutic Lasers take a high amount of laser energy but instead of beam collimation you get beam divergence resulting in tissue stimulation

Who is using Diowave •  Human - Physical Medicine and Rehab - Pain Management - Orthopedists, Neurologists, - Family Practice

•  Chiropractors and Physical Therapists •  Podiatrists, Naturopaths and DOM’s •  MLB, NBA, NFL •  College Sports Teams •  Medical and Veterinary Colleges •  United States Military and VA Hospitals •  Small and Large Animal Veterinarians

Biological Effects of Therapeutic Lasers

•  Laser therapy aims to bio-stimulate injured and dysfunctional tissues.

•  Clinical studies and trials of Class III & IV laser technology indicate the following beneficial effects of light therapy on tissues and cells.

Cellular Effects of Laser Energy

•  Chromophores are components of molecules which absorb light.

• The stimulation of chromophores on mitochondrial membranes incites the production of ATP.

• Leading to a biological cascade of events.

•  Increased Growth factor response within cells and tissue as a result of increased ATP and protein synthesis.

•  Accelerated cell reproduction and growth leading to faster repair of damaged tissues.

•  Increased metabolic activity – via increase in enzyme outputs, oxygen and nutrient availability.

•  Stem cell activation – There are now numerous studies showing the ability of laser light to stimulate stem cell activity. At high dosages this is probably the greatest factor in the healing process ofpathologic tissues.

Wound Healing Effects of Laser Therapy

•  Faster Wound Healing - Laser significantly increases fibroblast and collagen production which are essential for tissue repair.

•  Improved Vascular Activity - Increased capillary production leads to faster wound closure.

•  Greater Tensile Strength - Surgical repaired wounds heal with greater tensile strength, including skin, tendon, ligament and fascia.

•  Scar Tissue Reduction - Wounds heal with less scar tissue formation.

Wound Healing- Human

PRE-LASER AND AFTER TWO MONTHS OF TRADITIONAL THERAPY

AFTER TWO 5 MINUTE LASER THERAPY TREATMENTS AT 7.5 WATTS

One Hour post injury Two Days Post Injury

Wound Healing - Vet

WOUND DAY 1 WOUND DAY 7 SID TX 4 WATTS-3000

JOULES

Immune System Effects of Laser Therapy

•  Strengthening the immune system response via increasing levels of lymphocyte activity and through a newly researched mechanism termed photo-modulation of blood.

Acute Inflammation Reduction

Stabilization of cellular membrane Lubart R, Friedman H, and Lavie R. Photobiostimulation as a function of different wavelengths. The Journal of Laser Therapy. Vol 12. World Association of Laser Therapy. 2000. Karu T. et al. Changes in absorbance on monolayer of living cells induced by laser irradiation. IEEE Journal of Selected Topics in Quantum Electronics. IEEE Lasers and Electro-Optical Society. December 2001. 7(6):982. De Castro E Silva Jr. O, et al. Laser enhancement in hepatic regeneration for partially hepatectomized rats. Lasers in Surgery and Medicine. 2001. 29(1):73-77

Acute Inflammation Reduction

•  Acceleration of leukocytic activity

•  Increased Prostaglandin synthesis

•  Reduction in Interleukin 1(IL-1).

•  Enhanced lymphocyte response

•  Increased angiogenesis

•  Temperature modulation

Laser Therapy Cytochrome Activation Ros Production

Cell Membrane Changes

Proton Gradient Change

Ca, Na, K Ion Changes

ATP Increase Vasodilation PG Synthesis IL-1 Decrease

Increased Leukocyte Activity

Enhanced Lymphocyte Response

Temperature Modulation

Angiogenesis SOD Production

Acute Inflammation Reduction

Clinical Translation •  Laser light accelerates the inflammatory cycle, with

diminished symptoms and earlier normalization of pathologic tissues.

•  It can sometimes be so profound that there may be minimal swelling and inflammation even in traumatic injuries.

•  Take a look at the next slides where this patient was hit with a golf ball traveling at high speed. Cryo-therapy and laser were initiated immediately post injury

Summary of LT Biological Effects

•  Accelerated Tissue Repair

•  Accelerated Cell Growth

•  Stem Cell Activation

•  Faster wound Healing

•  Reduced Scar Tissue Formation

•  Anti-Inflammation

•  Anti-Pain (Analgesia)

•  Improved Vascular Activity

•  Increased Metabolic Activity

•  Improved Nerve Function

•  Immunoregulation

•  Trigger Point Resolution

•  Acupuncture Pt. Stimulation

Summary of LT Biological Effects contd..

•  Improved Vascular Activity

•  Increased Metabolic Activity

•  Improved Nerve Function

•  Immunoregulation

•  Trigger Point Resolution

•  Acupuncture Pt. Stimulation

Summary of LT Biological Effects contd..

High Power - High Dose Laser Therapy

as it Pertains to the Spine •  Decreased inflammation of disc,

nerve roots and the cauda equine •  Increase microcirculation of spinal

structures •  Accelerate healing of annular defects •  Decreased formation of

abnormal/non-functional scar tissue

•  Decreased scar tissue and non-osseous hypertrophic changes

•  Reduce pain associated with PRP – prolotherapy injection •  Decrease or even eliminate need for epidurals

High Power – High Dose Laser Therapy as it Pertains to the Lower Extremities

•  Decreased inflammation of nerve tissue

•  Accelerated Reinervation of nerve fibers

•  Increase blood flow and microcirculation of tissue structures

•  Accelerate healing of open wounds

•  Decreased formation of abnormal non-functional scar tissue

•  Increase synovial fluid and cartilage production

•  Increase collagen and fibroblast production

•  Increase osteoblastic activity and fracture healing

•  Decreased bony edema – osteochondral bone bruise

Laser Safety Overview

•  Safety Training begins with YOU!

•  Class IV Laser Beams can cause damage to the eyes

•  Safety Glasses must be worn by everyone in the treatment area AKA Nominal Hazard Zone (NHZ)

Laser Safety •  Safety protocols must

ensure sufficient

precautions are taken to

protect the health and safety of

employees and patients. Use

of safety goggles to prevent

retinal exposure is

paramount.

•  Laser safety eyewear is not a primary mode of protection

•  They do not replace proper laser safety education, training, and careful clinical practice.

Laser Safety

Laser Safety

Fluorescein angiography of retina after laser irradiation

Lesion

•  Training •  Equipment Purchase, Service,

Quality Assurance •  Room Design •  Protective Equipment / Optical

Laser Safety

•  Hazards

•  Routine Procedures

•  Administrative Controls/

Management

•  Electrical Hazards

Laser Safety

•  Medical Instruments (Reflex

Hammers, Stethoscope)

•  Jewelry (Rings, Watches, Earrings)

•  Treatment Table

•  Mirrors, Door Knobs and other

Fixtures

Laser Safety-Reflective Surfaces

Optical Hazards

Optical Hazards

Optical Hazards

Optical Hazards

Reflect

Absorb

Transmit

Scatter

Laser Classifications

Class 1 Lasers

Laser Printers

Compact Disc Players

Laser Classifications

Class 2 Lasers

Laser Classifications

Class 3a Lasers

Office Depot Laser Pointers

Laser Classifications

Class 3b Lasers

LLLT

Laser Classifications

Class 4 Lasers

Surgical Lasers Therapeutic Lasers

Laser Classifications

Human Contraindications •  Pregnant Females

•  Epiphyseal Lines In Children

•  Pacemaker

•  Thyroid, Gonads, & Testicles

•  Light Sensitive Medications

•  Corticosteroids

•  Intolerance

•  Eyes

•  Carcinoma

•  Hemorrhage

•  Immuno-Suppressant

Drugs

•  Sympathetic Ganglia, The Vagus Nerves & Cardiac Region In Patients With Heart Disease

All Lasers are Not Created Equally

• Although all therapeutic lasers bio-stimulate tissue, that is where the similarities end.

• Laser Therapy is all about Physics!

Therapeutic Laser Classifications

•  Therapy lasers are classified based on their power output

•  Class IIIa = lasers 1 to 5mw of power (laser pointers)

•  Class IIIb = lasers 6 to 500mw in power

•  Class IV = lasers above 500mw of power

•  TMA Laser Platforms = 1,000 – 60,000 mw maximum continuous wave output

Clinical Laser Medicine •  What we would like to do is find a

volunteer with knee pain to demonstrate the efficacy of high dose laser therapy

•  While we finish the lecture we will treat

the patient and have him/her give you feed back as to how the pain level and range of motion have changed.

The Technology Laser Therapy 101

Rule #1:

You Cannot Treat a Target That You Cannot Reach.

X-Ray Physics = Laser Physics Rule # 2

The Technology

Laser Therapy 101

Rule #3:

Overstimulation With Laser Energy Only Exists in

a Petrie Dish

The Technology

Laser Therapy 101

Rule #4:

Understimulation and Lack of Penetration are the #1

Reasons for Poor Clinical Outcomes!

The Technology

Energy Medicine and Therapeutic Laser Physics

•  The therapeutic dosage of laser energy is measured in Joules

•  Dosage is a function of the lasers power output

•  For every one watt of continuous laser power output, one joule of laser energy is delivered per second of time

•  For a pulsed laser the energy delivery depends on the duty cycle. Duty cycle tells us what percentage of time the laser is on or actively firing. If the duty cycle is 50% then the laser at 1 watt only delivers 0.5 Joules / Second.

•  For any given time period a continuous wave laser delivers twice as much energy than laser with a 50% duty cycle

Laser Physics The shorter the wavelength, the more readily the energy is absorbed in the body. The higher the wavelength, the deeper the penetration of photon energy.

980 nm: Low melanin, low water, low hemoglobin absorption thus an optimal wavelength to choose when designing a therapy laser for stimulating tissue at greater depths of penetration.

Absorption Curve

Laser Tissue Interactions

Physiological Effects Light – Tissue Interactions

•  65% of laser energy is absorbed in the skin and subcutaneous tissue layers with the following having a high affinity for absorption:

•  Hemoglobin in blood

•  Melanin in skin, hair, moles, etc.

•  Water (present in all biological tissue)

How Laser Light Penetrates Tissue

•  As light energy hits the surface of the skin and subsequent deeper layers, some of it is scattered and some of it is absorbed and some is reflected

•  At each tissue interface less energy is available to pass further through to the next layer because of the effects of absorption, reflectance and transmission

Laser Penetration

•  Laser Energy is just another form of energy on the electromagnetic spectrum.

•  Depth of penetration is determined by wavelength and energy density.

•  Just like with x-rays when deeper penetration is required, more energy must be delivered to reach the target tissues.

Clinical Therapeutic Laser Penetration

•  Prime Determinants of Laser Penetration and Concomitant Tissue Stimulation are:

•  Power – measured in Watts or milliwatts

•  Wavelength – measured in nanometers

•  Power Density – measured in mw / cm2

•  Frequency – continuous wave versus pulsing

Importance of Power Density

•  Since approximately 65% of the energy delivered is lost in the epidermis

•  If you don’t start with enough energy on the skin, there will not be enough to stimulate cell healing in deeper tissues

•  If you do not have sustained power density over a long enough period of time treatments may be ineffective

Single Wavelength, Multiple Wavelength, Continuous or Pulsed Wave Laser

•  A laser with two or more wavelengths only has the ability to penetrate as deep as each individual wavelengths allows

•  Most class iv lasers that pulse or have a high duty cycle coupled with multiple wavelengths of energy emission will not penetrate as deep as CW lasers of a single wavelength or lasers that can pulse but still maintain a high average power output

•  Continuous wave lasers = 100% duty cycle, laser is always delivering energy which is needed to overcome absorption in the superficial layers

•  Newer generation of TMA lasers can now pulse yet still maintain a high average power output allowing for greater tissue saturation with less thermal effects

•  Dual wavelength lasers only penetrate as deep as each wavelength individually. Penetration is not additive. There is no validated clinical benefit to this scenario. It is more of a marketing

In Laser Medicine 1 + 1 Does Not Equal 2

•  For purposes of penetration it is more advantageous to have one wavelength of greater power that stimulates cell metabolism and tissue regeneration at all tissues densities in its pathway

Is There A Magical Wavelength?

•  Throughout our 13 years of clinical experience using a 980nm treatment beam, we have experienced stellar results with both superficial and deep pathologies.

•  We still feel once you are treating within the infrared spectrum, power, power density and dosage are the key to better clinical outcomes.

Sponge Theory

•  In order to achieve penetration one must create significant energy density to overcome absorption in the superficial layers of the skin.

•  With low power or pulsed lasers it is like pouring small amounts of water onto a large sponge (the dermis and subcutaneous tissues) and expecting the water to leak through.

•  In order to do so you must saturate the superficial layers of the sponge- with enough water-energy to soak the sponge-superficial tissue structures

•  So as you pour more water-energy over the sponge it will start to penetrate or leak through.

•  This it what is needed to penetrate and why it is important to deliver a high amount of laser energy/dosage on the skin

•  Especially if you want to reach deep seated pathologies.

How Much is Enough

•  49-73 mw/cm2 for cell stimulation1

EFFECTS OF INFRARED LASER EXPOSURE IN A CELLULAR MODEL OF WOUND HEALING

Mark D. Skopin and Scott C. Molitor, Department of Bioengineering, University of Toledo, Toledo OH

•  This study shows an optimal wavelength (980 nm) and •  power density range for wound healing and tissue

stimulation

Laser & Tissue Powers Tissue Layer Max Power (mw/cm2)

Epidermis 206

Dermis Layer 182

Dermis Plexus Super. 135

2nd Dermis Layer 115

Dermis Plexus Prof. 93

Muscle Tissue 9.7

Power Setting 5 Watts, 3.0cm spot size, 980nm This is a snapshot in time. Calculated using computer models by U of Toledo.

•  Translation – As laser light or energy penetrates through the body more and more energy is absorbed so by the time you start reaching deeper structures there is not enough therapeutic energy to cause adequate tissue stimulation

•  Thus the reason why low power lasers as well as pulsing lasers cannot effectively treat deep seated pathologies.

Other Factors Affecting Lasers Penetration

•  Duty Cycle – 100%

•  Laser is firing continuously

•  Duty Cycle – 50%

•  Laser is firing 50% of the time. This will not only cut energy delivery but it will also affect ability to penetrate.

•  Pulsing – Lasers that pulse also do not emit continuous energy

•  Lasers that can operate at 100% continuous wave output or pulse the laser energy while still maintaining a high average power output is key to treating deep seated pathologies and better clinical outcomes.

Class III vs. “Class IV” Laser Beams

With a high power output the laser beam can easily penetrate deeper joints especially when compared to a class iii laser which at best only offers superficial penetration.

Why Therapeutic Lasers Fail

• Under penetration - The typical low level or cold laser or weak or pulsed class iv laser does not concentrate the laser energy sufficiently to allow for adequate penetration

• Under-dosage – The typical low level or cold laser or weak or pulsed class iv laser does not deliver enough energy to adequately stimulate deep seated inflammatory conditions

• TMA protocols are successful because they call for delivery of significantly larger amounts of therapeutic energy than industry standard protocols.

TMA-Diowave Philosophy

•  TMA’s goal has always been to build the most efficacious laser available to deliver the best outcomes.

•  Our lasers are built from the ground up and are designed to get patients who have failed traditional therapy better

•  Many other lasers are built based on economic factors or from taking laser from other markets like dentistry and converting them into weak class iv lasers

•  There are no shortcuts to treating deep seated pathologies and one must deliver the correct dosage of laser energy in order to get the best outcomes.

“The Key to Better Outcomes”

•  Higher the power output of laser energy

•  The Greater The Penetration and Dosage

•  The Faster the Therapeutic Outcome

•  The Quicker the Patient Returns to Normal

•  This is the main reasons we keep advancing our technology and developing more powerful lasers.

Why More Power is Better •  More power equates to deeper

penetration, faster delivery of the proper therapeutic dosage, and ultimately better outcomes

•  A 30 watt laser will not only penetrate deeper, it will put more therapeutic energy to the target pathology

•  It will do this 3X faster than a 10 watt laser and 5X faster than a 12 watt laser with a duty cycle of 50%

Recommendations for High Dose Laser Therapy

•  Small Joint - Extremities 6-10,000 Joules

•  Large Joint - 15-20,000 Joules

•  Spine - 20-30,000 Joules

Evidence Based Medicine •  The effects of HPLT can easily be documented

•  Clinician’s can measure results using outcome assessment tools:

•  Pressure Algometer

•  Inclinometer , Goniometer

•  Thermal Imaging and Doppler Studies

•  VAS, PDQ – Pain Disability Questionnaire

Lasers vs. Standard Modalities Currently Used to Treat Neuromusculoskeletal

Pathologies

LASER BRAND

(In watts) MDO(1)

DUTY

CYCLE

(2)

MPTD(3) JPM(4) CPW(5) WARRANTY

TMA - Diowave 60 60 100 60 w 3600 $834 3 yr

TMA - Diowave 30 30 100 30 w 1800 $1,167 3 yr

TMA - Diowave 15 15 100 15 w 900 $1,600 3 yr

TMA - Diowave 10 10 100 10 w 600 $1,500 3 yr

Litecure 15 7.5 100 7.5 w 900 $1,800 2 yr

Litecure 10 5 100 5.0 w 600 $1,750 2 yr

Klaser 12 6 50 3.0 w 360 $3,667 2 yr

Klaser cube 15 5 50 2.5 w 450 $3,600 2 yr

Cutting Edge 1.1 0.5 75 <1.0 w 45 $20,000 not published

Cutting Edge 3.3 1.1 75 <1.0 w 105 $15,000 not published

Class iii lasers 0.75 variable 0.75w 60-180 4,000-750,000 1-3 yr

PHYSICAL PARAMETERS OF SOME COMMON CLASS IV LASERS

1.   MDO = Maximum Diode Output

2.   Duty Cycle = Average Time Diodes Are Firing

3.   MPTD = Maximum Penetrating Therapeutic Dosage.

4. JPM = Joules Per Minute

5. CPW = Cost Per Watt

(Continuous Power Output)

•  Because wavelength and power determine penetration, and each wavelength penetrates independently, the maximum penetrating dose is no greater than the maximum power output of each diode. With a 50% duty cycle penetration of each diode gets cut in half.

• Maximum power output per wavelength is one of the most important factors in favorable treatment outcome.

• With a dual wavelength laser, laser beam penetration is reduced by 50%; with a 50% duty cycle setting and dual wavelengths, laser penetration is equal ¼ of the stated power output of the laser.

•  With multiple-wavelength lasers (2-3) beam penetration is reduced even more significantly. If a 50% duty cycle setting is paired with a three-wavelength laser, beam penetration is equal to 1/6 of the stated laser power output.

•  A 10W CW Diowave laser has a stronger maximum diode power output of any therapy laser currently produced.

HPLT —HDLT

A New Trend in Pain Management

•  Profound anti-inflammatory and analgesic effects

•  Pain relief typically immediate

•  Non-invasive and no side effects

•  Profound tissue regeneration of all tissue types

•  Overall contraindications minimal

Evidence Based Medicine •  The effects of HPLT can easily be documented

•  Clinician’s can measure results using outcome assessment tools:

•  Pressure Algometer

•  Inclinometer , Goniometer

•  Thermal Imaging and Doppler Studies

•  VAS, PDQ – Pain Disability Questionnaire

•  These tools are vital to document outcomes which ultimately lead to adequate reimbursement

Applications of Laser Therapy •  Disc Pathologies, Spinal Stenosis, Radicular Pain,

spondylolesthesis, and sacroiliac dysfunction

•  Failed surgical back syndrome

•  Accelerated Post Surgical, Soft and hard Tissue healing

•  Arthritis (Degenerative Joint Disease)

•  Foot Pain and Neuropathies

•  Muscle, Ligament and Tendon Injuries

•  Ulcerations and Open Wounds

What to Look For When Purchasing

a Class IV Therapy Laser

•  Single wavelength laser

•  True CW (Continuous Wave). Laser

will operate all day on CW without

issues

•  Highest CW Power

Introducing the 2012 TMA Suite of Laser Platforms

•  A technological advancement in energy output and delivery

•  The TMA suite of laser platforms offer the world’s most powerful and advanced therapeutic laser system ranging in power output from 10 – 60 watts or 10,000mw -60,000mw.

•  As a physician based company we have treated or will know how to treat any condition you are confronted with, the ultimate result being a better outcome

•  With the superior training and clinical support we provide clinicians, the above goal will readily be achieved

Introducing the 2014 TMA-Diowave

High Power – High Dose Lasers

10-15 Watt Laser Platform 20-30 and 60 Watt Laser Platform

Marketing High Power Laser Therapy in Veterinary Medicine

•  Laser Therapy is by far the most exciting new clinical treatment to advance physical medicine in the 21st century

•  It can also become one of your most significant profit centers in your practice

•  All that’s need to be done to accomplish is to follow the Diowave Turnkey marketing plan that comes with every laser purchase

•  For further information on bringing the a Diowave Laser into your practice you will find our contact information in the next page

For More Information Contact the Company by:

•  Email –

info@tmainternational.com

•  Phone – 866-862-6606

Better Outcomes Are Only a Phone Call or Email Away