Anodyne® TherapyReferring Provider

Information

Agenda

Technology and Mechanism of Action Treatment Protocols Cautions Research

Monochromatic Single wavelength

InfraRed – 890 nm Outside visible spectrum Penetrates 5 cm Absorbed by RBCs

Energy – 6240 mw Photo (Light) energy Small thermal component

Anodyne Therapy Emits MIRE

Infrared Light Causes Local Nitric Oxide Release From Hemoglobin

1998 Nobel Prize 60,000 papers published on N.O.

in the past 10 years NO= 1 Molecule Oxygen, 1

Molecule Nitrogen

Nitric Oxide - Vascular Effects

Nitric Oxide increases blood flow Dilates arteries, capillaries Dilates veins, lymphatics Mediator of angiogenesis

and other growth factors Reduced platelet aggregation

Why is Nitric Oxide So Important?

Red blood cells squeezing through capillary

Capillaries in extremities are size of a single RBC Pre-capillary sphincters can constrict

blood flow into capillaries High cholesterol and diabetes

contribute to Endothelial dysfunction Blood vessel narrowing and reduced

elasticity leading to hypertension High levels of blood glucose

Reduce availability of nitric oxide

Nitric Oxide reduces pain Direct mediator of the analgesic

effect of morphine Indirect Reduces hypoxia, ischemia Delivers nutrients to nerves Reduces inflammation,

swelling impinging on nerves

Nitric Oxide – Pain Relief

Conditions that can cause painful circulatory problems

Metabolic Conditions (Diabetes, Hypothyroidism) Vascular disease – PVD, PAD, Intermittent Claudication Alcoholism Cancer (Chemotherapy-related) Drugs (Statins, antibiotics, antivirals) Anemias Vitamin deficiencies (B12, Folate, Magnesium) Raynauds Syndrome/Scleroderma Poisoning from toxins (Lead, Mercury, Agent Orange)

Published Clinical Data 13 Published, peer-reviewed studies Over 4,500 subjects To request, email

studies@anodynetherapy.com

Journal of Diabetes and Its Complications -March 2006

7.2

2.4

012345678

Before MIRE After MIRE

10 P

oint

VA

S S

ca

67% Pain Reduction(0-10 Numeric VAS Scale)

P < 0.0001

N = 2239

Protocol: • 35 minutes• 3x per week• Average of 5 weeks

Protocol:• 30 minutes• 5x per week• 5-20 sessions + PT

98

40

2 0

4 0

6 0

8 0

10 0

12 0

Before After

Average Fall Risk Score

11.2

21.6

0

5

10

15

2 0

2 5

Before After

Total FallsIn 90 Days

P < 0.0001 vs. Before Treatment

N = 38

Journal of Geriatric Physical Therapy – April 2004

Journal of Geriatric Physical Therapy – April 2004

0

5

10

15

20

25

30

55 60 65 70 75 80 85 90 95 100

Age (Years)

AfterBefore

High Fall Risk

Moderate Fall Risk

Low Fall Risk

Protocol:• 30 minutes• 5x per week• 5-20 sessions + PT

93% Tinetti Score ImprovementN = 38

0

2

4

6

8

1 4 7 10 13 16 19 22 25 28 31 34 37

Patient #

Num

ber

of F

alls

98 Total Falls 3 Months Pre TX 4 Total Falls 3 Months Post TX

P <0.0001 vs. before Tx

Journal of Geriatric Physical Therapy – April 200496% Reduction in Falls

N = 38

Physical and Occupational Therapy In Geriatrics 2006

63% Improvement 81% Improvement

Diabetics

14.2

23.2

0

5

10

15

20

25

Tine tti Be fore M IRE Tinetti Afte r M IRE

Non-Diabetics

12.9

23.4

0

5

10

15

20

25

Tinetti Before M IRE Tinetti Afte r M IRE

81% of patients high fall risk – Only 9% remained high fall risk after intervention

N = 272Time: 34 minTX No:18 treatments

Practical Pain Management – July/August 2007

Pain Relief by Group after Treatment with MIRE No Pain

MedsDecr Meds

No Chg in Meds

Chg/Incr Meds

N 129 187 151 26% of Total on Meds 51% 41% 7%# Treatments 15 15 16 19VAS Pain Before 6.7 7.2 6.7 7.3VAS Pain After 2.4 2.5 2.6 2.6% Pain Decrease 64% 65% 61% 64%

7.186.19

3.14

5.06

0

1

2

3

4

5

6

7

8

Active Anodyne Placebo Control

BeforeAfter

MIRE® Pain Reduction vs. Placebo*

17.4% Pain Reduction

55.8% Pain Reduction

P <0.001

Pain Level

N = 1012N = 5609*Meta analysis of 6 Anodyne Therapy studies (5 Peer-reviewed) vs. 20 published clinical trials with placebo controls in drug and medical device trials

*

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Increases inCirculation withAnodyne Therapy

Improved MicrocirculationScanning Laser Doppler Images

ElbowElbow HeelHeel

KneeKnee

Up to 1300% increase in circulation after 20 minutes treatment

Anodyne vs. Heating PadPre-Scan Post-Scan

- 45%

+ 164%

Anodyne

HeatingPad

Chronic Patients: Patients with diabetes, PVD, high cholesterol or high

blood pressure will require lifetime use – as theses underlying conditions cause circulation to be poor in the extremities

Overuse injuries will continue to re-occur unless the patient modifies their activities

Acute Injuries/Wounds: Typically do not require lifetime use – clinical

treatments are sufficient to resolve most issues Chemotherapy Patients:

May require ongoing Anodyne® treatments depending on the severity of damage, and the length of condition

3 Anodyne Home Systems Available

Duration of Effect

Moor Scanning Laser Doppler PerfusionIncreased Blood Flow in Treated Area

020406080

100120140160180200

TreatedTissue

UntreatedTissue

Treated TissueUntreated Tissue

184.4

59.4

4 Year Venous Ulcer (40 Year History) 3 Year Follow-up

Scan at Three Year Follow-upDegree of perfusion3 years after MIREtreatments ceased

Anodyne Therapy is Not FDA-Cleared Specifically for Wound Healing

Anodyne Therapy is cleared for increasing local circulation and reducing pain and . . . Wounds need adequate blood supply,

oxygen and nutrients Many wounds are very painful.

Local Case Results

Consider mixing in some of your own your own case studies here

Baseline

1 month

5th Month- Full Tissue ThicknessNo recurrence 4 years

40 Year Venous Ulcer VA Medical Center – Denver, CO

Diabetic, Pressure Ulcer, Post-Op Wounds • Increased circulation in dialysis patient referred for BKA•No further breakdown for 2 years

Wound dehiscence2 months post-op

Pressure - 7 months with tendon exposure

April 16, 1997

Nov. 25, 1996

March 5, 1997

Oct. 16, 1996

Diabetic ulcer present 2 years

March 19, 1997

Oct. 16, 1996

Bottom photos at 5 months

3 Year Old Diabetic Plantar Ulcer Started Anodyne

Immediate pain relief Wound decreased in

size by almost 50% in 1 week

Wound then worsened due to poorly fitting foot orthotic

Fibrocol Initiated Anodyne discontinued

due to dressing Pain returned

46 YO Female – Wound w/ DPN, burning, pain -

Unresponsive to standard care, off loading and

topical agents including Regranex

Anodyne Restarted with FibrocolClosed in 12 weeks

Painful Scleroderma Ulcer with Raynauds

June 27, 2005

Treatments tried over 6 months• Vicodin, Percocet, Methadone for pain• Viagra, Procardia, Prednisone• Debridement; Carpal Tunnel Release;

Radial & Ulnar Artery Sympathectomies• 19 Physician office visits

• 7 weeks of Anodyne Therapy 25 minutes 3 x per week

• Off all narcotics; Able to button clothing, write, do needlework

• Patient discharged with home system

August 10, 2005

Arterial Disease with Painful Ischemia University of Texas - Houston

61 YO Latin American Male

Began as scratch Feb 2003

History: NIDDM, rheumatoid arthritis on prednisone, anemia, poor nutrition

MRA: Complete occlusion of left posterior tibial artery (peroneal and DP patent), mild to moderate focal stenosis of left SFA

8 Vicodin/day - ischemic pain

Advances in Skin and Wound Care Conference – April 2005

Initial Photo12/18/03

5/11/04

6/11/04

Tendon Exposure

16 months failed treatments:Angioplasty25 HBO Treatments4 Weeks Wound V.A.C.

12/29/04 20 weeks of MIRE

8/25/04 7 weeks of MIRE

9/15/04Vicodin reduced from 8/day to 1 qhs

Wound Completely Healed@ 24 weeks

Post Op - Total Knee ReplacementMedical Center of Aurora

Baseline 10 days 20 days 36 days

2 months post-op• PT unable to range, necrotic tissue present

Able to range after first treatment, no debridement required

Navy SEALS Team 5, San Diego

Also used at Walter Reed and numerous other military bases

Typical Plan of CareADD YOUR OWN SPECIFIC PLAN OF CARE HERE EX:

Gait and Balance Rehabilitation Anodyne Therapy for temporarily

Increasing circulation Reducing pain, stiffness, muscle spasm

Neuromuscular re-education for balance

Therapeutic exercise for Strengthening ROM

Sensory integrative techniques Gait training

Treatment GuidelinesChronic Disease Protocol 30 minutes, 3 x per

week 12-24 treatments

Post-Operative Protocol 15-20 minutes At each post-op visit

Safe Clinical Use

Contraindications and Cautions Active malignancy at site Over or near womb in pregnancy

Safe to use over all Metal pins, plates, screws Pacemakers and defibrillators No known drug interactions

Only potential known side effects Superficial burns if used

improperly Hypoglycemia (diabetics) due to

increased activity levels

Our Anodyne Therapy Program

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Local Patient Testimonial

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Questions?

1-800 Your Number Herewww.yourwebsitehere.comwww.anodynetherapy.com