recoveryrx® accelerated healing and better pain relief

OUR MISSION:

OUR MISSION AT ECHELON IS TO HELP PEOPLE ACHIEVE THEIR HIGHEST POTENTIAL TO LIVE HAPPY, PRODUCTIVE LIVES THROUGH OPTIMAL HEALTH AND WELLNESS.

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Bioelectroceutical™ Therapy Advances in Healing and

Pain Management www.EchelonHealthPro.com

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Device Specifications:

Carrier frequency

27.12MHz

Peak power

72 milliWatts/cm2

Pulse rate

1 KHz

Pulse duration

100 microsecond

Power source

Battery

Antenna size

12cm or 8cm

Treatment area

100cm2 of 70cm2

Weight 8 grams

Therapy Duration

24-hours a day

Battery Life

720 hours on/off capability

27www.EchelonHealthPro.com

Innovative Pulsed Bioelectric Therapy

• Reduces pain and inflammation and accelerates healing• Increases wound tensile strength

• Reduces chance of infection, dehiscence and scarring

• No adverse side effects

• Easy to use over bandages and wound dressings

• Inexpensive and labor free

• Significant reduced need for pain medications

• Clinically Proven Technology

• Seven published refereed medical journal studies.

• Confirming medical research at Tufts Medical and Dental School; University of Chicago

Medical School; University of British Columbia; University Hospital Ghent, Belgium;

University Hospital G. Martin, Messina, Italy and University of Otago, Dunedin, New

Zealand.4

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Mechanism of Action

Accelerated HealingIncreased blood flow serves to warm the injured region and bring oxygen and nutrients to the region to enhance tissue healing. The extended duration treatment of pulsed EMF has also been shown to directly enhance cell mobility, which accelerates tissue healing.

Safe and Effective Pain ReliefThe physiological response effects of pulsed electromagnetic fields are achieved with the soft tissue through a mechanism referred to as stochastic resonance. Stochastic resonance is a phenomenon where a periodic signal is boosted over a critical threshold by ambient noise in the system. The EMF of 27 MHz penetrates deeply into the body tissues, creating low level electrical fields which, in combination with electrical "noise" in the tissues, is able to significantly influence nerve activity.

Activated sensory nerves operate through a feedback loop to trigger motor nerves which results in muscle contractions. The increased muscle activity enhances blood flow into the treated area, and as well, pumps out lymphatic fluid to reduce swelling and pain.


Clinical Effects of RecoveryRx®When an injury occurs, cells separate and swelling starts to develop in the injured tissues which causes pain. Also, chemical signals are released by cells in the injury site activating nerves and causing an electrical impulse which signals pain in the injured tissue. Therefore, a reduction in tissue swelling “inflammation” reduces pain and allows injuries to heal.

Injured TissueInjured Tissue

RecoveryRx® accelerates injury recovery by increasing blood flow and reducing swelling. RecoveryRx® delivers a safe form of energy to the injured cells, which is used by the cells to recover and reduce inflammation. The application of this extended treatment device therefore results in a decrease in pain and accelerated tissue repair.

Inflammation andInflammation andswelling cause painswelling cause pain

Healing TissueHealing Tissue

The inflammation andThe inflammation andswelling is reduced swelling is reduced

resulting in pain reliefresulting in pain relief


Biological Evidence of Effectiveness• Research has shown up-regulation of both mRNA and opioid

peptide in response to exposure to pulsed shortwave

electromagnetic field at 27.12MHZ1.

• Cellular, animal and clinical results provide support for

Ca/CaM-dependent NO production as an important mediator

that may explain the observed effects of pulsed shortwave on

tissue repair, angiogenesis, pain and inflammation in many

studies2.

• Cellular and clinical research has shown pulsed shortwave

therapy decreases inflammation3.

• Studied effects on diabetic mice show decreased time to heal

wounds and increased collagen production4.

Overall Mechanism

1. Moffett J, Fray LM, Kubat NJ: Activation of endogenous opioid gene expression in human keratinocytes and fibroblasts by pulsed radiofrequency energy fields. J Pain Res 5, 347-357 (2012).2. Pilla AA: Nonthermal electromagnetic fields: From first messenger to therapeutic applications. Electromagn Biol Med 32(2), 123-136 (2013).3. Rohde C, Chiang A, Adipoju O, Casper D, Pilla AA: Effects of pulsed electromagnetic fields on interleukin-1 beta and postoperative pain: a double-blind, placebo-controlled, pilot study in breast reduction patients. Plast Reconstr Surg 125(6), 1620-1629 (2010).4. Kao HK, Li Q, Flynn B et al.: Collagen synthesis modulated in wounds treated by pulsed radiofrequency energy. Plast Reconstr Surg 131(4), 490e-498e (2013).


In Vitro Wound Healing

Experiment:

• Human dermal fibroblasts grown to confluence in cell culture dishes treated with mitomycin C to inhibit proliferation and re-plated to form uniform monolayers.

• Cell monolayers were then wounded and exposed to RecoveryRx® or untreated controls.

• Wound area assessed on day 1, day 2 and day 3 and expressed as wound size and percent of wound closure – (wound size assessed by three blinded researchers).

• On each day the treated cells wound size was significantly smaller. At day 3 wound closure was 75% in the treated cell compared to 50% in the untreated cells.

Cell culture demonstrate of cell migration, a critical aspect of wound healing

C = Control untreated E = Experimental treated


Human Skin Wounds Experiment• Experiment 1: Full thickness 2 cm wounds inner calf of a volunteer – placebo or actively treated – biopsied at 9 months

• Experiment 2: double blind randomized experiment - 20 volunteers 3 mm diameter full thickness wounds – 10 placebo – 10 actively treated. Biopsy at 1, 2, 3, 5, 7 and 14 days.

Results

Active RF treatment provides earlier:

• Epidermal budding

• Migration into the wound

• Appearance of rete ridges

• Normal depth of final epidermis

Conclusion

•Rate of healing was accelerated and the healed epidermis was more like normal skin than the scar tissue.

•Active treated wounds healed in 39 days vs. placebo 54 days (Experiment #1)

R.H.C. Bentall, LOW-LEVEL PULSED RADIOFREQUENCY FIELDS AND THE TREATMENT OF SOFT-TISSUE INJURIES. (1986) Bioelectrochemistry and Bioenergetics, 16 (1986) 531-548


Wound Healing

Case Studies


Case Series: Published in the International Wound Journal

• 4 patients: 3 with diabetic ulcers, 1 venous stasis ulcer.• Present longer than 4 months.• Wagner Grade II or higher.• Failed to heal after a variety of other treatments.

The use of a portable, wearable form of pulsed radio frequency electromagnetic energy device for the healing of recalcitrant ulcers: a case report.Rawe IM, Vlahovic TC. Int Wound J. 2012 Jun;9(3):253-8. doi: 10.1111/j.1742-481X.2011.00853.x. Epub 2011 Sep 20.


Case Series: Venous Stasis UlcerThe venous stasis ulcer of patient 1 is shown at week 0 , week 2, week, 4 and week 6 of RecoveryRx® treatment. Significant pain relief was reported by the patient after 2 weeks treatment. The ulcer had decreased in size from 4.0 x 2.5 cm to 0.7 x 0.5 cm after 6 weeks RecoveryRx® treatment. The ulcer continued onto healing using the PRFE therapy.


Case Series: Diabetic foot Ulcer

Patient 2 had a 0.5 x 0.5 cm diabetic ulcer at the beginning of RecoveryRx® treatment, which healed after 3 weeks RecoveryRx® therapy. The ulcer at week 0, week 1 and week 3 is shown.


Case Series: Wound MeasurementsPat

ientA

geLocati

onWeek

0Wee

k 1 Wee

k 2Wee

k 3We

ek 4We

ek 5Wee

k 6

16

6right

leg4 x

2.5 4 x

2.34 x 2

3 x 1.5

2 x 1.5

1 x 0.7

0.7 x 0.5

26

0right

foot0.5 x

0.50.3

x0.30.2 x

0.1ulcer healed

34

3left

heel4 x 1

2 x 0.5

1 x 0.3

ulcer healed

47

4right

heel2.5 x

1.752 X 2

2 X 1.5

1.7 X 0.7

1 X 1

1 X 0.5

1 X 0.5

• Ulcers had failed to heal with prior therapies.• Only change in treatment was addition of RecoveryRx®.• Ulcers showed a rapid response to RecoveryRx® treatment.• Case 1 and Case 4 went onto to complete healing with continued

RecoveryRx® use.


Exposed Prosthetic Vein Case Study

Left leg ulcer with exposed vascular prosthetic vein. Treatment consisted of debridement and two weeks of negative pressure wound therapy and then RecoveryRx® was introduced with polymeric dressing. The ulcer was 50% reduced in three weeks and went onto complete closure.

VAS pain 7

VAS pain 2


RecoveryRx® Resolution of Inflammation – Clinical Evidence

Pyoderma gangrenosum: skin ulcer linked to systemic inflammatory illness. Standard therapy - Underlying chronic wound inflammation treated with systemic drug therapy consisting of immunosuppressant's and corticosteroids.

RecoveryRx® was introduced, left panel is before treatment, middle panel 2 weeks therapy, pain had been eliminated and ulcers moved rapidly into healing phase. Right panel, ulcers healed in 11 weeks.

Patient with two pyoderma ulcers present for 2 years, vicodin used as a pain medication.


Venous Stasis Ulcer Patient

RecoveryRx® Device Ulcer present 1 year.

Amputation was being considered before RecoveryRx® treatment.

The wound closed after 6 weeks RecoveryRx® therapy.


Split Skin Graft

The split skin graft was successful, pain controlled and the remaining open wound healed with the combination of pulsed radiofrequency electromagnetic field and polymeric silver dressing

Pain VAS 7

Pain VAS 0


Persistent Chronic Wound Pain

Case Studies


Pyoderma Gangrenosum

Pyoderma ulcer on the foot for 2 years and failed systemic corticosteroid and immunosuppressant therapy. The wound base 50% red and 50% yellow with moderate serous exudate VAS pain 4. RecoveryRx® - pain declined to 0 > 1 year, change wound bed from the 50% red, 50% yellow to a 100% red granular wound bed (figure 2) and a decrease in serous exudate from moderate to low.


• Pyoderma ulcer present 3 yrs. Persistent and significant wound pain VAS 4 and wound drainage moderate

• Ulcer treated constantly with RecoveryRx® for 5 months, pain controlled VAS 0/1, wound drainage low, slowly healing

• 8 months RecoveryRx® therapy healed greater than 50%, pain controlled, low wound drainage.

• 9 months continuing to heal, pain controlled VAS 0


66 year old male with 15yr history of scleroderma. Leg ulceration worsening over past 5 years.

12 x Percocet daily (Hydrocodone/paracetamol) short acting

(fentanyl) narcotics.

8 x Percocet daily (Hydrocodone/paracetamol) short

acting (fentanyl) narcotics eliminated.

After 4 months withdrawal challenged - pain returned after discontinuing ActiPatch and markedly reduced again when reintroduced. Pain and decreased narcotic use sustained over a year

RecoveryRx® – reduces chronic pain and narcotic medication use

BASELINE


Patient undergoing painful Nephrostomy (Kidney drainage). Addition of RecoveryRx® reduced the pain being experienced by 75% (VAS 8 – 2).

After starting RecoveryRx® patient asked for continuation of the therapy.

Application of RecoveryRx®:Improves patient comfort

RecoveryRx®

VAS 8

VAS 2

VAS 2


RecoveryRx® Applications

Back Wrap•Chronic & acute back pain•Disc issues•Radiculopathy•Muscle soreness•Back strains & sprains•Nighttime back pain•Sciatic nerve pain•Back surgery recovery

Knee Wrap•Runners & jumpers knee •Tendonitis •Osteoarthritis•Knee strains & sprains•Ligament injury recovery •Knee surgery recovery

Other Applications•Muscle & joint soreness•Neck & shoulder pain•Diabetic ulcers•Carpal tunnel•Tennis elbow•Sprained ankle•Neuropathy•Post surgical wounds

Muscle & JointBack Pain Knee Pain


5x Better Back Pain ReliefCompared to OTC Drugs & 100% Safer

RecoveryRx® Compared to Other Therapies

RecoveryRx® Compared to Other Therapies


Pectoral Muscle Injury

Rawe IM, Lowenstein A, Barcelo CR, Genecov DG: Control of postoperative pain with a wearable continuously operating pulsed radiofrequency energy device: a preliminary study. Aesthetic Plast Surg 36(2), 458-463 (2012).

Postoperative Pain study:

• Mainly a pectoral muscle injury due to implant placement.

• Pain scores for 7 days recorded.

• Pain significantly less in the study group on each day (p < 0.05) than control group (placebo).

• 7 days shows the accumulated pain scores were 50% less in the study group.

• The study group consumed significantly less narcotic pain medications during the recovery period (p = 0.002).


Delayed Onset Muscle Soreness

RecoveryRx® Significantly Lowered DOMS Pain ScoreRecoveryRx® Significantly Lowered DOMS Pain Score

RecoveryRx®RecoveryRx®

RecoveryRx® vs Acetaminophen p = 0.05RecoveryRx® vs Acetaminophen p = 0.05

RecoveryRx® vs Control p = 0.001RecoveryRx® vs Control p = 0.001

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DOMS in Bicep Muscle• Bicep muscle exercise to induce

soreness 90 subjects• Randomized into three groups, control,

acetaminophen, RecoveryRx®. • Muscle soreness assessed at 48 hours.

DOMS study in Marathon Runners

• Independent RCT - Aalborg University Hospital, Denmark.

•Similar findings, significant decreased muscle soreness in study group as well increased post marathon exercise (running).

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Plantar Fasciitis - Clinical Study

Plantar Fasciitis• Randomized control trial (RCT).

• Average time with heel pain 13 months.

• AM pain declined by 40% in the study group after 7 days of overnight therapy,

• 7% in control group.

• Decrease was statistically significant.

• Trend to decreased medication use.

New Clinical Trial Completed (University of BC):A six month follow up results show Smart Insole™ Therapy is superior for pain and disability improvements for recalcitrant PR than platelet rich plasma, steroid injection, dextrose and extracorporeal therapy.


Tot

alme

anSD

median

P value

Placebo

145

18.1

5.9 20 -

Active 77 8.5 4.6 7

0.002

Patients in the study used narcotic pain medications hydrocodone and oxycodone. The average daily pill use is shown for the 7 day study period. The active group used a significantly lower total (p = 0.002) amount of narcotic pain medication.

Narcotic Pain Medication Use


• 72.5% reported a reduction in pain medication.• 61.3% reporting a moderately or greater reduction.• 16.5% completely eliminated pain medications

Figure 4: Reduction in pain medication use

Narcotic Pain Medication UsePatient Survey Results with RecoveryRx

DECREASING MEDICATION USE

Medication use 1. no effect, 2.reduced a little, 3. moderate amount, 4. large amount, 5. eliminated.


Articles Published

Study JournalPublication

Date EstimateAuthor Institution

BlepharoplastyAesthetic Plastic

Surgery1982;6(3):169-71

Frederick V. Nicolle,

Richard M. Bentall

London, United Kingdom

Postoperative Pain

Aesthetics of Plastic Surgery

Published:2012

Apr;36(2):458-63

Rawe IM, Lowenstein A.Barcelo

CR, Genecov DG

Genecov Plastic Surgery Group

Dallas, Texas

Chronic Wound Case Study

International Wound Journal

Published:2012 Jun;9

(3):253-8

T. Vlahovic, IM Rawe

Temple University Philadelphia,

PA

Plantar FasciitisJournal of Foot

and Ankle Surgery

Published:2012 May –

June;51(3):312-6

Brook J, Dauphinee DM

Korpinen J, Rawe IM

Hunts Regional Medical Center

Greenville, Texas

Osteoprogeniter Cell Differentiation In

To Bone

Journal of Craniofacial Surgery

Published2012

Mar;23(2):586-93Dr. Russell Reid

University of Chicago Medical

School

DOMS Marathon Runners

PLOS Medicine April 2014Dr. Sten

Rasmussen

AARHUS University Hospital

Aalborg, Denmark

Case for OTC use of shortwave

therapy

Pain Management

January 2014 Ian Rawe BioElectronics

Updated 10-4-1340www.EchelonHealthPro.com

Current Clinical TrialsStudy

Principal Investigator

LocationPrimary

Outcome MeasureEnrollment Status

Plantar FasciitisProfessor Jack Taunton

University British Columbia,

Vancouver, Canada

Pain at 4 weeks, follow up at 6

months40 (60)

Complete – data analysis

Osteoarthritis knee pain

Professor Gianluca

Bagnato

University Hospital G. Martin,

Messina, Italy

Knee pain and edema at 4 weeks

60Completion

Date November 2013

Lower Back PainDr. Steve

Tumilty

University of Dunedin, Otago, New

Zealand

Lower back pain

40Completion

Date November 2013

Bilateral Hernia Surgical Recovery

Dr. Frederik Berreveot

University Hospital Ghent, Ghent,

Belgium

Analgesic medication use and

pain over 7 day recovery.

50 Completion Date

April 2014

Venous ulcer wound healing

Dr. Sten Rasmussen

AARHUS University Hospital

Aalborg, Denmark

Wound healing and pain

40Recruitment

complete

3rd Molar Extraction

Dr. William Gilmore

Tuft Dental School,

Boston, MA

Pain and Edema at day 1, 3 and

560 Recruiting

Craniofacial pain case studies

Dr. Steven Scrivani

Tuft Dental School,

Boston, MAMyofascial pain -

Proceeding with ethics approval

Chronic Wound Pain

Geert VanWellegham

CNS Wondzorg, decubitus-en valpreventie

H-Hartziekenhuis

Roeselare-Menen vzw

Chronic wound pain case studies

- Ongoing

Menstrual Pain

Dr. Justin ClarkConsultant

Obstetrician and Gynecologist

Birmingham Woman’s Hospital, UK

Menstrual painMOOS

200Protocol

Development/ethics approval

Updated 10-4-13


1) Is RecoveryRx® safe?Yes. Shortwave therapies have a long history of safe use. RecoveryRx® is a non-invasive, localized therapy which can be worn by diabetics, arthritics, the elderly and bedridden. Over 500,000 products have sold worldwide with no adverse effects.

2) Is RecoveryRx® safe to use with metal implants and pacemakers?The RF field strength is too low for any significant heating from implanted metal so it is safe for all metal implants. There is no concern for pacemakers as they have built in RF protection. Though as a precaution, we don’t recommend using directly over the pacemaker.

3) Is RecoveryRx® a magnet?No. RecoveryRx® is not a magnet. It is a battery operated, pulsed shortwave electromagnetic field medical device. When activated, RecoveryRx® uses a pulsed shortwave radiofrequency to deliver a low level of energy into the injured tissue reducing pain, inflammation and promoting healing.

4) What will my patients feel when using the device?Only better. They will not feel the low level energy that is gently pulsed into the cells to restore damaged tissue. The device is sensation and odor free.

Frequently Asked Questions


5) How long until the patient will begin to feel relief?Pain is a very subjective sensation; however, patient pain levels will begin to subside typically after only 2-3 hours of wearing the device and will continue to lessen as long as the device is being used continuously.

6) Can the patient wear more than one device?Yes. You can wear more than one RecoveryRx® medical device at a time just as long as more than one device is not directly on top of another.

7) Does RecoveryRx® need to be in direct contact with the skin?No. While RecoveryRx® can be used in direct contact with the skin, the device’s energy is able to pass through wound dressing, various wraps and light clothing for easy application.

8) Can RecoveryRx® be placed under compression dressings?No. RecoveryRx® can’t be used under compression dressings; however, the device can be used over the compression dressing with the energy passing through to the tissue below.

Frequently Asked Questions


recoveryrx® accelerated healing and better pain relief

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