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
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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.
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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
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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).
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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
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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
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Wound Healing
Case Studies
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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.
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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.
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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.
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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
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3left
heel4 x 1
2 x 0.5
1 x 0.3
ulcer healed
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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.
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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
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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.
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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.
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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
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Persistent Chronic Wound Pain
Case Studies
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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.
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• 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
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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
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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
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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
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5x Better Back Pain ReliefCompared to OTC Drugs & 100% Safer
RecoveryRx® Compared to Other Therapies
RecoveryRx® Compared to Other Therapies
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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).
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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.
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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
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• 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.
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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
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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
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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
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