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OUR MISSION:
OUR MISSION AT ECHELON IS TO HELP PEOPLE
ACHIEVE THEIR HIGHEST POTENTIAL TO LIVE HAPPY,
PRODUCTIVE LIVES THROUGH OPTIMAL HEALTH AND
WELLNESS.
2
Bioelectroceutical™ Therapy
Advances in Healing and
Pain Managementwww.EchelonHealthPro.com
3
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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www.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.
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www.EchelonHealthPro.com
Mechanism of Action
Accelerated Healing
Increased 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 Relief
The 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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www.EchelonHealthPro.com
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 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 and
swelling cause pain
Healing Tissue
The inflammation and
swelling is reduced
resulting in pain relief
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www.EchelonHealthPro.com
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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www.EchelonHealthPro.com
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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www.EchelonHealthPro.com
Wound Healing
Case Studies
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www.EchelonHealthPro.com
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.
10
www.EchelonHealthPro.com
Case Series: Venous Stasis Ulcer
The 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.
11
www.EchelonHealthPro.com
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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www.EchelonHealthPro.com
Case Series: Wound Measurements
Patient Age Location Week 0 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6
1 66 right leg 4 x 2.5 4 x 2.3 4 x 2 3 x 1.5 2 x 1.5 1 x 0.7 0.7 x 0.5
2 60 right foot 0.5 x 0.5 0.3 x0.3 0.2 x 0.1 ulcer healed
3 43 left heel 4 x 1 2 x 0.5 1 x 0.3 ulcer healed
4 74 right heel 2.5 x 1.75 2 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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www.EchelonHealthPro.com
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
14
www.EchelonHealthPro.com
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.
15
www.EchelonHealthPro.com
Venous Stasis Ulcer Patient
RecoveryRx®
DeviceUlcer present 1 year.
Amputation was being
considered before
RecoveryRx®
treatment.
The wound closed
after 6 weeks
RecoveryRx® therapy.
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www.EchelonHealthPro.com
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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www.EchelonHealthPro.com
Persistent Chronic Wound Pain
Case Studies
20
www.EchelonHealthPro.com
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.
21
www.EchelonHealthPro.com
• 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
22
www.EchelonHealthPro.com
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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www.EchelonHealthPro.com
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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www.EchelonHealthPro.com
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
31
www.EchelonHealthPro.com
5x Better Back Pain Relief
Compared to OTC Drugs & 100% Safer
RecoveryRx® Compared to Other Therapies
32
www.EchelonHealthPro.com
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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www.EchelonHealthPro.com
Delayed Onset Muscle Soreness
RecoveryRx® Significantly Lowered
DOMS Pain Score
RecoveryRx®
RecoveryRx® vs Acetaminophen p = 0.05
RecoveryRx® vs Control p = 0.001
34
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).
www.EchelonHealthPro.com
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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www.EchelonHealthPro.com
Total mean SD 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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www.EchelonHealthPro.com
• 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 Use
Patient Survey Results with RecoveryRx
DECREASING MEDICATION USE
Medication use 1. no effect, 2.reduced a little, 3. moderate amount, 4. large amount, 5. eliminated.
38
www.EchelonHealthPro.com
Articles Published
Study Journal
Publication Date
Estimate
Author Institution
Blepharoplasty
Aesthetic Plastic
Surgery
1982;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 Fasciitis
Journal 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
Published
2012 Mar;23(2):586-93
Dr. Russell Reid
University of Chicago
Medical School
DOMS Marathon
Runners
PLOS Medicine April 2014 Dr. Sten Rasmussen
AARHUS University
Hospital
Aalborg, Denmark
Case for OTC use of
shortwave therapy
Pain Management January 2014 Ian Rawe BioElectronics
Updated 10-4-13
40
www.EchelonHealthPro.com
Current Clinical Trials
Study Principal Investigator Location
Primary Outcome
Measure
Enrollment Status
Plantar Fasciitis Professor Jack Taunton
University British
Columbia, Vancouver,
Canada
Pain at 4 weeks, follow
up at 6 months
40 (60)
Complete – data
analysis
Osteoarthritis knee pain
Professor Gianluca
Bagnato
University Hospital G.
Martin, Messina, Italy
Knee pain and edema
at 4 weeks
60
Completion Date
November 2013
Lower Back Pain Dr. Steve Tumilty
University of Dunedin,
Otago, New Zealand
Lower back pain 40
Completion 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
40
Recruitment
complete
3rd Molar Extraction Dr. William Gilmore
Tuft Dental School,
Boston, MA
Pain and Edema at day
1, 3 and 5
60 Recruiting
Craniofacial pain case
studies
Dr. Steven Scrivani Tuft Dental School,
Boston, MA
Myofascial 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 Clark
Consultant Obstetrician
and Gynecologist
Birmingham Woman’s
Hospital, UK
Menstrual pain
MOOS
200
Protocol
Development/ethics
approval
Updated 10-4-13
41
www.EchelonHealthPro.com
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
42
www.EchelonHealthPro.com
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
43
www.EchelonHealthPro.com
44

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RecoveryRx® Accelerated healing and better pain relief

  • 1.
  • 2. OUR MISSION: OUR MISSION AT ECHELON IS TO HELP PEOPLE ACHIEVE THEIR HIGHEST POTENTIAL TO LIVE HAPPY, PRODUCTIVE LIVES THROUGH OPTIMAL HEALTH AND WELLNESS. 2
  • 3. Bioelectroceutical™ Therapy Advances in Healing and Pain Managementwww.EchelonHealthPro.com 3
  • 4. 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 27 www.EchelonHealthPro.com
  • 5. 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 www.EchelonHealthPro.com
  • 6. Mechanism of Action Accelerated Healing Increased 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 Relief The 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. 6 www.EchelonHealthPro.com
  • 7.
  • 8. 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 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 and swelling cause pain Healing Tissue The inflammation and swelling is reduced resulting in pain relief 29 www.EchelonHealthPro.com
  • 9. 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). 30 www.EchelonHealthPro.com
  • 10. 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 7 www.EchelonHealthPro.com
  • 11. 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 8 www.EchelonHealthPro.com
  • 13. 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. 10 www.EchelonHealthPro.com
  • 14. Case Series: Venous Stasis Ulcer The 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. 11 www.EchelonHealthPro.com
  • 15. 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. 12 www.EchelonHealthPro.com
  • 16. Case Series: Wound Measurements Patient Age Location Week 0 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 1 66 right leg 4 x 2.5 4 x 2.3 4 x 2 3 x 1.5 2 x 1.5 1 x 0.7 0.7 x 0.5 2 60 right foot 0.5 x 0.5 0.3 x0.3 0.2 x 0.1 ulcer healed 3 43 left heel 4 x 1 2 x 0.5 1 x 0.3 ulcer healed 4 74 right heel 2.5 x 1.75 2 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. 13 www.EchelonHealthPro.com
  • 17. 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 14 www.EchelonHealthPro.com
  • 18. 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. 15 www.EchelonHealthPro.com
  • 19. Venous Stasis Ulcer Patient RecoveryRx® DeviceUlcer present 1 year. Amputation was being considered before RecoveryRx® treatment. The wound closed after 6 weeks RecoveryRx® therapy. 18 www.EchelonHealthPro.com
  • 20. 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 19 www.EchelonHealthPro.com
  • 21. Persistent Chronic Wound Pain Case Studies 20 www.EchelonHealthPro.com
  • 22. 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. 21 www.EchelonHealthPro.com
  • 23. • 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 22 www.EchelonHealthPro.com
  • 24. 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 23 www.EchelonHealthPro.com
  • 25. 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 24 www.EchelonHealthPro.com
  • 26. 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 31 www.EchelonHealthPro.com
  • 27. 5x Better Back Pain Relief Compared to OTC Drugs & 100% Safer RecoveryRx® Compared to Other Therapies 32 www.EchelonHealthPro.com
  • 28. 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). 33 www.EchelonHealthPro.com
  • 29. Delayed Onset Muscle Soreness RecoveryRx® Significantly Lowered DOMS Pain Score RecoveryRx® RecoveryRx® vs Acetaminophen p = 0.05 RecoveryRx® vs Control p = 0.001 34 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). www.EchelonHealthPro.com
  • 30. 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. 36 www.EchelonHealthPro.com
  • 31. Total mean SD 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 37 www.EchelonHealthPro.com
  • 32. • 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 Use Patient Survey Results with RecoveryRx DECREASING MEDICATION USE Medication use 1. no effect, 2.reduced a little, 3. moderate amount, 4. large amount, 5. eliminated. 38 www.EchelonHealthPro.com
  • 33. Articles Published Study Journal Publication Date Estimate Author Institution Blepharoplasty Aesthetic Plastic Surgery 1982;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 Fasciitis Journal 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 Published 2012 Mar;23(2):586-93 Dr. Russell Reid University of Chicago Medical School DOMS Marathon Runners PLOS Medicine April 2014 Dr. Sten Rasmussen AARHUS University Hospital Aalborg, Denmark Case for OTC use of shortwave therapy Pain Management January 2014 Ian Rawe BioElectronics Updated 10-4-13 40 www.EchelonHealthPro.com
  • 34. Current Clinical Trials Study Principal Investigator Location Primary Outcome Measure Enrollment Status Plantar Fasciitis Professor Jack Taunton University British Columbia, Vancouver, Canada Pain at 4 weeks, follow up at 6 months 40 (60) Complete – data analysis Osteoarthritis knee pain Professor Gianluca Bagnato University Hospital G. Martin, Messina, Italy Knee pain and edema at 4 weeks 60 Completion Date November 2013 Lower Back Pain Dr. Steve Tumilty University of Dunedin, Otago, New Zealand Lower back pain 40 Completion 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 40 Recruitment complete 3rd Molar Extraction Dr. William Gilmore Tuft Dental School, Boston, MA Pain and Edema at day 1, 3 and 5 60 Recruiting Craniofacial pain case studies Dr. Steven Scrivani Tuft Dental School, Boston, MA Myofascial 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 Clark Consultant Obstetrician and Gynecologist Birmingham Woman’s Hospital, UK Menstrual pain MOOS 200 Protocol Development/ethics approval Updated 10-4-13 41 www.EchelonHealthPro.com
  • 35. 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 42 www.EchelonHealthPro.com
  • 36. 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 43 www.EchelonHealthPro.com
  • 37. 44